Rented Medtronic tools linked to possible disease exposure

Metal surgical instruments rented from Medtronic ($MDT) by a New Hampshire hospital may have exposed several patients to Creutzfeldt-Jakob disease, a rare, fatal condition, The Boston Globe is reporting.

Medtronic, in a detailed statement to FierceMedicalDevices, says the company is working closely with the hospital in question--Catholic Medical Center--to help handle the matter. Company spokesperson Cindy Resman noted that "regardless of whether or not the hospital owns the instruments, the hospital still follows its required procedures and protocols for use, including sterilization of the instruments between surgeries."

"Pay-per-use agreements are very commonly used by hospitals and medical device manufacturers," Resman said.

As The Boston Globe article explains, as many as 8 patients at Catholic Medical Center in Manchester, NH, may have been exposed to the incurable disease between May and August. According to the story, surgeons used Medtronic's neuroprobe, a needle-shaped instrument that helps zero in on the right area of the brain for surgery. And three of the devices were used in the May operation on a now-deceased patient who doctors believed likely contracted Creutzfeldt-Jakob disease, which is spread by prions (abnormal proteins). Final test results are due in a month.

Those devices were subsequently cleaned and sterilized and likely used on the 7 other patients, according to the story. All have been notified of their potential exposure, the story explains, adding that 5 other unnamed patients in other states may have been possibly contaminated through use of the equipment. If exposure took place, it could take years for symptoms to appear. Health officials noted to the Globe that CJD has rarely been transmitted through contaminated surgical instruments.

As the article explains, standard sterilization methods used for surgical equipment before each operation aren't full proof against CJD. An NIH specialist also told the Globe that prion-related diseases are very hard to wipe out through sterilization.

Resman told FierceMedicalDevices that Catholic Medical Center notified the company "that our surgical instruments had been used on a patient who may have had sporadic CJD at the time of surgery." And once that happened, Medtronic responded proactively, she said.

"Upon notification that our instruments had been used in this case, we followed procedures to quickly track that specific set of instruments and have confirmed that they were used in 7 additional cases," Resman said. "We are assisting the hospitals and the appropriate state health authorities as they manage this situation. We have also notified the U.S. Food and Drug Administration [and] the hospitals are coordinating all communications with patients potentially involved in this situation."

- here's the Boston Globe story (sub. req.)
- see the full Medtronic statement

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