Docstoc

Report AAMI Meetings December 2007

Document Sample
Report AAMI Meetings December 2007 Powered By Docstoc
					                                Report AAMI Meetings December 2007

                                AAM/ST/WG 4, Biological indicators WG
                                        Monday, 3 December 2007
The meeting was cochaired by Mr. Gregg Mosley and Mr. Phil Schneider.
The Working Group reviewed the results of Dublin meeting and the status of ISO/DIS 14161, Sterilization
of health care products – Biological indicators – Guidance for the selection, use, and interpretation of
results. ISO/DIS 14161 had been submitted to ISO for DIS balloting and would probably be issued by ISO
in the first quarter of 2008. The AAMI BI WG would be parallel balloted for the US position on the
document and the US adoption of the document.
In Dublin, ISO/TC 198/WG 4 had agreed to re-start work on validating reduced incubaton times, which
had been the subject of the cancelled 16432 project. It was agreed to establish an ad hoc group to develop a
document to submit to ISO with a New Work Item Proposal. An ad hoc group was identified, and a
possible interim meeting of the ad hoc group was projected to be held at AAMI prior to the next ISO 198
meeting.
Also in Dublin, a resolution to develop a new ISO standard, 11138-6 for BIs for processes using vapour
phase hydrogen peroxide, was agreed to. Co chair Phil Schneider agreed to identify an ISO working group
member to develop an NWIP.
The next meeting was agreed to be held in conjunction with the next Sterilization Standards Committee
meeting, 23-25 June 2008 in Arlington, Va.


                        AAMI/ST/WG 06, Chemical Indicators Working Group
Mr. Steven Kirckof and Dr. Joel Gorski chaired the meeting.
The Working Group reviewed the results of the Dublin meeting of ISO/TC 198/WG 06, Chemical
Indicators and reported on the status of ISO/FDIS 15882, Sterilization of health care products-Chemical
indicators-Guidance for selection, use and interpretation of results. ISO/FDIS 15882 was being prepared
for submission to ISO and when ISO issued the FDIS it would be circulated to the U.S. Sub-TAG for
ISO/TC 198/WG 06 for final committee review. It was also noted that the working draft for the new
standard, ISO 11140-6 on steam penetration tests for small steam sterilizers (less than 54 liters) was being
revised based on the changes agreed to at the Cologne meeting, would be circulated for comment, and an
interim ISO meeting would probably be called to advance the working draft.
The following documents had been published by AAMI as American National Standards:
ANSI/AAMI 11140-3, Sterilization of health care products – Chemical indicators-Part 3 Class 2 indicator
systems for use in the Bowie and Dick-type steam penetration test;
ANSI/AAMI 11140-4, 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,
ANSI/AAMI 11140-5, Sterilization of health care products- Chemical indicators- Part 5: Class 2
indicators for Bowie and Dick-type air removal test
The Working Group agreed to meet in conjunction with the next Sterilization Standards Committee
meeting, 23-25 June 2008 in Arlington, Va.

                              AAMI/ST/WG 09, Aseptic Processing WG
The Working Group met to review the results of the Dublin meeting of ISO/TC 198/WG 9, Aseptic
processing, and the status of ISO/FDIS 13408-1, Aseptic processing of health care products – Part 1:
General requirement. The text of ISO/FDIS 13408-1 had been submitted to the ISO Central Secretariat
and was expected to be issued for Final Approval ballot (FDIS ballot) in early 2008.
When the FDIS ballot is initiated, AAMI will ballot all six parts of the ISO 13408 series to the Aseptic
Processing working group for adoption as AAMI/American National Standards. This should occur before
the next AAMI sterilization meetings in June 2007.
In Dublin, ISO/TC 198/WG 9 had also discussed new work on aseptic processing of solid medical devices
and on aseptic processing of tissue-based products. The U.S. agreed to take the lead in preparing the
NWIP proposal on solid medical devices and the delegates from the meeting had prepared a draft NWIP.
This was discussed and the attendees agreed to modify the proposal to clarify that the approach was based
on ISO 13408-1 and that standard would generally apply, but there would be some differences as solid
medical devices which are aseptically processes are usually produced in small batches and some of the ISO
13408-1 requirements (e.g., number of media fills) would not apply. This revised NWIP will be sent to the
ISO/TC 198 secretariat by early January so that it can be balloted and the results addressed at a meeting of
ISO/TC 198/WG 9 planned for early November 2008 in San Francisco.
The possible new work proposal on aseptic processing of tissue-based products, which was a German
proposal, was briefly discussed. No official documentation had yet been circulated, but when documents
are available, they will be sent to the AAMI Working Group for consideration.
The SSC thanks the Working Group for its report and confirms the plan to ballot the ISO 13408
series (parts 1 through 6) for U.S. adoption.
The SSC also agrees with the submission of the NWIP for solid medical devices to ISO/TC 198 for
ballot.

                AAMI/ST/WG 40, Moist heat (Steam) sterilization hospital practices WG
ANSI/AAMI/ST79, Comprehensive Guide for Steam Sterilization and Sterilty Assurance in Health Care
Facilities, is being updated annually under Continuous Maintenance Procedures. In accordance with these
procedures, 13 proposals for change were balloted by the Working Group. At the meeting, ballot
comments on each proposal were considered and a decision was made on whether each proposal would be
accepted. Of the 13 proposals, 9 were accepted (some with minor editorial modifications) and 4 were not
accepted. Task groups were formed to further investigate certain issues that arose in connection with
various ballot proposals: Class 5 chemical indicators, extended cycles and product families.

The Working Group also heard task group reports on section 10.7.5 on positive BI results and 8.3.8
(devices with luments) and considered questions regarding (a) the acceptance criteria for qualification
testing of flash sterilizers, and (b) product testing of containment devices.

Finally, the Working Group considered a request from the U.S. Department of Labor for comments on an
"Apprenticeship Determination Worksheet" for the occupation of Sterile Processing Technician. It was
noted that there was little time for AAMI to develop comments on this, though it might be possible to
submit a general statement of support for this concept. Individual members were encouraged to submit
personal comments. It was noted that IAHCSMM and AORN would be responding to this call for
comments.
The SSC thanks the Working Group for the report of its meeting and agrees that the approved
changes to ANSI/AAMI/ST79 should be processed for final approval and publication.

