This article is a repost from the #IFUCan blog hosted on LinkedIn. A snippet of the interview is teased below, and the full interview can be viewed by clicking here. Reposting the Fifth in a series, from June 2021 Technically, sterile processing and distribution (SPD) professionals should not be powerless in their desire for, influence on and requests for validated instructions-for-use (IFUs) to help them clean, disinfect and sterilize devices effectively and efficiently. Make that properly. But provider-based SPD professionals share the responsibility for obtaining validated device IFUs from the device manufacturers, according to two experts within ECRI. How? Simple. SPD should feel authorized, empowered and obligated to request them; device manufacturers should be willing to provide them, according to Amanda Sivek, Ph.D., Principal Project Engineer I, ECRI, and James Davis, MSN, RN, CCRN-K, HEM, CIC, FAPIC, Interim Manager, Infection Prevention and Control Services, ECRI. Sivek and Davis shared their insights, observations and recommendations with IFUcan’s Rick Dana Barlow. -- IFUcan: Four years ago, ECRI’s “Top Ten Health Technology Hazards for 2017” listed as the No. 2 challenge, “Inadequate Cleaning of Complex Reusable Instruments Can Lead to Infections.” Deeper into the report, ECRI recommended that facilities “Consider purchasing only instruments for which the manufacturer has validated its cleaning instructions. When applicable, request written information explaining the validation process.” What motivated ECRI to make this specific recommendation and why? SIVEK: The concern came from ECRI member reports and our consultation work. In addition, FDA’s 2015 guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” contains non-binding recommendations for device IFU validation. Continue reading the interview here