Cause of Device-Related Incident
*Not stated

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; Nursing; Pathology

Device Factors
*Not stated

Document Type
Guidance Articles

External Factors
*Not stated

Mechanism of Injury or Death
*Not stated

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

Investigating Device-Related "Burns"



Guidance [Health Devices Jul 1993;22(7):334-52]

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

The Occurrence of Accidental Skin Injury

Despite a great deal of care and concern by medical, nursing, surgical, and engineering personnel, patients continue to suffer inadvertent skin injury in the operating room (OR) and in special care areas (e.g., intensive care units [ICUs], cardiac care units [CCUs]) of the hospital. Such injuries can prolong morbidity and extend hospitalization, appreciably increasing medical costs to the patient and hospital. The hospital and surgical team may also face liability costs if the injured patient brings suit.

Medical devices are frequently blamed for accidental skin injuries. While such injuries may have the appearance of a full- or partial-thickness burn, thermal or electrical sources are not always involved. In many cases, the injury may be an abnormal or idiosyncratic physiologic response to otherwise normal conditions of use and performance of that device. Alternatively, the injury may be due to pressure necrosis, an adverse drug reaction, or a disease process that happens to develop in the area where a device was applied. (See "Causes of Accidental Skin Injuries," below.) It is therefore misleading (and in many cases inaccurate) to refer to an injury as a "burn." "Lesion" is a more appropriate term that allows the consideration of other causes.

In approaching the problem of skin injury, clinical engineers, risk managers, and OR managers need to address these questions: What are the various kinds of skin injury, and where in the hospital do they occur? What procedures should be followed immediately after discovery of an injury? Who should be involved in an investigation? What information should be gathered? What measures should be implemented to prevent future occurrences? How and when should the hospital communicate with the manufacturer of implicated devices?

An understanding of the possible causes and effects of skin injury, combined with an effective investigation procedure, enables investigators to identify the actual cause of a particular injury, recommend precautions, and minimize future risks to patients and the hospital.

This article presents guidelines for organizing and conducting a thorough skin-injury investigation. These guidelines apply to all sites in the hospital where accidental skin injury occurs or is discovered (e.g., ORs, recovery rooms, ICUs).

Causes of Accidental Skin Injuries

  • Electrical

Radio frequency (RF; electrosurgery, magnetic resonance imaging [MRI] field coils)

DC (batteries, circuit continuity monitors, pacemakers, nerve and muscle stimulators)

AC (60 Hz line voltage)

  • Thermal

Direct contact (heating pads, diathermy, electrocautery, unlubricated surgical drill shank, flash-sterilized surgical instruments, heated probes)

Irradiant (radiant warmers, exam and operating lights, fiberoptic light cables, lasers)

Exothermic chemical reaction (Merthiolate on aluminum electrode)

  • Chemical

Povidone-iodine prep solutions (problems with lot-specific formulations or solution pooled under a patient that reacts with other solutions or with residual laundry chemicals in linens)

Ethylene oxide (EtO; improper aeration of EtO-sterilized devices)

Improper electrode (ECG) plating components reacting with conductive paste

  • Mechanical

Constant high pressure in excess of two to three hours (e.g., positioning, supports, straps, pinching); time required may be shorter with very high pressure

Pneumatic tourniquets

Tenacious electrode adhesive

  • Pharmacologic Adverse Reactions

Warfarin therapy (e.g., Coumadin)

Intra-arterial injection of Bicillin (penicillin G)

Drug infiltration at a catheterization site

High-dose injected barbiturates

  • Physiologic/Medical

Allergic reaction (e.g., to adhesives, electrode gel, ointment, and skin prep solution)

Aplasia cutis (neonates)

Chronic chilblain (pernio)

Ecthyma gangrenosum

Lesions secondary to lupus erythematosus or Hodgkin's disease

Lichen sclerosus et atrophicus

Livedo reticularis

Livedo reticularis idiopathica

Purpura fulminans

Necrotizing fasciitis

Ischemic lesions resulting from:

a. Peripheral vascular disease

b. Diabetes mellitus

c. Cryoglobulinemia

d. Arterial emboli of atherosclerotic plaque (blue-toe syndrome)—iatrogenic, intraoperative, or otherwise

e. Anterior-compartment syndrome

Building Blocks for a Thorough Investigation

Steps taken before a surgical procedure will facilitate the investigation of any skin injury that develops afterward. Before a procedure, surgical nursing and/or medical personnel should thoroughly examine the patient's skin. A description of the general skin condition, as well as any unusual conditions (rashes, reddened or discolored areas, contusions, cuts, abrasions, or other abnormalities), should be recorded in the surgical notes.

