Reprocessing Reusable Medical Devices: Standards, Recommendations, and Guidelines, part 1
This article is part of a series discussing the importance of proper medical device reprocessing with this part explaining why compliance with standards, recommendations, and guidelines (i.e., best practices) is so important.
Around the world, reusable medical devices continue to become more and more complex, and so does compliance with reprocessing best practices. Complex reusable medical devices often have detailed multistep instructions for use (IFUs) that require special resources the healthcare facility may not have anticipated or have available when they purchase, borrow, or trial new devices. In fact, it is not uncommon for reprocessing technicians to need additional employee competencies, policies, and procedures to be updated; specific cleaning and packaging supplies to be purchased; along with sometimes new processing equipment; or at a minimum, existing cleaning and sterilization equipment cycles to be adjusted. Some reusable medical devices even require the cleaning cycle to be repeated multiple times, along with the use of special inspection devices to confirm cleanliness prior to HLD or sterilization.
When reusable medical devices are validated, laboratory technicians document how long the detailed IFU reprocessing takes; however, this information is seldom passed on to healthcare facilities so they can plan accordingly. Damien Berg wrote in a recent AAMI Horizons article, “Sterile Processing: The Tip of the Sword for Safe, Effective Patient Care,” “We are still providing reprocessing services like we did when I started in this field 26 years ago. Despite major advancements in technology and, with it, increased complexity in adhering to the device instructions for use (IFUs), not much has changed in the operations of the modern SPD. We are continuing to use traditional staffing and productivity models and, consequently, are struggling to keep up and do the right thing.”1 This is why all standards, recommendations, and guidelines recommend a written IFU should come with reusable medical devices, regardless of being purchased, borrowed, or trialed and the reprocessing department should review IFUs to confirm they have all the resources needed to ensure each device can be properly reprocessed.
In the USA, it is important to know that national survey organizations and many department of health (DOH) agencies now audit healthcare facilities for compliance with best practices as stated in our national standards, recommendations, and guidelines. This began several years ago when the Centers for Medicare & Medicaid Services (CMS) revised their Survey and Certification document to include more stringent audits in the areas of infection control and sterilization. Areas of emphasis include:
- Compliance with nationally recognized standards/documents
- Formal training in areas of infection control and sterilization
- Compliant cleaning, sterilization, and monitoring procedures
- Established criteria for immediate-use steam sterilization2
Around this same time, the Accreditation Association for Ambulatory Healthcare (AAAHC) added an infection control chapter to their standards handbook. Infection control highlights included “Adhering to standards, guidelines, and manufacturer’s instructions for cleaning, disinfection, and sterilization of instruments, equipment, supplies, and implants.”3 That’s also when The Joint Commission (TJC) started having surveyors spend additional time during surveys evaluating what they identified as three key areas of instrument reprocessing: cleaning, sterilization, and storage.
In 2011, TJC reported that their surveyors received in-depth training on sterilization processes. This education was provided in collaboration with the Association for Advancement of Medical Instrumentation (AAMI) and included a review of all aspects of the AAMI ST79 standard on steam sterilization.
Best practices for the reprocessing of reusable medical devices are detailed in AAMI Standards, such as ST40 which covers dry heat sterilization, ST41 which covers EO sterilization, ST58 which covers chemical sterilization, ST79 which covers steam sterilization, and ST91 which covers flexible and semi-rigid endoscope processing. In addition, reusable medical device reprocessing best practices are detailed in the Association for periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, the Centers for Disease Control and Prevention (CDC) Disinfection and Sterilization in Healthcare Facilities, the CDC Guidelines for Infection Control in Dental Health-Care Settings; as well as the Society of Gastroenterology Nurses and Associates (SGNA) Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes. Note: The CDC guidelines and the SGNA Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes are available free of charge on the internet at www.CDC.org and www.SGNA.org.
It is critical that best practices be adhered to in any profession because they reflect the values of that profession, especially in healthcare because adherence to medical device reprocessing best practices ensures patient safety as one of our greatest threats is healthcare associated infections (HAIs). The CDC states, “Although significant progress has been made in preventing some healthcare-associated infection types, there is much work to be done. On a given day, about one in 31 hospital patients has at least one healthcare-associated infection.”4 This number translates to more than a million reported HAIs and thousands of deaths each year. While improperly reprocessed medical devices are not the leading cause of HAIs, it has been documented by the CDC and reported in the national media as one of the causes. For this reason, compliance with best practices as detailed in national standards, recommendations, and guidelines is critical for patient safety, for maintaining your healthcare facility’s accreditation, and to keep your facility out of the national news. Compliance not just some of the time, not most of the time, but all of the time!
2. CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009.
3. CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009.
Chuck Hughes, retired founder of SPSmedical Supply Corp., has worked for 30+ years in the manufacturing industry in areas of regulatory affairs, marketing, research and development, microbiology, and sterilization training. He’s been a corporate member APIC, AORN, AST, IAHCSMM, OSAP, SGNA, and numerous other organizations, including AAMI and CSA, where he contributed to writing medical device reprocessing standards. A popular speaker at regional, national, and international healthcare conferences, Chuck has visited thousands of healthcare facilities during his career, providing continuing educational training and mock surveys of medical device reprocessing areas.
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