News and Stories from the Texas Medical Community


AAMI and FDA Target Risks From Reused Medical Devices

By on January 19, 2012 in National Health News with 0 Comments

Reusable medical instruments are used in a laparoscopy. Surgeons 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. Photo: FDA

by Health News Texas Staff

Every patient undergoing a medical procedure expects the environment and instruments used by the healthcare professionals to be clean and safe. In recent years, that expectation has been shaken by reports of patients put at risk of serious infection from reusable medical devices that were inadequately cleaned, sterilized, or disinfected—the domain known as reprocessing.

A 40-page report published by the Association for the Advancement of Medical Instrumentation (AAMI) urges healthcare facilities to “take action” on improving the reprocessing of reusable medical devices. The publication summarizes the priorities and challenges identified at an AAMI and U.S. Food and Drug Administration (FDA) summit – Priority Issues From the AAMI/FDA Medical Device Reprocessing Summit.

According to AAMI President Mary Logan, the report will help set a clear path forward.

“It will help those who were unable to attend to understand the issues discussed and priorities set,” said Logan. “It will also serve as inspiration for everyone to use the list of priorities and follow-up actions identified during the summit to do just that: follow up and take action.”

Virtually every stakeholder organization is keenly aware of the heightened patient safety concerns surrounding reprocessed medical devices. The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and The Joint Commission have issued warnings, guidance, and new reprocessing requirements.

The AAMI and other standards developing organizations have established or updated industry-recognized standards for reprocessing. Manufacturers and service providers have created new products and tools. Professional organizations have published guidance and recommended practices for healthcare staff, on the various aspects of reprocessing.

The report explains seven clarion themes developed at the summit. The clarion themes are broad goals, such as gaining a consensus on how “clean is clean” and creating standardized and clear instructions. The report also lists 10 immediate steps a facility can take to help solve the problem.

Reprocessing medical equipment remains a significant and tenacious concern. ECRI Institute cited cross-contamination from improperly reprocessed flexible endoscopes on its Top Ten Health Technology Hazards list for 2012, where it has appeared for several years.

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. Photo: FDA

Reprocessing reusable devices such as endoscopes and forceps is a routine procedure in healthcare, but it has come under increased scrutiny in the wake of reports of patients getting sick after being exposed to contaminated devices.

Pamela D. Scott, Senior Science Advisor for Reprocessing of Reusable Medical Devices at the US Food and Drug Administration and co-author of the call to action for the industry, recently had a personal interest in the topic of reprocessed devices.

Scott’s mother, Ophelia, recently had a colonoscopy. Before the procedure, Scott called the clinic and questioned the head nurse in charge of reprocessing medical devices if the clinic staff was aware of news reports about problems with the reprocessing of endoscopes,  and how did these reports affect how they clean and disinfect these tools?

The nurse responded 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,” explainded Scott.

According to William Maisel, MD, deputy director for science at the FDA’s Center for Devices and Radiological Health, “the risk of acquiring an infection from a reprocessed medical device is low. The benefits of these procedures in diagnosing and treating medical conditions far outweigh any risk.”

Working together, AAMI and the FDA will facilitate collaboration with other organizations, companies, and individuals to take the lead on different areas of the reprocessing challenge. No one group can do this alone, and the answer is not as simple as “more standards” or “more regulations.”

Read AAMI report.

Related posts:

Tags: , , , , , , , , ,

About the Author

About the Author: .


If you enjoyed this article, subscribe now to receive more just like it.

Post a Comment

Your email address will not be published. Required fields are marked *