Ideally, the surgical notes for each patient would also include information on the manufacturer, lot numbers, and expiration (or "use before") dates of prepping solutions, electrodes, and electrode gels, as well as information on manufacturers, models, hospital control numbers, and serial numbers of equipment. However, because it is impractical to expect OR personnel to record this information, it should be collected at the first sign of a skin injury.

As soon as possible following a surgical procedure, personnel should examine the patient's skin and record any observed changes or abnormalities. In some cases, the patient's physical condition may not permit an immediate and thorough postoperative skin check, but accessible areas (e.g., the buttocks, heels, thighs, elbows, head, electrode sites) should be checked. The nursing staff should check other areas as soon as possible.

When a suspected device-related lesion is discovered, personnel should preserve and thoroughly document the evidence, especially all disposables and packaging. Contaminated disposables or other instruments should be stored in appropriate biohazard containers. When practicable, color photos of the skin injury should be taken immediately after discovery and 24 and 48 hours afterwards (permission from the patient or family may be necessary). Photographs should have some indication of the scale of the lesion (e.g., using a coin or ruler).

If possible, surgical and medical personnel should not move or disconnect the equipment, except as necessary to care for the patient or to prevent further injury or equipment damage. When it is not possible to preserve the physical setup of the involved equipment and devices, personnel should record the scene with photographs or sketches. Color photographs should be taken before inspection of devices that may be damaged when examined (such as a disposable electrosurgical unit [ESU] dispersive electrode). Ensure that no involved materials or devices are released to the manufacturer until completion of the internal incident investigation. However, when required, a timely report should be supplied to the manufacturer in compliance with the Safe Medical Devices Act (SMDA; U.S. hospitals only).

The head nurse of the department in which the injury occurred should fill out an incident report and record the immediate observations of all involved personnel. To avoid premature or inaccurate conclusions, the incident report should include only facts (e.g., "Postoperative skin check revealed lesions on the patient's right buttock and heel") and not speculation or supposition (e.g., "Patient received electrosurgical burns on right buttock and heel"). The head nurse should make sure that all personnel involved in the incident complete incident reports, as well.

Discussion with the patient and family about the injury should be honest and cautiously diplomatic. The actual cause of the injury probably will not be known before the incident is discussed with the patient. As such, offering specific theories can be misleading and provoke litigation. For example, if a patient develops a palm-sized lesion over the sacrum on the day following a lengthy cardiovascular surgical procedure, pressure necrosis is the probable cause. But we know of cases like this in which the nursing, medical, or surgical staff told the patient, "The electrosurgical machine accidentally burned you during the surgery." Such statements frequently lead the patient to seek legal counsel, sometimes even before leaving the hospital. A more productive and factual approach is to tell the patient that there is "an injury" or "an area of skin breakdown" and that it will be treated. In some cases, it may be suitable to also mention that the cause is being investigated.

The Investigation Process

An investigation need not be a threatening experience for anyone. The goal of the investigation is to determine what happened and recommend appropriate preventive measures—not to assign blame. This should be explained to all personnel involved in the incident.

There are seven basic causes of medical device related injuries:

  1. Operator or patient error
  2. Design defect
  3. Manufacturing defect
  4. Random component failure
  5. Faulty repair, inspection, or calibration
  6. Sabotage or malicious intent
  7. An abnormal or idiosyncratic physiologic response to otherwise normal conditions of use and performance for that device

To ensure thoroughness and accuracy, each of these must be considered in any investigation. Time is also a significant factor. The longer it takes to mount and complete an investigation, the greater the probability that the cause will grow elusive as evidence is lost, memories dim, defensive rationalizations crystallize, and speculation clouds the process. The case studies below show the types of information that should be collected and considered during an investigation. If there is a reason to suspect medical device related injuries, there is also a limited timetable for submission of an SMDA report to the manufacturer.

The Investigation Team

The investigation team should include staff members who are familiar with the equipment used and the environment in which the incident occurred. The team might include a clinical engineer, an OR or critical care nurse (frequently the supervisor for one of these departments), a physician, an equipment technician, and the risk manager. The risk manager will help ensure that proper steps are taken to preserve confidentiality and maintain legal compliance.

The chosen coordinator should understand the various mechanisms of skin injury and the investigative process. To ensure objectivity, no one who had primary responsibility for the patient before or after the injury should be included on the team. Also, the team must be careful to fairly represent different interpretations of the incident: what one person calls operator error may be interpreted by someone else as inadequate equipment design or a device failure.

