Progress in Providing Guidance for the Industry - AAMI, ASTM, and Others - PowerPoint Presentation

1. Progress in Providing Guidance for the Industry - AAMI, ASTM, and OthersJohn A. Williams, Medtronic

2. John A. Williams, Medtronic2September 17, 2020AgendaRole of StandardsAAMI OverviewASTM OverviewStandards AlignmentOther Forums – Call to ActionContinuing the Conversation

3. John A. Williams, Medtronic3September 17, 2020Role of StandardsWhy does my organization use standards?Compliance with voluntary consensus standards enhances our ability to bring products to the global marketplace by: • Making regulatory submissions more uniform, faster and more cost effective. • Reducing regulatory submission review and approval times. • Reducing the regulatory need for more than one product design worldwide. • Assisting in the production of products with the greatest possible reliability and quality.

4. John A. Williams, Medtronic4September 17, 2020AAMI OverviewThe Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 professionals united by one important mission—the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.

5. John A. Williams, Medtronic5September 17, 2020AAMI OverviewST - Sterilization Standards Committee (U.S. TAG to ISO/TC 198)DescriptionThe AAMI ST - Sterilization Standards Committee provides input into international standards by acting as the mirror committee and U.S. TAG to ISO/TC 198 - sterilization of healthcare products which develops standards on the processes and equipment for sterilization of health care products. (32 Working Groups)ST/WG 01 - Industrial EO sterilization Working GroupST/WG 02 - Radiation Sterilization Working GroupST/WG 03 - Industrial Moist Heat Sterilization Working GroupST/WG 04 - Biological Indicators Working GroupST/WG 05 - Sterilization Terminology Working GroupST/WG 06 - Chemical Indicators Working GroupST/WG 07 - Packaging Working GroupST/WG 08 - Microbiological Methods Working GroupST/WG 09 - Aseptic Processing Working GroupST/WG 10 - Liquid Chemical Sterilization Working GroupST/WG 12 - Instructions for Reusable Device Reprocessing Working GroupST/WG 13 - Washer Disinfectors Working GroupST/WG 15 - Sterility Assurance Level (SAL) Working GroupST/WG 40 - Steam Sterilization Hospital Practices Working GroupST/WG 42 - Dry Heat Sterilization Working GroupST/WG 43 - Hospital Steam Sterilizer Working GroupST/WG 60 - EO Sterilization Hospital Practices Working GroupST/WG 61 - Chemical Sterilants Hospital Practices Working GroupST/WG 62 - Hospital Ethylene Oxide Sterilizer Working GroupST/WG 63 - Sterilization Residuals Working GroupST/WG 83 - Reusable Surgical Textiles Processing Working GroupST/WG 84 - Endoscope Reprocessing Working GroupST/WG 85 - Human Factors for Device Reprocessing Working GroupST/WG 86 - Quality Systems for Device Reprocessing Working GroupST/WG 91 - Resistometer Working GroupST/WG 92 - Process Challenge Devices Working GroupST/WG 93 - Cleaning of Reusable Medical Devices Working GroupST/WG 94 - Rigid Sterilization Container Systems Working GroupST/WG 95 - Water Quality for Reprocessing Medical Devices Working GroupST/WG 96 - Compatibility of Materials Subject to Sterilization Working GroupST/WG 11 - General Criteria for Sterilization Processes and Sterilizing Equipment Working GroupST/WG 16 - Vaporized Hydrogen Peroxide Sterilization

6. John A. Williams, Medtronic6September 17, 2020AAMI OverviewScopeIs focused on requirements for establishing, validating, implementing and monitoring radiation processes used to sterilize health care products with gamma, electron beam or x-rayIs the US TAG to ISO/TC 198 Sterilization of health care products, providing US input to development of ISO standards and technical specifications on Radiation SterilizationAuthors Technical Information Reports (TIRs) to provide guidance on aspects of radiation sterilizationMembership65 member companies, more that 100 active individuals~50% medical device manufacturers~25% consultants~20% service and equipment providers~5% regulatoryST/WG02 – Radiation Sterilization Working Group

