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
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
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
— Radio frequency (RF;
electrosurgery, magnetic resonance imaging [MRI] field coils)
— DC (batteries, circuit
continuity monitors, pacemakers, nerve and muscle stimulators)
— AC (60 Hz line
— 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)
— 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
— 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
- Pharmacologic Adverse Reactions
— Warfarin therapy (e.g.,
— Intra-arterial injection of
Bicillin (penicillin G)
— Drug infiltration at a
— High-dose injected
— Allergic reaction (e.g., to
adhesives, electrode gel, ointment, and skin prep solution)
— Aplasia cutis
— Chronic chilblain
— Ecthyma gangrenosum
— Lesions secondary to lupus
erythematosus or Hodgkin's disease
— Lichen sclerosus et
— Livedo reticularis
— Livedo reticularis
— Purpura fulminans
— Necrotizing fasciitis
— Ischemic lesions resulting
a. Peripheral vascular disease
b. Diabetes mellitus
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
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.
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
There are seven basic causes of medical device related injuries:
- Operator or patient error
- Design defect
- Manufacturing defect
- Random component failure
- Faulty repair, inspection, or calibration
- Sabotage or malicious intent
- 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
- Consideration of the incident report and collected
evidence, such as photographs
- Collection of baseline patient and equipment
- 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 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.
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
- Shape and dimensions at the time of discovery.
- Color and texture at discovery.
- Location on the body and relation to placement of
- Injury depth estimation upon discovery (i.e., first, second, or third
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.
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.
* * *
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
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
- 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
- Direct patient contact with a grounded metal object should be
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.
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.
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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