Manufacturers Instructions For Use - Responsibility for Ensuring Availability

Who is responsible for ensuring that instructions for use are available and used by staff reprocessing equipment and devices?

Any examples are for illustrative purposes only.

Because of the complexities associated with use of equipment and devices, leadership is responsible to ensure that IFUs are available and used by staff to ensure consistency among all staff involved in these processes. Compliance with IFUs should also be an integral part of initial and ongoing staff education, policy/procedure development, and training/competency assessments.
Examples of ways leadership can support the use of IFUs may include, but are not limited to:
  • Resource manuals provided by product and device manufacturers
  • Providing an alert to staff if specific equipment cannot be cleaned or disinfected with the commonly available disinfectant
  • Copies of IFUs maintained electronically
  • Subscribing to web-based resources that maintain IFUs
  • Educating staff on how to conduct internet searches to retrieve product IFUs
  • Educating staff on how to read and implement IFUs
  • Incorporating IFUs into Policies/Procedures and/or Standard Operating Procedures
Last updated on March 17, 2021
Manual: Hospital and Hospital Clinics
Chapter: Leadership LD

If no, please comment on how we could improve this response.

If you have additional standards-related questions regarding this topic, please use the Standards Online Submission Form