7. John A. Williams, Medtronic7September 17, 2020AAMI OverviewST/WG02 – Radiation Sterilization Working Group: Published DocumentsAAMI/ISO 11137 series of standards on Sterilization of Healthcare products – RadiationPart 1: Requirements for development, validation and routine control of a sterilization process for medical devicesPart 2: Establishing the sterilization dosePart 3: Guidance on dosimetric aspects of development, validation and routine controlTS Part 4: Guidance on process controlAND AAMI/ISO/TS 13004: Substantiation of selected sterilization dose: Method VDmaxSDAAMI TIR 35, Sterilization of health care products – Radiation sterilization – Product adoption and alternative sampling plans for verification dose experiments and sterilization dose auditsAAMI TIR 40, Sterilization of health care products – Radiation – Guidance on dose setting utilizing a Modified Method 2Documents to be withdrawnAAMI TIR 29, Guide for process characterization and control in radiation sterilization of medical devices – superseded by 11137-4AAMI TIR 37, Sterilization of health care products – Radiation- Guidance on sterilization of biologics and tissue-based products – will be superseded by ISO/TS 22456, Sterilization of health care products – Microbiological Methods – Guidance on conducting bioburden determinations and tests of sterility for tissue-based products (in committee draft process), and ISO/TS 11137-4

8. John A. Williams, Medtronic8September 17, 2020AAMI OverviewST/WG02 – Radiation Sterilization Working Group: Active Projects AAMI TIR 76, Sterilization of health care products – Radiation – Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmaxSD-SHas passed final ballot and is being prepared for publicationAllows for the substantiation of a chosen dose and at a chosen SALComplication of calculating required doses as well as the potential for error in using multiple look up tables led to the development of a software tool to accompany the documentIs the first use of SaaS (software as a service) as part of an AAMI publication, hopefully will lead to application for other dose setting methodsAAMI TIR 104, Guidance on transferring health care products between radiation sterilization sites or modalitiesInitiated in response to business continuity planning opportunities in validating product to be radiation sterilized in multiple sites and/or multiple modalitiesProvides guidance and clarification around the requirements in ISO 11137-4References newly published data that will greatly simplify the transfer of sterilization doseGuidance is provided on when testing should be done to transfer or reestablish maximum acceptable dose, and what tests may be appropriate

9. John A. Williams, Medtronic9September 17, 2020AAMI OverviewST/WG02 – Radiation Sterilization Working Group: ISO Projects Amendment to ISO 11137-2 to reference ISO/TS 13004Regulators outside of the US have rejected sterilization doses substantiated using ISO/TS 13004 because this document is not referenced in 11137-1 or 11137-2, and because it is only a technical specification and not a standardProposal to convert ISO/TS 13004 to a standard rather than a technical specificationThis is happening in parallel with the amendment to 11137-2 with the hope that both will pass and 11137-2 will then reference ISO 13004Revision to ISO 11137-1Last full revision was 2006Multiple suggested updates have been compiledWork program timeframe will be 36 monthsAmalgamation of ISO 11137-3 and 11137-4Longer term projectPlan to work in conjunction with ASTM to provide complimentary HOW documents to accompany the AAMI/ISO WHAT requirements

10. John A. Williams, Medtronic10September 17, 2020AAMI OverviewST/WG02 – Radiation Sterilization Working Group: How to participate AAMI members get one vote regardless of company sizeEach company can vote and provide comments on documents through a primary or alternate representativeCommenting is key!Coordination through your company Primary or Alternate voter is key in making sure that your comments are put forwardAll comments are given fair consideration and no comment will be rejected without feedback and discussionIf you want to drive change in the industry, and put forth best practice that will help provide better outcome for patients, then comment!ISO participants are limited to 5 per countryUS Experts are nominated from within AAMI membershipPreference goes to members who actively participate through productive discussions and commentsFor more information please contact either WG2 co-chair:Emily Craven, Boston Scientific, emily.craven@bsci.comElaine Daniell, EDan-SA LLC Consulting, elaine.daniell@edan-sa.com

11. John A. Williams, Medtronic11September 17, 2020ASTM OverviewASTM International is a globally recognized leader in the development and delivery of voluntary consensus standards. Today, over 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.This leadership in international standards development is driven by the contributions of members: more than 30,000 of the world’s top technical experts and business professionals representing 140 countries. Working in an open and transparent process and using ASTM’s advanced IT infrastructure, members create the test methods, specifications, classifications, guides and practices that support industries and governments worldwide.

