1. Monitoring (e.g., ECG, capnometry, pulse oximetry, nerve monitoring)
2. Patient warming and cooling
3. Surgical drills
4. Lasers
5. MR imaging
6. Fluoroscopy
7. Fiberoptic light sources.
8. Monitoring (e.g., ECG, capnometry, pulse oximetry, nerve monitoring)
9. Patient warming and cooling
10. Surgical drills
11. Lasers
The discussions of intraoperative tissue injury mechanisms from such electrical, thermal, or radiation emitting surgical devices highlight and point to the types of information that should be collected and considered during an investigation. Historically, the dissemination of innovation in healthcare has been a slow process [3]. Patient safety initiatives, as a facet of the process of healthcare delivery, also suffer from a slow pace of adoption, especially related to the safe use of medical technologies. For electrical, thermal, or radiation based surgical technologies , the reality is that the recommendations for safe application of the technologies have been in the medical literature and equipment user manuals, for decades in many cases, but the understanding and adoption of those safe practices by members of the surgical team has lagged [4–6]. Clinical residencies serve critical purposes for the surgical team members to become proficient in the use of technology. However, such didactic training rarely stresses the need for users to read the device’s user instructions or to understand how the device functions. This is remarkably different than industry safety standards. Understandably, time available for medical and nursing training is limited. However, safety of the surgical patient related to the technologies applied to them is enhanced by clinicians having an understanding of how a device functions along with the associated warnings and precautions .
Keeping the surgical patient safe from perioperative skin and tissue injury caused by electrical, thermal, or radiation emitting medical technologies is enhanced by surgical team members understanding potential etiologies of skin and tissue injury related to the involved technologies, knowing how to investigate such adverse events in order to develop and employ measures to prevent some of the more common causes of such injuries.
Etiologies of Intraoperative Tissue Injury
There are many potential etiologies of accidental injury to skin and tissues during surgery. Intraoperative injuries that are suspected of having been caused by a medical device and its related energy may, however, not be related to a technology. In many cases, the injury may be an abnormal or idiosyncratic physiologic response to otherwise normal conditions of device use and performance. Alternatively, the injury may be due to pressure necrosis, tissue chemical sensitivity, an adverse drug reaction, or a disease process that happens to develop in the area where a device was applied. The causes and prevention of tissue and nerve injuries related to pressure and patient positioning [7–12] are addressed in Chap. 17 in broader detail. In this regard, alternative etiologies beyond those of energy emitting technologies need to be recognized and considered to determine the nature of the injury, appropriate treatment, and develop recommendations for preventing recurrence. While these may appear obvious in particular cases, the seemingly obvious explanation for a skin injury is often not the correct one.
Although certain medical procedures (e.g., electrosurgical procedures) are known to present the risk of causing device-related burns or other accidental tissue injuries, it is important to not rush to judgment about the nature or cause of such injuries. Over a period of 45 years of investigating patient injuries and deaths from errors and accidents involving healthcare technology, instruments, devices, and systems, ECRI Institute has observed that perioperative skin and tissue injuries are usually much more complex than what they seem [4, 13–16]. Table 31.2 lists the potential etiologies to consider when presented with a skin or tissue injury that is suspected of having been caused by a medical technology or device. The major etiologies include electrical, thermal, radiation, chemical, mechanical, pharmacologic adverse or allergic reactions, and physiologic/medical (including diseases). Within these categories are listed the subordinate mechanisms of injury and the more common involved devices.