              AAMI/ST/WG 96, Compatibility of materials subject to sterilization WG
The Working Group considered the ballot results and comments on AAMI CDV-1 TIR17, Compatibility of
materials subject to sterilization, and resolved all comments received. 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 one-month editorial review
and forwarded to the AAMI Standards Board for approval.
The working group thanked co chairs Byron Lambert and Jeff Martin, and task group leaders France
Frechette, Karl Hemmerich, Ralph Makinen, Wayne Rogers, Dan Smith and Paul Somodi for their hard
work on the document.
The SSC thanks the Working Group for the report of its meeting and congratulates the working
group for its completion of the TIR.
       AAMI Sterilization Residuals Working Group Meeting (AAMI ST/WG 63)
The meeting was chaired by co-chairs Barry Page and Howard Cyr. Mr. Page reviewed the status of FDIS
10993-7He noted that the document is in the final stages of preparation to begin the ISO FDIS ballot. He
pointed out that WG members should pay particular attention to the requirement to also meet the TCL
(Tolerable Contact Limit) requirement or show that the device is non-irritating (meets the requirements set
out in ISO 10993-10). WG members expressed concern about the determination of area of contact between
devices and patients including measurement of device surface area. It was noted that the option remains to
don an irritation test on the device with the amount of EO residuals expected at release.
He also noted that CEN/TC 206 had unanimously agreed to a three-year transition period at their meeting
in Korea. As a result ISO/TC 194 circulated a ballot by mail to include a 3-year transition period. WG
members questioned whether and how a transition period will be accepted by regulatory authorities and
European Notified Bodies. Particular concern was expressed about acceptance by FDA/CDRH.
Dr. Harper updated the status of work with SPME/EO/ECH. He indicated that the submitted paper on the
work done would be published very soon. He also provided some pointers to how this technique should be
used in determining EO residuals.
 Dr. Harper indicated that his group had not been able to take the information available on the report on
round-robin study of automated headspace methods and get a publishable document. It had not been
possible to find all of the unedited raw data so unfortunately this work has had to be abandoned. He and his
staff were thanked for their efforts on this.
 Mark Schwab gave an update on the work his group has been doing using FTIR. He agreed to summarize
proposals for future work and submit them to the WG Co-Chairs. The proposal will be circulated to the
WG for comment.
It was noted that ISO 10993-17 (which is the basis for establishing the allowable limits for EO residuals)
was published 5 years ago and a systematic review ballot is circulating in ISO/TC 194
Under other business Dr. Cyr asked what the WG wanted to work on once the revised version of ISO
10993-7 has been published. WG members were asked to consider this proposal for discussion at the next
meeting.


Committee to discuss sterilization and disinfection in the home health care environment

The Ad hoc meeting on sterilization and disinfection in the home health care environment was called to
order to discuss an expected request from IEC/TC 62D on safety and performance for electro medical
devices to ISO/TC 198 to provide guidance on this subject. A standard under development by the IEC
requires that "the cleaning and disinfection processes intended to be performed in the home health care
environment shall be capable of being performed in the home health care environment." IEC was asking
for guidance as to what sort of cleaning and disinfection/sterilization methods could be expected to be
available in the home and is expected to formally as ISO/TC 198 for assistance. The present Ad Hoc
meeting was being held to help flesh out issues prior to the November 2008 meeting of ISO/TC 198 in San
Francisco.
It was noted that IEC has a definition for the Home Health Care Environment and Mr. Lewelling agreed to
circulate that definition to the attendees. It was also noted that infection control issues in the home health
care environment were broader than just instrument sterilization or disinfection and that even that issue
would involve both disinfection/sterilization of reusable instruments for reuse and rendering single use
instruments suitable for handling and disposal.
It was noted that while several instruments were specifically manufactured and sold solely for home use
(sphygmomanometers, contact lenses, thermometers, dialysis equipment and physical therapy equipment)
other instrumentation that be manufactured and sold for hospital use might also be used in home settings.
Mr. Lewelling noted that the issue of concern to IEC/TC 62D might involve respiratory equipment.
While the expected request was for guidance for manufacturers for labeling and instructions (and might be
addressed in ISO 17664 under ISO/TC 198/WG 12), guidance for home health care professionals and even
patients/care givers might also be useful.
A task group was formed consisting of Zory Glaser, Marty Favero, Vicki Hitchins and Steve Goldstine to:
    • Investigate the types of devices that are intended for use in the home or which might be commonly
        used in home settings
    • Assess the current regulatory/oversight status of these devices with relation to these devices
    • Review existing standards and practices for applicability in the home care setting
    • Compile incident reports related to home care disinfection/sterilization/contamination
    • Liaise with other organizations or agencies, such as APIC, the FDA, CPSC, and the CDC, to assess
        the need for guidance/standards
The task group asked Mr. Lewelling to help identify individual nurses or clinical personnel who could join
the group in this work.
The Working Group will report back to the Sterilization Standards Committee at the June 2007 meetings.

                        AAMI/ST/WG 01, Industrial EO Sterilization Meeting
                                 Tuesday, 4 December 2007
 1) The Working Group was reminded that ISO/PDTS 11135-2, Sterilization of health care
    products – Ethylene oxide -- Part 2: Guidance on the application of ISO 11135-1, has been
    submitted to the ISO Central Secretariat and, after editing, will be issued for parallel ISO and
    CEN confirmation ballots as a proposed draft Technical Specification.

 2) Task groups had previously been appointed to make recommendations for the future of the
    AAMI ethylene oxide sterilization TIRs after the 11135 series of documents is finalized.
    Based on these recommendations, the Working Group agreed that the following AAMI TIRs
    should remain in circulation and should be revised:
     •   AAMI TIR14:1997 (and Amendment 1:2004), Contract sterilization for ethylene oxide
     •   AAMI TIR15:1997, Ethylene oxide sterilization equipment, process considerations and
         pertinent calculations
     •   AAMI TIR16:2000, Process development and performance qualification for ethylene
         oxide sterilization -- Microbiological aspects
     •   AAMI TIR20:2001, Parametric release for ethylene oxide sterilization
     •   AAMI TIR28:2001, Product adoption and process equivalency for ethylene oxide
         sterilization
 3) The Working Group was updated on the advanced ethylene oxide sterilization course which will be
    offered by AAMI beginning in 2008. The course will be given from 7-9 April 2008 in Minneapolis
    and again from 20-22 October in Arlington.
 4) An update was given on activities the Ethylene Oxide Sterilization Association (EOSA) meeting.
The SSC thanks the Industrial EO Sterilization Working Group for the report of its meeting and
agrees that AAMI TIR14:1997 (and Amendment 1:2004), AAMI TIR15:1997, AAMI TIR16:2000,
AAMI TIR20:2001 and AAMI TIR28:2001 should remain in circulation and revised.

                  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. The agenda for the meeting
and the minutes of the last (24 April 2007) meeting were approved as written.

The proposed amendment to AAMI TIR22:2007, Guidance for ANSI/AAMI/ISO 11607, Packaging for
 terminally sterilized medical devices – Part 1 and Part 2:2006 was circulated for comment to the
 Packaging Working Group members with a deadline of 16 November 2007. The comments received were
 compiled and the working group resolved all comments during this meeting.