12. John A. Williams, Medtronic12September 17, 2020ASTM OverviewCommittee E61 on Radiation ProcessingScopeTo establish and maintain standard practices, methods, and guides for ionizing radiation processing and dosimetry for applications including medical products, pharmaceuticals, foods, polymers, and other consumer products.To develop standard methods for characterizing and operating gamma ray, x-ray, and electron beam irradiators, and encourage use of these standards in radiation processing through meetings, workshops, and symposia.To provide consultation in the application of dosimetry systems and identify areas for additional research.Membership140 members21 countries represented Six SubcommitteesE61.01 DosimetryE61.02 Dosimetry SystemsE61.03 Dosimetry ApplicationE61.04 Specialty ApplicationE61.05 Food IrradiationE61.06 Gas & Heat Processing

13. John A. Williams, Medtronic13September 17, 2020ASTM OverviewCommittee E61 on Radiation Processing: Published Documents (33)E61.01.01 Calibration of Routine Dosimetry Systems (51261)E61.01.02 Estimation of Measurement Uncertainty (51707)E61.01.03 Dosimetry in Radiation Processing (52628)E61.01.04 Performance Characterization of Dosimeters (52701)E61.02.01 Using the Fricke Dosimetry System (51026)E61.02.02 Ceric-Cerous Sulfate Dosimetry System (51205)E61.02.03 Radiochromic Film Dosimetry System (51275)E61.02.04 Polymethylmethacrylate Dosimetry System (51276)E61.02.05 Radiochromic Optical Waveguide Dosimetry System (51310)E61.02.06 Dichromate Dosimetry System (51401)E61.02.07 Ethanol-Chlorobenzene Dosimetry System (51538)E61.02.08 Radiochromic Liquid Dosimetry System (51540)E61.02.09 Alanine-EPR Dosimetry System (51607)E61.02.10 Calorimetric Dosimetry Systems for Electron Beam (51631)E61.02.11 Cellulose Triacetate Dosimetry System (51650)E61.02.12 Thermoluminescence-Dosimetry (TLD) Systems (51956)E61.02.13 LiF Photo-Fluorescent Film Dosimetry System (E2304)E61.03.01 X-Ray (Bremsstrahlung) Facility for Energies between 50 keV and 7.5 MeV (51608)E61.03.02 Electron Beam Facility at Energies Between 300 keV and 25 MeV (51649)E61.03.03 Dosimetry in a Gamma Facility (51702)E61.03.04 Dosimetry in an Electron Beam Facility for Energies Between 80 and 300 keV (51818)E61.03.05 Absorbed-Dose Mapping (52303)E61.04.01 Radiation-Sensitive Indicators (51539)E61.04.02 Dosimetry in Radiation Research on Food Products (51900)E61.04.03 Blood Irradiation Dosimetry (51939)E61.04.04 Sterile Insect Release Programs (51940)E61.04.05 Self-Contained Dry-Storage Gamma Irradiator (52116)E61.04.06 Mathematical Methods for Calculating Absorbed Dose (E2232)E61.05.01 Irradiation of Fresh Agricultural Produce as a Phytosanitary Treatment (F1355)E61.05.02 Irradiation of Fresh, Frozen or Processed Meat and Poultry (F1356)E61.05.03 Selection and Use of Contact Materials for Foods (F1640)E61.05.04 Irradiation of Finfish and Aquatic Invertebrates Used as Food (F1736)E61.05.05 Irradiation of Dried Spices, Herbs, and Vegetable Seasonings (F1885)E61.01 DosimetryE61.03 Dosimetry ApplicationE61.02 Dosimetry SystemsE61.04 Speciality ApplicationE61.05 Food Irradiation

