aami st/wg 01, industrial ethylene oxide sterilization · aami st/wg 01, industrial ethylene oxide...

1

STWG01 (March 2017)

AAMI ST/WG 01, Industrial Ethylene Oxide Sterilization

Hyatt Regency Baltimore Inner Harbor Baltimore, MD

───────────────────────────────────────────────────────────── Meeting date/time: Thursday 17 October 2017 9:00 pm to 5:00 pm ─────────────────────────────────────────────────────────────

The meeting of the Industrial Ethylene Oxide Sterilization Working Group was opened by Co‐Chairs Jeffrey Martin and Jonathan Bull at 9 a.m. Clifford Bernier, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted.

The minutes of the last meeting were approved as written. The comment received from Gerry O’Dell during the 15-day final committee review of AAMI TIR16, Microbiological aspects of ethylene oxide sterilization was considered. Ms.O’Dell agreed to withdraw her comment and the Working Group agreed to advance the document to the AAMI Standards Board for consideration for final approval. The results of the ballot on the US position/US adoption of ISO/DIS 11135:2014 Amd. 1, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single lot release were reviewed. The voting results unanimously supported approval. The comments received were resolved and the Working Group agreed to submit a US position of Affirmative with comments to ISO, submitting the comments approved at the meeting. The comments submitted on ISO/DTS-2 19572, Sterilization of health care products — Guidance on the application of ISO 14937 to the sterilization of medical devices using Ethylene Oxide in a flexible sterilization bag, which was proposed for US adoption, were reviewed. The working group resolved all the comments received and agreed to submit the approved comments to ISO. The comments submitted on ISO/WD-3 DTS 21387, Sterilization of health care products — Guidance on the requirements for the validation and routine processing of Ethylene Oxide (EO) processes using parametric release, were reviewed. The working group resolved all the comments received and agreed to submit the approved comments to ISO.

Delegates to the December 2017 ISO/TC 198/WG 1 London meeting included Jonathan Bull, Phil Cogdill, Jeff Martin, Ted May, Fenil Sutaria, and Steve Turtil.

2

The next in-person meeting would be held in conjunction with the next AAMI Sterilization Standards Committee meeting, 19-22 March 2018 in Baltimore, MD. The meeting was adjourned at 3:00pm.

3

ATTACHMENT A

Meeting Attendance List – to be completed.

Company Name Interest Category B Braun Erin Armstrong AAMI Cliff Bernier Spectranetics Carolyn Braithwaite- Jonathan Bull Greg Bush Tim Carlson

Sarah Chamberlain Liza Chenette Denny Christensen Gary Cranston Elaine Daniell David Dominguez Steven Elliott Dan Floyd Scott Giraud Mike Groendyk Doug Harbrecht Arthur Harris Deborah Havlik Jason Hedrick Clark Houghtling Nicole Jackson Satu King Elan Littley Jeff Martin Ted May David McGoldrick Nicole McGowan Gerry O’Dell Koyejo Obadina Mike Padilla Dave Parente Michelle Peterson Nancy Porteous Keith Reiner Tyrone Rouse Manny Saavedra

4

Harry Shaffer Bill South Sopheak Srun Liz Steiner Fenil Sutgaria Steve Turtil Craig Wallace Richard Warburton Beverly Whitaker Dennis Wildes Roberto Zumbado Marcus Reese Ketura Marion Chris Wiman Mike Graybill David Brodersen Kim Darnell Brian McEvoy Kim Mollohan Matt Thomas Anne Lucas Dean Bird Marga Foster Kate Davenport Kristi Bailye Chris Anderson Michael Fox Jason Pope Rob Grizzle Justin Large Lisa Cook Lizamarel Perez Elizabeth Lobo Kim Patton Vin Caputo Melanie Melbo Brian Davis Samantha Hodge Arun Le Francesco Famosi Kathleen Baskill Denise Carey Chris Dugard

5

Peter Veselovsky Trisha Fair Jennifer Asleson David Lin Mark Dott Daniel Howell Matt Roybal Jennifer Metch Angel Brightwell Timothy Roberts Gretchen Zimmerman Krista Bollnow Joe Conaghs Mike Nolan Richard Sparano Valencia Smith Phil Cogdill Mike Neilson Elizabeth Steiner Jessica Kaschak Christine Render Eva Maraspin Mason Schwartz John Bletsos Alejandro Mejia Tina Hill Franchette Vilaria Andrew Sharavara Om Sing

STWG02N258 (October 2017)

AAMI ST/WG 02, Radiation Sterilization


────────────────────────────────────────────────────────────── Meeting date/time: Wednesday 18 October 2017 8:00 am to 12:00 pm ──────────────────────────────────────────────────────────────

