Table of Contents

The following provides a complete list of the Hazard Reports, User Experience Network reports, Guidance articles, Posters and Checklists, and Frequently Asked Questions (FAQs) that make up Medical Device Safety Reports.  The information is listed in alphabetical order by title of the document.


Accidents Happen--An Immediate Action Plan
ECRI's recommended actions to be taken after every significant medical device incident are given in poster form.

Air Embolism and CO2 Insufflators: The Need for Pre-Use Purging of Tubing
ECRI investigated a case of suspected gas embolism associated with carbon dioxide (CO2) insufflation. During a hysteroscopy (performed with the patient under intravenous sedation), the patient gasped for air almost immediately upon uterine insufflation. Also, heart sounds suggesting intracardiac gas were heard. The procedure was halted, and the patient recovered without further complication.

Air Embolism and Exsanguination from Separation of Two-Piece Side Port/Hemostasis Valve Cardiac Catheter Introducers
A member hospital reported a fatal central venous air embolism caused by the separation of a specific manufacturer's side port/hemostasis valve catheter-to-sheath adapter from the same manufacturer's percutaneous sheath hub. The accident occurred when the standard Luer-lock fitting disconnected as a patient was moved from a bed to a chair.

Air Embolism during Calibration of Invasive Blood Pressure Monitoring Systems
ECRI received from member hospitals two reports of fatal cerebral air embolism immediately following routine recalibration of an invasive arterial blood pressure monitoring system. In both cases, the equipment was calibrated by pressurizing the system with air using a sphygmomanometer cuff inflation bulb and comparing the pressure monitor display with the pressure indicated by a mercury manometer.

Air Embolism through Central Venous Catheters
ECRI investigated an incident in which an air embolism developed after the male Luer taper (also known as a Luer slip) connector of a central venous catheter was inadvertently disconnected from an IV filter. The patient was receiving intravenous hyperalimentation, also known as total parenteral nutrition (TPN), through a subclavian (central venous) infusion site; the connector was secured with tape. While the patient was being assisted from a bedside commode, the catheter disconnected from the IV filter, and the patient immediately became unresponsive. The patient suffered neurologic damage and became numb in her left arm and leg.

Ambient Light Interference with Pulse Oximeters
A hospital reported that one brand of pulse oximeters when used with a disposable infant flex probe started displaying "Probe Off Patient" when under a hospital-constructed radiant warming unit. Covering the probes with a towel or blanket did not prevent the problem. As soon as the warmer was turned off, the oximeters returned to normal operation. The radiant warming unit included two 250 W infrared (IR) heat lamps and a household dimmer switch, which was used to control the power to the lamps and, thus, the radiated heat.

Amputations with Use of Adult-Size Scissors-Type Circumcision Clamps on Infants
We have become aware of several incidents involving the use of adult-size, scissors-type circumcision clamps for infant circumcision procedures. In these cases, part of the infant's glans penis was amputated along with the foreskin. Issues of clamp size versus patient size appear to be related to the incidents. The type of clamp used in these procedures is produced by several manufacturers.

Aneroid Gauges versus Mercury Manometers for Blood Pressure Measurements
ECRI discusses the pros and cons of aneroid gauges versus mercury manometers.

Anesthesia Ventilators with Descending Bellows: The Need for Appropriate Monitoring
Several healthcare facilities have requested guidance regarding the use of anesthesia ventilators with descending bellows. These facilities are concerned that, because a descending bellows will cycle up and down even when a leak or disconnection is present in the breathing circuit, caregivers may assume that the patient is being adequately ventilated when this is not the case.

Anesthesia Ventilators: Ease the Tedium, Not the Responsibility
ECRI's recommendations for the safe use of anesthesia ventilators are given in poster form.

Antishock Trousers May Support Life--Deflate with Care
ECRI's recommendations for the safe use of antishock trousers are given in poster form.

Are Aluminum Oxygen Regulators Safe?
ECRI provides recommendations for the safe use of aluminum oxygen regulators.

Are Spark-Gap Electrosurgical Units Safe to Use?
Member hospital: We have decided to replace spark-gap electrosurgical units (ESUs) with a newer technology. However, one of our surgeons refuses to use the newer ESUs for urology procedures because he states that they are not as effective as the spark-gap units. Does ECRI have any advice regarding this issue?

Audible Low-Battery Alarms on Pulse Oximeters
A member hospital reported that, on three separate occasions, a pulse oximeter backup battery became depleted, rendering the pulse oximeter nonfunctional. Because the pulse oximeter lacked an audible low-battery alarm and no one noticed the visual low-battery indicator, the staff was not alerted to the depleted battery condition. In at least one case, the AC power cord at the back of the unit was inadvertently disconnected, leaving the unit running on battery power. Fortunately, no adverse effects were reported.

Barotrauma from Anesthesia Ventilators
ECRI investigations of barotrauma associated with the use of anesthesia ventilators emphasize the need to bring two problems to the attention of users. The first problem concerns an operating characteristic of anesthesia ventilators with rising bellows. The second problem can develop if the airway hose from the breathing circuit to the ventilator is occluded.

Barotrauma from CPAP Systems Lacking Pressure Relief
ECRI is aware of several incidents in which the exhalation hose of certain user-assembled continuous positive airway pressure (CPAP) systems has become blocked. When this happens, the high gas flows and source-gas pressures used to provide CPAP can cause the pressure in the system to rise to dangerous levels almost instantaneously. This abrupt rise in pressure can cause barotrauma injuries to the patient before caregivers can respond to an airway pressure alarm.

Biohazard Related to Misuse of Infectious Substance Shippers
The clinical laboratory of a member hospital received 10 tubes of frozen hepatitis C virus sera in an infectious substance shipping container sent from another hospital. On receipt of the frozen sera, laboratory personnel attempted to open the plastic screw-cap container, but were unable to. They placed the container into the refrigerator to thaw the 10 frozen sera tubes. Approximately 15 minutes later, the screw cap blew off the container and broke seven of the plastic tubes, scattering shards of plastic and frozen sera throughout the refrigerator. Broken plastic and thawed serum pose a blood-contamination risk to laboratory personnel; fortunately, no one was injured in this case.

Blade Fracture of High-Speed Meniscus Cutters during Arthroscopic Surgery
We received three reports from three different member hospitals regarding incidents in which the blade of a high-speed, power-driven arthroscopic meniscus cutter broke during knee surgery, depositing metal shavings in the operative site. In each case, the broken meniscus cutter was manufactured by a different company. The blade pieces were successfully removed from the patient in only one of these three incidents.

Burns and Fires from Electrosurgical Active Electrodes
For more than 20 years, ECRI has warned users about problems related to inadvertent activation of electrosurgical unit (ESU) active electrodes. Inadvertent activation typically occurs when a surgeon places an ESU electrode on the patient or surgical drapes between intended ESU activations and a device malfunction or unintentional switch activation causes the device to become energized, resulting in a burn or fire.

Carbon Monoxide Exposures during Inhalation Anesthesia: The Interaction between Halogenated Anesthetic Agents and Carbon Dioxide Absorbents
ECRI has investigated several incidents of patient exposure to carbon monoxide (CO) during the administration of inhalation anesthetics through semiclosed circle anesthesia systems. In one of the incidents, patient injury resulted. In each case, after ruling out other possible sources of CO, we concluded that dangerous levels of the gas were generated within the anesthesia system under the conditions present during the incidents. These conditions included the presence of excessively dry carbon dioxide (CO2) absorbent in an anesthesia system being used to deliver halogenated anesthetic agents for the first case of the day.

Care about Your Catheterized Patient: Prevent Urinary Tract Infection (UTI)
ECRI's recommendations for the prevention of UTI in catheterized patients are presented in poster form.

Centrifuges
We have received numerous reports from member hospitals of exposure to bloodborne pathogens from blood and glass sprayed from beneath the lid of centrifuges. This Hazard Report Summary is in response to these reports and to numerous requests for information concerning the safety of and purchasing considerations for centrifuges.

Children Can Be Trapped in or Fall from Cribs
A member hospital reported that a 14-month-old child was found trapped between the raised head section and head rails of a canopy-style crib. The child was cyanotic but recovered without medical intervention. Another incident in which a child crawled through the opening of a similar crib was reported through the FDA's Device Experience Network in 1983. The child was caught before he fell to the floor.

Concentration Calibrated Vaporizers
ECRI has investigated or become aware of a number of hazards involving calibrated vaporizers produced by several manufacturers. In one case, a vaporizer had apparently been dropped. Other cases reported in the literature involved vaporizers that had been tipped, permitting the agent to get into upper gas passages.

Conductive Mattresses and Diathermy
A member hospital reported that the mattress on which a patient was receiving radio-frequency diathermy treatment began to smoke and burn. The treatment was discontinued, and no injuries resulted. Subsequent investigation disclosed that the mattress was the conductive type usually found in operating suites. Absorption of radio-frequency energy by the mattress caused the dangerous temperature rise, and, as a side effect, drastically diminished the therapeutic energy being delivered to the patient.

Connection of Electrode Lead Wires to Line Power
In a one-month period, two member hospitals reported incidents in which nursing staff inadvertently connected patient ECG lead wires to line power (120 VAC). In both cases, lead wire pins were plugged into the female connector of an energized line cord that was detached from an infusion device. One incident resulted in death by electrocution; the other produced severe third-degree burns that required plastic surgery.

Corrosiveness of Renalin Dialyzer Sterilant
During an investigation of a leaky drain in a dialysis unit, a member hospital discovered that the Renalin sterilant used to reprocess dialyzers had attacked the chrome-plated brass drain. Clinicians had been disposing of excess Renalin by pouring it into the sink. The Renalin had attacked the brass beneath the chrome plating of the drain until just a thin chrome shell was left. While Renalin containers indicate that the material is corrosive, the hospital was not aware that it could attack plumbing fixtures.

Crossed Connections in Medical Gas Systems
ECRI received two reports of cross-connected medical gas lines. In both reports, nitrous oxide and oxygen couplers had been unscrewed at the threaded fittings that connect the back of the coupler housing to the gas supply hose. When reassembled, the couplers were reversed. While both reports involved one brand of quick-connect hose couplers, similar cross-connections can occur with virtually all other manufacturers' systems. The purpose of this Hazard Bulletin is not simply to discuss the two specific incidents, but to remind hospitals how easily (and innocuously) cross connections can occur in any medical gas system.

