The Boston Globe has a report about a growing conflict between medical device manufacturers and hospitals regarding the reuse of surgical equipment:
The companies are pushing for a state law that would require patients to consent before being treated with reprocessed instruments. A State House hearing on the bill, sponsored by State Senator Susan C. Tucker, Democrat of Andover, is scheduled for today.
To bolster their case, manufacturers have distributed to legislators photos of fouled or damaged instruments they say were shipped for reuse by reprocessors.
For example, a photo provided by Boston Scientific Corp. shows dried blood on a forceps it manufactured, the Natick company said. Boston Scientific said the forceps was going to be used to obtain a gastrointestinal tract tissue sample until doctors noticed the stains.
Another photo, from Smith & Nephew PLC’s endoscopy unit in Andover, shows unidentified matter on a supposedly sterilized blade that was going to be used to trim torn tissue during knee surgery.
“It’s medicine’s dirty little secret,” said Nigel Wilkinson, vice president of quality assurance for Smith & Nephew, which makes surgical instruments. In addition to the increased risk of infection, the instruments aren’t designed for the stress of reuse, he said.
Tucker said Smith & Nephew proposed the idea of legislation. “To me it’s a consumer protection issue, and it deserves to be brought to attention,” she said. Though the proposal is likely to boost sales of the manufacturers’ single-use devices, Wilkinson and other executives say they’re mainly motivated by health concerns.
The devices were designed to be thrown away after single use, but sterilizing them for resale to hospitals at discount prices has become a $125 million business in the United States. Some organizations, including the Massachusetts Hospital Association and the American College of Cardiology, say reuse is safe, and manufacturers can only document a few instances of patients being put at risk. Used instruments can save a medium-sized hospital tens of thousands of dollars a year, according to the Massachusetts Hospital Association.
Our two cent opinion? Some of us here at Medgadget, have been intimately involved with clinical OR work for years. Never have we seen the issue of patient’s safety arise in the context of reusable, resterilized equipment. After all, resterilization is a standard practice across the world. If done correctly with appropriate oversight, the reuse of surgical tools is the way to go.
Flashback: Once is Not Enough for some medgadgets