The meeting of the Radiation Sterilization Working Group was opened by co-chairs Emily Craven and Elaine Daniell at 8:00 am. Colleen Elliott, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, and Code of Conduct were noted. The agenda was approved as amended to move the update on survey of experience with VDmax after item 3. The minutes of the last meeting were approved as written. Ms. Craven reminded members about the importance of actively participating in the committee, specifically voting and commenting. Survey of experience with VDmax Joyce Hansen led a brief discussion on the plans to do a survey of experience with VDmax, which has been widely available since 1991. Ms. Hansen noted that in the late 1980’s a survey of experience with Methods 1 and 2 was done, and the findings were very helpful and resulted in making adjustments to improve the methods. Those survey results were published in the Kilmer Conference proceedings. Ms. Hansen stated the importance of getting survey responses and respondents should include successes and failures. She will work with Wendy Wangsgard on putting together the survey. It was brought up that since we are currently working on a new VDmax TIR that timing for the survey should be soon so that we can incorporate feedback. Further to this discussion, some issues identified in TIR76 were brought up that could be addressed with survey responses (i.e. elimination of confirmatory dose experiment, validity of multiple sample sizes, etc.) John Kowalski was also approached to provide input to the survey. TIR40 Ms. Daniell led a review of the comments received on the ballot of TIR40. The ballot passed with a 75% return and 100% approval. After the comment resolutions are incorporated into the document, it will be circulated for final review and then sent to the AAMI Standards Board for approval. TIR76 Dr. Kowalski led a review of the comments received on the WD of TIR76. He will incorporate the resolutions of comments into the document. Input from the survey will also inform additional changes to the document. He asked for volunteers to assist with validation of the spreadsheet. David Broderson and Vu Le volunteered. Other interested members should contact Ms. Elliott to participate. A concern was raised about conflicts between TIR76 and 11137-2. Martell Winters suggested publishing a paper explaining the differences. At a minimum, there should be a note in TIR76 calling attention to the differences. 11137-1/DAmd2 The US voted 100% Approval. The US position is to proceed with the amendment exactly as written. This will be discussed by ISO/TC 198/WG2 at their meeting in London. 11137-3 The revision of ISO 11137-3 has been published. ANSI/AAMI/ISO 11137-3 was just approved and will be avaliable in the next 1-2 weeks. Reaffirmation of TIR29 Based on the ballot results, TIR29 will be reaffirmed. Once 11137-4 is published, the committee can decide if TIR29 should be withdrawn or there is still value in retaining some of the information and revising the document.

11137-4 Ms. Craven led a review of the comments on 11137-4. The comments from all of the countries will be discussed by ISO/TC 198/WG2 at their meeting in London. Other business A question was put forward by Stryker regarding guidance on use of dose estimates to release product when dosimeters are lost or damaged.

Lisa Foster stated that she and Joyce Hansen wrote an article on the topic in an AAMI publication (Dealing with Nonconformity in the Sterilization Process in AAMI Industrial Sterilization journal, 2013). The topic should be included as part of next NWIP on revision to 11137-1 if guidance belongs in routine processing in Annex.

Dr. Kowalski gave a presentation on a spreadsheet for calculation of average bioburden values (N257). It was suggested to develop a NWIP on dealing with low bioburden levels. Dave Brodersen, Dave Parente, Kim Patton, Aaron Dement and Vu Le volunteered to look at spreadsheet for low bioburden and/or TIR76 for validation.

Ms. Foster brought up an issue of requests from FDA for submission of sterilization data and LAL data in 510k, (although their guidance says the data is not required). Pat Weixel stated that he would follow up with Scott Colburn, FDA. Reviewers are receiving training the 21st Century Cures. Attendees to the London WG2 ISO meeting will be: Elaine Daniell, Pat Weixel, Denise Cleghorn, John Logar; and Kim Patton (pending her approval as a US expert).

Liaison reports Ms. Craven provided a report from ASTM on behalf of John Logar:

- Progress Report 83, which serves as our minutes, was distributed to the group (N252). Any questions or comment, please contact John Logar.

- 9th International Workshop on Radiation Processing was held in June 2017 in Toronto and was attended by 45 attendees. Plenary sessions were taped and the E61 Exec team is looking to make them available to the industry (through ASTM) early next year/

- Standard Revisions of Interest – 52303 on Dose Mapping; 51818 on Low Energy E-beam; Statistical Process Control (will be based on Workshop Content which was well received)

- 10th International Workshop on Radiation Processing is targeted for Spring 2020 in Europe. Members are encouraged to attend.

Ms. Craven provided an update on iia. IMRP will take place April 1-5, 2019 in Strasbourg France. GIPA has written a whitepaper which provides a comprehensive evaluation of ebeam vs xray vs gamma which will likely be published through the iia later this year.

Plans for the next meetings The next meetings will be held during the weeks of March 19-22nd and October 22-25th, 2018 at the Baltimore Hyatt Regency. There being no other business, the meeting was adjourned at 11:55 p.m.

ATTACHMENT A Meeting Attendance List

Anderson, Christopher Johnson & Johnson Boyter, MarJean Fresenius Medical Care Brightwell, Angela Medtronic Brodersen, David LexaMed Bryans, Trabue BryKor LLC Cardin, David Cook Inc Cleghorn, Denise Boston Scientific Craven, Emily Mevex Crego, Greg IUVO BioScience Daniell, Elaine CR Bard Elliott, Colleen AAMI Ely, Gordon MiMedx Group Fair, Trisha Cantel Fidopiastis, Niki Sterigenics International Foster, Lisa Adiuvo QS & SA Consulting Graybill, Mike 3M Healthcare Harbrecht, Doug Sterility Assurance LLC Hasanain, Fatima Sterigenics International Howard, Betty Steris Corporation Jackson, Nichole Ecolab Jacobson, Tara St. Jude Medical Inc King, Satu Spectranetics Corporation Le, Vu Abbott Laboratories Martin, Jeff Sterilization and Quality System Consulting LLC Nichols, Larry Company for Individuals O’Dell, Gerry Gerry O’Dell Consulting O’Hara, Kevin Sterigenics International Parente, Dave Ecolab Patton, Kim BD Reiner, Keith Terumo Americas Rupert, Jody WL Gore & Associates Schoene, Mike Bausch & Lomb Inc Srun, Sopheak Quality Tech Services Inc Sutaria, Fenil Medline Industries Wangsgard, Wendy Nelson Laboratories Weisman, Bud Fresenius Medical Care Weixel, Pat FDA Whitaker, Beverly Indigo Consulting Group LLC Winters, Martell Nelson Laboratories Observers: Asleson, Jen BSI Beers, Eric Mevex Bolenow, Krista Sterigenics Brenner, Tammie Sterilization Services Brown, Lloyd L Brown Consulting Bush, Greg Alcon Chamberlain, Sarah Avista Pharma Solutions Chenette, Liza Avista Pharma Solutions Connor, David Sterilization Services Dement, Aaron Sterigenics Dukerich, Zach Arthrex Eldred, Venice Medline Hansen, Joyce J&J Kramer, Terra Nelson Labs