 It was agreed that the proposed amendment will be circulated to the Working Group for committee ballot
 following this meeting.

 It was announced that prEN 868-2 through prEN 868-10 documents were circulated for information and
 comments and although U.S. is not allowed to vote on the European documents, attendees were reminded
 that comments were allowed and to submit them to AAMI staff as soon as possible.

 The Packaging Working Group plans on meeting next during the June 2008 meeting of the
 Sterilization Standards Committee and Working Groups.



                               AAMI/ST/WG 08, Microbiological methods WG
The AAMI Microgbiological Methods Working Group meeting was chaired by Kim Darnell and Martel
Winters.
It was noted that ISO/TC 198 had reviewed comments on the Committee Draft of ISO 11737-2 and had
prepared an Enquiry draft for DIS ballot. This ballot was expected to begin in December or January and the
AAMI Microbiological Methods Working Group will ballot the document both to determine U.S. consensus
and to determine its suitability as a revision of the current edition of ANSI/AAMI/ISO 11737-2.
It was noted that ISO/TC 194 had approved the new work item on pyrogenicity testing and formed a new
working group (ISO/TC 194/WG 16) to develop the standard. AAMI had formed a Sub-TAG (BE/WG 16)
and interested parties are invited to join that Working Group. ISO/TC 198/WG 8 is expected to have an
official liaison with ISO/TC 198/WG 16. It was reported that the work item would include all acceptable
commonly used test methods (e.g, LAL, whole blood method, achromogenic, gell clot, etc.) and that the ISO
patent policy would apply to the working group's output.
A task group was formally appointed to address the comments received during the reaffirmation ballot of
ANSI/AAMI/ST72 and to prepare a working draft revision for consideration at the June 2007 meetings.
The Working Group also reviewed the results of the ballot of the draft AAMI TIR on product innoculation.
The results were positive, but over 150 comments had been submitted. All comments were resolved and it
was agreed that the revised TIR would be circulated to the Working Group so that votes could be confirmed
(or changed) prior to submission to the AAMI Standards Board for final approval.


                           AAMI/ST/WG 10, Liquid chemical sterilization WG
 The Working Group considered comments on ISO/WD 14160.2, 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 February 2008 meeting of ISO/TC 198/WG
 10 in Miami. It was agreed that Charles Roberts (Johnson & Johnson) Dennis Wildes (St. Jude Medical)
 and Christine Loshbaugh (Edwards Life Sciences) should attend the meeting as US delegates.
 The SSC thanks the working group for the report of its meeting, and agrees that Mr. Roberts, Mr.
 Wildes, and Ms. Loshbaugh should serve as U.S. delegates to the February 2008 meeting of ISO/TC
 198/WG 10 in Miami.

                         AAMI/ST/WG 13, Washer-disinfector Working Group
 The Working Group meeting was led by Dr. Steve Goldstine.
 The Working Group reviewed the results of the Dublin meeting of ISO/TC 198/WG 13, Washer
 Disinfectors, on 27-28 June 2007. ISO/TC 198/WG 13 had met in Dublin in conjunction with the ISO/TC
 198 Plenary meeting.
It was noted that the text of EN/ISO 15883-4 Washer disinfectors — Part 4: Requirements and tests for
washer disinfectors employing thermal disinfection for thermolabile instruments including endoscopes,
had been submitted to ISO for parallel ISO and CEN Final Approval ballot in July, but the ballot had not
yet been initiated. The submitted text was available in Doc. 198 N794, but staff warned that it was subject
to further editing by ISO editors and the CEN Technical Consultant prior to ballot and could change.
When the ballot was initiated, the Working Group would be canvassed to determine whether the U.S.
should vote for approval, against approval or should abstain. The Working Group also agreed to use the
final text of ISO 15883-4 to prepare a U.S. standard that would be similar to the International Standard, but
would contain substantive U.S. deviations.
It was also reported that, in Dublin, ISO/TC 198/WG 13 appointed a Task Force to undertake laboratory
studies aimed at producing the data necessary to effect a revision of EN ISO 15883-5 by reducing the
recommended test methods and soils. A first meeting of the Task Group was held in Austria in September
2007 (see minutes) and a second meeting is planned for early December in Berlin. Kevin Corrigan and
Harriet Chan-Myers attended the September meeting in Austria. And were expected to attend the Berlin
meeting as well.
In Dublin, it has been agreed to add ISO/CD 15883-6, Washer-disinfectors - Part 6: Requirements and
tests for general purpose washer-disinfectors employing thermal disinfection to the ISO/TC 198/WG 13
work program. A Committee Draft is expected to be issued for ballot in early December. This is joint
work with CEN under the Vienna Agreement but with an ISO lead. The U.S. would be balloted to develop
the U.S. consensus on whether the document should be advanced to the DIS stage. In response to U.S.
comments raised in Berlin, the scope of ISO 15883-6 had been clarified to eliminate any perceived overlap
with ISO 15883-2.
Dr Simpson, the convener of ISO/TC 198/WG 13 in Dublin gave advance notice to the WG of her
intention to retire from the convenership by the next plenary meeting in November 2008. The ISO/TC 198
Secretariat is consulting with the Secretary of CEN/TC 102 to identify a suitable replacement.
It was reported that AAMI will continue to develop standards on washer-disinfectors based on the ISO
15883 series but with significant deviations. A draft of AAMI/ST 15883-1 (based on ISO 15884-1) d will
be issued for ballot by the first quarter of 2008. The AAMI working group begins review of ISO 15883-2
and ISO 15883-3 to identify necessary U.S. deviations so that working drafts can be prepared and issued
for comment prior to the next AAMI meetings in June 2007.
The Sterilization Standards Committee thanks AAMI/ST/WG 13 for the report of its meeting and
agrees with the plans for processing AAMI standards on washer-disinfectors based on the ISO 15883
series.