Cylinders with Unmixed Helium/Oxygen
A member hospital reported that a medical gas cylinder labeled "certified mixture of 30% oxygen and 70% helium," intended for patient breathing, was connected into a breathing system.When the gas was delivered to a patient, the oxygen monitor in the system indicated that the mixture consisted of less than 21% oxygen. Further investigation showed that the gases had not been mixed before delivery to the hospital, even though the mixture had been labeled as certified. Following this discovery, the remaining cylinders in the lot were tested, and some of them contained unmixed gases.

Damage to Plastic Components from Loctite
During a preventive maintenance check of an anesthesia ventilator, a member hospital found that a low-pressure alarm malfunctioned because of a broken pressure switch. Two other pressure switches in the unit were also found to be damaged. The damage apparently occurred after the previous preventive maintenance inspection.

Damaged Reusable ESU Return Electrode Cables
We investigated an incident (and have documentation on another similar incident and unsubstantiated reports of four others) in which a patient was burned during electrosurgery when arcing within the dispersive electrode cable ignited the cable's insulation, the foam backing of the dispersive electrode, and nearby surgical drapes. Although this incident involved a specific model of electrosurgical generator and reusable dispersive electrode cable, the factors that led to this incident could occur with other combinations of ESUs and cables.

Danger from Removable IV Extension Tubing Slide Clamps
A removable slide clamp from an intravenous (IV) extension tubing set being used on a pediatric patient was found in the patient's crib by his mother. There was concern that the clamp may pose a risk of choking.

Defibrillation in Oxygen-Enriched Environments
A member hospital reported that a fire occurred after a lengthy (40 min), unsuccessful resuscitation attempt on a cardiac arrest patient. The fire was confined to the patient's treatment cubicle, but the spread of noxious smoke forced the evacuation of the entire ICU.

Disk Misplacement in Anesthesia Exhalation Check Valve
An exhalation check valve disk on an anesthesia absorber migrated from its normal position and occluded the hose connection to the anesthesia ventilator. Personnel installed a new disk, perhaps not realizing the hazard associated with a migrated disk or assuming that the original disk had been removed. The resulting disk arrangement caused an occlusion that prevented exhaled gases from refilling the ventilator bellows or reservoir bag. Pressure in the patient breathing circuit helped to hold the misplaced disk in the occluding position. The ventilator pressurized the breathing circuit in a few breaths and the patient became hypoxic and suffered a pneumothorax.

Disposable Blood Pressure Transducers: Calibration Methods
Member hospital: We are currently looking at different suppliers from whom to obtain disposable blood pressure transducers. Several models that we are looking at do not have the back-side calibration feature that our current models have. Can you provide us with your opinion on those models that do not have the back-side calibration port?

Disposable T-Tube Oxygenators: Do Not Use before Inspecting or Testing
A member hospital reported that a pediatric patient in the Postanesthesia Care Unit (PACU) suffered barotrauma and died after being connected to a defective, preassembled T-tube oxygenator. No one inspected the oxygenator or noticed that the reservoir tube was occluded by a tightly fitting disk near its end.The disk was apparently left in the tube inadvertently during the manufacturing process; the manufacturer subsequently recalled the lot and found no other defective units.

Ear Thermometer Accuracy
ECRI provides four recommendations for avoiding diagnostic errors and measurement inconsistency when using electronic infrared ear thermometers.

ECG Artifact in the OR
Member hospital: During open-heart surgery, we often face the problem of artifact on ECGs. The artifact is periodic and looks somewhat like QRS or pacemaker spikes. What is the likely cause, and how can it be corrected?

ECG Electrodes: Selection Practices
Member hospital: We are beginning an evaluation of ECG electrodes to determine which brands are technically suitable for hospital application. Can you offer any guidance?

ECG Electrodes: Use on Resuscitation Carts
Member hospital: We have had occasional problems with noisy ECG signals during codes. We are concerned that the electrodes may be drying out, but the nurses insist on having electrodes preattached to reduce delay and to reduce costs compared with using electrodes packaged in threes or fives. What does ECRI recommend?

ECRI Responds to FDA Public Health Advisory on IV Free-Flow
In a Public Health Advisory issued on March 1, 1994 ("Avoiding Injuries from Rapid Drug or I.V. Fluid Administration Associated with I.V. Pumps and Rate Controller Devices"), the FDA stated that it had received reports of injuries and deaths from uncontrolled, rapid infusion of medications and/or fluids associated with IV pumps and rate-control devices. The Advisory focuses on uncontrolled gravity flow, or what is commonly referred to as free-flow. However, it does not adequately describe free-flow protection mechanisms and makes suggestions that are misleading, unwarranted, hazardous, or expensive to implement. One suggestion places patients at greater risk than the problem it is intended to prevent.

Electric Beds Can Kill Children
A five-year-old male patient was fatally crushed beneath the pedestal-style electric bed in which he was placed upon admission to the hospital. In this case, the accident apparently occurred when the boy was playing with or accidentally operated the bed's walk-away down control, which causes the bed to continue to descend even after the control switch is released. It was reported that the hospital placed the child in an adult bed in an adult area because the pediatric ward was full. It was also reported that the hospital had established policies and procedures for use of electric beds with pediatric patients.

Electric Beds Can Kill Children (Update)
A five-year-old male patient was fatally crushed beneath the pedestal-style electric bed in which he was placed on admission to the hospital. This is the fourth death due to crushing beneath an electric bed reported by hospitals since 1981. In this case, the accident apparently occurred when the boy was playing with or accidentally operated the bed's walk-away down control, which causes the bed to continue to descend even after the control switch is released. It was reported that the hospital placed the child in an adult bed in an adult area because the pediatric ward was full. It was also reported that the hospital had established policies and procedures for use of electric beds with pediatric patients.

Electric Beds: Do Not Use in Psychiatric Wards
We investigated an incident in which a schizophrenic patient in a psychiatric hospital was found crushed to death beneath his pedestal-style electric bed. His head and neck were crushed within the frame of the bed, which was equipped with a functioning walk-away down control. We believe that the use of electric beds in psychiatric wards is unnecessary and hazardous, and we recommend discontinuing this practice.

Electrical Plugs: A Compendium of Problems
This report presents a summary of the information we have gathered from member hospitals to date, including what we have learned from several hazard investigations. These hazards and reported problems involved right-angle, locking, and straight parallel-blade plugs.

Electrical Safety for You and Your Patients Depends on Three Things
ECRI's recommendations for electrical safety in healthcare facilities are presented in poster form.

Electrical Safety Questions and Answers
ECRI answers four of the most commonly asked questions regarding electical safety in healthcare facilities.

Electrical Safety Requirements: Patient Care Areas versus Non-Patient-Care Areas
ECRI defines non-patient-care areas and the applicable standards and requirements for electrical safety in these areas versus patient care areas.

Electromagnetic Interference and Medical Devices: An Update on the Use of Cellular Telephones and Radio Transmitters in Healthcare Facilities
In an August-September 1993 Guidance Article we discussed the potential effects of electromagnetic interference (EMI) from various radio-frequency (RF) transmitting devices on medical devices—a topic that continues to be of interest and concern to many healthcare facilities. Since the publication of the 1993 article, we have encouraged others to report to us any EMI-related experiences. Although the risks are still not clearly defined, the information we have obtained from reporting hospitals and other sources has enabled us to relax our recommendations. In this update, we provide our current perspectives and present new recommendations for addressing this issue.

Electronic Equipment Mounted on IV Poles
Member hospital: We have experienced several incidents in which electronic medical equipment mounted beneath an IV container on an IV pole sustained damage from a fluid spill. In most of the incidents, physiologic patient monitors or their associated accessories and modules short-circuited after fluid from the IV container seeped between two electrically conductive components. A short circuit in a line-powered device could cause tripping of a circuit breaker, with resultant loss of power to devices connected at several receptacles. How can we protect our electronic equipment from such fluid spills?

Electrosurgery Checklist
ECRI's precautions and procedures for electrosurgery are presented in checklist form. 

Electrosurgery Is Dangerous
ECRI's recommendations for the safe use of electrosurgical equipment are given in poster form.

Electrosurgical Airway Fires Still a Hot Topic
ECRI continues to receive many reports of electrosurgical airway fires and to investigate a number of them. Although these fires are often mistakenly attributed to malfunction of electrosurgical units (ESUs) used during surgery, in our experience they are actually the result of other factors. Airway fires are very serious and, if not quickly extinguished, can be deadly. All surgeons, whether experienced or newly trained, need to recognize the hazards presented by using ESUs in the oxygen-enriched atmospheres (OEAs)—atmospheres containing more than 23% oxygen—that are commonly present in the oropharynx.

Electrosurgical Unit Activation Tone Control
ECRI continues to receive problem reports and investigate incidents of burns caused by inadvertent activation of electrosurgical units (ESUs). Liability and malpractice litigation often follow such injuries. The frequency and severity of these incidents can be greatly reduced if the volume control for the ESU activation tone is maintained at an audible level. Some surgeons are disturbed by the tone and turn the volume down to an inaudible level, risking undetected activation of the ESU and possible injury to the patient. The activation tone on ESUs is an important safety feature that should never be neglected or disabled, regardless of the personal preferences of surgeons or other members of the operating team.

Entry of Abdominal Fluids into Laparoscopic Insufflators
A member hospital reported an incident in which blood was delivered from inside a laparoscopic insufflator to a patient. Bacterial cultures were taken to determine whether the patient had been contaminated; the results were negative. Two days before this incident, a long operative laparoscopic procedure had been performed using the same insufflator. The hospital suspects that the CO2 E cylinder used for insufflation was emptied during the earlier procedure; because the pressure at the patient connector was lower than the abdominal pressure, blood from the patient's peritoneal cavity was able to flow into the insufflator.

Errors in Using Blood Glucose Monitors in Hospitals
Between 1994 and 1996, the U.S. Food and Drug Administration (FDA) has received more than 400 medical device reports on blood glucose monitors (BGMs), and ECRI continues to receive reports of errors involving the use of these units in hospitals. The most common errors are discussed in this report.

