Report AAMI Meetings April 2007

Transcription

1 Report AAMI Meetings April 2007 The meetings were held in Arlington Virginia April 23, 24, I attended the following meetings; 1) AAMI/ST/WG 40, Moist heat (Steam) sterilization hospital practices WG. ST79 2) AAMI/ST/WG 60, Ethylene Oxide Sterilization Hospital Practices Working Group 3) AAMI U.S. Sub-TAG for ISO/TC 198/WG 7, Packaging Working Group 4) AAMI/ST/WG 83 Reusable Surgical Textile Reprocessing WG 5) AAMI/ST/WG 43, Hospital Steam Sterilizer Working Group 6) AAMI/ST/WG 92, Process Challenge Devices Working Group Reports for these meetings are below. AAMI/ST/WG 40, Moist heat (Steam) sterilization hospital practices WG The WG reviewed requests for changes to ANSI/AAMI ST79, under AAMI s new continuous maintenance procedures. Numerous proposed changes were accepted for ballot. Among these proposed changes was the addition of text defining Class 6 emulating indicators in accordance with the new standard ANSI/AAMI/ISO The Working Group has decided, however, not to address the use and application of Class 6 indicators at this time. Ballots results will be considered at the WG s December 2007 meeting. Accepted changes will be incorporated into ST79. It was announced that the Working Group was one of the first two recipients of AAMI s new technical committee award, in recognition of its development of ANSI/AAMI ST79. AAMI/ST/WG 60, Ethylene Oxide Sterilization Hospital Practices Working Group The WG reviewed comments filed during the second ballot of revised ANSI/AAMI ST41, Ethylene Oxide Sterilization in Health Care Facilities Safety and Effectiveness. All substantive comments were addressed; the remaining editorial comments were delegated to the co-chairs for disposition. As a result of the Working Group s review and resolution of comments, two of the four negatives filed during the ballot were withdrawn. There was general agreement that while the major issues associated with the document appeared to have been resolved; the document should be balloted once again because significant changes had been made. In accordance with AAMI procedures, the revised draft will also be made available for concurrent ANSI/AAMI public review. At the outset of the meeting, it was announced that Ms. Jacqueline Daley had been appointed user co-chair of the WG. U.S. Sub-TAG for ISO/TC 198/WG 7, Packaging Working Group The meeting was chaired by Mr. Nick Fotis and Ms. Jackie Daly Johnson. It was announced that the AAMI TIR22:2007, Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices Part 1 and Part 2:2006, is now published and available to the public. The working group discussed the possibility of writing an annex which serves as a guidance in complying to the ANSI/AAMI/ISO series for hospitals. The working group members were very interested and Mr. Hal Miller and Ms. Colleen Landers of CSA volunteered to lead the task group in developing this annex, which would be added during the next revision of AAMI TIR22:2007. It was decided that a rough draft/outline will be developed by the task group before the next meeting of the Packaging Working Group. Ms. Johnson discussed worst case conditions and it was decided that this would be added as another annex to the TIR22. A draft of this section will also be available to the working group members by the next meeting. The group briefly discussed the wording for ANSI/AAMI/ISO :2006, section 6.3 and 6.4, regarding separation of package stability/aging testing and package performance testing. Mr. John

2 Spitzley gave a brief update of the meetings and discussions at ASTM. It was decided that this section will be looked at and expanded upon during the next revision of the ANSI/AAMI/ISO series. Members were encouraged to look at the article which will soon appear in Pharmaceutical Medical Packaging News for background information on this topic. AAMI/ST/WG 83 Reusable Surgical Texile Reprocessing WG The WG reviewed comments on the first working draft revision of ANSI/AAMI ST65, Processing of Reusable Surgical Textiles in Health Care Facilities. All substantive comments were addressed and several work assignments were made. A second working draft of the document will be distributed for comment prior to the WG s December 2007 meeting. It is hoped that the revised draft ensuring from that meeting will be ready for ballot by the WG. Many of the proposed changes submitted by Canada were discussed and many accepted. AAMI/ST/WG 43, Hospital Steam Sterilizer Working Group The Hospital Steam Sterilization WG reviewed comments on the third working draft of revised ANSI/AAMI ST08, Hospital Steam Sterilizers. All comments were addressed, and there was general agreement to ballot the next draft of the standard and make it available for ANSI/AAMI public review. The plan is to ballot the