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From: TSS ()
Subject: Reused Devices, Surgery's Deadly Suspects Patients May Be Exposed to Rare Brain Disease From Prior Operations
Date: December 30, 2005 at 7:16 am PST

Reused Devices, Surgery's Deadly Suspects
Patients May Be Exposed to Rare Brain Disease From Prior Operations

By Alec Klein
Washington Post Staff Writer
Friday, December 30, 2005; Page A03

One day, Daniel Blejer took a shower. The next, he couldn't recognize soap.

Over the following eight months, the scientist from Alexandria deteriorated quickly. In June, he could barely speak. Three months later, he lost his vision. And on Jan. 2 last year, he died in a Washington hospice at the age of 52.

"There is no person there," said his wife, Hatte. "All that's left is the body."

While she learned the cause of her husband's death -- a rare brain disease called Creutzfeldt-Jakob disease, or CJD -- she still does not know how he got it. She believes he may have contracted the disease from contaminated surgical devices when he underwent a series of brain operations from 1977 to 1980 in Texas and Massachusetts to relieve cranial pressure and remove a tumor, or from human cadaver tissue used in one of the operations.

Surgical devices used during brain surgery frequently are reused on other patients after being sterilized. But medical experts say traditional sterilization methods do not always eradicate the infectious agent from surgical instruments exposed to CJD because it is not a conventional bacteria or virus; it is believed to be an abnormal protein, or prion. In addition, CJD and other prion diseases are difficult to detect and can take years to emerge -- through dementia or neurological impairments.

As a result, when hospitals reuse such devices, medical experts say, there is a small risk that they may be exposing patients to a fatal disease with no known cure. Over the past five years, dozens of patients in at least four U.S. hospitals have been potentially exposed to the disease because their surgeons reused medical instruments first used on patients who had the rare brain disorder, according to documents and interviews.

Blejer, shown at a picnic, underwent a series of brain operations in the late '70s to relieve cranial pressure and remove a tumor.
In 2000, at Tulane University Hospital and Clinic in New Orleans, an autopsy revealed that a patient who underwent brain surgery had CJD. But the hospital had already reused some of the surgical instruments on eight other patients whose identities it did not disclose. The hospital said it has changed its procedures to protect against a recurrence.

Also that year, at Exempla Saint Joseph Hospital in Denver, a patient who did not show prion symptoms underwent a brain biopsy, according to the Joint Commission on Accreditation of Healthcare Organizations. Three weeks later, the pathology report confirmed the patient had CJD, but by then, six other undisclosed patients had undergone brain procedures using the same instruments.

One of those patients, 73-year-old David Thomsen of Littleton, Colo., said he was in "disbelief and shock" when his doctor told him that some of the instruments used in his surgery may have been contaminated. Thomsen said the devices should have been quarantined or destroyed. For about five years, Thomsen said, he has struggled with depression and sleepless nights, wondering if he will contract the deadly disease.

Jeffrey D. Selberg, president and chief executive of Exempla Healthcare, which operates St. Joseph Hospital, said it has revised its instrument procedures to protect against another such accident.

Creutzfeldt-Jakob victim Daniel Blejer died last January.(Family Photo)
Then, in 2001, at Madigan Army Medical Center in Tacoma, Wash., a shunt was placed in a patient to reduce cranial pressure during a brain operation, according to hospital officials. Later, at a California hospital, she was diagnosed with CJD. Madigan said it suspended its neurological surgeries and destroyed all equipment reused in such cases, but not before five unnamed patients may have been exposed.

In 2004, at Harborview Medical Center in Seattle, up to 12 patients whose names were not released were potentially exposed to a prion disease. During brain surgery on a patient who showed signs of dementia, a surgeon used a reusable biopsy forceps, said Richard G. Ellenbogen, chairman of neurological surgery at the University of Washington, which manages Harborview.

Reused Devices, Surgery's Deadly Suspects
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.


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