Disposable Battery Operated Lavage System (BOLS)

September 8, 2008

Audience: Operating room, outpatient and emergency room supervisory staff and physicians, risk managers

[Posted 09/08/2008] FDA notified healthcare professionals about the potential for sparks, fires, toxic fumes, and explosions when disposable battery operated lavage systems’ (BOLS) cables are cut. BOLS are used in the OR, ER, burn units, and nursing units. The cutting of the battery pack's cable can lead to a short circuit, causing the batteries to discharge rapidly, producing intense heat and flammable gases with a resulting explosion that expels flammable gases and toxic chemicals endangering both patients and staff. Recommendations for avoiding this risk are provided in the medical device safety alert.

[September 04, 2008 - Medical Device Safety (Reprinted Article) – FDA]

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