FDA Publishes Final Guidance on Reprocessing Reusable Medical Devices

By on 2:43 PM

In response to the growing reports of contamination and subsequent infection related to gastrointestinal scopes including duodenoscopes, the Food and Drug Administration (FDA) has released final guidance on reprocessing reusable medical devices.

This guidance serves to help reduce the risk of contamination and subsequent infection by providing manufacturers with recommendations to validate their reprocessing instructions to ensure devices remain safe and effective for reuse.

FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” (pdf) was issued about a week after Cedars-Sinai Medical Center in Los Angeles became the latest hospital to report patient infections with carbapenem-resistant Enterobacteriaceae (CRE) as a result of duodenoscopes. The four patients at Cedars-Sinai may have had exposure to the superbug from a single scope, which appears to be the same model implicated in other outbreaks.

Given the volume of inpatient hospital and outpatient ambulatory surgery center (ASC) gastrointestinal (GI) scope procedures including duodenoscopes, it is imperative that every facility ensure it has infection control expertise and advice or guidance for the proper cleaning, decontamination, disinfection and sterilization of GI scopes.

Infection prevention expert Phenelle Segal, president of Infection Control Consulting Services, is at the forefront of healthcare-associated infection (HAI) reduction and prevention, providing services to the acute care hospitals, surgery centers and many other providers. To learn what ICCS can do for your organization, contact Phenelle Segal at (215) 692-3485 or e-mail info@iccs-home.com.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.