                      AAMI/ST/WG 83 Reusable Surgical Texile Reprocessing WG
The Working Group reviewed comments on the 2nd working draft revision of ANSI/AAMI/ST65,
Processing of Reusable Surgical Textiles for Use in Health Care Facilities. All comments were
satisfactorily resolved and there was general agreement that the revised draft should be placed on
concurrent Committee Ballot and Public Review
THE SSC THANKS THE WORKING GROUP FOR THE REPORT OF ITS MEETING AND
AGREES THAT THE DRAFT REVISION OF ANSI/AAMI/ST65 SHOULD BE PLACED ON
PUBLIC REVIEW AND UNDERGO COMMITTEE BALLOT PRIOR TO THE JUNE 2008
MEETINGS

                     AAMI/ST/WG 92, Process Challenge Devices Working Group
This meeting was chaired by co-chairs Mr. Steve Kirckof of 3M and Ms. Susan Klacik of IAHCSMM. The
agenda for the meeting and the minutes of the last meetings (24 April 2007 meeting and 26 September
2007 conference call) were approved as written.
The AAMI/CDV2 TIR31:200x, Process challenge devices/test packs for use in health care facilities, was
circulated recently for a second committee ballot. During the 26 September 2007 conference call, the
Process Challenge Devices Working Group resolved the comments received on the first ballot of the
proposed TIR31. During current meeting, the group took a look at the 2nd committee ballot version of the
document and decided that few areas in the document still needed to be revised or were not resolved to the
satisfaction of the working group. It was decided that the scope and a couple of sections will be revised
and the document will be re-circulated with an extended ballot deadline of late February 2008.
There was a discussion on working on possible standard on extended cycle PCDs. It was decided that the
co-chairs will develop a new work item proposal on extended cycles to present to the rest of the working
group. Ad hoc committee of Gary Socola of SPS, Rod Parker of Stryker, Lon Bruso of Steritec, Barb
Smith of Getinge, Chris Justi of Synthes, Tom Frazar of DePuy/J&J, Richard Bancroft of Albert Browne,
Jonathan Wilder of H&W Technology, Joan Spear of Aesculap, Eugenia Arluk of Alcon, and Sandra Lee
along with co-chairs was formed to look into extended cycles. A conference call is being planned in
February for the ad-hoc committee.
The Process Challenge Devices Working Group plans on meeting next during the June 2008 meeting of
the Sterilization Standards Committee and Working Groups.




                         AAMI/ST/WG 2, Radiation sterilization Working Group
                                        Wednesday, 5 December 2007
   1.   It was announced that AAMI TIR 27:2007, Sterilization of health care products-Radiation-
        Guidance of Sterilization of Human Tissue-Based Products was in publication.
   2.   The WG established a task force to develop the newly-approved work item for a TIR on Radiation
        Dose setting for low bioburden products utilized a modified method 2. The task group planed to
        meet immediately after the working group meetings, and agreed to have a draft ready for comment
        in Spring 2008. The task group will be led by David Parente and Deborah Havlik.
   3.   The WG agreed that Byron Lambert should be appointed liaison to the International Irradiation
        Association (IIA).
   4.   The WG discussed the possibility of developing a new work item to address isotope leading. Steve
        Yeadon plans to submit a new work item proposed on this issue to AAMI. This proposal might be
        formatted as a reason to AAMI TIR 29.
   5.   It was reported that a request for changes to ISO 11137-1 had been received from the U.K. Based
        on this request; the secretary of ISO/TC 198 may issue a new work item proposal to reuse the
        standard.
   6.   Dr. Whitby was congratulated on receiving the first ever AAMI standards-developer award.
   7.   FDA confirmed that it is no longer registering contract sterilizers.

            U.S. Sub-TAG for ISO/TC 198/WG 03, Industrial moist heat Working Group

Jim Kaiser, Bausch & Lomb Inc.
Gregg A. Mosley, Biotest Laboratories Inc.
Russell R. Nyberg, Raven Biological Laboratories
Mike Sadowski, Baxter Healthcare Corp.
Donna Swenson, AppTec
Others based on sign-in sheet
1. The Working Group met to review the results of the London ISO WG 3 and the Dublin TC 198
meetings on ISO/PDTS 17665-2: Sterilization of health care products -- Moist heat – Guidance on the
application of ISO 17665-1 (doc. 198 N758).
Based on the substantive nature of the U.S. comments and the fact that
the document failed to provide useful guidance on ISO 17665-1 (due primarily to
formatting issues), the U.S. had voted negative on the ballot.
Charlie Hancock and Donna Swenson attended the 30 April to 2 May 2007 London meeting as the U.S.
representatives. Poor progress was made at the London meeting toward resolution of US comments and
concerns. However, following this meeting and prior to the Dublin meeting, the convener, Keith Oates of
the UK, undertook a masterful rewrite of the -2 document aligning the format with the -1 document.
At the Dublin meeting, the U.S. was represented by Mr. Hancock, Dr. Lin, Ms.
Swenson and Mr. Mosley. The results of the Dublin meeting were that the major objections from the US,
UK and Japan (all of which voted negative on the document) were resolved. The US delegation concurred
that all major US points were satisfactorily adopted and no major objections on the document remained.
During the Wednesday Dec. 5, 2007 meeting the attendees for AAMI WG 3 concured without dissent that
the US should accept the 17665-2 document and proceed toward national adoption.

2. The Working Group also discussed whether AAMI TIR 13, Principles of Moist Heat Sterilization,
should be withdrawn, revised or remain without revision. It was discussed that some of the information in
the TIR had not been captured by 17665-1 and -2. In particular, prescriptive recommendations for
achieving parametric release of moist heat sterilization processes were not adequate. After some
discussion it was determined that a small break out group should first review the new revision of PDA
Technical Report 1, Revised 2007, (TR1) Validation of Moist Heat Sterilization Processes Cycle Design,
Development, Qualification and Ongoing Control should be reviewed along with the coming associated
PDA TR and AAMI TIR 13. Input on the extensive and scientific nature of the PDA revised document
were provided by Mike Sadowski and Bob Reich. After this assessment the group will make a
recommendation to the committee as to whether all matters considered essential from TIR 13 had already
been captured in the PDA documents, in which case AAMI TIR might be merely withdrawn.
The four members of the working who will make the evaluation are:
Richard O’Donnell, Steris
Mike Sadowski, Baxter (chair of the PDA working group for the new TR)
Co-chairs: Donna Swenson
Gregg Mosley
                 AAMI/ST/WG 60, Ethylene Oxide Sterilization Hospital Practices WG
The Working Group considered the results of the ballot and submitted comments on the third committee
ballot of ANSI/AAMI/ST41, Ethylene Oxide Sterilization in Health Care Facilities: Safety and
Effectiveness. All comments were considered and addressed. The comments accompanying the single
negative ballot were not accepted.
Upon motion, the Working Group members present unanimously agreed that the revision of ST41, as
revised editorially at this meeting, should be submitted to AAMI and ANSI for Final Approval. The
Working Group also agreed to recommend that following publication, the document be maintained
according to Continuous Maintenance Procedures like ST79.

THE SSC THANKS THE WORKING GROUP FOR THE REPORT OF ITS MEETING AND
AGREES THAT THE REVISION OF ST41, AS EDITORIALLY REVISED AT THIS MEETING,
BE FORWARDED TO THE AAMI STANDARDS BOARD AND ANSI FOR FINAL APPROVAL.

