• E-mail
• Print
• RSS

Industry wants to crack down on medical device reuse

Ambulatory Safety Monitor, June 23, 2005

Want to receive articles like this one in your inbox? Subscribe to Ambulatory Safety Monitor!

A new bill has been filed in Massachusetts that, if passed, would require doctors and other providers in the state to inform patients if equipment designed and marketed as one-time use devices, intended for a single use and subsequent disposal, are reprocessed and reused.

Patients would have the choice of refusing the use of the equipment-such as surgical blades and some catheters-with failure of the doctors to inform the patients leading to fines up to $10,000 for a first offense, according to the Boston Business Journal. Reprocessing companies and doctors would also be held liable if a device is reused and is found to be unsafe or ineffective.

It is potentially the first bill in the nation that mandates this practice despite the fact that the practice has gone on legally for years.

The state's medical community, including executives from Smith and Nephew Endoscopy, is pushing for the state law.

"People have a right to know they have used-car parts from a third-party manufacturer instead of an original supplier. Why shouldn't the same be applied to medical instruments?" said Nigel Wilkinson, Smith & Nephew Endoscopy's vice president for regulatory affairs and quality, in the Boston Business Journal.

Representatives of the hospital and reprocessing industry say the bill is unnecessary because reprocessing is heavily regulated and safe.

"It is a decades-old practice with a stellar safety record," said Dan Vukelich, deputy executive director of the Association of Medical Device Reprocessors in Washington, D.C., adding that some medical devices are now labeled as single-use when they used to be labeled for multiple uses, even though nothing has changed about them.

"And doctors and nurses have continued to reuse durable medical equipment that can be reprocessed, regardless of the label," Vukelich said.

The state's Committee on Public Health will hold a hearing concerning the issue on October 19.

To view the bill, Senate Bill 1321, click here.

Want to receive articles like this one in your inbox? Subscribe to Ambulatory Safety Monitor!

• E-mail to a Colleague
• Print
• RSS
• Archive