next draft revision of AAMI ST08, and make it available for ANSI and AAMI public review. AAMI/ST/WG 92, Process Challenge Devices Working Group This meeting was chaired by co-chairs Mr. Steve Kirck of 3M and Ms. Susan Klacik of IAHCSMM. It was announced that both Mr. Kirck and Ms. Klacik have been approved as co-chairs of this working group by the chairs of the AAMI Sterilization Standards Committee. The group decided to look at the recently circulated AAMI/CD2 TIR31:200x, Process challenge devices/test packs for use in health care facilities, which includes updates in the extended cycles section of the document as well as resolution to the comments received on the AAMI/CD1 TIR31:200x. Since the last meeting of the working group in November 2006, an ad-hoc task group composed of Mr. Kirckof; Ms. Klacik; Mr. Richard Bancroft of Albert Browne; Mr. Lon Bruso of Steritec; Mr. Denny Christensen of Process Challenge Devices; Mr. Tom Fraser of DePuy/Johnson & Johnson; Ms. Geetha Jayans of FDA; Ms. Barb Smith of Getinge; Mr. Gary Socola of SPS Medical; Ms. Eugenia Stern of Alcon Laboratores; Dr. Jonathan Wilder of H & W Technology; and Mr. Bill Young of Sterigenics, conducted several conference calls to revise the section on extended cycles. The working group addressed the draft and corrected several sections in the document to get the draft TIR ready for committee ballot to begin in early May 2007 following this meeting. This document will go for public review and I have been asked to get comment from the CSA extended cycle committee. Other meeting reports follow as I was only bale to attend the above meetings as three to four meetings ran at the same time. U.S. Sub-TAG for ISO/TC 198/WG 4, Biological indicators Working Group The meeting was co chaired by Mr. Gregg Mosley and Acting Co chair Dr. John Gillis, filling in for Mr. Phil Schneider, who could not attend. The Working Group reviewed the comments received on the International ballot of ISO 14161, Sterilization of health care products Biological indicators Guidance for the selection, use, and interpretation of results. Comments identified by the co chairs as needing Working Group input were discussed in order to give guidance to the US experts for the June 2007 ISO Dublin meeting. Delegates for the June 2007 ISO Dublin meeting were identified: Phil Schneider, Joel Gorski, Gregg Mosley, John Gillis, and Rich O Donnell.

3 U.S. Sub-TAG for ISO/TC 198/WG 06,Chemical Indicators Working Group Dr. Joel Gorski and Mr. Steven Kirckof chaired the meeting. The Working Group reviewed the US position (Affirmative with comments) on ISO/DIS 15882, Sterilization of health care products-chemical indicators-guidance for selection, use and interpretation of results, and noted that a new comment on the test method for paper porosity to show equivalence to the Bendtsen method had been added. There were no objections to the additional comment. A graph for clarifying the slope for time/temperature response for Class 5 integrating indicators had been added to the US position on ISO/DIS and was agreed to by the Working Group. A working draft for a new standard, ISO on steam penetration tests for small steam sterilizers (less than 54 liters) was being developed in ISO, and an interim meeting would probably be called to advance the working draft. It was reported that the following documents had been approved and published by ISO, approved by ANSI, and would soon be published by AAMI as American National Standards: ISO/FDIS , Sterilization of health care products Chemical indicators-part 3 Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test; ISO/FDIS , Sterilization of health care products- Chemical indicators- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-Type test for detection of steam penetration; and, ISO/FDIS , Sterilization of health care products- Chemical indicators- Part 5: Class 2 indicators for Bowie and Dick-type air removal test AAMI/ST/WG 96, Compatibility of materials subject to sterilization WG The Working Group considered the comments received on AAMI/WD 1, Medical Devices -- Guidance on the selection and compatibility of materials subjected to sterilization. The Working Group agreed that, based on progress made at its 24 April meeting, a new draft would be developed and circulated for ballot in early September AAMI/ST/WG 42, Dry heat sterilization Working Group The Meeting was chaired by Deborah Havlik, who is also convener of ISO/TC 198/WG 14. The Working Group reviewed the results of the Orlando meeting of ISO/TC 198/WG 14 in February. The ISO Working Group met to review comments on ISO/CD (ISO/TC 198 N748), Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices. Responses had been prepared to all comments and a revised text had been prepared and submitted to ISO. That text had been