• Electrical |
– Radiofrequency (RF): electrosurgical units (ESUs), RF prostate heating probes, intrauterine ablation probes. |
– Direct Current (DC): nerve and muscle stimulators, pacemakers, batteries, ESU circuit continuity monitors |
– AC (60 Hz line voltage): OR table, general electro-medical equipment in the OR. |
• Thermal |
– Direct contact: heating pads, cooling pads, electrocautery, diathermy, heated irrigation solution bag, heated cotton blanket, powered surgical handpieces (drills, saws) unlubricated, flash-sterilized surgical instruments, heated prostate or intrauterine probes |
– Irradiant: (radiant warmers, exam and operating lights, fiberoptic light cables, lasers, high intensity aiming lights in mobile X-ray heads) |
• Chemical |
– Povidone-iodine prep solutions (problems with lot-specific formulations; solution pooled under a patient that reacts with other solutions or with residual laundry chemicals in linens; mixing with alcohol or hydrogen peroxide) |
– 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 contours, supports, straps, worn OR table mattresses pinching); time may be shorter with very high pressure |
– Pneumatic tourniquets |
– Tenacious electrode adhesive |
• Radiation |
– Diagnostic imaging |
– Therapeutic treatment |
• 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 injection in subcutaneous or fat layer |
• Physiologic/Medical/Disease |
– Allergic reaction (e.g., to adhesives, electrode gel, ointment, and skin prep solution) |
– Aplasia cutis (neonates) |
– Chronic chilblain (pernio) |
– Ecthyma gangrenosum |
– Disseminated intravascular coagulopathy (DIC) |
– Lesions secondary to lupus erythematosus or Hodgkin’s disease |
– Lichen sclerosus et atrophicus |
– Livedo reticularis |
– Livedo reticularis (including idiopathica) |
– Purpura fulminans |
– Necrotizing fasciitis (“flesh eating bacteria”) |
– Ischemic lesions resulting from: |
⚬ Peripheral vascular disease |
⚬ Venous stasis |
⚬ Diabetes mellitus |
⚬ Cryoglobulinemia |
⚬ Arterial emboli of atherosclerotic plaque (blue-toe syndrome)—iatrogenic, intraoperative, or otherwise |
⚬ Anterior-compartment syndrome |
Medical devices are frequently blamed for perioperative accidental skin and tissue injuries, particularly for those that have the appearance of a full- or partial-thickness burn. However, thermal or electrical sources are not always involved. It is therefore misleading—and in many cases inaccurate—to refer to such an injury as a “burn.” For these injuries, “lesion” is a more appropriate term because it enables a more deliberate discussion about the consideration of other causes when analyzing the root causes of the lesion [18].
Histology and Etiology
Histologic examination of specimens from the injured tissue can potentially be revealing as to the type of energy insult that caused the injury, including differentiating between an electrosurgical injury and a thermal injury. Guidance for undertaking histologic analysis has been published specific to electrosurgical injuries [19, 20] and is available in a well-known pathology reference text [21]. The pathology and pathogenesis of cutaneous thermal burns is addressed in the seminal works on the study of thermal injury in humans [22, 23].
If tissue specimens can be obtained without stress to the patient, such analysis can go a long way in understanding the root cause of injury, including the devices truly involved in the cause, and aid in understanding how to prevent recurrence. It can also prevent rancorous debate between departmental clinical staff and prevent legal challenges. Unfortunately, tissue specimens are not typically available for histologic analysis. Nevertheless, awareness of the ability of histologic examination to assist in differentiating between an electrosurgical insult and a thermal insult should be part of the investigative approach.
Investigation Guidelines for Perioperative Skin and Tissue Injuries
When an accidental injury is suspected to have occurred during surgery, healthcare facilities typically initiate an investigation to determine both the nature of the injury and the cause. While these may appear obvious in particular cases, the seemingly obvious explanation for a skin injury is not always the correct one [17, 24]. The guidelines presented here will help healthcare personnel organize and conduct a thorough skin injury investigation to identify the cause of an accidental skin injury. The questionnaire in Appendix 1 facilitates the investigation process (see page 538).
When approaching the problem of tissue injury, the questions listed in Table 31.3 need to be addressed in addition to the questions contained in Appendix 1.
