NC patients exposed to rare, fatal brain disease through dirty surgical tools

Dirty surgical tools may have once again placed neurological patients at risk for Creutzfeldt-Jakob disease (CJD), a rare and fatal degenerative condition. It's something that medical device companies are probably watching pretty closely, depending on how the affected medical center managed its operating room.

Reuters and other media outlets reported that 18 brain surgery patients at the Novant Health Forsyth Medical Center in Winston-Salem, NC, are now at risk of contracting the disease. The reason: Hospital officials acknowledged they didn't sufficiently sterilize the instruments after their use on a patient in mid-January who was subsequently found likely to have Creutzfeldt-Jakob disease. The hospital said it has added an "enhanced sterilization process" for brain surgery instruments and is working on preventing the problem in the future.

Creutzfeldt-Jakob disease is rare but still a risk when unsanitary surgical instruments come into play. When they do, medical device and surgical instrument manufacturers could face some serious liability issues, depending on how hospitals manage their operating rooms. That's because they don't always own the surgical tools in question. Increasingly, medical centers sign pay-per-use agreements with device makers governing some equipment and surgical tools, a practice designed to be more efficient and save money.

Novant Health Forsyth Medical Center has not said whether the affected surgical tools are rented or where they came from. FierceMedicalDevices contacted the medical center's media center about the issue, and hadn't yet gotten a response at deadline.

Last September, for example, as many as 8 patients at Catholic Medical Center in New Hampshire faced possible exposure to Creutzfeldt-Jakob disease from metal surgical instruments rented from Medtronic ($MDT). As a result, Medtronic was drawn deeply into that crisis. After receiving notification that one of the hospital's patients faced possible CJD exposure using its instruments, Medtronic tracked their use and confirmed 7 additional cases of possible exposure. The company worked with the hospital, state health authorities and the FDA to assist and coordinate communication with potentially affected patients.

Medtronic also went out of its way to note that the hospital followed its required protocol and procedures regarding sterilization of the instruments between surgeries.

- read the Reuters story
- here's the News & Observer's take

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