issued on 19 April 2007 for ballot. Subsequently, Sweden had raised questions about guidance for dry heat in health care facilities and indicated that they felt the document provided insufficient guidance It was expected that Sweden would not be happy with the resolution of their comments on the Committee Draft regarding this issue. Unfortunately the ISO working group felt constrained by resolutions passed by ISO/TC 198 (advocated by CEN) that the process standards treat the development and validation of the sterilization process the same in every venue. In other words, ISO/TC 198 had dictated that standards should not differentiate between requirements for hospitals and requirements for manufacturers. The underlying reason for this was that the CEN mandated standards MUST address sterilization processing equally in venues. From the U.S. s perspective, different standards for performing sterilization in industrial settings and healthcare settings are perfectly acceptable, but different standards were not acceptable for the purposes of the CEN mandate. As ISO was not approved as a CEN work item, however, the need to have a single standard cover both healthcare facilities and industrial processing was less valid. That left ISO/TC 198 with two options: 1) ISO/TC 198 could add back the industrial restriction to scope of ISO It would be necessary to get permission for this at the ISO/TC 198

4 U.S. Sub-TAG for ISO/TC 198/WG 11, General criteria for sterilization processes WG It was announced that John Kowalski had been appointed as chair of the Working Group. The user co chair position was open and nominations were invited. AAMI/CDV (ISO/TC 198 N762), Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices, had been issued for ballot by ISO/TC 198 as a revision of ISO The results of the ballot were to be considered by ISO/TC 198/WG 11 and ISO/TC 198 at their meetings in Dublin, June 2007, and if the ballot is approved, ISO/CD would be advanced for Enquiry (DIS) ballot. This draft was also proposed as a revision of the U.S. adoption of ISO 14937:2000 (ANSI/AAMI/ISO 14937:2000) and the AAMI General Criteria for Sterilization Processes Working Group (U.S. Sub-TAG for ISO/TC 198/WG 11) had been balloted to determine the U.S. position on ISO/CD and the acceptability of that document as a revision of the current American National Standard. The results of the U.S. Sub-TAG ballot were circulated as doc. stwg11n011 and were considered at the Working Group's meeting. The Working Group responded to all comments and agreed on U.S. comments to be submitted along with the U.S.'s affirmative vote. AAMI/ST/WG 01, Industrial Ethylene Oxide Sterilization Working Group 1) The Working Group considered the ballot results and comments on AAMI CDV-1 TIR (ISO/PDTS) , Sterilization of health care products Ethylene oxide -- Part 2: Guidance on the application of ISO , and development of the US position on ISO/PDTS Of the 53 members who voted, 51 voted to affirm and two voted negative. All comments were resolved, and based on the resolution to the comments and the results of voting, it was agreed that the US should vote affirmative with comments on ISO/PDTS Also based on the results of voting and the resolution to the comments, one member agreed to change her vote from negative to affirmative with comments. Thus, the final ballot results were: Of the 53 members who voted, 52 voted to affirm and one voted negative. 2) The Working Group agreed that Craig Meadows (Medtronic) and Gary Cranston (PCS) should be nominated as new U.S. Experts on ISO/TC 198/WG 1. The Working Group thanked Carolyn Kinsley, Ralph Makinen and Steve Yeadon for their past participation as U.S. Experts. Co-chairs Phil Cogdill and Gerry O Dell will also serve as U.S. Experts. 3) The Working Group considered the future of the AAMI ethylene oxide sterilization TIRs after the series of documents is finalized. The following was agreed to: AAMI TIR14:1997 (and Amendment 1:2004), Contract sterilization for ethylene oxide The Working Group formed a task group to determine whether or not the document should be revised, and if a revision is called for, what the scope of the revision should be. The task group will report back to the working group in time for the December 2007 meeting of ST/WG 01. AAMI TIR15:1997, Ethylene oxide sterilization equipment, process considerations and pertinent calculations The Working Group agreed not to consider the status of this document until the series of documents is finalized. U.S. Sub-TAG for ISO/TC 198/WG 03, Industrial moist heat Working Group The meeting was chaired by Greg Mosley and Donna Swenson. The Working Group met to review the international ballot results on ISO/PDTS , Sterilization of health care products -- Moist heat Guidance on the application of ISO (doc. 198 N758).

