FDA Targets Risks From Reused Medical Devices

Some medical devices are reused many times in common surgical and diagnostic procedures, and have been for years. They include instruments used in surgery (like clamps and forceps), and endoscopes (like bronchoscopes and colonoscopes) used to visualize areas inside the body.

And the Food and Drug Administration (FDA) wants to ensure that they are safely reused.

The agency is working with healthcare providers, manufacturers, organizations that set standards, and other government agencies to reduce the risk of infection from the inadequate “reprocessing” of these durable devices designed for repeated use. Reprocessing means cleaning and high-level disinfection or sterilization.

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These reusable medical instruments are used in a laparoscopy; a surgeon inserts these thin instruments through small incisions in the belly and uses a lighted tube with a tiny camera to look at the contents of a patient's abdomen or pelvis.

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When Ophelia Scott was scheduled to have a colonoscopy, her daughter Pamela —a biomedical engineer at FDA—had questions about how the clinic cleans and disinfects the reusable medical devices used in such procedures.

FDA has received reports of patients being exposed to microscopic amounts of blood, body fluids and tissue from other patients that may have occurred because the reusable devices were inadequately reprocessed and these contaminants were not removed. Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there.

So if you’re scheduled to have a medical procedure, how worried should you be about this?

Not worried enough to cancel or delay your plans, says FDA.

The risk of acquiring an infection from a reprocessed medical device is low, says William Maisel, MD, deputy director for science at the FDA's Center for Devices and Radiological Health. The benefits of these procedures in diagnosing and treating medical conditions far outweigh any risk, he says.
That said, there are questions you can ask your healthcare providers.

Frank Nemec, MD, a Las Vegas gastroenterologist and patient advocate who spoke at an FDA-sponsored workshop in June, advises his patients to ask this question: What precautions are in place to ensure that the procedure will be done safely?

One person who did ask that question is Pamela D. Scott, a biomedical engineer who has been working on this issue at FDA.

Earlier this year, Scott’s mother, Ophelia, was about to have a colonoscopy. Scott called the gastro-intestinal clinic and asked to speak to the person in charge of reprocessing medical devices. In this case, it was the head nurse.

Scott asked if the clinic staff was aware of news reports about problems with the reprocessing of endoscopes. And, if they were aware, how did these reports affect how they clean and disinfect these tools?
The nurse replied that clinic had recently assessed its reprocessing procedures and called in the manufacturer to make sure staff members are properly cleaning and disinfecting or sterilizing the devices.

“Just to know that they took steps, that they had procedures, that helped me,” Scott says.

So ask questions, just as Nemec recommends and Scott did on her mother’s behalf. Before having any medical procedure, it’s a good idea to learn more about the procedure and steps the healthcare facility takes to keep patients safe.

Health care providers are one source of this information. Many professional organizations, including the American Academy of Family Physicians, offer advice on how to ask such questions of your healthcare provider.

FDA is working with manufacturers and healthcare providers to:

Make sure that the makers of these devices are providing reprocessing instructions that are clear and scientifically validated.
Make sure that staff at hospitals and other healthcare facilities understand and are following the manufacturers’ instructions.
Identify device designs that facilitate optimal cleaning, disinfecting and sterilization.

And FDA has created a new website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/default.htm) with information about these medical tools. To report a problem, the site also provides a link to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Posted December 28, 2011
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