Maher, Jim BD McGoldrick, David Abbott Laboratories McLaren, Jami Boston Scientific Padilla, Mike Sterigenics Palagi, Greg LA-CO Industries Tempil Inks Pankratz, Jen BSI Rymer, Terri Baxter Song, Ruby Medline Tavares, Leslie WuXi Apptec Yeadon, Steve Boston Scientific


AAMI ST/WG 03, Moist heat sterlization


────────────────────────────────────────────────────────────── Meeting date/time: Monday 16 October 2017 1:00 pm to 3:00 pm ──────────────────────────────────────────────────────────────

The meeting of the Moist Heat Sterilization Working Group was opened by Co‐Chairs Gerry O’Dell and Silas McAghon at 1 p.m. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted. The agenda was approved as written following a motion and a second with a voice vote for approval with no dissenting votes. The minutes of the last meeting were approved as written following a a motion and a second with a voice vote for approval with no dissenting votes.

Gerry O'Dell opened the discussion by reviewing the status of the revisions to ISO 17665 series. The discussion consisted of the following points • ISO 17665 parts 1,2 and 3 will be combined into a single document • A small US task group was formed a team to create a more cohesive annex for moist heat microbial

qualification. This draft was submitted to Brian Kirk in September. • A draft that includes this revised Annex and a combined document has gone out for review of the ISO

working group and all comments will be discussed at the London meeting. • Requested feedback from the working group to provide input for major technical changes to the current

documents. The US task group, along with some other countries, will have some comments. • An example of a technical issue was discussed. This was the ISO 17665 requirement to correlate

pressure and temperature during the sterilization process. The following points were addressed o The state of the art measurement equipment cannot be totally accurate o The problem is that you cannot discern that you have saturated steam. o The counter point was that how else can it be shown that saturated steam is present. o Other types of tests including small load thermo tests o The intention of the correlation is for a gross leak scenario. Not to detect minor leaks. o Suggestion made to delete requirement, this met with resistance

Gerry O'Dell will represent the US as an expert at the London WG3 meeting on December 5 and 6. None of the other current experts can attend. Jason Pope from Nelson Laboratories will explore the possibility of attendance as another expert. Following this meeting it is expected that the document will be circulated to the entire working group for comment. The next meeting of WG3 will be March 2017. There being no other business, the meeting was adjourned at 1:45 p.m

1

STWG04Nxxx (October 2017)

AAMI ST/WG 04, Biological Indicators


────────────────────────────────────────────────────────────── Meeting date/time: Thursday 16 October 2017 1:00 am to 5:00 pm ──────────────────────────────────────────────────────────────

The meeting of the Biological Indicators Working Group was opened by Co‐Chairs Tony Piotrkowski and Craig Wallace at 1 p.m. Clifford Bernier, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted. The agenda and the report of the last meeting were approved as written.

The ISO 11138 series documents had been published. The US adoption of those documents had been approved as American National Standards and would be published shortly.

ISO 14161 had been redesignated as ISO 11138‐7 and ISO 16342 as ISO 11138‐8.

The ballot results for the US position on ISO/DIS 11138‐7, Sterilization of health care products - Biological indicators - Guidance for the selection, use, and interpretation of results were reviewed. One Negative vote had been received. The Working Group responded to all of the comments and agreed to submit a US position of Affirmative with Comments to ISO, submitting the comments approved at the meeting. Jonathan Wilder, The sole Negative voter, from changed his vote to Affirmative based on the resolution of comments. The status of ISO/WD‐1 11138‐6, Sterilization of health care products - Biological indicators - Part 6: Biological indicators for hydrogen peroxide sterilization processes was reviewed. Position papers supporting liquid dip and vapourized test methods would be reviewed by the ISO WG at its interim meeting in November 2017. Tony Piotrkowski reviewed the results of the previous round robin testing. Another round of round robin testing will be proposed in ISO. The status of the Amendment to ISO 11138‐5, Sterilization of health care products -- Biological indicators -- Part 5: Biological indicators for low temperature steam and formaldehyde sterilization processes ‐‐ Annex C, Alternative method for determining the D-value of LTSF SCBI was reviewed. The document will be addressed at the November 2017 ISO meeting.

2

The status of the development of ISO 11138‐8, Sterilization of health care products - Biological indicators - Method for validation of a reduced incubation time for a biological indicator was reviewed. Data collection is in progress and data will be reviewed at the ISO meeting in November 2017. The ISO resistometer standard, ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment – would be issued for FDIS ballot shortly. Delegates to the November 2017 ISO/TC 198/WG 4 London meeting included Kurt McCauley, Tony Piotrkowski, Krissy Singleton, and Craig Wallace. Clarence Murray would possibly attend if approved. The next in‐person meeting would be held in conjunction with the next AAMI Sterilization Standards Committee meeting, 19‐22 March 2017 in Baltimore, MD. The meeting was adjourned at 1:55pm.