THE SSC ALSO AGREES THAT ST41 SHOULD BE MAINTAINED IN THE FUTURE
ACCORDING TO CONTINUOUS MAINTENANCE PROCEDURES.

                  AAMI/ST/WG 11, General criteria for sterilization processes WG
The Working Group heard the report of the meeting of ISO/TC 198/WG 11 in Dublin. The ISO Working
Group had met to consider the ballot results of ISO/CD 14937 (general criteria for sterilization processes, 2nd
ed.) and all submitted comments. Based on the ballot results and progress made in resolving the comments,
ISO/TC 198/WG 11 had agreed to advance the document for Enquiry ballot as ISO/DIS 14937. This parallel
ISO and CEN ballot had been initiated on November 28th. The results will be considered at the ISO/TC
198/wG 11 meeting tentatively planned for November 2008 in San Francisco.
AAMI would ballot the document to determine the U.S. consensus and the document's acceptability as a
revision of ANSI/AAMI/ISO 14937:2000. As the ISO ballot was scheduled to end on either 28 April 2008 or
28 May 2008 it may be necessary for the U.S. Sub-TAG for ISO/TC 198 to hold an interim meeting by
conference call to resolve any issues related to the U.S. position and U.S. comments. The AAMI Working
Group meeting in June 2008 will be devoted to reviewing all international comments in preparation for the
November 2008 ISO/TC 198/WG 11 meeting.

                        AAMI/ST/WG 42, Dry heat sterilization Working Group
The AAMI Working Group heard the report of the Dublin meeting of ISO/TC 198/WG 14 and reviewed
the results of the ballot of ISO/DIS 20857, Sterilization of health care products — Dry heat—
Requirements for the development, validation and routine control of an industrial sterilization process for
medical devices.
ISO/DIS 20857 was circulated for ballot from 13 April 2007 2006 through 13 October 2007. The results of
the ballot were affirmative and tentatively support advancement of the Draft to Final Approval (FDIS)
stage. However, due to issues discussed at the Dublin meeting of ISO/TC 198 and ISO/TC 198/WG 14
(relating primarily to the need for the standard to better address dry heat sterilization in health care
settings) and due to the number of comments received on the document, it is likely that ISO/TC 198 will
issue a second DIS for Enquiry ballot. Comments had been received from Australia, Austria, Canada,
Denmark, Japan, Sweden, the United Kingdom and the USA and were to be considered by at a meeting of
ISO/TC 198/WG 14 scheduled for 5-7 December 2007 in Arlington.
The AAMI Working Group reviewed the submitted International comments in preparation for the ISO/TC
198/WG 14 meeting and agreed that the U.S. should support the circulation of a second DIS ballot if this is
proposed.

The SSC thanks the Working Group for its report and agreed to support a second DIS ballot of
ISO/DIS 20857 if that is proposed.

                       AAMI/ST/WG 43, Hospital Steam Sterilizer Working Group
The WG considered comments filed during the first ballot of the revision to ANSI/AAMI/ST 08 R,
“hospital steam sterilizers”. All comments where considered and addressed, and all three negative votes
filed during the ballot where withdrawn. Because substantive changes where made in the draft standards in
order to resolve comments, there were general agreements to re-ballot the documents as revised at the
meeting. It will also be made available again for ANSI/AAMI public review. It is hope that at it’s January
2008 meeting, the WG will be able to resolve all comments from the 2nd ballot and finalized the standard.
In the course of the meeting, it was suggested that the AAMI terminology WG be reactivated to address
certain terminology questions that have arisen for ST 08R and other AAMI standards.

        ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION
                     AAMI Sterilization Standards Committee (SSC)/

                                  Wednesday, 5 December 2007
                                         Minutes of the Meeting

1.     Opening and introductions
       The meeting was called to order by the co chairs Vickie Hitchins and Bill Young. A list of the
       attendees is attached (Attachment A).

2.     Approval of the agenda
       The agenda (doc. stn042) was approved as distributed.

4.     Review of relevant FDA activities; other regulatory/government matters
     Information on relevant activities of the FDA and other regulatory agencies was presented. See
     Attachment B.

5.   Discussion of other AAMI activities relating to sterilization
     An update on AAMI sterilization education programs was given. Staff reported that the AAMI
     Sterilization Courses were continuing, with offerings in ethylene oxide sterilization and radiation
     sterilization scheduled for 2008. A web seminar on SAL determination was held on 16 February
     2006. Additionally, a new radiation sterilization course is also now being offered on a biannual basis.
     This course would be revised over the next year and could include a module on sterilization
     packaging. A webinar on Reprocessing Medical Devices: Current Standards, Guidance, and New
     Developments in Validating Cleaning, Disinfecting and Sterilization Processes, would be offered on
     December 5 2006.

     •   AAMI Sterilization CD and plans for publishing new AAMI sterilization standards and books in
         2008

     A presentation entitled Sterilization Standards: Upcoming Changes in the Approach to Medical
     Device Sterilization, was offered at the 2006 AAMI International Standards Conference, held from
     22 to 23 March 2006.

6.   Call for cochair nominations
     Staff noted that cochair positions were open on AAMI ST/WG 63, Ethylene oxide residuals Working
     Group. Nominations are requested.

7.   Report of the AAMI Industrial Ethylene Oxide Sterilization Working Group/U.S. Sub-TAG for
     ISO/TC 198/WG 1 [ST/WG 01]

     Working Group members were informed that ISO/FDIS 11135-1 was likely to be issued in early
     2007. At that time, AAMI would re-ballot the document (for thirty days) instead of putting the
     document through the standard "30-day final review" process.
     Working Group members were informed that ISO 11135-2 was still in Working Draft stage, but the
     PDTS ballot was likely to be issued before ISO 11135-1 is finalized.

     The Working Group considered the future of the current AAMI ethylene oxide sterilization TIRs
     after the ISO 11135 series is finalized, and decided that the status of the documents should not be
     changed at present, but should be re-evaluated at the next Working Group meeting in Spring 2007.
     The Working Group also decided to establish a task group to consider options for possibly revising
     and/or consolidating certain of the TIRs to correspond with the future 11135-1 and 11135-2.
     The SSC thanked the Working Group for the report of its meeting.

