Corrected September 6, 2013, at 11:30 a.m.
Medtronic (NYSE:MDT) warned that a pair of New England hospitals that rented surgical instruments may have exposed 7 patients to a deadly brain disease, according to reports. Local healthcare authorities warned that 6 additional patients may be at risk, some who weren’t treated with Medtronic’s devices.*
The tools in question, designed for neurosurgical operations, were used on a patient suspected of carrying Creutzfeldt-Jakob disease, a rare and fatal prion disease that manifests with symptoms similar to "mad cow" disease, Medtronic told reporters. The same surgical kit was then used during several other procedures after having undergone standard hospital sterilization processes.
The risk of actual infection is "extremely low," especially because the at-risk patients underwent spinal surgery rather than brain surgery, according to a Mass. Dept. of Health notice, but healthcare regulators are taking extra care because the prion responsible for CJD isn’t fully eradicable through the usual procedures.
In patients treated with Medtronic’s devices, the culprit instrument was a metal reference frame and a brace used during surgical navigation, Medtronic spokeswoman Cindy Resman told Reuters. The frame and brace were part of a surgical instrument kit provided 1st to a New Hampshire hospital, where the device may have exposed 8 patients to CJD, and subsequently to Massachusetts’ Cape Cod Hospital, where another 5 patients may have been exposed.
Physicians are conducting an autopsy on the initial New Hampshire patient suspected of carrying CJD. That patient died last month.
CJD is a degenerative brain disease that can take years to develop, often becoming symptomatic around the age of 60; 90% of patient die within 1 year, according to the National Institutes of Health. There is no single diagnostic test, meaning infections must be diagnosed with either a brain biopsy or autopsy, and there is no known cure. Symptoms include memory problems, vision loss, dementia, behavioral changes and poor muscle coordination.
*Correction: This article originally stated that Medtronic had warned of 13 cases of potential contamination. Medtronic warned on 7 cases, the other 6, some of which were not treated with Medtronic devices, were reported by local hospitals and healthcare authorities.