3

ATTACHMENT A Meeting Attendance List-To be completed

Company Name Interest Category Jenny Berg Cliff Bernier Rachel Brewer Fiona Collins Tricia Cregger Gary Cranston David Dominguez Shawn Doyle Sylvie Dufresne Deborah Havlik Amy Karren David McGoldrick Jen Metch Michael Nolan David Opie Mike Padilla Tony Piotrkowski Adrian Ponce Tyrone Rouse Matt Roybal Terri Rhymer Manny Saavedra Kristen Singleton Gary Socola Kristy Vogt Craig Wallace Scott Wasiluk Beverly Whitaker Jon Wilder Dennis Wildes Kurt McCauley Cameron Palmer Alexandra Cooper Anthony Powell Christina Nash Kurt McCauley Jason Pope Gary Benning

4

Dean Wellman Andy Sun Denise Carey Mark Dott Rob Howard Daniel Howell Mike Neilson Jim Maher Beth Gonzalez Melanie Melbo Elizabeth Lobo Lizamarel Perez Emily Socola


AAMI ST/WG 05, Terminology


────────────────────────────────────────────────────────────── Meeting date/time: Tuesday 17 October 2017 1:00 pm to 5:00 pm ──────────────────────────────────────────────────────────────

The meeting of the Terminology Working Group was opened by co-chair Lena Cordie at 1:00 pm. Co-chair Phil Cogdill was unable to attend. Colleen Elliott, AAMI staff, served as recording secretary. Attendees introduced themselves The Anti‐trust statement, Patent Policy, and Code of Conduct were noted. The agenda and minutes of the last meeting were approved as written. ISO/DIS 11139 Ms. Cordie led a review of the US comments on ISO/DIS 11139, including several late comments from Nelson Labs. The comments that were accepted will be sent to ISO for consideration by ISO/TC 198/WG5. Jonathan Wilder changed his vote to affirmative. Joint meeting of ISO/TC 198/WG 5 and CEN/TC 102/WG 1 Ms. Cordie noted that a joint meeting would take place with ISO/TC 198/WG 5 and CEN/TC 102/WG 1 in London on 4 December.

Other business There was a discussion about whether AAMI should adopt ISO 11139 as an American National Standard. Mike Scholla noted that it takes money and resources to adopt and maintain ANS’s, and terminology standards rarely sell. In addition, all ISO terms are available on the online browsing platform. AAMI is considering adoptions overall and developing a strategy. Whether or not it is adopted, mirror groups working on ISO documents must use the terms in 11139, and all ST groups should be encouraged to use the terms. Dr. Scholla suggested that all AAMI co-chairs of mirror groups to ISO/TC 198/WGs should be members of AAMI/WG5.

Plans for the next meetings The next meetings will be held during the weeks of March 19-22nd and October 22-25th, 2018 at the Baltimore Hyatt Regency. There being no other business, the meeting was adjourned at 3:14 p.m.

STWG07NXXX (October 2017)

AAMI ST/WG 07, Packaging Working Group


────────────────────────────────────────────────────────────── ────────── Meeting date/time: Thursday 19 October 2017 8:00 am to 12:00 pm ────────────────────────────────────────────────────────────── ──────────

The meeting of the Packaging Working Group was opened by Co‐Chair Nick Fotis at 8 a.m. Hae Choe, AAMI staff, served as the recording secretary. It was announced that Jordan Montgomery was appointed by the AAMI President as the new Co-Chair replacing Dave Johnson. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted. The agenda was approved as written. The minutes of the last meeting were approved as written.

Nick Fotis opened the discussion on the MDR (medical device regulation) labeling requirement and SBA white paper and explained that Mike Scholla would present on this topic. M. Scholla shared his presentation to explain why the revision of the 11607 series become more extensive than what was originally envisioned. He explained that the MDR labeling requirements and the need to meet the new directives precipitated some updates to the standards. Brief update of ISO/TC 198/WG 07 was given. This group is responsible for the ISO 11607 series, which is currently out for vote as DIS (draft International Standards). ISO 16775 recently underwent a periodic review. The results were mixed with 6 countries asking for revision to the Technical Report. ISO/TC 198/WG 07 will be meeting in February 2018 in Copenhagen, Denmark. The group will resolve the comments from the DIS ballots of the 11607 series as well as make a decision on the next steps for 16775. It has been the original intent of this group to tackle the revision of 16775 once the 11607 series have undergone the balloting stage and onto the FDIS stage. Therefore, international work on the revision of 16775 will probably begin during the September 2018 meeting of ISO/TC 198/WG 07. It was noted how important it is to obtain a Harmonized document. Currently ISO 11607 series are undergoing a concurrent cycle with ISO and CEN and with the U.S. adoption of the proposed standards, this would exemplify one standard for this subject matter. M. Scholla’s summary comparing the ISO DIS 11139 to ISO DIS 11607 was circulated to the Working Group members and it was noted that the pertinent comments for the definitions aligning the 11607 series to ISO 11139 will be sent in as part of the U.S. comments/position. The ISO deadline for the 11607 series, which are standards that U.S. plans to adopt as American National Standards, is 11 December 2017. The U.S. deadline for the ballots is 10 November 2017. However since the Packaging Working Group’s meeting had been scheduled for 19 October, committee members were encouraged to submit comments by the meeting date so that they can be discussed within the face to face meeting of the committee. Those comments, which were received were discussed at the meeting. It was noted that more comments may be sent in and if so, a conference call will be held to discuss and formulate the U.S. positions of the two documents. A date of Monday, 13 November 2017(East coast time of 12 noon to 3 p.m.) was set for the conference call of the committee. If no or little additional comments are received, the conference call may be cancelled. From the ballot results thus far, U.S. will most likely submit an affirmative vote with comments on both of the documents within the 11607 series. For the February 2017 ISO/TC 198/WG 07 meeting, it was noted that the following U.S. experts will be attending to present the U.S. position: ‐ Nick Fotis; Jackie Daly Johnson; Jordan Montgomery; Rodney Patch; and Steve Turtil. Looking over the predicted work of the ISO group, the Packaging Working Group will plan to meet in March 2018 to

develop comments on ISO 16775. There being no other business, the meeting was adjourned at 12:00 p.m.