Essential Safety Features and Practices for Infant Home Apnea Monitors
ECRI's recommendations for essential safety features of infant home apnea monitors and essential safety practices for their use are presented in poster form.

ESU Burns from Poor Dispersive Electrode Site Preparation
In January 1987, ECRI reported on electrosurgical burns resulting from poor dispersive electrode site preparation (see our Hazard Report, based on incidents reported to and investigated by ECRI, in Health Devices, 16[1]:35-6). Unfortunately, these incidents, which can be easily avoided, continue to occur. This has prompted us to update our previous report and to reemphasize the need to follow certain precautions.

ESU Burns from Poor Return Electrode Site Preparation
ECRI continues to receive problem reports and to investigate incidents of burns occurring underneath electrosurgical dispersive electrodes. In the incident reported here, a burn was detected after the surgeon attempted to activate an electrosurgical unit (ESU) several times with no surgical effect. The burn occurred directly underneath the dispersive (return) electrode and corresponded to a charred section near the edge of the electrode's conductive adhesive surface, which indicates that arcing probably occurred between that section of the dispersive electrode and the patient's skin.

EtO Sterilization of Medical Devices
A member hospital reported failure of the clear polycarbonate (Lexan) blade assembly on specific brand of hospital grade plugs. This assembly holds the blades in place and permits visual inspection of terminals after wiring. Failure of the assembly allows one or all of the blades to move back into the body of the plug, making the plugs dangerous or unusable. The ground blade pushes back into the body, resulting in loss of ground continuity. The power blades could also short against each other when pushed back into the body, although no such cases have been reported.

Excessive Cornstarch Powder on Latex (Esmark) Bandages
A member hospital reported finding clumps of excessive cornstarch on latex (Esmark) bandages. The reporting hospital is concerned that these clumps, exposed as the bandage is unrolled, may drop onto the operative area.

Extension Cords and Multiple Outlet Strips
ECRI discusses applicable standards and safety considerations regarding the use of extension cords and multiple outlet strips.

Extinguishing Airway Fires
ECRI's recommended emergency procedures for extinguishing airway fires are presented.

Fading Images on Thermal Paper
We have received several reports of fading images on thermal paper used with the thermal printers in electronic sphygmomanometers and ECG monitors. Although the initial images were good, they faded after a few months in storage. Because patient records are usually kept for years, loss of diagnostic traces can create medical and legal difficulties.

Failure of a Centrifugal Heart-Lung Bypass Pump
A member hospital reported that while a patient was on heart-lung bypass, the rate control of the centrifugal arterial blood pump used to perfuse the patient malfunctioned. Before the malfunction, the pump had been set to deliver 3.5 L/min. As a result of the malfunction, the pump would deliver only its maximum flow rate, 9.9 L/min.

Fatal Air Embolism from Misuse of Closed-Wound Suction Units
A member hospital reported a patient death from an air embolism associated with the use of a closed-wound suction unit. In several departments throughout the reporting hospital, users had difficulty draining thick secretions through the unit's inlet port antireflux valve, which prevents back flow of serosanguineous fluid and air. For this reason, in the reported case the user bypassed the antireflux valve by inserting a length of tubing connected to a stopcock through the valve. The drain plug in the outlet port, which allows air to be released while compressing the unit to create suction, inadvertently closed. Consequently, air was forced into the patient's chest, resulting in a fatal air embolism.

Fatal Gas Embolism Associated with Intrauterine Laser Surgery
ECRI investigated two incidents of fatal gas embolism that occurred during intrauterine Nd:YAG laser surgery at different hospitals. CO2 was used to distend the uterus in one of the incidents, while liquid was used in the other. In both cases, a fiberoptic delivery system with coaxial air fiber cooling was used. The procedures were done without the use of a sapphire contact tip, and the laser was activated at times while the fiber tip was in contact with endometrial tissue.

Fatal Gas Embolism Caused by Overpressurization during Laparoscopic Use of Argon Enhanced Coagulation
ECRI investigated an incident in which a patient died from complications of a gas embolism caused by intra-abdominal overpressurization during a laparoscopic cholecystectomy. An argon beam coagulator was used to coagulate bleeding on the liver bed during the incident. Shortly after application of argon enhanced coagulation (AEC), the patient's intra-abdominal pressure increased above the insufflator's alarm limit, activating an audible alarm. When the alarm was noticed, the intra-abdominal pressure displayed on the insufflator was 33 mm Hg. Concurrently, the patient began experiencing difficulties consistent with gas embolism; the embolism was later confirmed by autopsy.

Faulty Gauge on Nitrogen Regulator Causes Decreased Aspiration during a Vitrectomy Procedure
Member hospital: During ophthalmic surgery to perform a posterior vitrectomy, our surgical staff noticed reduced aspiration while using the vitrectomy feature of an ophthalmic surgery unit. Other than this decreased performance, the unit provided no indication of a problem. After the procedure, biomedical engineering personnel tested the unit. No problems were found, and the unit was returned to service. Reduced aspiration was encountered during a subsequent procedure and again could not be duplicated in testing.



Ferromagnetic Sandbags Are Hazardous in Magnetic Resonance Imaging (MRI) Environments
A member hospital reported that a sandbag containing ferromagnetic pellets was inadvertently brought into the magnetic field of a 1.5-tesla magnetic resonance imaging (MRI) unit. As the patient was brought toward the MRI unit, the sandbag was violently pulled from its position and became pinned to the wall of the MRI tube. The patient received bruises to her chest and head. Although the MRI unit sustained no damage, two men were required to remove the sandbag from the bore of the magnet.

Fighting Fires on the Surgical Patient
ECRI's recommended emergency procedures for fighting fires on the surgical patient are presented.

Fire Caused by Improper Disposal of Electrocautery Units
A member hospital experienced a small trash fire when an electrocautery unit was discarded in a surgical refuse bin without the proper safety cover in place over the tip and activation switch. The weight of additional refuse placed on top of the unprotected unit activated the ON switch, causing the cautery tip to heat to a temperature sufficient to ignite a trash fire.

Fires during Surgery of the Head and Neck Area (Update)
In the previous report, we discussed the fire hazards associated with enriched oxygen and nitrous oxide concentrations present during surgery of the head and neck area and made recommendations for minimizing these hazards. In our continuing studies, we have found that a water-soluble sterile surgical lubricating jelly may be used to minimize fire hazards posed by the presence of hair near the operative site.

Fires from Blankets Warmed in Microwave Ovens
A member hospital reported that a blanket warmed in a microwave oven burst into flames when it was passed into a hyperbaric oxygen chamber. The hospital suspects that the blanket was smoldering within its folds when it was placed in the chamber. Our tests have confirmed that this is a likely scenario. We know of at least one other case where a blanket ignited while being heated in a microwave oven.

Fires from Defibrillation during Oxygen Administration
ECRI continues to receive reports and investigate incidents of patients and their bedding being set on fire during defibrillation. In these cases, defibrillation was performed in the presence of oxygen administration devices, which are necessary in resuscitation attempts and which inherently spill excess oxygen. This oxygen enriches the space around the patient's head and chest and allows an electric arc sometimes produced during defibrillation discharge to ignite body hair. The fire flashes rapidly over the patient, consuming body hair and igniting nearby bedding materials and medical devices.

Fires from Oxygen Use during Head and Neck Surgery
We have seen an increase in the frequency of fires during head and neck surgery. Some are small and easy to extinguish, while others are large and cause extensive patient injury, and sometimes death. The majority of these fires are caused by oxygen enrichment of the surgical field from various types of oxygen-delivery devices and are ignited by heat-producing surgical instruments (e.g., electrosurgical unit [ESU] or electrocautery unit pencils, lasers).

For Emergency Defibrillation
ECRI's recommendations for safely performing emergency defibrillation are given in poster form.

Formaldehyde Safety
ECRI's recommendations for the safe use of formaldehyde are given in poster form.

Fracture of Bronchoscopic Biopsy Valve
A surgeon at a member hospital was performing a procedure with a flexible bronchoscope when a small piece of the reusable biopsy valve broke away and entered the patient. Removal of the piece extended the procedure by 20 minutes.

Full Enclosure Needed to Prevent Contamination during Pulmonary Procedures
Several types of aerosol treatment enclosures are intended to enclose patients and protect bystanders from contamination by infectious aerosols or toxic drugs during treatment of patients infected with tuberculosis (TB) or the human immunodeficiency virus (HIV). However, enclosures that do not provide full enclosure do not isolate the patient and can be effective only if the patient's face is fully inside the cart. Unenclosed patients can easily move out of the airflow and contaminate the room air by coughing, which typically occurs during inhalation treatments for TB and HIV-related diseases (e.g., Pneumocystis carinii pneumonia).

Furby Toys Are Not Likely to Interfere with Hospital Equipment
Member hospital: Occasionally, pediatric patients and younger visitors to the hospital bring a toy called a Furby with them into the facility. Because these toys are mechanized and can transmit infrared signals, some of our clinical staff have expressed concern that the toy may interfere with medical equipment. Is this a valid concern?

Gas-Powered Resuscitators
ECRI has followed the development of gas-powered resuscitators and contributed to their improvement by conducting formal evaluations, investigating reports of problems, participating in standards development, and educating users. Unfortunately, injuries and deaths related to malfunction, misassembly, poor maintenance, and misuse of gas-powered resuscitators continue to occur.

Ground-Resistance Testing
Member hospital: We have an external compression pump that has a three-prong power plug with the ground wire connected to the chassis, which is entirely covered in plastic. No metal parts are exposed, leaving no way to make a ground-resistance measurement. How should we handle electrical safety testing during inspection and preventive maintenance (IPM) procedures?

Handle High-Pressure Oxygen with Care
ECRI recommendations for the safe handling of high-pressure oxygen are given in poster form.

Header Cracks Related to Reprocessing of Single-Use Hemodialysis Dialyzers
A member hospital reported that several of one brand of hollow-fiber dialyzers used in two of its five dialysis clinics developed cracks in the threaded portion of the headers (i.e., end caps). The affected models are those in predominant use in these clinics. In each case, the cracks were noted after the dialyzers had been reprocessed several times.