5 This document had been issued for ISO ballot after the November 2007 meeting and the U.S. Sub- TAG had been balloted to determine the U.S. position. The voting results were unclear with several negative votes and there were many comments. The co chairs had held an open conference call in early March to respond to the Sub-TAG comments and to finalize which comments would be submitted to ISO. The ballot results and compilation of all U.S. Sub- TAG comments (and co chairs' responses) were circulated as doc. STWG03N029 and the U.S. comments as submitted were circulated as doc. STWG03N030. Based on the substantive nature of the U.S. comments and the fact that the document failed to provide useful guidance on ISO (due primarily to formatting issues), the U.S. had voted negative on the ballot. The Sub-TAG then reviewed the International Ballot results and comments (contained in doc. 198 N767) and prepared U.S. positions on key points. ISO/TC 198/WG 3 was to consider the comments at meetings in London, 30 April to 2 May 2007, and in Dublin in late June Charlie Hancock and Dr. Chiu Lin were to attend the London meeting as the U.S. representatives, but Dr. Lin would not be able to attend due to important FDA business. As it was felt necessary for the U.S. to be fully represented at that meeting, Donna Swenson was asked to attend. At the Dublin meeting, the U.S. would be represented by Mr. Hancock, Dr. Lin, Ms. Swenson and Dr. Mosley. The U.S. would decide on processing ISO for national adoption with or without modifications after the results of the London and Dublin meetings were known. U.S. Sub-TAG for ISO/TC 198/WG 10, Liquid chemical sterilization WG The Working Group considered comments on ISO/WD 14160, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants, and prepared for US representation at the June 2007 meeting of ISO/TC 198/WG 10 in Ireland. It was agreed that Charles Roberts (Johnson & Johnson) and Steven Elliott (App Tec) should attend the meeting as US delegates. U.S. Sub-TAG for ISO/TC 198/WG 08, Microbiological methods Working Group The meeting was chaired by Martell Winters and Kim Darnell. The Working Group met to review the U.S. Sub-TAG ballot results on U.S. Sub-TAG ballot of AAMI/ISO CD , Sterilization of medical devices Microbiological methods Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process (The document was circulated as doc. STWG08N037 and the results are contained in doc. STWG08N041). The Sub-TAG reviewed and responded to each comment and agreed on the U.S. comments to be submitted with the U.S.'s affirmative vote. The Working Group agreed to continue processing the document for U.S. adoption as a revision of ANSI/AAMI/ISO :1998. The Working Group also reviewed the results of the reaffirmation ballot of ANSI/AAMI/ST72:2002 (contained in doc.stwg08n044). After reviewing the results and comments the Working Group agreed to revise the document and appointed a task group to develop a first draft for consideration. The Working Group then reviewed comments submitted on doc. STWG08N039, AAMI- WD2- TIR(ST08), Sterilization of health care products - Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices. The Working Group responded to comments (contained in doc. STWG08N043) and agreed to ballot a revised draft TIR prior to the Working Group's December 2007 meeting. Finally the Working Group noted that ISO/TC 194 had balloted a NWIP to develop a new guidance document on pyrogen testing. The U.S. Sub-TAG for ISO/TC 194/WG 7 (AAMI/BE/WG 07, Systemic toxicity) had prepared the U.S. position contained in doc. BEWG07 N017. Harry Shaffer, the convener of ISO/TC 198/WG 8 stated that he would request that a liaison be established between ISO/TC 198/WG 8 and ISO/TC 194/WG 7 on this work item. It was confirmed that U.S. delegates to the Dublin meeting of ISO/TC 198/WG 8 would be Trabue Bryans, Martell Winters, Craig Herring, Kim Darnell and Deborah Havlik.