8.   Report of the AAMI Radiation Sterilization Working Group/U.S. Sub-TAG for ISO/TC 198/WG 2
     [ST/WG 02]
     The Working Group was informed that ANSI/AAMI/ISO 11137-1:2006, ANSI/AAMI/ISO 11137-
     2:2006 and ANSI/AAMI/ISO 11137-3:2006 were in publication.
     It was added that AAMI TIR33:2005, Sterilization of health care products — Radiation
     sterilization — Substantiation of a selected sterilization dose for VDmax, had been published.
     Staff also announced that AAMI TIR35, Sterilization of health care products — Radiation
     sterilization — Alternative sampling plans for verification dose experiments and sterilization dose
     audits, would be submitted to the AAMI Standards Board for final approval in November 2006.
      The Working Group considered the ballot results and comments on AAMI/CDV-2 TIR(ST02)1,
      Guidance on Radiation Sterilization of Human Tissue-Based Products. Based on the ballot results
      the comments received, it was determined that significant substantive changes would be required
      for the document. Therefore, the Working Group agreed that the document should be revised and
      re-balloted for consideration at the next meeting in April 2007.
      The Working Group agreed that a New Work Item Proposal (NWIP) should be developed for a
      guidance document on modifying Method 2 of ANSI/AAMI/ISO 11137-2.
      The SSC thanked the Working Group for the report of its meeting.

9.    Report of the AAMI Industrial Moist Heat Sterilization Working Group/U.S. Sub-TAG for ISO/TC
      198/WG 3 [ST/WG 03]
         • Status of ISO 17665-1 (Moist heat sterilization – requirements)
         • Status of publication of ANSI/AAMI/ISO 17665-1 as a revision of ANSI/AAMI/ISO
             11134:1994
         • Status of Committee Draft of ISO/TS 17665-2 (Moist heat sterilization – guidance) and U.S.
             plans for processing document

10.   Report of the AAMI Biological Indicators Working Group/U.S. Sub-TAG for ISO/TC 198/WG 4
      [ST/WG 04]
      The Working Group reviewed the results of the US ballot of ISO 14161, Sterilization of health care
      products – Biological indicators – Guidance for the selection, use, and interpretation of results. It
      was noted that the ballot closed on 16 November 2006 and that more votes were needed for a valid
      ballot. The Working Group reviewed the comments submitted on the ballot and provided responses
      to each one. Significant changes to be forwarded to ISO in the US position included revision of
      annexes, harmonization with ISO 11138 (2006) series stanudards and inclusion of additional
      guidance for determination of process lethality. The Working Group agreed that a US position of
      Affirmative with Comments should be forwarded to ISO.

      It was reported that the ISO 11138 series documents had been published by ISO and the US
      adoptions had been published by AAMI. Additionally, ISO 18472 had been published by ISO and
      the US adoption had been published by AAMI. Furthermore, it was noted that an error in ISO
      11138-3 specifying a lower come-down time than that in ISO 18472 had been identified and that a
      Technical Corrigendum might be issued to correct that.

      Delegates for the ISO TC/198 meeting in Dublin were identified.
      The SSC thanked the Working Group for the report of its meeting.

11.   Report of the AAMI Sterilization Terminology Working Group/U.S. Sub-TAG for ISO/TC 198/WG
      5 [ST/WG 05]
      This Working Group was not currently active and did meet in conjunction with the AAMI
      sterilization meetings.

12.   Report of the AAMI Chemical Indicators Working Group/U.S. Sub-TAG for ISO/TC 198/WG 6
      [ST/WG 06]
      The Working Group reviewed the results of the parallel ballot of ISO/DIS 15882, Sterilization of
      health care products – Chemical indicators – Guidance for selection, use and interpretation of
      results and provided responses to each of the comments received. It was noted that this ballot
      officially closes November 24, 2006, and that more votes were needed to record a valid ballot. It was
      also noted that the draft balloted in AAMI to determine the US position on the ISO document was the
      same text submitted to ISO for DIS processing; however, ISO had not issued the formal DIS text yet,
      and the official ISO DIS text could have editorial changes, but the technical requirements would not
      be changed. The Working Group agreed that, assuming no negative votes were received on the
      AAMI ballot, a US position of Affirmative with Comments should be submitted to ISO once the DIS
      ballot was issued. It was further agreed that if any other comments were received by AAMI during
      the ballot and public review periods, the Working Group Cochairs would provide recommended
      responses to them and they would be circulated to the Working Group for confirmation prior to being
      added to the US position on the DIS.

      It was reported that the following documents had been submitted to ISO for FDIS ballot:

      •   ISO/FDIS 11140-3, 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 11140-4, 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 11140-5, Sterilization of health care products – Chemical indicators – Part 5: Class 2
          indicators for Bowie and Dick-type air removal tests

      It was reported that once ISO issued the FDIS's, AAMI would circulate the documents for final 30-
      day committee review before submission to the AAMI Standards Board for authorization to submit
      them to ANSI for approval as American National Standards. It was emphasized that comments would
      not be solicited during final 30-day committee review. Assuming there were no objections to the
      documents during final 30-day committee review, U.S. votes of Approval would be submitted on the
      ISO FDIS's.

      It was reported that ISO 18472 had been published by ISO and the US adoption had been published
      by AAMI.

      It was reported that EN 867-5, Non-biological systems for use in sterilizers - Part 5: Specification for
      indicator systems and process challenge devices for use in performance testing for small sterilizers
      Type B and Type S was being revised for proposed adoption as ISO 11140-6 under the Vienna
      Agreement, ISO lead. A meeting of ISO/TC 198/WG 6, Chemical indicators would be held in Europe
      in early 2007 in order to develop a Committee Draft for balloting in time for results to be considered
      at the ISO/TC 198 meeting in Dublin in June 2007.

      Delegates for the June 2007 meeting of ISO/TC 198/WG 6 in Dublin were identified.
      The SSC thanked the Working Group for the report of its meeting.

13.   Report of the AAMI Sterilization Packaging Working Group/U.S. Sub-TAG for ISO/TC 198/WG 7
      [ST/WG 07]
      It was announced that Ms. Jacqueline Johnson’s appointment as a co-chair of this working group
      had been approved by the co-chairs of the Sterilization Standards Committee, and that Ms. Johnson
      had accepted the position.

      The AAMI/CDV for TIR 22, which is the proposed draft revision of AAMI TIR 22:1998, was
      circulated to the AAMI Packaging Working Group in August with a committee ballot deadline of
      29 September 2006. With 72% of the members voting, the ballot was considered valid. Out of 36
      members, 24 returned affirmative votes (6 with comments) and one returned an abstention vote.
      The Working Group members reviewed and resolved all of the ballot comments. It was agreed that,
      once all of the changes and corrections were in the draft, the document would be circulated for final
      30-day review. The Packaging Working Group hoped to have this revised TIR finalized by the end
      of this year.

      It was noted that a special acknowledgement (to be inserted in the committee representation page)
      should be written for the Task Group members responsible for this document.

      The Working Group discussed a possibility of writing a technical information report for the
      hospital workers (users), and it was decided that the group would start working on a possible annex
      for the hospital workers, which could be considered for adoption as an addition to AAMI ST79 or
      published separately.
      The SSC thanked the Working Group for the report of its meeting.

