Federal regulators have warned that cutting the cable on disposable battery-operated lavage systems (BOLS) can cause toxic fumes, sparks, fires, and explosions.  BOLS devices are used to provide pulsed irrigation for the removal of necrotic or infected tissue and debris from wounds. They are powered by 8 to 20 AA batteries.

The Food & Drug Administration (FDA) issued the warning for BOLS devices following a report  of a patient who was transferred to the post-anesthesia care unit following  a wound debridement procedure in the OR with a disposable battery-operated lavage system (BOLS).  A staff member in the OR separated the battery pack from the device by cutting its cable. She put the battery pack on a cart and disposed of the rest of the device. A short time later, the battery pack exploded, spreading ash-like substances throughout the OR. Fortunately, the OR was empty at the time of the explosion, and no one was injured.

The FDA said it has also received reports of sparks and smoke occurring after battery pack cables were cut. The FDA’s investigations into these cases found that the cables had also been cut.  According to the agency,  in some cases, the cables were cut because staff members were told to dispose of batteries in hazardous waste instead of with regular trash.  In other cases, staff members wished to take batteries home for personal use because very little battery energy is used up during procedures.

According to the FDA, in all of these cases, cutting the battery pack’s cable caused a short circuit. The batteries discharged rapidly and produced intense heat and flammable gases. Pressure that built up inside the battery pack resulted in an explosion. Battery explosions expel flammable gases and toxic chemicals. The agency warned that even though no serious injury or damages have been reported, patients and staff are at risk any time sparks, arcs, and explosions occur.

The FDA has recommended that hospital staff take the following precautions to avoid the risk of sparks, fires, toxic fumes, and explosions:

• Read the device manufacturer’s labeling, paying particular attention to warnings. Manufacturers generally warn users not to cut the battery pack’s cable to avoid electric shock, sparks, fire, or explosion. Some manufacturers put only one labeling booklet in a box with several BOLS devices, so make sure a copy of the labeling is placed with each device.
• Don’t remove used batteries or other used items from any patient-care setting for personal use. This practice is
• inconsistent with infection control guidelines.
• Follow your facility’s policy for disposing of batteries in accordance with appropriate state and local regulations.
• Most states don’t require alkaline batteries to be discarded with hazardous material.
• If a battery pack explodes, notify your facility’s hazardous materials response team as soon as possible. Make
• sure the fumes and decomposition products don’t contact anyone’s eyes or skin and vapors aren’t inhaled.
• If battery materials contact someone’s eyes, flush them with large amounts of tepid water for 30 minutes. Contact a physician at once.
• If a battery leaks on a person’s skin, irrigate the exposed area with large amounts of tepid water for at least 15 minutes. Contact a physician if irritation, pain, or injury persists.
• If someone inhales vapors from a leaking battery, his respiratory passages may be irritated. Take him to an area with fresh air. Contact a physician if irritation continues.

This entry was posted on Tuesday, September 9th, 2008 at 5:37 am and is filed under Defective Medical Devices, Legal News.