Heart-Lung Bypass Oxygenators
A member hospital reported that the plastic shell of a disposable blood oxygenator was severely damaged when liquid anesthetic spilled on it during a cardiopulmonary bypass procedure. The perfusionist observed blood seeping out of cracks in the oxygenator and interrupted extracorporeal perfusion to replace it. The patient suffered no adverse effects from the interruption of circulation.

Heated Humidifiers
ECRI's recommendations for the safe use of heated humidifiers are given in poster form.

Heated Wires Can Melt Disposable Breathing Circuits
ECRI has learned of several incidents in which the heated wires used with heated-wire humidifiers have melted and sometimes charred disposable breathing circuits. Melting of the plastic tubing can occlude the breathing circuit, resulting in hypoventilation; if charring occurs, fumes may enter the patient's lungs. Melting poses another hazard during general anesthesia: leaking of oxygen-enriched gas creates an oxygen-enriched atmosphere (OEA) in or near the surgical field, which increases the risk of fire during laser surgery, electrosurgery, or electrocautery.

Hemolysis and Renal Dysfunction Associated with Autotransfusion
In two investigations of intraoperative autotransfusion procedures at different institutions, ECRI determined that excessive vacuum levels and insufficient normal saline wash volumes during orthopedic surgery led to gross hemolysis and subsequent renal dysfunction. In each case, the patient required hemodialysis for two to three weeks, and one also required mechanical ventilation for three weeks.

Ignition of Debris on Active Electrosurgical Electrodes
A member hospital reports that flames briefly flashed from the tip of an active electrosurgical electrode during a tonsillectomy. The patient was not harmed and no surrounding materials caught fire, but the risk that the fire could have spread or caused significant injury certainly existed. After the flash, staff noted that the shaft insulation near the tip of the electrode was badly melted and therefore suspected that a defect in the electrode might have initiated the fire.

Importance of Pretreating Municipal Water Used for Dialysis
Member hospital: We purchased a portable reverse osmosis water purification system for use in our hemodialysis clinic. Shortly after the first use of this system, a physician noted a 5% drop in the patient's hematocrit levels. (The drop in hematocrit required no medical intervention.) It was determined that the patient was receiving excess amounts of chlorine from the product water. We have since learned that the carbon pretreatment filter supplied with our reverse osmosis unit could not effectively treat our source water, whose chlorine level exceeds the maximum specified by the manufacturer. When is pretreatment (or additional pretreatment) needed? Why is it necessary?

Improper Connection of Laparoscopic Insufflators and Gas Cylinders
While replacing a CO2 gas cylinder during a laparoscopic procedure, a member hospital unintentionally connected a cylinder containing a N2/CO2 /He gas mixture, which is intended for use only with laser equipment, to the laparoscopic insufflator. This improper connection occurred as a result of using two sealing washers instead of one between the insufflator's yoke and the gas cylinder's valve assembly. The patient was not injured, even though the error was detected after completing the procedure. However, introducing a gas or gas mixture that has a low blood solubility and the ability to support combustion can lead to the formation of a gas embolism or fire, respectively.

Improper Dialysate
ECRI received a report of a patient death due to the inadvertent use of acid concentrate (the acid part of a two-part bicarbonate concentrate system) in a hemodialysis machine designed to proportion acetate concentrate. The conductivity monitor of the dialysis machine indicated improper (low) conductivity, but the dialysis technician was able to readjust alarm limits of the conductivity monitor (a poor practice) to bypass the alarm and proceeded to dialyze the patient. The patient died of metabolic acidosis during dialysis.

Improperly Connected Ethylene Oxide Sterilizer Supply Cylinder
A member hospital reported that, when changing the supply cylinders on its 15-year-old ethylene oxide (EtO) sterilizer, service personnel had been using a wrench to tighten the fitting into the valve stem of the new EtO-CFC (Freon) cylinders. Following advice from the manufacturer, the service personnel started hand-tightening the connection. Moments after a cylinder had been changed using hand-tightening, nearby employees experienced respiratory and eye irritation. On investigation, the cylinder connection was found to be spraying the EtO-CFC mixture into the air. As a result, a worker was sprayed in the face, and employees in the area were exposed to high levels of EtO.

Inaccurate O2 Concentrations from Oxygen-Air Proportioners
Member hospital : We have recently experienced incidents of inaccurate oxygen concentrations being measured from oxygen-air proportioners (blenders) in our neonatal intensive care unit (NICU). Does ECRI know what the cause of the problem might be?

Inadequately Secured Connections on ECMO Tubing Circuits
In the course of investigating an incident in which tubing separated at a connection during extracorporeal membrane oxygenation (ECMO), which contributed to a patient's death at a member hospital, we learned that some hospitals performing ECMO do not use supplemental securement devices, but instead rely solely on hosebarb connections to secure tubing/component junctions in the ECMO circuit. Because ECMO patients are already severely compromised, tubing separation in an ECMO circuit can cause hypovolemic complications or death, depending on the location of the separation.

Inappropriate Phototherapy Replacement Tubes
ECRI received several reports of inappropriate replacement of fluorescent and halogen light tubes with ultraviolet (UV), germicidal, and suntanning tubes in phototherapy units.While the inappropriately replaced tubes emit blue light and are the same size as the correct tubes, they are not intended for phototherapy and may emit wavelengths other than blue light (outside the visible range), possibly causing patient injury.

Inappropriate Use of Oxygen to Inflate or Power Medical Devices
ECRI has long recognized the hazards of inflating pneumatic tourniquets with oxygen. We have learned that some emergency medical service (EMS) personnel use or are considering use of oxygen as the inflation gas for antishock trousers and as the driving gas for pneumatic-powered devices being developed to enhance the effectiveness of cardiopulmonary resuscitation (CPR).

Incompatibility of Disposable Heated-Wire Breathing Circuits and Heated-Wire Humidifiers
ECRI is aware of several incidents in which disposable heated-wire breathing circuits have overheated before or during use because of incompatibility with the heated-wire humidifiers with which they were being used, resulting in melting or charring of the plastic breathing circuit.

Infant Home Apnea Monitors: Essential Safety Features and Practices
Four features that are lacking on many older apnea monitors (and some newer ones) are necessary for effective monitoring; these are 1) heartbeat detector, 2) remote alarm, 3) power-loss alarm (nonbattery-operated units), and 4) safe electrodes. Parents can continue to use existing monitors, but should arrange to replace or modify them as soon as possible. A fifth feature--battery-charge or AC-power indicator--is also important for safe monitoring, but replacing or modifying a unit without it is not as crucial if parents take the precautions discussed.

Infant Home Apnea Monitors: Essential Safety Features and Practices (Update)
This material updates the recommendations published in our hazard report of Apr 1990;19(4):43-5.

Infant Radiant Warmers Can Burn: Use with Care
ECRI's recommendations for the safe use of infant radiant warmers are given in poster form.

Infiltration during Infusion Therapy
Member hospital: While using an infusion pump to deliver a saline bolus to an infant, our staff noticed swelling and discoloration of the infant's forearm caused by infiltration. The infusion was stopped, and the pump was removed from service for inspection. The pump did not alarm during the infiltration, but we could not detect any problems with the device. The supplier informed us that the device was not intended to detect or prevent infiltration.

Infusion Pump Air Detection
ECRI discusses the appropriate range of air-detection volumes for infusion pump air-in-line detectors.

Infusion Pumps
ECRI's recommendations for the safe use of infusion pumps are given in poster form.

Inspection and Preventive Maintenance--Don't Forget the Nuts and Bolts
ECRI has received several reports of a wide variety of medical equipment failures related to loose or missing fasteners (e.g., screws, bolts). In almost all these instances, proper inspection and preventive maintenance (IPM) of the equipment could have prevented the failures.

Inspection and Testing of Dermatomes
ECRI provides recommendations on inspecting and testing dermatomes for optimal performance.

Inspection Frequency for Blood/Solution Warmers
ECRI discusses applicable guidelines and other considerations for determining the optimal inspection frequency for blood/solution warmers.

Interference between Telemetry Transmitters Programmed to the Same Frequency
Report from Member Hospital: A patient was being monitored with an ambulatory telemetry transmitter when the display of the patient's rhythm at the central station monitor changed from normal sinus rhythm to ventricular tachycardia and then to ventricular fibrillation. A defibrillator was rushed to the patient's room, but the patient did not appear to be in distress. When a portable bedside monitor was connected to the patient, it displayed a normal sinus rhythm. The telemetry transmitter was disconnected from the patient and the batteries were removed, but the abnormal rhythm was still displayed on the central station monitor for that telemetry channel.

Internal Leakage from Anesthesia Unit Flush Valves
A hospital reported that a large leak in the flush valve of an anesthesia unit resulted in delivery of a gas mixture with an excessive oxygen concentration to an anesthetized patient. Such delivery will result in lighter anesthesia than intended.

Intra-Aortic Balloon Perforations (Update)
In Health Devices 18(12), December 1989, ECRI published a Hazard Report addressing perforations of intra-aortic balloons (IABs). Although rare, balloon perforations are a recognized complication of intra-aortic balloon pump (IABP) therapy, and we continue to receive reports of perforations involving all brands of IABs. Therefore, we are updating the original Hazard Report to review the causes and possible serious consequences of IAB perforations, along with methods to minimize their incidence.

Intra-Aortic Balloon Pumps: Inspection and Infrequent Use
Member hospital: We use the intra-aortic balloon pump (IABP) in our cardiac catheterization laboratory (cath lab) very infrequently and are wondering whether we should reduce our current biannual inspection and preventive maintenance (IPM) interval to one time per year.

Investigating Device-Related "Burns"
We discuss a procedure for investigating skin injuries sustained by patients in the operating room and special care areas of the hospital. Skin injuries are often mistaken for burns, and medical devices are immediately blamed as the cause; however, such a hasty conclusion can overlook the actual cause of the injury and delay the implementation of measures to prevent future occurrences. We describe a thorough investigation process for uncovering the real cause of the injury. We also list potential causes of accidental skin injuries and present two investigation case studies.