14. John A. Williams, Medtronic14September 17, 2020ASTM OverviewCommittee E61 on Radiation Processing: Active ProjectsE61.03.06 Process Control (WK46751)Scope: This document provides guidance for the statistical analysis of the irradiation process from dosimetric data. E61.03.07 Operational Qualification of Gamma Irradiators (WK65046)Scope: This document provides guidance on operational qualification tests for gamma irradiators. The tests are not requirements but may help the user gain an increased understanding of operational aspects of their irradiator. Based on facility-specific assessments for routine operation, certain tests listed in this document may be deemed to be unnecessary and omitted. Requirements for OQ when sterilizing healthcare product can be found in ISO 11137-1.E61.03.08 Operational Qualification of Ebeam/X-Ray Irradiators (WK72480)Scope: This document provides guidance on operational qualification tests for accelerator-based electron beam irradiators. The tests are not requirements but may help the user gain an increased understanding of operational aspects of their irradiator. Based on facility-specific assessments for routine operation, certain tests listed in this document may be deemed to be unnecessary and omitted. Requirements for OQ when sterilizing healthcare product can be found in ISO 11137-1.

15. John A. Williams, Medtronic15September 17, 2020ASTM OverviewCommittee E61 on Radiation Processing: How to participateA membership fee of $75Join Committee E61 on Radiation Processing Join as many technical committees you desire at no extra costOne Complimentary Volume of Annual Book of Standards ($230 value)Access to the Web-based Committee InformationUpcoming MeetingsDates: 6-9 December 2020; Location: Renaissance Orlando at SeaWorld; Orlando, FL US. Virtual meeting Dates: June 2-4 2021; Location: Jackson Hole, WY (Snow King)Dates: September 18-23, 2021 (in conjunction with the 10th Workshop on Radiation Processing); Location: Prague, CZDates: 15 -18 May, 2022; Location: Hyatt Regency Seattle; Seattle, WA US

16. John A. Williams, Medtronic16September 17, 2020Standards Alignment – What & How ASTM E61 Standards Alignment with ISO/TC 198 WG2Scope: To develop a process between SDO working groups (ASTM E61 and ISO/TC 198 WG2) that ensures ASTM E61 standards are written, reviewed and published in a manner to provide complimentary guidance and practices in direct support of delivering the requirements established in the ISO 11137 series of standards. Charter: To deliver a complimentary series of standards from ASTM E61 that can be directly referenced in ISO 11137 series of standards and will deliver industry best practices for meeting the requirements of the radiation sterilization of healthcare products.

17. John A. Williams, Medtronic17September 17, 2020Standards Alignment – What & How ASTM E61 Standards Alignment with ISO/TC 198 WG2There are four areas of focus to get alignment between ISO 11137 and ASTM E61 documents:1) Dosimetry system calibration, performance characterization and dosimetry uncertainty2) Operational Qualification3) Performance Qualification4) Radiation Process ControlAn exploratory committee will evaluate options for meeting this alignment proposal and will report to ASTM Committee E61 at the December 2020 meeting with a recommendation.

18. John A. Williams, Medtronic18September 17, 2020Other ForumsIndustry Events like this oneKilmer Conference 2022International Meeting on Radiation ProcessingPublications AAMI - Industrial Sterilization: Process Optimization and Modality ChangesIndustry AssociationsThe Council on Ionizing Radiation Measurements and Standards (CIRMS)International Irradiation Association (iiA)The Panel on Gamma and Electron Beam Irradiation Society for Sterility Assurance Professionals (SfSAP)Promoting new technologies – A call to action

19. John A. Williams, Medtronic19September 17, 2020Other ForumsPromoting new technologies – A call to action“We need science to push the advances in standards and not the standards to push science.  If we do not publish our experiences in application of these methodologies, we will not be able to advance and improve the standards for products of the future.”“Sharing this type of knowledge and best practices doesn’t take away from the development of company-specific products or threaten intellectual property, so I'd like to encourage others in my position and similar positions to think about contributing to a frequent cross-pollination of information, which allows us all to learn and grow as a community.”Joyce M. HansenVice President, Johnson & JohnsonMicrobiological Quality & Sterility Assurance

20. John A. Williams, Medtronic20September 17, 2020Thank you for your attention.Special thanks to:Denise Cleghorn & Emily Craven, Boston ScientificJoyce Hansen & John Logar, Johnson & JohnsonQuestions / Comments?