Skin Lesions from Agressive Adhesive on Electrosurgical Return Electrode Pads
User Experience Network™ [Health Devices Apr 1995;24(4):159+]
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
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
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.
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.
Do the following, regardless of which return electrode brand or model is
- 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.
- 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].
ESU burns from poor dispersive electrode site preparation [Hazard Update].
Investigating device-related "burns" [Guidance Article]. 1993
Electrodes, Electrosurgical, Return [11-500]
Cause of Device-Related
User error: Failure to read label
Mechanism of Injury or