Table 31.3
Questions to consider when investigating perioperative skin and tissue injuries suspected of having been caused by a medical technology
1. What are the various kinds of skin and tissue injury, and where in the hospital do they occur? |
2. What procedures should be followed immediately after discovery of an injury? |
3. Who should be involved in an investigation? |
4. What information should be gathered? |
5. What measures should be implemented to prevent future occurrences? |
6. How and when should the hospital communicate with the manufacturer of implicated devices? |
7. What are the various kinds of skin and tissue injury, and where in the hospital do they occur? |
8. What procedures should be followed immediately after discovery of an injury? |
9. Who should be involved in an investigation? |
10. What information should be gathered? |
11. What measures should be implemented to prevent future occurrences? |
An understanding of the possible causes and effects of perioperative skin and tissue injury, combined with an effective investigation procedure, enables investigators to identify the actual cause of a particular injury and recommend precautions, thereby helping to minimize future risks to patients and to healthcare facilities.
Injury Prevention and Management: Pre- and Post-Operative Considerations
Perioperative Steps:
A few routine clinical steps and recorded information, listed in Table 31.4, will facilitate the investigation of any skin injury that develops afterward.
Table 31.4
Clinical steps and recorded information that facilitate the investigation
Skin condition | 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 patient history, perioperative record, or surgical notes. Information obtained during a preoperative skin check will allow staff to identify changes that might have occurred during or after the procedure |
Perform a postoperative skin check | 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., buttocks, heels, thighs, elbows, head, electrode sites) should be checked. The nursing staff should check other areas as soon as possible. Pictures should be taken immediately and in regular intervals to follow the progressing of the skin injury |
Medical technology information | The surgical notes for each patient should 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 operating room personnel to record all this information, the available information should be collected at the first sign of an injury by the investigative team |
Finding an Injury
If an injury is found or suspected, the steps detailed in Table 31.5 will help in determining the cause:
Table 31.5
Clinical steps and recorded information that facilitate the investigation
Evidence preservation | Preserve and document the evidence. 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 |
Delayed injury onset | Be aware that injury to internal organs, e.g., bowel, from electrosurgical current may not manifest until several days post-op. Nevertheless, upon discovery, efforts need to be made to obtain relevant information on the electrosurgical devices and instruments used |
Photographs of injury | In collaboration with risk management personnel, and if practical, take color photos of the injury immediately after discovery and 24 and 48 h afterward (permission from the patient or family may be necessary). Photographs should provide some indication of the scale of the lesion (e.g., using a coin or ruler) |
Medical equipment handling | 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 dispersive electrode used with an ESU |
Maintaining evidence possession | Ensure that no involved materials or devices are released to the manufacturer or other outside parties until completion of the internal incident investigation or until approval has been given by risk management or administration |
Incident Report Documentation
Completion of an incident report and record of immediate observations of all involved personnel is indicated. To avoid premature or inaccurate conclusions, the incident report should include only facts, not speculation or supposition. For example:
Incorrect: “Patient received electrosurgical burns on right buttock and heel.”
Correct: “Postoperative skin check revealed lesions on the patient’s right buttock and heel.”
Patient and Family Discussion
Institutional policy will guide the discussion with the patient and family. The discussion with the patient and family about the injury should be honest with full disclosure while being cautiously diplomatic [17, 25]. The actual cause of the injury probably will not be known before the incident is discussed with the patient and their family. 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 with many potential underlying co-morbidly factors that contributed to the lesion development. Unfortunately, in many such cases, the nursing, medical, or surgical staff has told the patient, “The electrosurgical machine accidentally burned you during the surgery.” 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 mention that the cause is being investigated in open and transparent matter [26].
Components of a Thorough Investigation
Skin or tissue injuries sustained—or suspected of having been sustained—by patients in the operating room are often initially mistaken for thermal or electrical burns, with medical devices immediately blamed as the cause. However, such a hasty conclusion can overlook the actual cause of the injury (see Table 31.1 for the list of potential etiologies) and delay the implementation of measures to prevent future occurrences. Below is a thorough investigation process to help clinical investigators uncover the real cause of an accidental skin injury.
