In January 2021, the American National Standards Institute and Association for the Advancement of Medical Instrumentation released four amendments related to steam sterilization and sterility assurance in healthcare facilities, presenting a lot of information for healthcare facilities to unpack.
In an April 14 webinar, sponsored by Healthmark and hosted by Becker's Hospital Review, two healthcare industry experts discussed the key components of the amendments and offered tips to ensure healthcare organizations are meeting the latest guidance.
The presenters were:
- Seth Hendee, SPD educational coordinator, Healthmark
- Cheron Rojo, SPD educational coordinator, Healthmark
1. Have a disciplined approach to standards compliance.The key to ensuring compliance with new standards is having a disciplined and planned approach. Mr. Hendee recommends first setting up a multidisciplinary committee to examine the current state of compliance, develop guidelines, recommendations and a gap analysis tool and determine the best timeline for implementation.
"You can't do anything on an island. You really do need help and input from all of the people involved," Mr. Hendee said.
2. Words matter in standards compliance.The words used in guidelines and standards put out by the AAMI have distinct meanings, Mr. Hendee said. For example, "shall" or "shall not" are used to express requirements, "should" or "should not" are used to express recommendations, while "may" or "may not" are used to express possibility.
"Understanding the words within the standards and guidelines is critical for understanding the risk for following or not following the recommendations," Mr. Hendee said.
3. Pay attention to the rationales added for amendments.Always look for the rationale provided by AAMI, as it can help justify some of the changes and recommendations to staff, Mr. Hendee said.
4. Amendment 2 adds integrity recommendations for insulated instruments.AAMI added Section 8.2.1 to address the inspection of insulated instruments intended for use with electric current, Mr. Rojo said. One key recommendation is that processing departments should test these instruments for integrity each time they are processed, Mr. Rojo said.
"This is really great verbiage because it is saying each time," Mr. Rojo said, adding that often sterilization departments test these once per week and that these devices can be damaged during the procedure or transport.
5. Amendment 2 addresses organization of instruments intended for use with electric current.Another key component of amendment 2 states that instruments should be organized and protected from damage. This means ensuring that trays are organized properly. There are container systems and tip protectors available for providers to ensure they can meet these recommendations, Mr. Rojo said.
To learn about all four of the amendments and more tips to ensure your facility is meeting the new guidance, listen to the webinar here.