Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; Obstetrics and Gynecology; OR / Surgery

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Burn (electrical, thermal, chemical); Fire

Support System Failures
Error in hospital policy

Tampering and/or Sabotage
*Not stated

User Errors
Inappropriate reliance on an automated feature; Incorrect control settings

UMDNS
Electrosurgical Units [11-490]; Electrosurgical Units, Bipolar [18-230]; Electrosurgical Units, Monopolar [18-299]; Electrosurgical Units, Monopolar/Bipolar [18-231]; Electrodes, Electrosurgical, Active [16-860]; Electrodes, Electrosurgical, Active, Foot-Controlled [16-206]; Electrodes, Electrosurgical, Active, Hand-Controlled [11-499]

Burns and Fires from Electrosurgical Active Electrodes



Hazard Update [Health Devices Aug-Sep 1993;22(8-9):421-2]

Problem

For more than 20 years, ECRI has warned users about problems related to inadvertent activation of electrosurgical unit (ESU) active electrodes. Inadvertent activation typically occurs when a surgeon places an ESU electrode on the patient or surgical drapes between intended ESU activations and a device malfunction or unintentional switch activation causes the device to become energized, resulting in a burn or fire. (For assistance in investigating such incidents, see our Guidance Article "Investigating Device-Related 'Burns.'")

Although we have repeatedly recommended the use of clearly audible activation tones and safety holsters, we continue to receive problem reports and to conduct accident investigations related to inadvertent ESU electrode activation. This has prompted us to update our previous reports and to reemphasize the need to use safety features and precautions.

Discussion

Most currently available ESUs have an adjustable audible activation tone that, except on a few units, cannot be adjusted below clearly audible levels. In our investigations of active electrode burns, we have often encountered second- and third-degree burns that required surgical treatment. Use of an audible activation tone can prevent such burns or at least minimize the severity of injury.

Some surgeons oppose the use of an activation tone because it is irritating or can upset conscious patients undergoing surgery. However, no exceptions should be made to the use of this critical safety feature. Surgeons should be made aware that disabling the tone significantly increases the probability of accidental electrosurgical burns and associated malpractice claims. Explaining the tone to conscious patients should reduce their anxiety, and some surgeons provide patients with headphones to mask disturbing noises, including audible activation tones. This can be especially useful for delicate procedures, during which a surgical mishap could result if a patient is startled by electrosurgery or other OR sounds.

However, the best way to prevent burns from inadvertent ESU activation is to always place unused electrosurgical electrodes in well-insulated safety holsters, which provide a convenient storage location for electrodes that are not in use. Even with an audible activation tone, a brief accidental activation of an active electrode can arc through surgical drapes, causing immediate ignition of the drapes or of latent vapors from flammable prepping agents or ointments. ECRI has investigated numerous surgical fires that were started in this manner.

Although most electrosurgical electrodes can be purchased with prepackaged safety holsters, many hospitals, unfortunately, neglect to use them. Also, the recent increase in minimally invasive surgery has increased the use of longer ESU active electrodes that can be used inside a laparoscope or other endoscopic device, and these longer electrodes do not fit in most safety holsters.

However, the concern about inadvertent activation with these or any electrodes still exists. The surgeon can place the electrode on an instrument tray or Mayo stand away from the patient or surgical drapes; if the surgeon insists on placing the electrode on or near the patient or drapes, the active electrode cable should be disconnected from the ESU to eliminate any risk of burn or fire from inadvertent activation while the electrode is not in use.

Recommendations

  1. Remove from service and replace all ESUs that lack audible activation tones. Also, replace units that have adjustable activation tones; alternatively, contact the ESU manufacturer, and request that the minimum volume setting be modified to ensure that it remains at an audible level.
  2. Always place unused ESU active electrodes in a safety holster. If using a holster is inconvenient or awkward (e.g., when using endoscopic electrosurgical electrodes), place the electrode away from the patient and surgical drapes on an instrument tray or Mayo stand; if this is not possible, disconnect the active electrode cable.

References from Health Devices:

Electrosurgical unit activation tone control [hazard report], 14(13), November 1985.

Hand-switched electrosurgical active electrode pencils [evaluation], 15(6), June 1986.

Investigating device-related "burns" [guidance article], 22(7), July 1993.

"The patient is on fire!" A surgical fires primer [guidance article], 21(1), January 1992.

Using holsters to prevent electrosurgical burns [article within evaluation], 15(6), June 1986.

UMDNS Terms

  • Electrosurgical Units [11-490]
  • Electrosurgical Units, Bipolar [18-230]
  • Electrosurgical Units, Monopolar [18-299]
  • Electrosurgical Units, Monopolar/Bipolar [18-231]
  • Electrodes, Electrosurgical, Active [16-860]
  • Electrodes, Electrosurgical, Active, Foot-Controlled [16-206]
  • Electrodes, Electrosurgical, Active, Hand-Controlled [11-499]

Cause of Device-Related Incident

Device factor: Design/labeling error

User errors: Inappropriate reliance on an automated feature; Incorrect control settings

Support system failure: Error in hospital policy

Mechanism of Injury or Death

Burn; Fire


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