Issues in Selecting and Using Apnea Documentation Systems
The primary purpose of apnea monitoring is to ensure adequate warning of certain life-threatening respiratory and cardiac events, often in infants monitored at home. However, parents often become frustrated by frequent alarms, and others may not use the monitor at all. Unfortunately, ECRI has received a number of incident reports in which infants have died while not connected to their monitors or where a failure to monitor was suspected. We believe that some of these deaths may have been prevented if monitoring had been used properly.

Laser Safety Officer
ECRI discusses the need for a laser safety officer, the standards and guidelines relating to laser safety, and the duties of the laser safety officer as defined by regulatory and accrediting agencies.

Leaching of Plasticizer from PVC Tubing in Heart-Lung Bypass Unit Tubing Circuits
Member hospital: While inspecting a heart-lung bypass unit circuit, we noticed that a cloudy, oily substance had collected inside the tubing immediately leading into and coming out of the anesthetic (isoflurane) vaporizer. The substance proved to be a plasticizer that had leached from the PVC (polyvinyl chloride) tubing when it was exposed to the vaporized isoflurane. (Although we were using isoflurane, the manufacturer of the anesthetic stated that any halogenated anesthetic agent would produce the same reaction.)

Leakage Current Limits for Electronic Equipment Used in Non-Patient-Care Areas
ECRI discusses acceptable leakage current limits for electronic devices used in non-patient-care areas to ensure staff safety.

Leaving SPECT Patients Unattended
During a scanning procedure involving a single photon emission computed tomographic (SPECT) gantry system, the patient's arm became trapped between the rotating detector and the table assembly while the technologist was temporarily out of the room. When the patient cried out, the technologist returned and immediately operated the emergency (abort) safety switch. The gantry stopped before the patient sustained any injury. ECRI believes that the incident was probably avoidable and that users of all SPECT systems should be aware of the possibility of injuries resulting from patient entrapment.

Leaving Ventilator-Dependent Patients Unattended
ECRI has always recommended that ventilator-dependent patients never be left unattended. These patients cannot breathe spontaneously for substantial periods of time and cannot manually ventilate themselves. In the past, ventilator-dependent patients have been in special care units, where constant attention was available. Recently, however, medically stable patients (e.g., spinal cord injury patients) have been moved to other hospital rooms or even to home care.

Lesions and Shocks during Iontophoresis
A member hospital reported two separate incidents in which the skin beneath the negative electrode of an iontophoresis unit was found to be reddened following iontophoresis therapy. In addition, at the end of therapy, both patients reported receiving a shock when the iontophoresis unit was turned off. In both cases, the unit had been set at 4.0 volts for a duration of 15 min. After each case, the unit was removed from service and tested by a qualified technician, who found no problems. These incidents highlight two possible adverse outcomes of iontophoresis: 1) lesions, including burns, and 2) shocks.

Loose Screws in TV Mounts
A member hospital reported an incident in which a television set fell from its mounting bracket when a nurse attempted to swivel it. The TV struck the nurse on the shoulders and back, fell to the floor, and then shattered. It was subsequently discovered that the locking screw in the swivel that holds the TV tray to the wall bracket of the mount had backed out.

Loose-Lead Alarms Resulting from Dried-Out Disposable Electrodes
Member hospital: During apnea monitoring of pediatric patients, our hospital recently experienced numerous "loose-lead" alarms resulting from dry electrode gel. Our central supply department had been opening the manufacturer's foil pouch (i.e., primary packaging), which contains 30 pregelled electrode sets, and distributing the individual sets, which are packaged in clear polyethylene bags (i.e., secondary packaging). Despite unopened secondary packaging, the electrode gel was becoming dry enough to increase the electrode impedance, causing the loose-lead alarms.

Low-Pressure Alarms for Sensing Ventilator Disconnects
Low-pressure alarms are often used to detect the drop in peak inspiratory pressure (PIP) that occurs when a patient becomes disconnected from a ventilator. Reports from several hospitals indicate that users are unaware of the ineffectiveness of these alarms if the low-pressure alarm point is adjusted too low by the user or preset too low by the manufacturer. Failure to detect such a disconnect can be fatal to the patient.

Material Degradation of Angiographic Catheters
Several member hospitals have reported instances of angiographic catheter degradation during storage. Catheters have been found to be discolored, brittle, or ruptured when removed from their protective packaging. In most cases, the degradation was readily apparent, but in rare instances, the catheters were used in patients and fractured during use. A degraded catheter that breaks in this manner can release irretrievable fragments into the arterial system.

Mechanical Malfunctions and Inadequate Maintenance of Radiologic Devices
ECRI continues to receive and review numerous reports of mechanical failures in radiologic equipment that either resulted in or had the potential to cause serious patient injury or death. In one instance, a cobalt therapy unit fell and killed a patient. After examining many other malfunctions that occur with radiologic equipment and assessing how these malfunctions are detected, we have concluded that mechanical components are not being properly inspected during routine inspection and preventive maintenance.

Medical Device Problem Reporting for the Betterment of Healthcare
Given that there are nearly 5,000 individual classes of medical devices, tens of thousands of medical device suppliers, and millions of healthcare providers around the world, device-related problems are bound to happen. But effective problem reporting can help reduce or eliminate many of these problems--not only within an institution, but also potentially around the world. In this Guidance Article, ECRI traces the problem reporting process from its beginnings in the hospital to its global impact in making critical information available throughout the healthcare community.

Medical Gas and Vacuum Systems Flows and Pressures
ECRI discusses the standards and requirements for flows and pressures for medical gas and vacuum systems.

Medical Gas System Fittings
A member hospital reported that a patient was injured when a suction regulator with a quick-connect fitting was inadvertently pushed into a quick-connect oxygen wall fitting. The pressurized oxygen reportedly damaged the suction regulator and injured the patient.

Medication Errors Associated with Packaging and Labeling of IV Bags
A member hospital reported an incident in which 800 cc of sterile water, instead of saline solution, was accidentally administered to a patient during surgery. The infusion of water caused the patient's blood to hemolyze. (The subsequent condition of the patient was not reported.) In this incident, a  1,000 mL bulk pharmacy intravenous (IV) bag containing sterile water had been mistaken for a similar-looking 1,000 mL IV bag containing 0.9% sodium chloride (i.e., saline) solution.

Membrane Switch Failures
Many electronic medical devices have membrane (touch-panel) control switches. These switches offer resistance to fluid entry, thereby reducing the possibility of electrical shock and switch malfunction. To avoid inadvertent activation, many manufacturers have designed these switches so that they require greater force to activate. ECRI received several reports of membrane switch failures due to operator abuse. Personnel have damaged the membrane switches by using sharp instruments to activate them.

Minimizing EtO Exposure When Changing Gas Cylinders
Question from a member hospital: On removing an EtO hose while changing a 140 lb ethylene oxide (EtO) gas cylinder, two staff members were sprayed with EtO from a failed shut-off valve. Apparently, the valve failed to close when it was screwed completely down to the OFF position, resulting in a leak. How can exposure to EtO be minimized from such failures, which are unpredictable?

Minimum Requirements for Ventilator Testing
All ventilators should be tested after each use to verify performance before the unit is used for another patient. Ideally, a complete operational verification procedure, established by the facility and usually based on the manufacturer's recommendations, will be performed each time. There is, however, an interim solution for instances when the staff has insufficient time to complete a full operational verification procedure on an older unit. That is, staff can instead test only those features that will be or that are likely to be required for the patient about to be ventilated. The minimum tests that should be performed and documented to ensure the safe use of a ventilator are presented in this Guidance Article.

Misassembly of Supplemental IMV and Breathing Circuits
ECRI received a problem report concerning misassembly of supplemental intermittent mandatory ventilation (IMV) gas circuits. While the patient was being mechanically ventilated, a nurse misassembled an IMV system after it had been accidentally disassembled. The patient was unable to breathe spontaneously and was later discovered in a hypoxic state. Although the patient in this case was not adversely affected, permanent injury or death could result under similar circumstances.

Misconnection of Bipolar Electrosurgical Electrodes
We have received more than a dozen reports of serious patient injury due to inappropriate connection of bipolar electrosurgical electrodes to the handswitched monopolar electrode jacks on electrosurgical units (ESUs). Such misconnection will almost always result in inadvertent activation of the ESU's monopolar mode, which can produce a much higher output than the bipolar mode. The problem has most often been reported following laparoscopic fallopian tube sterilization procedures with subsequent bowel perforation.

Misconnection of Vitrectomy Handpieces and Vitrectomy Units
Two hospitals reported incidents in which eye injuries occurred when one of the lines from a pneumatically driven vitrectomy handpiece was misconnected to the vitrectomy unit's high-pressure actuator line. With this type of misconnection, a large blast of compressed air enters the eye on activation of the handpiece.

Mislocated Pop-Off Valve Can Produce Airway Overpressure in Manual Resuscitator Breathing Circuits
ECRI has learned that manufacturers of manual resuscitator breathing circuit accessories have provided hospitals with setups with a mislocated pop-off valve. When this valve is positioned incorrectly, patients can be subjected to dangerously high airway pressures that are not indicated to the caregiver.

Mispackaging of Disposable Pressure Transducers and Continuous-Flush Devices
A member hospital reported an incident in which an adult patient received an overinfusion of saline through a 30 mL/hr continuous-flush device on a disposable pressure transducer set, which is usually used for neonates. The patient became hypervolemic, but was successfully treated.

Misuse of "Quick-Look" Defibrillator Paddles
A hospital reported to us a case in which misuse of a defibrillator/monitor equipped with external "quick-look" paddles led to injury of a nursing assistant, who had held the paddles to her own chest to check the defibrillator's ECG monitor. While positioning the paddles, she accidentally charged and discharged the defibrillator, shocking herself and receiving burns at the paddle contact sites.

Needlestick Injury during Disposal of Blood-Collection Needle
A member hospital reported that a needlestick injury occurred when a technologist was removing a direct draw adapter from a butterfly blood-collection needle to discard the needle in a sharps container. The patient's blood was HIV positive. Although this injury occurred with a specific manufacturer's product, we believe that a similar injury could occur with the use of other manufacturer's blood-collection tube adapters designed for specific blood-culture bottles.

