A quality assurance (QA) plan for the medical device reprocessing (MDR) department serves as an outline for safety, standards and management. It includes not only documentation requirements for medical devices, but defines the roles and responsibilities of everyone involved, resources for staff, policies and procedures, and a measurement of internal compliance. This plan is a requirement of the Non-hospital Medical and Surgical Facilities Accreditation Program (NHMSFAP) standards, and should be reviewed and revised annually, as needed.
A comprehensive QA plan includes:
- management roles and responsibilities
- department resources
- staff training, education and competency assessments
- internal compliance and reporting systems including adverse events/incident reports
- standards and best practices
- reprocessing cycle management including policies and standard operating procedures, testing/monitoring results, equipment maintenance
- current manufacturer’s instructions for use (MIFU) for reprocessing equipment and for the medical devices being reprocessed
- occupational health and safety, including safety data sheets (SDS)
- a protocol to address any reprocessing failure, e.g. recall following failed sterilization
The quality assurance plan is an overarching guide that serves as a resource for personnel and a tool to make sure the MDR department is performing as intended. It is a key component to MDR and should be continually improved to meet industry standards and the needs of the facility. It ensures quality, efficiency and overall safety for patients and staff.
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