FDA Recommendation: Stop Using System 83 Plus AERs for Duodenoscope Reprocessing

By on 11:49 AM

The U.S. Food & Drug Administration (FDA) recently issued a recommendation advising healthcare facilities no longer use Custom Ultrasonics' System 83 Plus automated endoscope reprocessors (AERs) for reprocessing duodenoscopes.

Contained within this notice to facilities that reprocess duodenoscopes is the following FDA advice: "Identify and transition to alternate methods to reprocess duodenoscopes, such as manual high-level disinfection, alternative AERs, liquid chemical sterilization, or other sterilization methods according to the duodenoscope manufacturers' reprocessing instructions."

Infection Control Consulting Services (ICCS) cautions facilities that may choose manual high-level disinfection (HLD) upon ceasing use of System 83 Plus AERs that every step for reprocessing in this manner must follow manufacturers' instructions for use (IFUs). This includes IFUs available from the scope manufacturer, HLD chemical manufacturer and other items that may be used during reprocessing. In addition, facility written policies must be followed. Guidelines set forth by associations and agencies, including the FDA and Centers for Disease Control and Prevention (CDC), if applicable, should be followed as well.

ICCS finds during on-site visits that facilities performing manual HLD are subject to a higher rates of process failure than facilities conducting automated HLD. Breakdown in processes include, but are not limited to, failure to test the temperature and viability of the chemical(s). Documentation of steps taken as well as monitoring of technician methods for conducting this process is important. At a minimum, annual reprocessing competencies should be conducted. They should occur more frequently if a change in procedure or product is introduced. Change of reprocessing personnel requires a competency as well.

Note: FDA communicated that Custom Ultrasonics' System 83 Plus AERs remain in service for the reprocessing of endoscopes other than duodenoscopes.

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.