Nitrogen Distribution Systems
A member hospital reported that after installation of a new anesthesia machine equipped to use oxygen, nitrous oxide, and air, pre-use tests of the unit produced no airflow through the unit until one of the OR personnel turned on the regulator on a wall-mounted nitrogen control panel installed for the use of nitrogen-powered tools. What appeared to be airflow was then determined to be nitrogen. Delivery of such a hypoxic gas component to a patient would be a serious risk.

Nitrous Oxide (N2O) Cryosurgical Units Must Be Scavenged
Member hospitals frequently inquire about the need to scavenge cryosurgical units (CSUs) that use nitrous oxide (N2O) as the cryogen (i.e., refrigerant gas). Confusion continues to exist about the rationale for scavenging this equipment, appropriate scavenging methods, and available options that eliminate the need for scavenging.

Nitrous Oxide (N2O) Cryosurgical Units Must Be Scavenged (Update)
ECRI continues to receive frequent inquiries from member hospitals about scavenging cryosurgical units (CSUs) that use nitrous oxide (N2 O) as the cryogen (i.e., refrigerant gas). Confusion still exists about the need to scavenge this equipment, appropriate scavenging methods, and available options that eliminate the need for scavenging. To fully inform current medical, surgical, OR nursing, hospital clinical engineering, and risk management staff about this serious hazard, we are updating our earlier reports.

Nonstandard User Modification of Gas Cylinder Pin Indexing
A member hospital reported that a nitrous oxide cylinder was connected to the wrong gas cylinder yoke after the hospital's machinist had modified the yoke's pin indexing for use with cylinders containing Entonox, a mixture of oxygen and nitrous oxide used for analgesia. However, the machinist had drilled the hole intended for the yoke's single large pin completely through. Although some manufacturers have also made the error of drilling pinholes all the way through the yoke, that was not the case in this incident.

Nurse-Call Systems Interfaced to Bedside Patient Monitors
Member hospital: Our physiologic patient monitoring system is interfaced to a central station monitor that has an arrhythmia computer. We have also interfaced our nurse-call system to the alarm-out jack on each of the bedside monitors to provide redundant audible alarms at the nurses station, as well as a visual indicator above the door of the patient's room. However, because heart-rate alarms will not activate the alarm-out relay, heart-rate alarms are not annunciated by the nurse-call system.

Only You Can Prevent Surgical Fires
ECRI's recommendations for the prevention of surgical fires are presented in poster form.

Operating Microscopes in Ophthalmic Surgery
Exposure to light from an operating microscope during extracapsular cataract extraction (ECCE) and intraocular lens (IOL) implantation can result in photic retinopathy (light-induced retinal damage), particularly in patients with existing retinal impairment. ECRI investigated several incidents in which eye lesions occurred in patients who underwent ECCE with IOL implantation. The shape and orientation of these lesions were consistent with those that would be expected from retinal exposure to excessive light intensity from a fiberoptic, focused delivery system. Contributing factors were prolonged exposure and high illumination levels.

OR Fires Caused by Fiberoptic Illumination Systems
We received two reports from member hospitals of fires ignited by fiberoptic illumination systems (which consist of the light source, or projector, and the light-transmitting cable) during arthroscopic surgery. In one incident, the fiberoptic cable was disconnected from the arthroscope and placed on the surgical drapes with the xenon light source activated. In a second incident, the disconnected fiberoptic cable ignited disposable nonwoven surgical paper drapes that had trapped a pocket of oxygen (leaked from a faulty inflation connector of a pneumatic tourniquet).

OR Renovations and the Use of Isolated Power and Explosion-Proof Plugs
Member hospital: We are in the process of renovating our ORs. Our existing ORs have isolated power and explosion-proof plugs. Is it necessary to continue using these systems, or can we use normal ground-referenced power and parallel-blade plugs and receptacles?

Overinfusion Caused by Gravity Free-Flow from a Damaged Prefilled Glass Syringe
A member hospital reported an overinfusion of Demerol when a cracked prefilled glass syringe was used in a patient-controlled analgesia (PCA) infusion pump. The crack, which may have developed either before or during installation of the syringe in the pump, allowed gravity free-flow of the analgesic from the syringe. Gravity free-flow of a potent medication, such as Demerol, can cause potentially fatal respiratory and/or cardiac complications.

Oxygen Regulator Fire Caused by Use of  Two Yoke Washers
An ECRI investigation of a fire that occurred between an oxygen regulator and an E-cylinder valve revealed that the fire resulted from the use of two washers between the regulator body and the E-cylinder yoke. In this incident, a specific model oxygen regulator, which had a durable washer, had been placed on a new E-cylinder without first removing the cylinder's disposable washer. The use of two washers allowed an oxygen leak on the high-pressure side of the regulator, which, in the presence of minor hydrocarbon contamination, resulted in a flash fire between the regulator and the cylinder valve.

Patient Burn Caused by Excessive Illumination during Surgical Microscopy
A member hospital reported that a patient suffered a third-degree burn during routine plastic surgery. At the end of the procedure, the burn was discovered on the skin surrounding the surgical site, which had been continuously illuminated for 3 hr by a xenon light source used on a surgical microscope with a high-efficiency fiberoptic illumination cable. It is likely that the reported problem was related to the equipment configuration and the type of surgical procedure, not to this manufacturer's devices.

Patient Circuit Disconnections
For many years, tapered 15 and 22 mm connectors have been used in breathing circuits to form joints between fittings and hoses; between various fittings in ventilator, resuscitator, and anesthesia circuits; and for fresh gas hoses and reservoir bags on anesthesia equipment. Through long experience, most users know that these connectors are prone to accidental disconnections.

PEEP Valves in Anesthesia Circuits
ECRI investigated an incident caused by incorrect placement of a positive end-expiratory pressure (PEEP) valve in the inspiratory limb of an anesthesia circle system. The combination of the one-way-flow design of the valve and its improper placement occluded gas flow to the patient and caused serious injury.

Phototherapy Bililights for the Jaundiced Infant
ECRI's recommendations for the safe use of phototherapy bililights for the care of jaundiced infants are given in poster form.

Plastic Thermal Blankets
We received a report of an infant death due to hyperthermia associated with the use of a "bubble blanket" on an infant being cared for under a radiant warmer.The hospital reports that the 12-day-old, very-low-birthweight (VLBW) infant had previously experienced major problems but had been stable for six days. When routine vital signs were taken, the infant's temperature was normal. However, one hour later, the infant was extremely hyperthermic (axillary temperature greater than 42° C). The infant died shortly thereafter, reportedly as a direct result of hyperthermia. At the time that the infant was found to be hyperthermic, hospital personnel noted that the radiant warmer's temperature sensor was adhering to the plastic thermal blanket, rather than the infant's skin.

Pneumatic Tourniquets Used for Regional Anesthesia
In 1982, a British medical report (Health 1982) cited five deaths associated with the use of pneumatic tourniquets during administration of regional anesthesia by a technique known as intravenous regional anesthesia (IVRA) or Bier's block. At least three of these accidents were caused by personnel deflating the tourniquet prematurely. However, in some cases, equipment design and/or malfunction might have been contributing factors.

Pre-Use Anesthesia Check Fails to Find Faults
A patient suffered cardiac arrest during surgery when an excessive amount of anesthetic agent was delivered because of two malfunctions in the anesthesia unit that went undetected during pre-use check.

Pre-Use Checklist for Anesthesia Units (Machines and Accessories)
ECRI's recommended pre-use proceudres for anesthesia units are presented in checklist form.

Pre-Use Inspection of Disposables
ECRI continues to receive and investigate problems involving disposable medical devices. These problems range from packaging defects and mislabeling to defects in the device itself, such as catheter lumen occlusions and breathing circuit connector failures. Although some investigations reveal a significant or lot-specific problem and merit publication as a hazard report in Health Devices or an Action Item in Health Devices Alerts, the majority identify isolated or random defects.

Pre-Use Inspection of Disposables (Update)
ECRI continues to receive and investigate problem reports involving disposable medical devices. These problems range from packaging defects and mislabeling to device defects. In some cases, the problems have been hazardous or life-threatening—for example, breathing circuits occluded by mold flashing that could cause barotrauma or hypoxia, and packaging with sterility breaches that could lead to infections.

Pre-Use Testing Prevents 'Helpful' Reconnnection of Anesthesia Components
A member hospital reported that a 19 mm scavenging transfer hose on an anesthesia machine became disconnected. Someone who was not familiar with anesthesia or scavenging circuits found the disconnection and, being well meaning, attached it to a 3/4-inch nut on the bottom of the absorber. This improper connection left the scavenging system open to the atmosphere; thus, the waste anesthesia gases could have discharged into the OR.

Pre-Use Verification of Breathing Circuits
The quality of disposable breathing circuits varies among lots and individual units. Therefore, whenever a breathing circuit is replaced, the new circuit should be visually inspected before use, and its performance should be verified. ECRI's recommendations for pre-use verification of breathing circuits are presented in checklist form.

Preventing Patient Entrapment in Beds
ECRI provides five specific recommendations to minimize the risk of common causes of patient entrapment in beds.

Problems Related to EtO Sterilization of Infant Oxygen Hoods
Member hospital: Does sterilizing infant oxygen hoods with ethylene oxide (EtO) between uses present any problems?

Recommendations for Complying with the Bloodborne Pathogens Standard
ECRI's recommendations cover specific ways to comply with the standard based on information from the Occupational Safety and Health Administration (OSHA), hospitals, and other sources. ECRI's recommendations derive, in part, from research conducted to answer questions asked by Center for Healthcare Environmental Management (CHEM) members.

Reduce Exposure to Waste Anesthetic Gases
ECRI's recommendations for reducing exposure to waste anesthetic gases are given in poster form.

Reducing the Risk of Power Loss to Critical Equipment
ECRI regularly receives reports of power failures in life-support or emergency care equipment because units were not plugged in or their power cords became disconnected. Power loss to a critical device can pose a risk of death or injury to patients. Even though this problem is well recognized, incidents continue to occur.