14.   Report of the AAMI Microbiological Methods Working Group/U.S. Sub-TAG for ISO/TC 198/WG
      8 [ST/WG 08]
      It was announced that Ms. O'Brian's term as cochair would end on 31 December 2006 and that she would
      be replaced by Martell Winters.

      The Working Group discussed the planned meeting of ISO/TC 198/WG 8 in Arlington at the end of
      January 2007 to revise ISO 11737-2. U.S. comments had already been prepared and it was agreed that the
      U.S. would be represented at this meeting by Trabue Bryans, Debbie Havlik, Martell Winters, Craig
      Herring and Kim Darnell. It was expected that a Committee Draft would be issued after this meeting and
      circulated for ballot by ISO/TC 198, with the results to be considered at the ISO/TC 198/WG 8 meeting in
      Dublin in June 2007.

      It was announced that ISO 11737-3 would be withdrawn because its content had been added to the revised
      ISO 11737-1.

      The Working Group then reviewed the first working draft of a proposed AAMI TIR, entitled "Sterilization
      of health care products - Guidance on selecting a microbial challenge and inoculation sites for
      sterilization validation" and consideration of submitted comments. All comments were responded to, and
      it was agreed that a revised draft would be issued to the Working Group prior to the April 2007 meetings.
      The SSC thanked the Working Group for the report of its meeting.

15.   Report of the AAMI Aseptic Processing Working Group/U.S. Sub-TAG for ISO/TC 198/WG 9
      [ST/WG 09]
      This working group did not meet in conjunction with the Fall 2006 sterilization meetings.
         • Status of ISO/DIS 13408-1, 2nd ed., (aseptic processing –general requirements) and plans for
             U.S. adoption of this standard
         • Status of ISO 13408-2 (filtration), ISO 13408-3 (lyophilization), ISO 13408-4 (Clean-in-
             place technologies). ISO 13408-5 (sterilization in place) and ISO 13408-6 (isolator
             technologies) and plans for U.S. adoption.

16.   Report of the Liquid Chemical Sterilization Working Group/U.S. Sub-TAG for ISO/TC 198/WG 10,
      Liquid chemical sterilization [ST/WG 10]
      The Working Group discussed plans for the December 2006 meeting of ISO/TC 198/WG 10 in
      Berlin. It was announced that ISO/TC 198/WG 10 would meet in Berlin to begin working on a
      revision of ANSI/AAMI/ISO 14160:1998, Sterilization of single-use medical devices incorporating
      materials of animal origin - Validation and routine control of sterilization by liquid chemical
      sterilants. The ISO meeting was being held in conjunction with the meeting of ISO/TC 194/SC 1,
      Tissue product safety. It was announced that Charles Roberts (U.S.A.) had been appointed
      convener of ISO/TC 198/WG 10. The goal of ISO/TC 198/WG 10 would be to issue a draft
      revision for Committee Draft ballot prior to the Dublin meeting of ISO/TC 198 in June 2007.

      The Working Group also considered a marked-up version of ISO 14160:1998, incorporating
      embedded comments submitted during periodic review and notations by the ISO/TC 198
      Secretariat, and agreed on a U.S. position for these comments to be conveyed at the December
      meeting of ISO/TC 198/WG 10 in Berlin.
      The SSC thanked the Working Group for the report of its meeting.

17.   Report of the AAMI General Criteria for Sterilization Processes Working Group/U.S. Sub-TAG for
      ISO/TC 198/WG 11, General criteria for sterilization processes [ST/WG 11]
      David Liu, John Kowalski, Joel Gorski, Chui Lin and Nelson Lao were nominated as U.S. experts
      to participate in the revision of ISO 14937 (general criteria) and to represent the U.S. at the
      Arlington meeting of ISO/TC 198/WG 11 on 31 Jan 2006 to 1 February 2007.

      It was noted that several of the U.S. comments submitted in response to the periodic review of ISO
      14937 made general suggestions but did not provide specific text for consideration. John Kowalski
      agreed to draft text for consideration at the Arlington meeting.

      Members of the Working Group were advised to submit any additional comments or concerns
      about ISO 14937 to AAMI (jlewelling@aami.org) by 15 December 2006, and that these would be
      forwarded to the U.S. delegates for consideration.
      The SSC thanked the Working Group for the report of its meeting and approved the
      nominations of David Liu, John Kowalski, Joel Gorski, Chui Linn and Nelson Lao as U.S.
      experts to participate in the revision of ISO 14937.

18.   Report of the AAMI Instructions for the Reprocessing of Resterilizable Medical Devices Working
      Group/U.S. Sub-TAG for ISO/TC 198/WG 12, Instructions for the reprocessing of resterilizable
      medical devices [ST/WG 12]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

19.   Report of the AAMI Washer-Disinfector Working Group/U.S. Sub-TAG for ISO/TC 198/WG 13,
      Washer-disinfectors [ST/WG 13]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.


20.   Report of the Moist Heat Sterilization Hospital Practices Working Group [ST/WG 40]
      • It was announced that AAMI/ST79, Comprehensive guide to steam sterilization and sterility
         assurance in health care facilities hah been published
      • Plans to maintain ST79 on a continuous basis (yearly revision)

21.   Report of the Dry Heat Sterilization Working Group [ST/WG 42]
      The Working Group met to review the results of the international ballot of ISO/CD 20857,
      Sterilization of health care products – Dry heat – Requirements for the development, validation and
      routine control of sterilization processes for medical devices, in preparation for the 12-13 February
      2007 meeting of ISO/TC 198/WG 14 in London. It was noted that the venue of this meeting might
      be changed to the U.S. if it appeared no European delegates were planning to attend. The U.S
      would be represented at this meeting by Bonnie Stewart and James Gibson, with Deborah Havlik
      serving as the U.S. convener. It was added that, if additional individuals would like to attend as
      U.S. representatives, they should contact Joe Lewelling at jlewelling@aami.org for more
      information.

      The AAMI Working Group reviewed all 132 comments that had been submitted by seven different
      countries (with two countries voting negative) and agreed on U.S. positions for each comment.

      Ms. Havlik noted that, as the convener of the ISO Working Group, she would prepare proposed
      resolutions for consideration at the London meeting and these resolutions might or might not be
      consistent with the U.S. positions.
      The SSC thanked the Working Group for the report of its meeting.

22.   Report of the Hospital Steam Sterilizer Working Group [ST/WG 43]
      The Hospital Steam Sterilizer Working Group reviewed comments on the second working draft of
      AAMI ST8R, “Hospital Steam Sterilizers.” All substantive comments were considered and
      resolved. A new draft of the revised standard would be distributed for comment prior to the April
      2007 meeting.

