Cause of Device-Related Incident
User errors

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; OR / Surgery

Device Factors
*Not stated

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Mechanical (puncture, perforate, lacerate, break, cut, tear, nick, crush)

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Failure to read label

UMDNS
Electrodes, Electrosurgical, Return [11-500]

Skin Lesions from Agressive Adhesive on Electrosurgical Return Electrode Pads



User Experience Network™ [Health Devices Apr 1995;24(4):159+]

Hospital

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

We are concerned that these injuries may be electrosurgical burns and that patients may be at risk of experiencing more serious injuries unless we learn how to prevent them.

Manufacturer Action

We are aware of the accounts of injuries reportedly caused by our return electrodes. We believe that a number of these reports are consistent with injuries associated with electrode removal technique rather than with electrosurgical burns. Therefore, we have provided instructions on the package insert that tell the user to remove the electrode pads slowly to prevent skin wounds. Although not mentioned in the insert, we also recommend supporting the underlying tissue with one hand while removing the pad with the other.

ECRI

We agree with the hospital that common causes of electrosurgical return electrode burns are partial detachment of the return electrode pad or poor site preparation (e.g., lack of shaving of the return electrode site). However, we also agree with the manufacturer that the reported injuries are not likely to be electrosurgical burns. This brand of return electrode pad has an inner conductive adhesive layer surrounded by a narrow strip of nonconductive adhesive, and the reported injuries coincided with the outer nonconductive border of the pad. If they had been electrosurgical burns, they would have been located directly under some portion of the conductive area of the electrode pad. Another possible cause of the injuries is skin reaction to the return electrode pad's conductive adhesive; however, because the injuries corresponded with only the outer portion of the pad area, this, too, is unlikely.

We are aware of more than 20 reports of skin injuries beneath electrosurgical return electrodes. On this model electrode, the adhesive on the outer border of the pad is slightly more aggressive than that on the rest of the pad, as well as the adhesives on other manufacturers' pads. After investigating some of these reported incidents, in which the injuries were similar to those described by the hospital (i.e., more common around the outer border area of the pad), we determined the cause to be skin tears or irritations caused by the adhesive as the return electrode pad was removed from the patient after the procedure.

The manufacturer states that designing the adhesive properties of return electrode pads is difficult because of the variety of skin types they will be applied to. However, the manufacturer also states that the number of reports of the pads' inability to adhere to patients and of aggressive adhesive injuries are approximately equal. The manufacturer believes that the level of adhesive on its return electrode pads offers an appropriate compromise between good adherence and the potential for skin injury.

Although the more aggressive adhesive may slightly increase the risk of adhesive injury, the greater adherence of the pads may also help minimize the risk of more serious injuries from electrosurgical burns. Overall, ECRI believes that these electrodes are safe to use.

Recommendations

Do the following, regardless of which return electrode brand or model is being used:

  1. Always remove the return electrode pad from patients slowly to minimize the risk of skin trauma. This is particularly important during dry weather and for patients with dry or fragile skin.
  2. If a skin injury is present after the return electrode pad is removed, note the location, size, and description of the lesion. Also, save the return electrode with the pad and packaging and notify the personnel responsible for investigating medical device related incidents. ECRI's investigation questionnaire for accidental skin injuries can be used to help determine the cause of the injury.

References from Health Devices

ESU burns from poor return electrode site preparation [Hazard Report]. 1987 Jan;16(1):35-6.

ESU burns from poor dispersive electrode site preparation [Hazard Update]. 1993 Aug-Sep;22(8-9):422-3.

Investigating device-related "burns" [Guidance Article]. 1993 Jul;22(7):334-52.

UMDNS Term

Electrodes, Electrosurgical, Return [11-500]

Cause of Device-Related Incident

User error: Failure to read label

Mechanism of Injury or Death

Mechanical


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