Reprocessing and Inspection of Manual Pulmonary Resuscitators
We have received two reports of failure to ventilate patients due to resuscitator malfunction: one due to a missing valve component and the other due to a valve component from a different unit that became wedged in the inlet valve of a resuscitation bag, causing it to malfunction

Responding to Fires in Areas of Oxygen Use
A fire started in the hospital room of a patient using oxygen, quickly rupturing the oxygen hoses attached to the piped oxygen wall outlets. The free-flowing oxygen then intensified the fire, which rapidly involved most of the flammable objects in the room. Copious amounts of smoke were forced out into the hall and throughout the patient floor, necessitating the evacuation of many patients. When the firefighters arrived, they shut off the oxygen to the room, which reduced the intensity of the fire and enabled them to extinguish it.

Risk of Barotrauma and/or Lack of Ventilation with Ventilatorless Anesthesia Machines
During our investigation of a case in which a patient sustained pulmonary barotrauma and subcutaneous emphysema, ECRI determined that, under certain circumstances, patients can be exposed to high pressures (approaching 5 psi) by anesthesia machines with an absorber module that has no ventilator attached.

Risk of Electric Shock from Patient Monitoring Cables and Electrode Lead Wires
In 1987, we published a Hazard Report on patients who received electric shocks when they were inadvertently connected to line power (120 VAC). These incidents occurred when electrode lead wires, which should have been attached to the patient cables connected to ECG or home apnea monitors, were instead plugged into energized detachable power-line-cord plugs.

Risk of Electrosurgical Burns at Needle Electrode Sites
We investigated an incident in which a patient received electrosurgical burns at the site of subcutaneous needle electrodes used for monitoring evoked potentials (evoked responses) during the procedure. The burns were caused by radio-frequency (RF) leakage current, which is normally present when an electrosurgical unit (ESU) is operated in the monopolar configuration (i.e., with an active and a dispersive electrode). The leakage current in this case was sufficient to cause a high current density through the needles, which had a small area of tissue contact.

Risk of Ineffective Assisted Ventilation Using Fenestrated Tracheostomy Tubes with 15 mm Connectors
A hospital reported a case of ineffective emergency ventilation of a patient in respiratory arrest when a manual resuscitator was connected to the 15 mm male connector on the fenestrated inner cannula positioned inside a fenestrated low-pressure cuffed tracheostomy tube. During the resuscitation attempt, significant portions of the administered gas escaped through the fenestrations in both the inner cannula and the outer tube. Rather than entering the lungs, this gas exited through the patient's mouth and nose.

Risk of Injury and Infection from Broken Glass Ampules
A member hospital reported that, in three separate incidents, employees were cut on the fingers when opening glass ampules of clinical laboratory human-based quality control material.



Risks from Centrifuges
In Health Devices 20(1), Jan 1991, we published a Hazard Report on centrifuges without safety interlock latches on their cover lids. We recommended that all centrifuges have safety interlocks to avoid exposure to spinning rotors and blood or body fluid tubes. Since our previous report was published, we have learned that some centrifuges with latch interlocks allow the lid to be opened before the rotor has completely stopped.

Risks of Using Intravenous Administration Sets with Non-Self-Sealing Injection Sites
A member hospital reported a case of blood loss through a Luer-fitting injection site that was not capped (i.e., was unsealed). The injection site was near the patient end of an infusion pump administration set, which was connected to a peripheral catheter. The administration set was provided by an infusion pump manufacturer to satisfy the hospital's request for a needleless connection set. Similar products are available from other suppliers. This incident raises a concern about the risk of air embolism, exsanguination, and contamination with the use of non-self-sealing injection sites.

Routine Inspection Needed for Scissors-Type Circumcision Clamps
ECRI’s ongoing surveillance of incidents involving scissors-type circumcision clamps has revealed that the gap between the clamps’ jaws when they are fully open may increase due to damage, faulty repair, or extended wear. This is particularly hazardous for infants, since it can allow more than just the foreskin to be pulled into the gap, potentially contributing to injury to the glans penis during circumcision.

Rubber Universal Breathing-Circuit Adapters: Risk of Increased Disconnections
With the widespread use of standard conical fittings, which meet the current ASTM Standard F1054-87, breathing-circuit disconnections and the hazards they cause have become rare; when they do occur, they are usually detected by alarms. Although conical fittings can be engaged tightly enough to resist disconnection from most normally encountered forces, some users continue to use soft rubber universal adapters (which stretch to fit different sizes and types of connectors) in patient circuits; these adapters do not meet the ASTM standard and are prone to disconnection.

Safe Use of Supplemental Oxygen with Powered Wheelchairs
Member hospital: A major wheelchair manufacturer told us not to use an oxygen cylinder (E-cylinder) with its powered wheelchair. We are concerned that such use presents a risk of fire for our patients who use powered wheelchairs and supplemental oxygen. What is an appropriate policy?

Scavenging Gas from Membrane Oxygenators
While investigating a heart-lung bypass accident involving gas embolism, ECRI discovered that some perfusionists use what may be unsafe techniques to scavenge waste gas from membrane oxygenators.

Scleral and Corneal Burns during Phacoemulsification
In December 1988 (Health Devices 17[12]), ECRI published a Hazard Report addressing the occurrence of scleral and corneal burns during phacoemulsification—a delicate and complex procedure performed to remove cataracts. Our investigations of such incidents revealed that the injuries were caused by overheating of the phacoemulsification probe tip. However, malfunctioning equipment was not to blame in any of the cases reported to us; instead, the complications experienced could be traced to issues related to surgical technique—issues that we addressed in our published report.

Selection, Purchasing, and Use Considerations for Laser Safety Eyewear
We evaluated 48 models of the most popular LSE offered by 11 manufacturers for use with the most widely used surgical laser wavelengths: 10,600 nm (CO2, invisible), 1,064 nm (Nd:YAG, invisible), and 532 nm (green). However, some surgical lasers (e.g., argon, dye) that are not commonly used for general surgery still require the use of LSE protection, and many of the following considerations apply to LSE designed for these wavelengths as well. We provide an outline of LSE selection, purchasing, and use considerations to help users make informed decisions.

Shortwave or Microwave Diathermy: A Fire Hazard?
Question from member hospital: The cover material of a couch was burned during shortwave diathermy treatment in which the cables were positioned close to the couch. When we duplicated the effect in our biomedical engineering laboratory, a hole was burned through the material in about three minutes. No flame was observed in either case. Does this represent a fire hazard and does it indicate defective equipment?

Siphon Gas Cylinders and Cryosurgical Units
A member hospital reported that nitrous oxide (N2O) gas leaked from the trigger valve of a cryosurgical probe and caused frostbite injuries on the operator's hands. The leak was probably caused by the fact that liquid nitrous oxide had been delivered into the pneumatic circuits of the cryoprobe from a mislabeled N2O siphon tank.

Skin Injury in the OR and Elsewhere
Despite a great deal of care and concern by medical, surgical, and engineering personnel, inadvertent skin destruction in the operating room and intensive care areas continues to occur. These injuries may lead to prolonged morbidity, extended hospitalization, and increased cost, in addition to damaging the patient's trust in the hospital and medical staff to the extent that legal redress is sought.

Skin Lesions from Agressive Adhesive on Electrosurgical Return Electrode Pads
Member hospital: We have experienced several incidents in which patients received minor skin injuries beneath a specific brand of electrosurgical return electrodes immediately after the electrodes were removed following the procedure. In each case, a reddened or blistered lesion approximately 1 x 3 cm was found at the return electrode site in the area corresponding to the outer adhesive border of the electrode pad. No signs that the pads had become detached during the procedure or that the return electrode site was not prepared properly (e.g., not shaved) were present; we understand that both circumstances are common causes of electrosurgical injuries. Each lesion was treated with ointment and resolved within a few days.

Soldered Medical Gas Piping
Sections of our medical gas piping installed long ago are joined by lead solder. Does this present any problems or concerns?

Sparking from and Ignition of Damaged Electrosurgical Electrode Cables
ECRI has received reports from several member hospitals describing incidents of sparking from or ignition of electrosurgical electrode cables used during various surgical procedures. In some cases, sparking severed the electrode cable. In others, the cable ignited, starting a fire that spread to nearby surgical drapes. These incidents caused delays in treatment and, in a few cases, injuries to staff members and to the patient. Medical device reporting databases contain numerous recent reports of other such events.

Special Care Beds Require Special Attention
Special care beds and tables, including rocking beds (also called kinetic treatment tables), turning frames, circle beds, and air-fluidized and low-air-loss flotation therapy beds, are used in hospitals to accommodate a variety of patient needs and conditions. To ensure safe and effective use of these beds, hospital personnel must be thoroughly familiar with their design features, applications, patient restraint systems, and adjustments. A member hospital reported finding a comatose patient on the floor of her room. Apparently, she had fallen out of the rocking bed when it rotated to one side.

ST-Segment Distortion in Manual Report Mode of Electrocardiographs
Member hospital: Using a 12-lead electrocardiograph with a 0.5 Hz baseline wander filter (low-frequency filter) engaged, we generated both an auto report and a manual report from the same patient. When comparing the two reports, we noticed that the manual report contained distortion of the ST segments; that is, certain leads had elevated ST segments compared with those on the auto report. We are concerned that ST-segment distortion of this type could be misinterpreted as representing a cardiac abnormality (e.g., myocardial infarction, myocardial ischemia). Why does this distortion occur, and how can it be prevented?

Stand-Alone Low-Pressure (Disconnect) Alarms Can Be Fooled: Proper Setup Is Essential
ECRI recommendations for the proper setup of stand-alone low-pressure (disconnect) alarms are given in poster form.

Suggested Guidelines for Blood Warmer Use
ECRI's recommendations for the safe use of blood warmers are given in poster form.

Suggested Guidelines for Pneumatic Tourniquet Use
ECRI's recommendations for the safe use of pneumatic tourniquets are given in poster form.

Surgeon's Guide to the Safe Use of Shielded Trocars
ECRI provides general recommendations and precautions for the safe use of shielded trocars for minimally invasive surgery in poster form.