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. To aid the patient safety process during investigation of a perioperative skin or tissue, the questionnaire in Appendix 1 can be used by investigators to collect information during staff interviews and to summarize needed baseline patient and equipment data.
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, a surgical or critical care nurse, 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, the surgical setting, and the investigative process. To ensure objectivity, no one who had primary responsibility for the patient before or after the injury should be included in 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 [27].
It may be beneficial to deploy qualified, independent external investigators in some cases including experts in human factors and accident investigation in the healthcare setting [28]. 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. External investigators are usually objective and cooperative, rather than defensive or adversarial. With in-house investigators, there may also be the risk of damaging long-term working relationships.
Identifying the Cause
When trying to ascertain the cause of any accident involving healthcare technology, instruments, devices, and systems, the investigation should consider the five broad categories listed below [13, 29]. Within each of these categories are listed the relevant subcategories that may need to be considered when investigating suspected perioperative device-related skin or tissue injuries or burns. To ensure thoroughness and accuracy, each of the factors and issues listed in Table 31.6 must be considered in any investigation.
Table 31.6
Causal factors to consider in the investigation
Device factors | Device failure |
Design or labeling error | |
Manufacturing error | |
Packaging error | |
Software deficiency | |
Random component failure | |
Failure of an accessory | |
Device interactions | |
Improper maintenance, testing, repair, or lack or failure of pre-use incoming inspection | |
Improper modification | |
External factors | Power supply failure |
Medical gas/vacuum systems | |
Electromagnetic or radiofrequency interference (EMI or RFI) | |
Environmental conditions: temperature, humidity, light | |
Water supply (especially temperature) | |
Tampering/sabotage | Family member |
Patient | |
Healthcare worker: doctor, nurse, aide | |
Enemy | |
Random act | |
Supplier | |
Support system failure | Poor device evaluation during trial process |
Lack or failure of incoming and pre-use inspections | |
Using inappropriate devices | |
Improper storage | |
Failure to train and credential | |
Poor incident/recall reporting system | |
Lack of competent accident investigation | |
Failure to sequester incident devices | |
Error in hospital policy | |
User or use error | Abuse of the device |
Accidental misconnections | |
Improper (“bad quality”) connection | |
Device misassembly | |
Failure to monitor | |
Labeling ignored | |
Inappropriate reliance on an automated feature | |
Incorrect clinical use | |
Incorrect control settings | |
Maintenance or incoming inspection error | |
Pre-use inspection not performed |
It helps to remember that a patient may have specific physiologic sensitivities, abnormalities, or diseases. As such, a patient’s suspected “burn” or tissue injury may ultimately be determined to be an abnormal or idiosyncratic physiologic response to otherwise normal conditions of use and performance for that device. It may also be determined a technology was not at all involved.
Time is also a significant factor in starting an investigation. 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 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.
Before performing equipment inspections and interviews the investigation team should review and be familiar with the clinical and surgical procedures and conditions surrounding the incident as well as understand the lesion’s clinical appearance and collect the baseline information.
Lesion Assessment
Details about a lesion’s clinical appearance and progression are important to determining its cause. A guide for collecting critical information about the lesion can be remembered by the mnemonic OPALSS—Onset, Progression, Appearance, Location, Shape, and Size. These six descriptive criteria are central to assessing the cause of a lesion and the potential involvement of a medical device. For example, pressure necrosis injuries (decubitus ulcers) from intraoperative pressure may show up several days after the insulting event, whereas electrosurgical burns are visible immediately at the end of surgery and do not suddenly appear days later.
The following list illustrates how the OPALSS criteria can be applied to obtain needed details about a lesion. The list is not intended to be all-inclusive, but rather to stimulate thinking during the investigation (Table 31.7).