Meeting Attendance List Ralph J. Basile – Healthmark Industries Jennifer Benolken - DuPont

Henk Blom – Rollprint Adam Brakoniecki – Becton Dickinson Gary Brennar – Hill-Rom Rachel Brewer – IUVO Bioscience Jonathan Bull – Johnson & Johnson Greg Bush - Alcon Hae Choe – AAMI Nick Fotis – Cardinal Health Elyse Gaudreau – TSO3 Inc. Kevin J. Grum – DuPont Seth Hendee – UVMMC Mike Hurley - Nuvasive Jackie Daly Johnson – Flexible Packaging Association Jeffrey Klein – Edwards Lifesciences Matt Lapham – Packaging Compliance Labs Jack Leclair – Memorial Hermann Cindy Lepak – Hill-Rom Paul Littley – Nelson Laboratories Wendy S. Mach – Nelson Laboratories Jami McLaren – Boston Scientific Cindy O’Leary-Swinson – WL Gore & Associates Mike Packet - DuPont Rodney Patch – Johnson & Johnson Geoffrey Pavey – Oliver Tony M. Piotrkowski – Steris Scott Prochaska – LA-CO Industries Terri Rymer - Baxter Michael H. Scholla – DuPont Chris Sczublewski - VHA Ram Singhal – Flexible Packaging Association Carol Smith – Boston Scientific Joan M. Spear – B. Braun of America Dawn Tomac - APIC Steven E. Turtil - FDA

ST WG 8 N 189 (October 2017)

AAMI ST/WG 8, Microbiological Methods Working Group


Meeting date/time: Thursday 19 October 2017 8:00 am to 1:00 pm

The meeting of the Microbiological Methods Working Group was opened by Co‐Chairs Carolyn Braithwaite Nelson and Martell Winters at 8 a.m. Jennifer Moyer, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. Members were asked to note the Anti‐trust statement and the code of conduct that were attached to the agenda, and to note the conditions for participating in AAMI work that is attached to the sign-in sheet.

The agenda was approved with a slight modification: the TIR reaffirmation discussions were moved to follow agenda item 4. The minutes of the last meeting were approved as written.

A brief update was provided on activities in ISO/TC 198/WG 8. It was noted that ISO/WD TS 22456, Sterilization of health care products – Microbiological methods – Guidance on sterility and bioburden and testing of biologics and tissue-based products, is out for comment with the ISO working group and comments are due to ISO by December 12. Members of this working group expressed an interest in seeing the draft document so staff will circulate it in the very near future for information.

It was reported that ISO/FDIS 11737-1, Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products, is open within ISO until November 2. Members were reminded that the US voted to approve the FDIS. AAMI is also adopting the ISO document without modification. It is anticipated that the document will be published in Q1 of 2018. One member asked if there would be a transition period for this document. Staff will make inquiries into how to request a transition period from notified bodies and report back to the cochairs.

The committee draft, ISO CD 11737-2, Sterilization of medical devices -- Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, is also open for ballot. It was noted that the AAMI ballot closes on October 19 and members were reminded to vote. Martell Winters noted that the draft did not appear to have all accepted working draft comments incorporated into the current draft. Mr. Winters and Ms. Braithwaite-Nelson will review the document against the previous comments and submit them as comments on the committee draft.

Chris Loshbaugh, Edwards Lifesciences, gave a presentation on animal tissue procurement. See the attached slides in Attachment B for more details.

Carolyn Braithwaite Nelson led the discussion of the comments received on the ballot, AAMI CDV-1 ST72, Bacterial endotoxin – Test methods, routine monitoring and alternative to batch testing. The comments, along with their final resolutions, will be circulated after the meeting. There was a question as to whether or not additional exclusions could be added to the scope. Staff will check on this and report back to the cochairs. Members agreed to meet via conference call to complete the resolution of comments. The goal is to ballot the document again in early 2018 so that comments can be addressed at the March meeting.

Members reviewed the comments submitted on the reaffirmation ballot of AAMI TIR39:2009/R2013, Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices. Following discussions, members agreed that the document should be reaffirmed and the comments held until the working group has the time to commit to a revision. This will be discussed again in the fall of 2018.

Members also reviewed the comments submitted on the reaffirmation ballot of AAMI TIR52:2014, Environmental monitoring for the manufacture of terminally sterilized healthcare products. Following discussions, members agreed that the document should be reaffirmed. There was discussion about moving this document to ISO. The idea would be to incorporate the reaffirmation comments into the TIR and to use that as the document for the ISO new work item proposal. Members agreed that this would be an ideal way to proceed with this document but the working group will revisit this in the fall of 2018.

Amy Karren provided a brief update on the activities within USP. See Attachment C for a summary of that report. Gordon Ely provided an update on activities within IEST. See Attachment D for a summary. Debbie Havlik provided an update on activities within PDA.

The next meeting of the Microbiological Methods Working Group will be held in conjunction with the spring AAMI Sterilization Standards Week the week of March 19, 2018.

Gerry O’Dell, Martell Winters, Carolyn Braithwaite Nelson, Debbie Havlik, and Kim Darnell were nominated to attend the interim meeting of ISO/TC 198/WG 8 in February 2018 in Berlin.

There being no other business, the meeting was adjourned at 12:15 pm.

Meeting Attendance List <name1> <name2> <name3> <name4> …


AAMI ST/WG 11, General criteria for sterilization processes and sterilizing equipment


────────────────────────────────────────────────────────────── Meeting date/time: Tuesday 17 October 2017 5:00 pm to 5:30 pm ──────────────────────────────────────────────────────────────

