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
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
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
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?
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
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
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
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.
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
investigated or become aware of a number of hazards involving calibrated
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
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
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
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
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
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
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
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
beginning an evaluation of ECG electrodes to determine which brands are
technically suitable for hospital application. Can you offer any
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
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
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
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
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, 16:35-6). 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
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
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
Extinguishing Airway Fires
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
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
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
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
For Emergency Defibrillation
ECRI's recommendations for safely performing
emergency defibrillation are given in poster form.
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
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
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.
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
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
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.
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.
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
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
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
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
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
Infusion Pump Air Detection
ECRI discusses the appropriate range of air-detection
volumes for infusion pump air-in-line detectors.
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
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
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
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
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
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
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
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
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
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
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
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
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
Misconnection of Bipolar Electrosurgical Electrodes
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
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
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
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
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
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
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
OR Renovations and the Use of Isolated Power and Explosion-Proof Plugs
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
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
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
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
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
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
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
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
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)
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
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
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
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), 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
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
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
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
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
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
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
The Difficulty of Reprocessing Reusable Rigid Laparoscopic Forceps and Other Endoscopic Accessories: Are Disposables the Answer?
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
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
The Risks Associated with HVAC Drip Pans
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
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
Training Recommendations for Autotransfusion Unit Operators
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 (21:931-7) and the May 1993 issue of the American Journal of Critical Care (2:189-95).
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
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
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
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
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
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
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
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.