FDA Working to Reduce Risk from Reused Medical Devices

It was an unconventional question, but one that nevertheless had to be posed. So without hesitation, Pamela Scott called the gastroenterology clinic that was about to perform a colonoscopy on her mother Ophelia and asked about the procedures the facility had in place to safely clean and disinfect endoscopes.

Last fall, Ottawa Public Health advised patients who visited a certain clinic between April 2002 and June 2011 to be checked for hepatitis B, hepatitis C and HIV. Isra Levy, M.D., Ottawa’s chief medical officer, claimed some “infection prevention and cleaning protocols” were
“not always followed” at the clinic in question. The infection scare prompted a wave of anxiety among patients who were scheduled to undergo endoscopies or colonoscopies at private clinics.

Hence the reason for Scott’s question.

The nurse that Scott spoke to at the clinic where her mother was scheduled to undergo a colonoscopy told the biomedical engineer that the facility recently had assessed its reprocessing procedures and asked the manufacturer to help ensure staff members are properly cleaning and disinfecting or sterilizing the instruments. “Just to know that they took steps, that they had procedures, that helped me,” Scott said.

Such proactivity also helps the U.S. Food and Drug Administration (FDA) in its quest to better target infection risks from improperly reprocessed medical devices. The agency has created a website featuring an article about those risks as well as the preventative measures many clinics have in place to prevent infections. “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,” the article states. “Transmission of infection was extremely rare, but the potential for becoming infected by an inadequately processed device was there.”

According to the agency, FDA officials are working with device manufacturers and healthcare providers to:
• Ensure the makers of (endoscopic) devices are providing reprocessing instructions that are clear and scientifically validated;
• Ensure that staff at hospitals and other healthcare institutions understand and are following manufacturers’ instructions; and
• Identify device designs that facilitate optimal cleaning, disinfecting and sterilization.

The FDA’s new website includes information about preventative measures and steps patients can take to ensure the clinics they visit safely clean their devices. The site also enables patients to report a problem by linking them to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.