The meeting of the General Criteria for Sterilization Processes and Sterilizing Equipment Working Group was called to order by Mike Scholla, Cochair of the AAMI Sterilization Standards Committee, at 5:05 PM. Amanda Benedict, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted. The agenda was approved as written following a motion by Gerry O'Dell, seconded by Lena Cordie. There were no minutes from the previous meeting available to approve. Mike Scholla and Amanda Benedict provided an overview of the status of the working group. This group serves as the US mirror group to ISO/TC 198/WG 11. It has been a while since this group has met and the roster is outdated and will need to be scrubbed and then replenished. Both of the cochair roles are currently vacant and a call for nominations has been circulated. The group is in need of additional experts to provide input to the newly added ISO/TC 198 project on general requirements for sterilizer equipment. Interested parties were encouraged to submit an application for membership. It was noted that it will be important to get sterilizer manufacturers to join this working group. There are two US experts currently serving as registered members of ISO/TC 198/WG 11: Ted May and Lena Cordie. Additional experts are needed and a call for nominations will be circulated and will go through the usual process for nominations. As there is a meeting of the ISO working group in early December in London, it is hoped to add additional US experts in time for that meeting, so the nomination process will start soon. The ISO working group will meet to discuss ISO/NP TS 22421 and start work on drafting the document. The US working group might meet again in March 2018 or when there is a need for a US discussion. There being no additional business raised, the action items were summarized as follows: 1. AAMI will make efforts to purge the ST/WG 11 roster of outdated data and members who no longer wish to participate. 2. Interested parties will submit applications to join ST/WG 11. 3. WG 43 members and particularly sterilizer manufacturers will be encouraged to join. 4. The process to nominate US experts will start soon. The meeting was adjourned at 5:30 PM following a motion by Gerry O'Dell, seconded by Jonathan Wilder.


AAMI ST/WG 12, Instructions for Reusable Device Reprocessing Working Group


Meeting date/time: Thursday 18 October 2017 12:30 pm to 3:00 pm

The 18 October 2017 meeting of the Instructions for Reusable Device Reprocessing working group was chaired by Ralph Basile. Nancy Chobin sent her regrets. Members were asked to review the AAMI policy statements that were attached to the agenda. Members then introduced themselves. An attendance list is attached.

The agenda was reviewed and a motion made and seconded to approve. There were no objections. The report of the 23 March 2017 meeting was reviewed. A motion was made and seconded to approve. There were no objections.

Ralph Basile provided an update on ISO/FDIS 17664, Sterilization of medical devices - Information to be provided by the device manufacturer for the processing of reusable medical devices. A few outstanding issues have been resolved with ISO and will be published soon.

It was also reported that ISO/NP 22913, Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices -- Part 2: Medical devices not intended for direct patient contact, was approved and that this committee submitted comments. The proposal was approved and will be assigned to ISO/TC 198/WG 12.

Members then reviewed the comments received on N 96, Document for comment: Proposed annex on standardized cleaning protocols. The working group was only able to get through half of the comments on the annex and it was agreed that an interim meeting would be scheduled to discuss the remaining comments on the annex as well as the comments on the draft TIR12.

It is anticipated that an interim meeting will be held in conjunction with WG 93 sometime in the January time-frame.

Delegates to the ISO/TC 198/WG 12 meeting in December are Emily Mitzel, Ralph Basile, Lena Cordie, Steve Turtil, and Nupur Jain.

Members agreed to also meet in conjunction with the March 2018 Sterilization Standards Week.

There being no further business, the meeting adjourned at 3:00 p.m.


AAMI ST/WG 13, Washer Disinfectors Working Group


Meeting date/time: Wednesday 18 October 2017 3:00 pm to 5:30 pm

The 18 October 2017 meeting of the AAMI Washer Disinfectors Working Group was co-chaired by Emily Mitzel and Pat McCormick. Members introduced themselves and an attendance list can be found in attachment A. Members present were asked to review the various AAMI policies that were attached to the agenda.

The agenda was reviewed and approved without modification. The meeting report from the 22 March 2017 meeting was reviewed and approved without modification.

Emily Mitzel and Pat McCormick provided an overview of the comments that the US submitted on ISO CD 15883-5, Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy. During the ISO meeting in April, the group got through approximately half of the comments submitted. There is another meeting scheduled on November 30 and December 1 to continue discussions on the comments.

Gerry McDonnell provided background information on the discussions regarding the action and alert levels definition issue and the compromises reached at the international level. Richard Bancroft noted that the document will go out for ballot again and if a number of countries object to the definitions, they will be changed. Ms. Mitzel indicated that there is a push to have consistency on cleaning around the world, like there is with sterilization. Members discussed perhaps using other terms since those are well defined and used in process control.

Ms. Mitzel also reported that the ISO working group has continued to meet to resolve the comments on ISO/DIS 15883-4, Washer-disinfectors – Part 4: Requirements and tests for washer -disinfectors employing chemical disinfection for thermolabile endoscopes. Ralph Basile was able to participate on the last WebEx and reported that there many comments to be resolved. The discussions will continue during the November/December meeting.

Emily Mitzel, Ralph Basile, Gerry McDonnell, and Brian Wallace were nominated to attend the interim meeting of ISO/TC 198/WG 13.

Members agreed to meet in conjunction with the March 2018 Sterilization Standards Week.

There being no further business, the meeting adjourned at 4:05 p.m.


AAMI ST/WG 15, Assurance of sterility


────────────────────────────────────────────────────────────── Meeting date/time: Wednesday 18 October 2017 1:00 pm to 5:00 pm ──────────────────────────────────────────────────────────────

The meeting of the Assurance of Sterility Working Group was opened by Co‐Chairs Byron Lambert and Trabue Bryans at 1:06 p.m. Amanda Benedict, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted.