6 The SSC approves plans to revise ST72 and the plan to ballot the revised draft TIR on product inoculation prior to the December 2007 meeting. U.S. Sub-TAG for ISO/TC 198/WG 2, Radiation sterilization Working Group The Working Group considered the ballot results and comments on AAMI/CDV-3 TIR(ST02)1, Guidance on Radiation Sterilization of Human Tissue-Based Products. Based on the ballot results and resolutions to the comments received, the Working Group agreed that the document, as revised in accordance with the resolutions to the comments, should be circulated for a final one-month editorial review and then forwarded to the AAMI Standards Board for approval. It was reported that ASTM E10.01, Radiation Processing: Dosimetry and Applications is preparing to re vise its mathematical modeling and calibration standards, and also is developing a new umbrella document relating to dosimetry system requirements. The Working Group considered comments received on the NWIP for a guidance document on modifying Method 2 of ANSI/AAMI/ISO The Working Group agreed to modify the scope of the NWIP to specifically address both Method 2A and Method 2B. The revised NWIP is attached. The revised NWIP will be forwarded to the AAMI Standards Board for consideration. TIR(ST02)1, as revised in accordance with the resolutions to the comments, will undergo a one-month editorial review and then be forwarded to the AAMI Standards Board for approval. AAMI Sterilization Residuals Working Group Meeting (AAMI ST/WG 63) The meeting was chaired by co-chair Barry Page and attended by 48 committee members and guests. Mr. Page reviewed the status of FDIS The document prepared after the TC 194/WG 11 meeting in Chicago in July 2006 has been through several edits by the DIN secretariat and should be forwarded to the ISO Central Secretariat in the next few days. Next the French translation of the document will be prepared and in about two months the FDIS should be circulated for ballot, at about the end of June. This will be a two-month ballot so if all goes well the document should be finalized and published by the end of 2007, Committee members asked if a transition period had been considered when the new standard was introduced. Mr. Page indicated that this was discussed in Chicago but no decision had been made pending consultation with ISO concerning ISO policy in this area. Ike Harper gave an update on the status of report on round-robin study of automated headspace methods and indicated that final edits were being made and it was hoped that the paper would be submitted in about a month. Dr. Harper updated the status of work with SPME/EO/ECH, including method development and round robin validation. A paper on the method applied to EO was submitted in February to J. Chromatogr. B and this should be published soon. Dr. Harper reported that his group has also looked at SPME for ECH and for EO and ECH together. EO overpowers ECH in partitioning from the aqueous solution to the SPME fiber so sensitivity is much lower. Paul Fioriti indicated that his group had the same experience. It was suggested that the method in the standard may be suitable for ECH. Mark Schwab gave an update to the work his group has been doing using FTIR. There was a brief discussion of WG expert members use of the dissipation curve approach outlined in ISO When asked none of the members present were using the dissipation curve that is in the standard. It was suggested that the international experts be asked if they were using this approach and for any comments if they were. U.S. Sub-TAG for ISO/TC 198/WG 13, Washer-disinfector Working Group The meeting was led Dr. Steve Goldstine and Dr. Chiu Lin. The Working Group reviewed the status of the washer-disinfector standards developed under the Vienna Agreement with a CEN lead:

7 EN ISO , Washer-disinfectors Part 4: Requirements and tests for washerdisinfectors employing chemical disinfection for thermolabile endoscopes. ISO/FDIS :2007, a revised draft of Part 4 was recently received but with insufficient time for review prior to this meeting. The draft was apparently based upon a 2005 CEN/TC 102 review and resolution of comments as well as an additional CEN/ TC 102 / WG8 independent review. Because of this second CEN review and the lack of documentation of the of the resolution of comments, it was recommended that discussion and action on this new draft be postponed until after the June 2007 ISO/TC 198 meeting in Dublin by which time issues related to the production of this draft should be resolved. ISO/TS , Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy of washer disinfectors (published November 2005) There had been a CEN meeting in early 2006 to discuss revision of this document, with the goal of recommending a single test soil and protocol, but the scheduling and administrative details of this effort have not yet been finalized. No new information about the document or meeting schedules has been received. New Work Item Proposal for EN ISO , Washer-disinfectors Part 6: Requirements and test for general purpose washer-disinfectors employing thermal disinfection. (ISO/TC 198 N765) A New Work Item Proposal was circulated by ISO along with an early draft developed by Work CEN in May The scope of this document is for washers-disinfectors that are intended to be used for general purpose reusable items, other than those penetrating skin or in contact with mucosal surfaces. The Working Group believed that the scope of the document fell under the previously-approved ISO and the NWIP failed to make a clear case for the need of another standard. The members present unanimously voted not to approve the NWIP (9 to 0) and recommend that if it were approved, the work should be developed with an ISO/TC 198 lead. The NWIP will be circulated to the full committee for a final vote. EN ISO , Washer disinfectors Part 1: General requirements, definitions and tests A version with U.S. deviations will be circulated for ballot shortly. I am presently gathering information from Canadian hospitals on extended cycles that are being re experienced in health care to add to the PCD document. I am also gathering information on packaging to share with the subcommittee for packaging TIR 22 to add an Annex for users to this TIR. If anyone has material on either topic please forward it to me via . I received permission from AAMI to share documents with the CSA Technical committee to assist me when commenting on documents which will be a great asset. I will be forwarding the TIR on PCD s for your comment in the next few weeks as this document will be the one that will effect extended cycles in the USA. I wish to thank the CSA for allowing me to attend these meetings and represent the CSA. Next meetings December 8 th to 10 th Colleen Landers, Registered Nurse