Table 31.7
Criteria for lesion or skin injury assessment
Onset | When was the lesion discovered? Get the precise time and date |
When did surgery occur? | |
How long was the patient immobile in the recovery room or intensive care unit after surgery? | |
At what time was the last heat therapy device or heated product used on the patient and how long was it applied? | |
Where was discovery made and by whom? | |
Progression | After discovery, did lesion get larger, deeper? |
Did blister(s) form? When? | |
Did an eschar form? | |
Appearance | What did the lesion look like upon discovery and as it progressed? |
Note the color and texture of both the central area and the surrounding areas | |
Cation | Where was lesion on the body? |
Record the lesion location in relation to electrodes, high pressure areas of contact, positioning devices | |
Is there a clearly definable electrical current path through the area of injury? | |
Specify the validity of the alleged electrical current path in collaboration with engineering staff | |
Shape | Note the geometry of the lesion |
Are there patterns of devices or electrodes within the lesion? | |
Does the shape correspond to heat therapy devices or electrodes? | |
Size | Measure the injury dimensions |
What is the area of the injury, including ALL affected tissue area (e.g., perimeter halos)? | |
If there are multiple lesions, what is the combined area? |
Baseline Information
Baseline information should be collected from both the patient and the equipment as 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 inspection, preventive maintenance, and repair history records 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 or tissue injury, all equipment that may be involved, including disposables should be sequestered until it has been inspected. While rarely possible, due to the need for use of equipment and instruments that were obviously not involved in an accident, it may also be helpful to cordon off the operating room or physical location in which the adverse event happened to reduce change of contaminating the accident location and preventing advertent or inadvertent tampering. Most equipment 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 ready 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.
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. Consider videotaping these investigations to avoid further confusion and legal challenges.
Using the Investigation Questionnaire
The questionnaire in Appendix 1 is a guide for collecting information during interviews, as well as for summarizing baseline patient data and recording necessary details about each device involved in the investigation [13]. Although it is designed for skin injuries that occur in the OR, the questionnaire may also be used to investigate skin injuries that occur in the recovery room and special care areas or skin injuries noticed on any patient exposed to heating and illumination devices, tenacious tape or electrode adhesives, or prepping and degreasing agents. The completed questionnaire should be filed with the incident report and not with the patient’s record. Most information can be recorded directly on the questionnaire form. Lengthy answers to questions and device identification details should be recorded on a separate sheet of paper with the numbers corresponding to the questions.
The questionnaire is divided into five main sections:
- A.
Baseline Patient Information
- B.
Baseline Equipment Information
- C.
The Surgical Procedure
- D.
The Injury
- E.
The Equipment
These sections are discussed below. Additional sections for the interviewer’s and the interviewee’s summary comments are also provided.
Instructions
Record the baseline patient and equipment information (Lists A and B).
Make a separate copy of the partially completed questionnaire for each person who is to be interviewed.
Note: Each person involved in the incident should be interviewed. Relevant questions should be directed to all appropriate people because multiple responses will help corroborate data on the time and sequence of events. Although it is unlikely that any one person will be able to answer all the questions, everyone can provide useful information based on his or her general observations and discussions with other personnel involved in the incident.
Record the interviewee’s answers to all relevant questions in Lists C through E.
Note: Most information can be recorded directly on the questionnaire form. If needed, lengthy answers to questions or device identification details can be recorded on a separate sheet of paper with the numbers corresponding to the questions. Be sure to record the interviewee’s name and your name on all attached sheets.
File the completed questionnaires with the incident report. The questionnaires should not be filed with the patient’s record.
- A.
Baseline Patient
The need for baseline information is self-evident.
- B.
Equipment Information
Information about each involved device, including disposables, will also be needed for a thorough investigation to be conducted.
- C.
The Surgical Procedure
Patient surgical and medical records typically provide information that is only marginally useful in determining the cause of a device-related injury. The investigation team must interview all surgical, medical, and nursing staff involved in the procedure and postoperative care of the patient. It may also be necessary to question technicians and other personnel responsible for cleaning, sterilizing, inspecting, and maintaining the equipment and supplies used for the injured patient.
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