      The Working Group also heard a report from WG member Mr. Steve Peake regarding the
      American Dental Association’s Working Group on small steam sterilizers. Mr. Peake, who co-
      chairs that Working Group, indicated that the ADA would consider endorsing ANSI/AAMI ST55 if
      certain changes were made regarding cassette sterilizers (now excluded from ST55) and dental
      hand pieces. There was general agreement that the AAMI Working Group would entertain
      proposed revisions to ST55, either as an amendment or as part of the general revision process. Mr.
      Peake agreed to provide consensus recommendations from the ADA Working Group, for
      consideration at the next meeting of the AAMI Working Group in April 2007.
      The SSC thanked the Working Group for the report of its meeting.

23.   Report of the Ethylene Oxide Sterilization Hospital Practices Working Group [ST/WG 60]
      The EO Sterilization Hospital Practices Working Group reviewed comments submitted during the
      first ballot of the revised recommended practice, “Ethylene Oxide Sterilization in Health Care
      Facilities: Safety and Effectiveness” (ST41R). Much of the discussions pertained to the use of the
      challenge test pack for qualification testing. A second major issue was the extent to which ST41R
      should incorporate previsions of ST79, particularly concerning cleaning and decontamination.

      Substantive changes were made in the document and there was general agreement that ST41R, as
      amended at the meeting, should be re-balloted. Comments submitted during the ballot would be
      considered at the April 2007 meeting of the Working Group.
      The SSC thanked the Working Group for the report of its meeting.

24.   Report of the Chemical Sterilants Hospital Practices Working Group [ST/WG 61]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

25.   Report of the Hospital Ethylene Oxide Sterilizer Working Group [ST/WG 62]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

26.   Report of the Sterilization Residuals Working Group [ST/WG 63]
      This working group was not scheduled to meet in conjunction with the AAMI sterilization meetings.
27.   Report of the Decontamination Working Group [ST/WG 82]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

28.   Report of the AAMI Reusable Surgical Textile Reprocessing Working Group [ST/WG 83]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

29.   Report of the AAMI Microbiological Quality/SAL Working Group [ST/WG 90]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

30.   Report of the AAMI Indicator-Evaluator Resistometer Working Group [ST/WG 91]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

31.   Report of the Process Challenge Devices Working Group [ST/WG 92]
      Three sections in AAMI CD TIR 31:2003, Process challenge devices/test packs for use in health
      care facilities, were updated, which included sections on extended cycles, hydrogen peroxide
      sterilization, and ozone sterilization. The draft was circulated for comments to the committee
      members and all of the comments received were resolved during the meeting. The draft would be
      revised and the resolution of comments as well as the revised draft would be circulated to the
      Working Group members.

      The members also formed an ad-hoc task group to explore further the concept of PCDs for
      extended cycles. The task group would be composed of Mr. Kirckof; Ms. Klacik; Mr. Lon Bruso of
      Steritec; Mr. Denny Christensen of Process Challenge Devices; Mr. Kevin Corrigan of Advanced
      Sterilization Product; Mr. Tom Fraser of Johnson & Johnson; Ms. Barb Smith of Getinge; Mr. Gary
      Socola of SPS Medical; Ms. Eugenia Stern of Alcon Laboratories; Mr. Jonathan Wilder of H & W
      Technology; and Mr. Bill Young of Sterigenics.

      It was agreed that the ad-hoc group would meet and submit updates to the draft to address extended
      cycles. These additions as well as the result of the discussion by the ad-hoc group would be
      presented at the next meeting of the Working Group. After the next meeting, the Working Group
      hoped to circulate TIR 31 for committee ballot.
      The SSC thanked the Working Group for the report of its meeting.

32.   Report of the Cleaning of Reusable Medical Devices for Reprocessing Working Group [ST/WG 93]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

33.   Report of the Rigid Sterilization Container Systems Working Group [stwg94]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

34.   Report of the Water Quality for Reprocessing Medical Devices Working Group [ST/WG 95]
      This working group is not currently active and was not scheduled to meet in conjunction with the
      AAMI sterilization meetings.

35.   Report of the Qualification of Materials to be Sterilized Working Group [ST/WG 96]
      The Working Group reviewed and consolidated the draft texts for each section of the draft TIR on
      the selection and compatibility of materials subjected to sterilization.

      The Working Group agreed to appoint Mr. Patrick Nolan (DDL, Inc.) as the liaison to AAMI
      ST/WG 07, Packaging Working Group.

      The Working Group agreed that, based on progress made at the 13 November meeting, a new draft
      would be developed and circulated for ballot in mid-February 2007.
      The SSC thanked the Working Group for the report of its meeting.

36.   Sterilization Standards Committee program of work
      Other than those items discussed in the reports of various working groups, no new work item
      proposals for the AAMI Sterilization Standards Committee were considered.

37.   ISO/TC 198 program of work
      Other than those items discussed in the reports of various working groups, no new work item
      proposals for proposal to ISO/TC 198 were considered.

38.   Plans for 18th meeting of ISO/TC 198 and affiliated working groups and future meetings
      It was announced that a meeting of ISO/TC 198 and selected working groups was scheduled for Fall
      2008 in San Francisco.

39.   ISO/TC 198 liaisons (only matters not yet discussed)
      IEC/TC 66/WG 7, Sterilizers for medical purposes; ISO/TC 84, Medical devices for injection;
      ISO/TC 209, Clean rooms and associated environments; ISO/TC 210, Quality management and
      corresponding general aspects for medical devices; CEN/TC 102, Sterilizers for medical purposes;
      CEN/TC 204, Sterilization of medical devices; others?

40.   Review of standard setting activities by other groups in the U.S. and Canada
      Other than those items discussed in the reports of various working groups, no activities were
      discussed.

41.   General announcements
      Other than those items discussed in the reports of various working groups, no announcements were
      made.

42.   Plans for the next meeting:
      In 2008, the meetings are scheduled for the following dates:

      Monday-Wednesday, 23-25 June 2008 in Arlington

      Monday-Wednesday 8-10 December 2007 in Arlington

      In 2008, ISO/TC 198 will also meet as follows:

      Monday-Friday 3-7 November 2008 in San Francisco .

      The subsequent meeting of ISO/TC 198 will likely be held in the latter half of 2010.

       We need to now plan the 2009 meetings of the AAMI Sterilization Standards Committees and
      affiliated working groups. We will again hold two sets of meetings, one in late April to June
      2009 and the other in late October to early December 2009. One possibility would be for the first
      2009 AAMI sterilization meetings to be held in conjunction with the 2009 AAMI Annual meeting,
      which is planned for 6-8 June 2009 in Baltimore .


43.   Adjournment
      There being no other business to report, the meeting was adjourned.

				
DOCUMENT INFO