Surgical Devices Omitted from Equipment Control Programs
ECRI has published reports on sternal saws, pneumatic tourniquets, electrosurgical forceps, and cryosurgical units. The common element in these reports, and in numerous other problem reports on surgical devices, is that malfunction and patient injury were caused by inadequate or nonexistent device inspection and preventive maintenance procedures. Too often, surgical equipment is omitted from the hospital's routine inspection and preventive maintenance program because the devices are reprocessed across departmental boundaries, the devices are owned by private physicians, or the need for maintenance goes unrecognized. In addition, some clinical engineering departments focus so heavily on electrical safety issues during inspections that they overlook devices without line cords.

The Difficulty of Reprocessing Reusable Rigid Laparoscopic Forceps and Other Endoscopic Accessories: Are Disposables the Answer?
Member hospital: While unwrapping reusable rigid laparoscopic forceps after steam sterilization, our OR staff noticed that the inner wrap was stained with dried blood. We believe that this problem occurred because the designs of many of our reusable rigid endoscopic instruments make thorough cleaning difficult, and we are concerned that we may be using contaminated instruments on our patients. The operator's manuals for some of these instruments do not provide adequate reprocessing instructions. Can ECRI provide us with guidance on reprocessing our rigid laparoscopic forceps and other reusable rigid endoscopic accessories?

The Patient is on Fire! A Surgical Fires Primer
Virtually all operating room fires ignite on or in the patient, and about 10 surgical patient fires a year come to ECRI's attention. these fires typically result in little damage to equipment, cause considerable injury to patients, and are a complete surprise to the staff. The basic elements of a fire are always present during surgery. A misstep in procedure or a momentary lapse of caution can quickly result in a catastrophe.Surgical fires are preventable, and their impact can be lessened through an understanding of fire and how to fight it. The article identifies the basic elements of fire and discusses how to prevent surgical fires from starting.

The Risks Associated with HVAC Drip Pans
Member hospital: Drip pans in our patient room heating, ventilation, and air-conditioning (HVAC) system sometimes overflow and have been found to contain a variety of microorganisms. What are the risks associated with cooling system drip pans?

Thermal Injuries and Patient Monitoring during MRI Studies
We received several reports of incidents in which patients undergoing MRI studies have sustained second- and third-degree burns. Such thermal injuries usually occur where the skin is in contact with a monitoring sensor or cable (e.g., ECG electrode or cable, pulse oximeter sensor) or an MRI accessory (e.g., surface coil). Although some of the reported thermal injuries have been serious enough to require skin grafts, no life-threatening incidents have been reported.

Thoracic Impedance Measurements Can Interfere with Impedance-Based Rate-Responsive Pacemakers
Member hospital: After an electrocardiograph (ECG) cable from a physiologic monitor's ECG/respiratory rate module was connected to a patient being paced by a minute-ventilation rate-responsive implantable pacemaker, we noted that the patient's heart rate increased from 60 to 120 beats per minute (bpm). We canceled the respiratory rate function on the monitor, but the patient's heart rate remained at 120 bpm. We are concerned that the monitor's respiratory rate function is interfering with the pacemaker.

Tracheal Cuff Inflation Tube Mistaken for Enteral Feeding Tube
A member hospital reported that an enteral pump set was inadvertently connected to the cuff inflation tube (pilot tube) of a cuffed endotracheal tube. The female connector of the pilot tube is similar in shape and color to the connector of the feeding tube that was used on the patient. The enteral formula overinflated the endotracheal tube cuff, completely occluding the tracheal tube. The ventilator alarmed, and the patient suffered respiratory arrest but survived.

Tracheal Tube Kinking
A member hospital reported that a patient extubated his tracheal tube so that it was coiled in his mouth as he was being rolled onto his side for bathing. Whether those manipulations or a cough previous to rolling generated the necessary force for extubation is unknown. The patient was not heavily sedated, his arms were restrained, and he had also been using his tongue to push on his tracheal tube. This tonguing may have contributed to extubation. High insufflation pressures were not used.

Training Recommendations for Autotransfusion Unit Operators
Member hospital: What is the minimum training recommended by ECRI for operators of autotransfusion units?

Transilluminators and Patient Burns
ECRI discusses how transilluminators can cause patients burns and the precautions to take to avoid this occurrence.

Transporting Critically Ill Patients
Guidelines for transporting critically ill patients were published simultaneously in the June 1993 issue of Critical Care Medicine (21[6]:931-7) and the May 1993 issue of the American Journal of Critical Care (2[3]:189-95). Developed by a task force composed of members from the American College of Critical Care Medicine, the Society of Critical Care Medicine, and the American Association of Critical-Care Nurses (AACN), these guidelines, summarized below, outline the reasons and requirements for transporting patients, including the personnel who should be involved and the equipment (including monitors) that should accompany the patient. The task force's recommendations are consistent with ECRI's previous recommendations, also summarized below, but are more comprehensive and stringent in some respects and provide additional details.

Undetected Upstream Occlusions in Volumetric Infusion Pumps
After a member hospital evaluated its infusion pumps, it found that several pumps could not detect an occlusion in the upstream (bottle-side or proximal) IV line. This problem can result when hospital personnel fail to release the upstream manual clamp (if one is present) after activating the pump. Other mechanisms that can cause an upstream occlusion are a clogged upstream filter or a nonvented bottle used with a nonvented IV set. In these situations, some pumps will continue to operate, but the patient will not receive the infusion.

Undetected Venous Line Needle Dislodgment during Hemodialysis
ECRI recently received two reports of hemodialysis machine venous line needles dislodging from patients during treatment without triggering a venous pressure alarm. In both cases, it was determined that the back pressure created by the narrow-bore needles that were being used had prevented the machine's venous pressure monitors from sensing the loss of pressure created by the dislodgment.

Unshielded Radiant Heat Sources
A member hospital reported that heat radiating from an infant warming lamp caused two nearby compressed air hoses to burst. Although a patient was in an incubator below the warming light at the time of the incident, no injury occurred. However, the reporting hospital expressed concern that a fire could result if such a rupture occurred in an oxygen hose.

Use Heated Nebulizers Properly
ECRI's recommendations for the safe use of heated nebulizers are given in poster form.

Use of Filters on Medical Gas System Outlets and Vacuum System Inlets
Member hospital: For several years, we have been using filters on our medical gas system outlets to trap dirt, bacteria, and water conveyed by the systems. We have also been using filters on our medical vacuum system inlets to prevent fluids, condensate, and smoke from contaminating the system. Are these uses of filters appropriate? Also, is it appropriate to use our vacuum system for smoke evacuation?

Use of Inadequate (Old) Anesthesia Scavenger Interfaces
ECRI investigated an incident in which a patient undergoing a laparotomy under general anesthesia suffered a bilateral pneumothorax at the end of surgery, requiring ventilation with a resuscitator. The pneumothorax developed immediately after the selector switch of an anesthesia absorber was shifted from "Ventilator" to "Bag/APL" (adjustable pressure limit) and the flush valve was pressed to fill the bag. The bag did not fill, and the flush and fresh gas then flowed directly into the patient. An old scavenger interface was in use at the time of the incident.

Use of Incompatible Dermatomes and Blades
In preparation for harvesting skin for grafting, one brand of disposable dermatome blade was inserted into a different brand of dermatome. The disposable blade apparently fit well, although it had no marks identifying the manufacturer or the proper blade orientation. When the surgeon attempted to use the dermatome to shave off a thin patch of skin, it made deep lacerations. The blade was then turned over and used again with the same result. A blade that is of the same brand as the dermatome has a different shape than the incident blade and is designed so that it cannot be installed incorrectly, was then used, and the dermatome performed properly.

Use of Nurse Call Pendants and Pillow Speakers by Patients Receiving Oxygen Therapy
Member hospital: Our nurse call pendants and pillow speakers bear a notice stating that they are not to be used in locations where oxygen is being administered. We understand that other institutions are permitting patients who are receiving oxygen to use these controls. What should we do?

Use of Wrong Gas in Laparoscopic Insufflator Causes Fire
In preparation for laparoscopic surgery, a technician was directed to obtain a full "E" cylinder of carbon dioxide for the laparoscopic insufflator. The technician obtained a cylinder that was gray on top and green on its lower section and that had only part of a label that read "Carbon Dioxide." The technician connected the cylinder to the gas yoke of the insufflator, and the surgery proceeded.

Near the end of the procedure, the operative field rapidly became obscured by black smoke. After withdrawing the electrosurgical probe, the surgeon found that the probe's insulation had been burned away and that the trocar sheath had partially burned and melted.

Use of Wrong Gas in Laparoscopic Insufflator Causes Fire (Update)
In our original Hazard Report on a fire that occurred during laparoscopic surgery, we noted that pin indexing of medical gas cylinders and yokes can help prevent the use of the wrong gases with laparoscopic insufflators. In that incident, a cylinder containing a mixture of carbon dioxide and oxygen was used instead of a cylinder of carbon dioxide only.

Use Special Care with Disposable Anesthesia Patient Circuits
ECRI's recommendations for safe use of disposable anesthesia patient circuits are given in poster form.

User Checklist for Defibrillator/Monitor/Pacemakers
ECRI's user checklist for the safe use of defibrillator/monitor/pacemakers is presented. 

User Error and Defibrillator Discharge Failures
Many incidents have been reported involving failure of the defibrillator of battery-powered defibrillator/monitors to discharge during cardiac emergency responses. Most of the affected units were being used to provide external emergency defibrillation for ER, CCU, or ICU patients at the time of the failures.

Using Portable Hyperbaric O2 Chambers in Patient Rooms
Member hospital: Is it safe to use portable hyperbaric oxygen chambers in patient care rooms? We intend to use these devices for wound therapy on limbs.

Vaporizer Leak with Mapleson Breathing Circuits
A member hospital reported that a leaky vaporizer caused a child to suffer a cardiac arrest when used in a system composed of a humidifier and a Mapleson E breathing circuit. A pre-use test had disclosed a leak in the humidifier. The leak was tightened, and this supposedly corrected the problem. The leak test was performed only on the complete system, which is permitted a higher leakage rate, not on the anesthesia unit alone.

X-Ray Detectable Surgical Sponges
Member hospitals have reported an inability to radiographically detect sponges labeled as "X-Ray Detectable" or "Radiopaque" following loss in patients during surgery. The problem is most acute with small sponges used in surgery of the head and spine, since their presence is frequently masked by nearby bone.




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