biolink Regulatory Column – May 2014
Thursday, May 22, 2014
April Showers Bring Sterilization Standards Flowers
Ralph J. Basile, Vice President of Marketing, Healthmark Industries
As it turns out, April was the month of sterilization standards meetings, both domestically and internationally. The month began with ISO/TC 198 meeting down under in Sydney, Australia. 11 days after the completion of those meetings, the AAMI Sterilization Standards Committee met in Baltimore. I had the good fortune to attend both meetings. Someone pointed out that it was to be two famous harbors in less than 2 weeks. Both harbors are fun places to visit, but for some reason, I was more excited at the opportunity to visit Sydney Harbor.
Not surprisingly, the work of both committees, national and international, are very similar. Indeed, The U.S., as a signatory to ISO, actively participates and adopts directly or indirectly many of the ISO standards. AAMI not only manages the U.S. participation in ISO/TC 198, but also administers the International Secretariat for the Committee. There is always an effort to harmonize to the international standards. All things being equal, this makes good sense, as medical device companies in this country, if they export product, have to comply with standards in other markets. The more standards in each country can align with an international standard, the less burdensome these guidelines are on each manufacturer. Of course, differences between markets exist and national standards, including those of AAMI, reflect this.
The highlights? Personally, the dinner cruise on Sydney Harbor was one of mine (and a "side trip" with my wife to The Great Barrier Reef). As far as sterilization standards? Here is a synopsis:
WG 1, Ethylene oxide sterilization:
WG 4, Biological indicators
ISO 11138-1, -2, -3, -4, -5 (Sterilization of health care products -- Biological indicators) will be reviewed and revised.
ISO 16342 (Method for validation of a reduced incubation period for a biological indicator) should be added to the ISO/TC 198 active work program for development as an International Standard.
Work on ISO 11138-6 (Biological indicators for hydrogen peroxide vapor sterilization processes) should be discontinued.
WG 5, Terminology
WG 6, Chemical indicators
WG 8, Microbiological methods
ISO 11737-1:2006 (Sterilization of health care products – Microbiological methods –Part 1: Determination of the population of microorganisms on product) will be reviewed and revised.
New work proposal on microbiological testing of biological and tissue-based products for sterilization validation will be circulated for ballot.
WG 9, Aseptic processing
The draft of ISO 18362, as revised in Sydney, should be advanced for enquiry ballot as a Draft International Standard, with the new title (Processing of cell-based health care products requiring control of microbial contamination).
Confirmation of ISO 13408-6:2009 (Aseptic processing of health care products - Part 6: Isolator systems).
Add revision of ISO 13408-2, (Aseptic processing of health care products - Part 2: Filtration) to the Technical Committee's as an active program of work.
WG 12, Instructions for processing
WG 13, Washer-disinfectors
TG 1, Assurance of sterility
AAMI Sterilization Standards Committee
There are many more committees meeting during AAMI, so I will provide some of the highlights:
WG7, Sterilization Packaging
The final proposed amendment/adoption of ISO 11607-2:2006/A1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging (Amendment 1) was released for final 30-day review.
The final proposed amendment/adoption of ISO 11607-2:2006/A1, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (Amendment 1) was released for final 30-day review.
Review status of ISO 16775/Ed.1, Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.
WG40 Steam Sterilization Hospital Practices
The proposed reaffirmation of ANSI/AAMI ST79:2010 (including amendments) was released for final 30-day review.
Reviewed comments related to the newest draft of ST79. Comments remain for review for upcoming teleconference meetings.
WG84, Endoscope Reprocessing Work Group
WG85, Human Factors for Device Reprocessing
WG86, Quality systems for device reprocessing
WG94, Rigid Sterilization Container Systems
WG95, Water Quality for Reprocessing Medical Devices
The next AAMI Sterilization Standards Committee meeting will be October 20 - 22 in Alexandria, VA. Sure to be another busy time in the world of sterilization standards.
While it is no longer April but now the month of May, I write the finishing touches on this article as I return from Toronto, Canada from the ASTM F04, Medical Devices, meeting. I participated in sub-committee F04.15.17, Device Cleanliness Validation. Amongst the items under consideration by this group is WK33429, Standard Practice/Guide for Standard test soils for validation of cleaning methods for reusable medical devices, which is a guide to test soils to be used for cleaning validation testing by device manufacturers. Progress for this brand new document is moving along well and hopefully some time in the not too distant future, device manufacturers will have further guidance on the appropriate test soils to use for their devices based upon the clinical application of their devices.
Read more from the May 2014 issue of biolink.