It may be beneficial to deploy qualified, independent external investigators in some cases. For example, the hospital may lack the in-house expertise to investigate the incident; also, the potential for bias or concealment exists in any in-house investigation. External investigators can be helpful in exploring both technical and legal issues, especially when litigation is likely. Because they have no preconceived notions, external investigators are usually objective and cooperative, rather than defensive or adversarial. With in-house investigators, there may be the risk of damaging long-term working relationships.

The Investigation Format

A thorough investigation of accidental skin injury should include the following:

  • Consideration of the incident report and collected evidence, such as photographs
  • Collection of baseline patient and equipment information
  • Documentation and assessment of the lesion's appearance and progression
  • Inspection and testing of equipment used
  • Interviews with involved personnel

The investigation team should review the clinical and surgical procedures and conditions of the incident and the lesion's clinical appearance and collect the baseline information before performing equipment inspections and interviews.

Baseline Information

Baseline information on both the patient and the equipment is required for the investigation. Much of the patient baseline information will come from the patient's chart. Before conducting any interviews, the patient's chart should be thoroughly reviewed because it will indicate the hospital personnel most appropriate to be interviewed. The investigation team should make sure that equipment information is recorded for all devices involved in the incident, including disposables. For devices that are routinely inspected, the date of the "last" inspection and the "due" date must be recorded. If available, equipment performance history should also be reviewed.

Lesion Assessment

Characteristics of the lesion itself are frequently the best indicators of its cause. They include the following:

  • Time of lesion discovery in relation to the patient's surgery or application of a suspect device (the actual elapsed time is very important). Lesions from thermal or electrical sources (e.g., ESUs) typically show up right away. Lesions due to chemical exposure or pressure necrosis will take longer to appear, often hours or days after a procedure.
  • Shape and dimensions at the time of discovery.
  • Color and texture at discovery.
  • Location on the body and relation to placement of suspect devices.
  • Injury depth estimation upon discovery (i.e., first, second, or third degree).

Changes in any of these characteristics should be noted as the injury progresses. Color photographs are the best way to document changes in the condition of the injury. The time, date, and scale should be recorded for each photograph. The use of the same lighting conditions should be maintained when taking photographs.

Equipment Inspection

After discovery of a suspected device-related skin injury, all equipment that may be involved, including disposables, should be sequestered until it has been inspected. Most equipment, of course, can be immediately returned to service because it will be obvious that it played no role in the injury. However, no suspect device should be returned to service until it has been eliminated as a possible cause of patient injury. The manufacturer should not be permitted to remove equipment or disposables from the hospital because the hospital then loses all access to them. The hospital should not send such devices to their manufacturers or distributors, nor should vendors be permitted unwitnessed access to the devices for inspection or repair. In many cases, evidence that might protect the hospital is lost or compromised.

Depending on the nature and location of the injury, the equipment, devices, and solutions that may have to be inspected include ESUs and accessories (active electrodes, dispersive electrodes, cables, and electrode gels); hypo/hyperthermia units (with associated blankets and patient temperature probes); heating pads; heat lamps; lasers and laser fibers; radiant warmers; diathermy units; endoscopes (with their light sources); transilluminators; transcutaneous oxygen and carbon dioxide electrodes; pulse oximeters and pulse oximeter probes; nerve stimulators and stimulator electrodes; intra-aortic balloon pumps; tourniquets; antishock trousers; monitors such as ECG, EEG, and temperature (with associated cables, electrodes, and probes); cardiopulmonary bypass equipment; beds; OR tables; anesthesia masks and tubing; prepping and degreasing agents; ointments; and linens.

No one who ordinarily maintains suspect equipment should inspect it following an incident, as he or she may not recognize past errors or may even try to conceal them. If alternate technical personnel are not available, an outside, independent examination of equipment may be most effective. The manufacturer may want to witness equipment inspections, and it is usually in everyone's best interest that this be permitted. Inspections are best undertaken by the hospital's risk manager and clinical engineer, an outside investigator, and the manufacturer simultaneously.

* * *

CASE STUDIES

The following composite case studies of skin injury are based on ECRI investigations. Both show, in brief, the type of information that an investigation should strive to obtain.

Case Study I

A male patient underwent a transurethral resection of the prostate that took approximately 55 minutes to complete. A ground-referenced electrosurgical unit (ESU) was used for the procedure. An ECG monitor was connected to the patient.

The ESU was set up by the circulating nurse, and the dial was initially set at 3 in the cut mode. The dial setting was increased from 3 to 7 after the surgeon noticed inadequate surgical effect. Before the request for the increased dial setting, a member of the OR staff tripped on the dispersive electrode cable.

