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Based on observation, interview, and policy review, the hospital failed to ensure proper procedures were followed for 2 of 3 patients (P1, P2) related to the use of the cautery holster to prevent the risk of burns to the patient and surgical fires.

Findings include:

Review of the hospital's policies indicated they had not developed policies and procedures, nor had they implemented manufactures guidelines, to ensure proper use of the cautery holster during the procedures using electro-cauterization in the surgical department.

Surgery was observed 6/1/11, on patient (P1) at approximately 10:45 a.m. for repair of a right lingual hernia. Dura prep (pre-operative alcohol based skin prep) was used to prep the abdomen and no pooling or wet drapes were observed. The dry time was observed to be over five minutes before draping occurred. During the procedure electro-cauterization was observed. The sheath or holster for the cautery pencil was clipped to the drape above the surgical site. The cautery pencil was observed to be placed on the drape over the lower abdomen, multiple times, from two seconds to over four minutes. One time the cautery pencil tip was placed on a four by four piece of gauze. The last time the surgeon used the cautery pencil he laid the cautery pencil on the drape above the patient's chest for seven minutes and 50 seconds and left the room. The physician's assistant started to close the patient's incision and the cautery pencil remained laying on the drape, above the patient's chest. When the physician's assistant was interviewed about the use of the cautery pencil she put the cautery pencil into the sheath/holster. The cautery pencil had been laying on the drape for over eight minutes and not in use.

Interview with the director of surgery on 6/1/11, at 11:35 a.m. indicated that the sheath/holster for the cautery pencil was used mostly to keep the cautery from falling out of the sterile field. She further indicated that it was the physician's judgement when to use the holster/sheath when using the cautery pencil. She confirmed they did not have any policies or procedures on the use of the cautery pencil's holster/sheath. However, they do have education once a year on it's use from Valleylab.


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Surgery was observed on 6/1/11, at 10:00 a.m. for P2 in the ambulatory surgical site located off the hospital grounds. The surgery performed was removal of a melanoma on the left leg. Dura prep was used to prep the leg and no pooling or wet drapes were observed. The dry time was observed and recorded at three minutes before draping occurred. During the procedure electro-cauterization was observed. The sheath for the cautery pencil was clipped to the drape above the surgical site. During the procedure which lasted approximately 40 minutes the cautery was used various times and the cautery pencil when not in use was laid down on the drape to the left side. The cautery pencil was never placed in the sheath during the procedure.

Interview with the ambulatory surgical manager on 6/1/11, at 11:35 a.m. who stated the cautery pencil was to be placed in the sheath in between usage. She further stated the ambulatory surgical department follows the same policies and procedures as the hospital.

Interview with Chief Medical doctor (DR) was conducted on 6/1/11, at 3:10 p.m. The DR indicated he was aware of the fire potential with the use of alcohol based solutions and cautery but felt the chance was very small. He further stated in over 170,000 cases no incidents have ever occurred. He further stated it would be a waste of valuable surgery time to place the pencil in the sheath in between usage.

Review of the manufacturer guideline from Valleylab revised 5/2011, indicated: "Fire Hazard Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes), flammable gases, or high levels of oxygen.... When not using active accessories, place then in a holster or in a clean dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns."

The director of surgery indicated that they used the "Recommended Practices for Electrosurgery" dated 7/2009, to educated their staff on the use of the holster/sheath. This indicated: "IV.b. When not in use the active electrode should be placed in a clean dry non conductive safety holster... Use of the nonconductive safety holster prevents the active electro from falling off the sterile filed and unintentional activation."


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