The agenda for meeting was updated with document numbers and approved following a motion by Betty Howard, seconded by Joyce Hansen. The report from the last meeting was approved following a motion by Wendy Wangsgard, seconded by Tim Carlson. Amanda Benedict gave an update on the status of ISO/TS 19930. The document was approved and comments were addressed at the ISO/TC 198/WG 15 meeting in April. Agreed-upon edits were made to the draft and submitted to ISO Central Secretariat for editing. The proof was reviewed and responded to by the convenor and TC secretary and is now with ISO/CS to finalize and publish the document. The group shifted into reviewing comments submitted on WD-4 ST67. Trabue noted that about half of the comments were purely editorial. She proposed to move quickly by accepting the editorial comments but encouraged people to speak up on any of those that needed discussion. The working group reviewed and resolved or responded to all comments. Working group members agreed to submit any outstanding assignments by November 30th. The comment resolutions and additional inputs will be used to create a committee draft for vote as the next iteration of this revision. Given that the group will meet again in person during the week of March 19th, 2018, the intent is to have the committee draft out by mid-January for working group vote and comment and public review. A half-day meeting will be planned for the group during March 2018 Sterilization Standards Week. The request was made to start at 9 AM if the meeting must be scheduled for a morning. The co-chair nomination process will be starting soon, as Trabue had only intended to assist again in the role temporarily. AAMI will reach out to previous nominees to ensure that they are still interested and also solicit a call for new nominations. The preference is to have the nominations process completed by early December so that the new co-chair appointment can be made that month. There being no other business, the meeting was adjourned at 3:42 PM following a motion by Byron Lambert, seconded by Trabue Bryans.


AAMI ST/WG 43, Hospital steam sterilizers


────────────────────────────────────────────────────────────── Meeting date/time: Thursday 19 October 2017 8:00 am to noon ──────────────────────────────────────────────────────────────

The meeting of the Hospital Steam Sterilizers Working Group was opened by Co‐Chairs Sue Klacik and Jonathan Wilder at 8 a.m. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted. The agenda was approved as written following a motion by Anthony Powell, seconded by Michael Bacik. The minutes of the last meeting were discussed. Questions were raised regarding the noted responses to two comments:

Comment #43. Question raised about the observation noted in STWG43N116 for this comment, and whether there was further work to be done. Anthony Powell asked if there is an issue with lumens and steam penetration. Richard Bancroft indicated that coiling doesn’t seem to make a difference, but other factors like material and pre-capture volume do. Suggestion raised that it might be more the responsibility of the PCD working group. Comment #30: Question raised about the response “not technically feasible.” Jonathan Wilder suggested that the issue might have been terminology related: air detection vs. air removal. The comment has been resubmitted on WD-1 ST8 and will be discussed with that set of comments.

Following this discussion, the report of the previous meeting were approved without change following a motion by Don Tumminelli, seconded by Michael Bacik. All comments received on WD-1 ST8 were reviewed and resolved or responded to. Any remaining inputs (e.g., task group assignments) are due by December 8th. The working group will have at least one more working draft for the March meeting (next Sterilization Standards Week is March 19-22), and then likely proceed to a committee draft for vote and public review. Some members of WG 43 have not yet received their ST55 complimentary copies; will receive them soon. There being no further business, the meeting was adjourned at 11:42 AM following a motion by Anthony Powell, seconded by Gary Benning.


AAMI ST/WG 61, Chemical sterilants hospital practices


────────────────────────────────────────────────────────────── Meeting date/time: Monday 16 October 2017 1:00 pm to 5:00 pm ──────────────────────────────────────────────────────────────

The meeting of the Chemical Sterilants Hospital Practices Working Group was opened by Co‐Chair Janet Prust at 1 p.m. Amanda Benedict, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted. The agenda was reviewed and approved. The minutes of the last meeting were approved as written following a motion by Rose Seavey, seconded by Richard Warburton.

Janet Prust opened the discussion by reviewing the status of TIR67. The group reviewed results of the CDV-1 ballot and confirmed that there were no negative votes and a sufficient return on the ballot. No additional comments were submitted with votes cast after the October 2016 meeting until the close of the ballot. There were no objections to proceeding to final 15-day review for this document. The working group shifted into reviewing the ballot results and comments from CDV-1 TIR68. All comments were resolved or responded to. The working group agreed that the edits resulting from the resolution of comments were not sufficiently technical to warrant another ballot and that the document with edits based on resolved comments can proceed to 15-day final review. ANSI/AAMI ST58:2013 will undergo periodic review next year, which could lead to initiation of a revision. Amanda Benedict provided an overview of the periodic review process. Janet Prust stated that her term as co-chair is finished and that she will be stepping down. As the other co-chair role is vacant, a call for nomination will be circulated soon for both the industry and non-industry co-chair roles. Amanda Benedict explained the co-chair nomination and appointment process. The working group will most likely meet in March 2018 if needed to resolve outcomes from the periodic review of ST58. There being no other business, the meeting was adjourned at 5:00 p.m. following a motion by Sue Klacik, seconded by Mary Ann Drosnock.


AAMI ST/WG 84, Endoscope processing


────────────────────────────────────────────────────────────── Meeting date/time: Tuesday 18 October 2017 8:00 am to 5:00 pm

Wednesday 19 October 2017 8:00 am to noon

──────────────────────────────────────────────────────────────

The meeting of the Assurance of Sterility Endoscope Reprocessing Working Group was opened by Co‐Chairs Nancy Chobin and Mary Ann Drosnock at 8:00 a.m. Amanda Benedict, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted.

