The Association for the Advancement of Medical Instrumentation (AAMI) presents action steps that sterile processing departments can take to improve the quality of medical device and surgical instrument reprocessing:
1. The basics: Cleaning and disinfection/sterilization of reusable devices are separate, equally important processes and must be performed before each patient use according to the device manufacturer’s written instructions for use (IFU).
For more information go to: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm.
2. The right tools: Have the manufacturer’s instructions for use ( IFU) as well as all cleaning implements and equipment required by the IFU readily available in all the reprocessing areas.
3. Create a multidisciplinary committee to review the priority issues and set a plan for solving them throughout the organization. The following areas should be represented: OR, infection prevention and control, healthcare technology management (biomed), endoscopy, risk management, quality, safety, education, and materials management.
4. Share lessons learned: Remind senior management and safety officers that it costs a lot less to “do it right the first time.” Share lessons learned from other healthcare organizations that have had to inform patients of exposure to inadequately reprocessed reusable devices.
5. Written procedures: Establish a formal program for reprocessing, including written standardized policies and procedures that include a chain of accountability. Expert guidance can be obtained from industry experts in order to resolve conflicts between the IFU and facility policies. Written procedures should also be developed and implemented for central sterile processing reporting of inadequate instructions, equipment problems, and in-service issues to the manufacturer and, when applicable, to the FDA’s MedWatch program.
6. Standards matter: Know the current standards, recommended practices, and IFU.
7. Purchasing: Central sterile processing should be included in purchasing decisions for medical devices, to provide input on whether the device can be reprocessed for medical devices, to provide input on whether the device can be reprocessed appropriately and with the facility’s existing resources.
8. Separate and standardize functions and locations: Separate central service (warehouse, stocking, etc.) from reprocessing; create standardized job descriptions and functions.
9. Training: Train, train, and retrain. Ideas include: assess staff competencies; negotiate for training budget with cost/benefit analysis to prove value; partner with vendors for education; create a list of available continuing education units (CEUs) for easy access by staff; work with human resources to create career ladders for certification and promotion; promote the importance of certification. Note: In-service for loaner or new instruments should include reprocessing in- service areas that are separate from (or in) central sterile processing.
10. Assessment: Conduct an audit of compliance with standards and regulations, using any number of available tools and resources. See References and go to: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance
Source: Association for the Advancement of Medical Instrumentation (AAMI). Reprocessing Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit. 2011.