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Reused Devices, Surgery's Deadly Suspects
Blejer's daughter, Ariella, and widow, Hatte, who says contaminated surgical instruments may have caused her husband's death. Sterilization may not remove CJD-carrying prions.
(By Susan Biddle -- The Washington Post)
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Ellenbogen said the hospital resterilized the biopsy forceps, which were used on the other patients. The risk of exposure was "minuscule," he said, when it resterilized reusable devices first used on a patient who the hospital did not think had a prion disease. He added that it can cost about $800 for reusable biopsy forceps.
"That's a lot of money," he said. "There's a cost-benefit ratio."
So far, Ellenbogen said, none of the patients has shown signs of a prion disease. The hospital has changed its policies so that if the diagnosis is uncertain, it will use disposable instruments only once.
The Association of Medical Device Reprocessors said that none of its three members, which dominate an industry that reconditions some disposable medical devices, reconditions invasive devices used in brain surgery. It is unclear whether any hospitals resterilize neurological devices specifically designated for one-time use.
The Centers for Disease Control and Prevention recommends using disposable surgical devices for the brain only once, said Ermias D. Belay, a medical epidemiologist there. Reusable devices should either be cleaned using sodium hydroxide and a high-temperature autoclave or quarantined until a biopsy confirms that the patient is not infected with the fatal disease. Belay said these are CDC recommendations. "We don't make rules," he said.
The Joint Commission on Accreditation of Healthcare Organizations recommends against reusing instruments in brain biopsy procedures when a patient's diagnosis is uncertain. But it does not have any requirements about how to handle devices potentially exposed to prion diseases. "The reality is, we're dealing with a small number of cases," said Rick Croteau, executive director for the group's patient safety initiatives. "It's a matter of picking your fights."
The Food and Drug Administration has not imposed rules to address the issue, either. The agency said it is unclear from research how to effectively decontaminate devices potentially contaminated by prions. As a result, the federal agency said in an e-mail response to questions, "There are no specific rules/regulations that address this issue presently nor any acceptable decontamination protocols."
Staff researcher Richard Drezen contributed to this report.