Mary Ann gave a summary of the endoscope stakeholders meeting presentations and discussions. The AAMI news article may have given the impression that a decision was made during that meeting to move all endoscopes to sterilization immediately, and that's not correct. It was clarified that the consensus of the group was that endoscope processing needs to move that way. However, it is up to WG84 to decide how or if to implement those recommendations. Mary Ann thanked those who attended the meeting in September. Nancy commented that one of the accrediting agencies mentioned that things are not enforceable when the standard uses terms like "ideally" or "if possible." Other attendees of the stakeholder meeting commented on their impressions of the meeting. Rose Seavey mentioned that there is a need for drying indicators. Other attendees underscored the need to have one standard rather than conflicting guidelines, and recalled that Dr. Rutala said that AAMI should be that one. At a minimum, the different guidelines at least all need to say the same thing. Janet Prust provided the clarification that classification of a device as a critical device depends on how it is used. This working group has been called upon to have the courage to step up and put out strong guidelines. AAMI has gathered a consensus group, which makes it ideal for developing the "one" standard. Group was reminded that this document is an American National Standard, and that there is no specified charge to look at what's being done internationally. A suggestion was raised for the working group to form a task group to write a new classification system and perhaps add it as an annex to ST91. Nancy suggested contacting the CDC to get involved in that. Janet commented that HICPAC seems to be focused on other things right now, and the previous HICPAC task group was comprised of a lot of this working group's members. It was noted that this group would be writing a clarification of what we mean by Spaulding and how that affects how these devices are processed. There is a recognized need to bring everyone together to work on this, and many of the stakeholders were at the September 11th meeting. A suggestion was raised for this group to work on recommendations as a first step, and call another stakeholder's group meeting. One possible approach is group to take a position of clarifying how to classify in the scopes and then how to process them accordingly. Seth reminded the group that originally endoscopes were to be sterilized and people have lost sight of that. Janet stated that HLD has been the standard of care and it should be based on how the endoscope is used. Marsha Benedict reminded the group that one of the task groups proposed a decision tree which covers that. Damien commented that recommendations need to be practical for the SPD, and that technicians won't know how a scope has been used. Joan commented that clinicians (endoscopists) need to be involved in this effort. Mary Ann reminded the group that ASGE was at the stakeholders meeting. Additionally, a comment was raised that the

surveyors need to be included, evidently surveyors were auditing on ST79:2017 right after it came out in facilities didn't have any awareness of what the changes were in the new addition. Holger Biering supplied the European ESGE/ESGENA endoscope processing position statement for the group's review. Main differences compared with ST91 were single-use brushes and conducting microbiological surveillance every three months. Nancy commented that one of her takeaways from the endoscope stakeholder meeting was the idea of fissures/damage inside of the scopes and the need for cleaning verification. The cleaning section in ST91 may end up being the biggest section. There have been research findings that thorough cleaning isn't happening, sometimes due to pressure for speed in processing. Facilities need to provide the resources to get the job done properly: time, training, capital resources. Rose reminded the group of the importance of drying. The consensus of WG 84 members present was to write a clarification of the Spaulding classification, and to make a recommendation to sterilize endoscopes that enter sterile tissues and are compatible with sterilization. The group agreed to circle back to pulling up that task force work on sterilization and see what can be taken from that work. The working group shifted into reviewing and responding to comments from WD-1 ST91. There were 322 comments received. The group would like to ensure that ST91 is formatted like ST79. The timing for reformatting will need to be worked out, as it might need to be a subsequent working draft when the document appears to be close to going to CDV. AAMI might work with an editor such as Judy Veale to call out the "shoulds" in the text and reformat it. The concern was raised in the surveys that auditors were already surveying to ST79 the day after it was published. Recommendation was made to address the transition from one addition to the next, and whether a statement could be made in the preface of the next edition of the documents. AAMI will check into best options for addressing the transition time. The suggestion was made to put together a table for cleaning frequency similar to what's in ST79. The group addressed comments through #157 on Tuesday. The WG 84 meeting reconvened at 8:05 AM on Wednesday and started with reviewing outstanding assignments for rewording from the Tuesday meeting. The group reviewed and made edits to the proposed physical separation language from Nancy Chobin; Mary Ann and Nancy will work on editing the content based on group feedback. Janet's proposed rewrite for 6.4.2 was reviewed, edited and agreed-upon for inclusion in the next draft. Jon Fish's submission was edited, and Mary Ann will do further edits based on group input. A new bullet will be added for wiping down leak testers. The group circle back to discussion of high-level disinfection versus sterilization of endoscopes. There was overwhelming agreement in the room that processing of endoscopes needs to move towards sterilization. The question is how to move the guidance that way. A suggestion raised to re-form the risk assessment test group to work on creating an annex was tabled for now; it was decided to complete the review of the comments and then determine if there were any gaps to necessitate a new annex. The working group resolved and or responded to comments through number 178. The working group felt strongly that in-person meetings are the most effective means for this group to resolve comments. There will need to be an in term meeting prior to the next sterilization standards week, perhaps in early December at AAMI Standards Week in Redondo, California or in January perhaps at or near AAMI. AAMI will look into options and get back to the group. The meeting was adjourned at 12 PM following a motion by Jon Fish.

ST WG 93 N 059 (October

2017)

AAMI ST/WG 93, Cleaning of Reusable Medical Devices


────────────────────────────────────────────────────────────── Meeting date/time: Wednesday 18 October 2017 8:00 am to 12:00 pm ──────────────────────────────────────────────────────────────

The meeting of the Cleaning of Reusable Medical Devices Working Group was opened by Co‐Chair Nupur Jain at 8:00 a.m. Jennifer Moyer, AAMI staff, served as recording secretary. Attendees introduced themselves [see ATTACHMENT A for attendance list]. The Anti‐trust statement, Patent Policy, Code of Conduct and Conflict of Interest statement were noted.

The agenda was approved as written following a motion and a second. There were no objections. The report of the last meeting was approved as written following a motion by and a second. There were no objections.

The working group reviewed the comments on WD-1 TIR30, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices (circulated as N 58). The group was able to review approximately half of the comments submitted. Members agreed that the document should be reformatted as agreed to in comment 2 of N 58 and then a small task group will review the document and the comments to determine how many of the comments still apply. The group may hold an interim meeting, if needed, to complete the discussions of the comments and the submitted action items. Members also agreed that the document should be converted from a TIR to a standard. Staff will assist the cochair with that process.

Ms. Jain indicated that the nomination for the open cochair position was circulated to the working group for feedback. It is anticipated that there will be a second cochair by the time of the next meeting.

The working group agreed to meet in conjunction with the spring Sterilization Standards Week during the week of March 19.

There being no other business, the meeting was adjourned at 12:00 p.m.

aami st/wg 01, industrial ethylene oxide sterilization · aami st/wg 01, industrial ethylene oxide...

Documents