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biolink Regulatory Column - December 2014

Thursday, December 18, 2014   (0 Comments)
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AAMI Sterilization Standards Week, October 2014

Ralph J. Basile, Vice President of Marketing, Healthmark Industries

From October 20 - 22, the AAMI Sterilization Standards Committee had their twice annual meeting at the Westin Hotel in Alexandria, Virginia. During that time, well over 100 experts in sterilization from healthcare facilities, industry, government and academia continued their work on various guidance documents for device sterilization practices in the United States. I was fortunate to be there and able to report some of the most significant events.


Statement on Biohazardous Waste

Ebola is in the news and ebola was very much on the mind of attendees at the AAMI meeting. In particular there was concern amongst the user community (and other stakeholders as well) that some sterile processing departments might be directed to use their sterilizers to decontaminate biohazardous waste, something that neither the sterilizers nor staff are designed to. AAMI ST/WG40 is the largest Sterilization Standard Committee workgroup, with a great diversity of members from AAMI stakeholder groups. So it made sense that this group would take up the issue and author the initial draft of AAMI’s position on this matter. During its meeting on October 20th the workgroup did just that. This draft was then shared with the wider AAMI Sterilization Standards Committee, the AAMI Board, as well as with other key industry groups: AORN, APIC, AST and IAHCSMM for their input and approval as a multisociety statement, that can be viewed here.


Industrial Sterilization Certification

AAMI sought input and discussed plans for a certification program for sterilization professionals. It was discussed that for the personnel from the hospital, the CBET and similar certifications are often obtained. AAMI’s certification program would be geared more towards the industry. This could then be further divided into separate groups e.g. certification for operators, service/repair, engineers etc. This certification would make the personnel more current in their knowledge, and would also offer companies a certification to look for when hiring someone for a related position. Volunteers were invited to help put together the testing material. The group will then form a chat/email group to further discuss this.


New AAMI Policies and Procedures Manual

Members of AAMI were encouraged to attend a summary presentation about the new version of AAMI’s Policies and Procedures Manual. Over the last several months, AAMI staff has worked to make this document more brief (from around 90 pages to less than 40), provide greater flexibility, and bring the document in line with current AAMI policies and practices. This document has been updated on the web site and available to view here.


It was another busy week at AAMI, and no doubt there were many other events of significance not captured here. As AAMI continues to grow, as does its influence, AAMI weeks are getting busier and more productive. Interested in participating in the next sterilization standards meeting? Then mark your calendar for April 27 - 30, 2015 in Annapolis, Maryland.



ASTM Committee on Medical Devices met the week of November 10 in New Orleans. I personally participated in the meeting of ASTM Subcommittee F04.15.17 on Wednesday November 12. A number of work items moved forward, including a significant rewrite of WK33439: Test soils for cleaning validation. This new draft has moved this document a significant step closer to be put out for wider consideration and subcommittee ballot. ASTM F04 will again meet as a full committee the week of May 18, 2015 in Anaheim, CA.

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