The dispersive electrode was applied to the lateral left thigh before the patient was placed in the lithotomy position for the procedure. The electrode was not checked for proper contact with the patient following repositioning. After the procedure, when the drapes were removed from the patient, it was noticed that the conductive portion of the dispersive electrode was no longer in contact with the patient. There was no injury beneath the dispersive electrode. However, a routine postoperative skin check revealed an area of skin injury behind the patient's knee, which had been in contact with a portion of the metal knee support. The knee supports were covered with padding, except where a portion had been worn away. The injured area was a light cream color, was hard to the touch, and had a red rim. It measured approximately 1.5 x 3 cm.

What Caused the Injury?

When the OR staff member tripped on the cable, the dispersive electrode was pulled off the patient. Because the intended path for electrosurgical currents was no longer connected to the patient, the electrosurgical currents found an alternate pathway through the patient/metal contact on the knee support. The dial setting was increased to overcome the resistance offered by the patient's dry skin in contact with the knee support. Current flow through this small area of patient contact caused tissue damage at this site.

Precautions

  • The patient should be placed in the final surgical position before the dispersive electrode is applied. If the patient is repositioned, the patient/dispersive electrode contact should be checked.
  • During a surgical procedure, the dial setting on the ESU should not be increased without first checking all cables and connections, especially the dispersive electrode. Any increase should be minimal; the large increase from 3 to 7 was an indication that something was wrong.
  • Direct patient contact with a grounded metal object should be avoided.

Case Study II

An obese, middle-aged, diabetic patient with a history of peripheral vascular insufficiency underwent emergency surgical repair of a ruptured aortic aneurysm. The surgery lasted five hours; the patient remained unconscious in the recovery room for another three hours. During the surgery, the aortic cross-clamp time was 1 hour and 45 minutes. A grounded ESU and hypo/hyperthermia unit with an attached disposable full-length pad were used throughout the procedure.

The ESU dial was initially set at 3 in the cut mode and 4 in the coagulation mode. The coagulation dial setting was increased from 4 to 5 at the surgeon's request midway through the procedure. The dispersive electrode was applied to the patient's left thigh and was found intact at the end of the procedure.

The hypo/hyperthermia unit and pad were used during the beginning of surgery to cool the patient. They were then used to warm the patient during the last hour of surgery and during the three hours when the patient was in the recovery room. When warming, the unit operated at its normal maximum temperature of 105° F to 107° F.

Because this was emergency surgery, the surgical prepping solution had been poured on the patient, and it had pooled beneath him on the operating table.

The routine postoperative skin check revealed no obvious injuries other than slight mottling on the patient's back, buttocks, and legs from the patterns in the hypo/hyperthermia pad. Eighteen hours after surgery, blistering skin lesions were found on the patient's sacral area and adjoining upper buttock area. This lesion area measured approximately 7 x 15 cm, was red across its entire surface with blisters beginning to form, and felt warm and firm in and around the involved area. In addition, erythematous lesions began to develop on the posterior and lateral aspects of the patient's calves. Within 24 hours, the calf lesions developed red discoloration and blisters and had progressed to frank necrosis in some areas.

What Caused the Injury?

Inspection of the hypo/hyperthermia unit and pad revealed that they were operating within the manufacturer's specifications, as was the ESU. Neither of these devices caused the lesions. Rather, the injuries were caused by two separate mechanisms unrelated to the technology used during the surgery.

The sacral injury was ischemic pressure necrosis resulting from prolonged immobility and aortic clamping during the lengthy surgery. Further immobility during recovery also contributed to the development of the lesions, as did the wetness from pooled prep solutions. The lesions on the lower legs were an adverse drug reaction to warfarin, an anticoagulant that the patient was taking preoperatively and postoperatively as treatment for his poor peripheral perfusion.

Precautions

In this case, the patient's injuries were idiosyncratic responses to equipment employed under normal operating conditions. The extent of the sacral injury may have been somewhat lessened by the use of a silicone gel-filled operating table pad or an air mattress operating table pad, but this is by no means certain.

OR staff should also have taken care during prepping to prevent pooling of prep fluids beneath the patient. Pooled fluids can cause skin maceration, making the skin less tolerant of intraoperative pressure.

Conclusion

A thorough investigation of a skin injury includes consideration of all possible device and/or solution interatctions. It must also  consider the possibility that the injury was an allergic reaction, disease, or idiosyncratic response. While it is easy to assume that a certain device or solution caused the injury simply because it was used, such assumptions are often incorrect and may preclude considerations of other possibilities. Hasty conclusions that a device or operator was at fault may bias the investigation, mislead the patient into bringing suit, and unjustly impugn personnel, equipment, service organizations, or manufacturers.

The investigation team must make sure that all possiblities are explored and that everyone involved in the incident is questioned. Only then will it be possible to develop effective preventive measures.

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