AAMI Standards Monitor Online 16 July 2018

Transcription

1 National Standards New work/call for participation The following documents were recently approved for work by the AAMI Standards Board. If you would like additional information or to join the consensus body, please contact the listed staff person. AAMI TIR42, Evaluation of acute particulate generation associated with vascular medical devices (revision). See also a Call for Members below. Staff contact: cbernier@aami.org. AAMI TIR99, Dilators, transesophageal and ultrasound probes processing in health care facilities (new technical information report). See also a Call for Members below. Staff contact: abenedict@aami.org. AAMI ST100, End-to-end sterility assurance (new standard). See also a Call for Members below. Staff contact: abenedict@aami.org. AAMI TIR101, Fluid delivery performance testing for infusion pumps (new technical information report). See also a Call for Members below. Staff contact: jmoyer@aami.org. AAMI TIR102, US FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems (new technical information report). See also a Call for Members below. Contact: wvargas@aami.org. AAMI EQ103, Alternative equipment maintenance in healthcare delivery organizations (new standard). See also a Call for Members below. Contact: pbernat@aami.org. AAMI EQ56, Recommended practice for a medical equipment management program (revised standard with an expanded scope). See also a Call for Members below. Contact: pbernat@aami.org. AAMI Call for Comments If you would like to comment on one of the draft documents listed below, contact the individual indicated by or click on the indicated URL to download the draft. These copies are free. Published documents proposed for reaffirmation can be purchased from the AAMI Store: Comments due 30 August 2018 AAMI/ISO :2013, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose (reaffirmation of an American National Standard). Specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kgy or 15 kgy as the sterilization dose to achieve a sterility assurance level, SAL, of This part of ISO also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. Defines product families for sterilization dose establishment and sterilization dose audit. Users, regulators and general interest members are encouraged to join AAMI/ST/WG02, radiation sterilization. Can be purchased from the AAMI Store: Contact: celliott@aami.org Page 1 6

2 AAMI/ISO 14160, Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (revision of an American National Standard). Specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. Covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Users, regulators and general interest members are encouraged to join AAMI/ST/WG10, Liquid chemical sterilization. Contact: abenedict@aami.org Download from Consensus Body Members Needed The committees listed below are seeking new members in the indicated stakeholder interest category to participate in the development of their documents. Definitions of the various stakeholder groups are: User: An individual or organizational representative, who purchases, utilizes or receives the materials, products, systems, or services covered in the scope of technical documents developed by AAMI in the delivery of healthcare; individuals in this interest category include clinicians, employees or representatives of Healthcare Delivery Organizations, clinical consultants, patients, etc. Industry: An individual or organizational representative involved in the commercial production, promotion, sale, use or distribution of materials, products, systems, or services covered in the scope of technical documents developed by AAMI; this interest category includes manufacturers, those involved in supply chains, employees of test labs or commercial labs, industry consultants, etc. Regulatory: An individual or organizational representative involved in the regulation of the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI; this interest category includes those representing federal, state, local, foreign, or other government entities. General interest: An individual or organizational representative with a general material interest in the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI and who does not fit into any of the preceding categories; this interest category can include noncommercial academicians, noncommercial researchers, patient or consumer advocates, representatives of accrediting organizations, representatives of other organizations, etc. Please contact the staff person indicated for more information on how to join. Infusion Device Committee Users, regulatory, and general interest stakeholders needed to participate in the development of a new technical information report, AAMI TIR101, Fluid delivery performance testing for infusion pumps. Staff contact: jmoyer@aami.org Medical Equipment Management - Industry, regulatory, and general interest stakeholders needed to participate on two recently approved projects, AAMI EQ103, Alternative equipment maintenance in healthcare delivery organizations (new standard) and AAMI EQ56, Recommended practice for a medical equipment management program (revision with an expanded scope). Staff contact: pbernat@aami.org. Assurance of Sterility Working Group - Users, regulatory, and general interest stakeholders needed to participate in the development of a new standard, AAMI ST100, End-to-end sterility assurance. Staff contact: abenedict@aami.org. Page 2 6

3 Application of Quality Systems to Medical Devices Working Group - Users, regulatory, and general interest stakeholders needed to participate in the development of a new technical information report, AAMI TIR102, US FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems (new technical information report). Staff contact: wvargas@aami.org. Endoscope Reprocessing Working Group - Users, regulatory, and general interest stakeholders needed to participate in the development of a new technical information report, AAMI TIR99, Dilators, transesophageal and ultrasound probes processing in health care facilities. Staff contact: abenedict@aami.org. Medical Device Particulates - Users, regulatory, and general interest stakeholders needed to participate in the revision of AAMI TIR42, Evaluation of particulates associated with vascular medical devices. Staff contact: cbernier@aami.org. Radiation sterilization - Users, regulators, and general interest stakeholders needed for the reaffirmation of AAMI/ISO :2013. See the public review listing above for details. Staff contact: celliott@aami.org. Liquid Chemical Sterilization Working Group - Users, regulators, and general interest stakeholders needed for the revision of AAMI/ISO See the public review listing above for details. Staff contact: abenedict@aami.org. Rigid Sterilization Containers Working Group - Multiple documents, including AAMI ST77. Staff contact: abenedict@aami.org. Biological Evaluation Committee (U.S. Technical Advisory Group to ISO/TC 194) - Multiple standards and Technical Information Reports, particularly the ISO series. Staff contact: abenedict@aami.org. Blood Filter/Cell Salvaging Committee - Multiple documents. Staff contact: cbernier@aami.org. Cardiac Occluders - Cardiovascular implants: Cardiac occluders. Staff contact: cbernier@aami.org. Cardiovascular Absorbable Implants Committee-Revision of AAMI/ISO TIR 17137, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants. Staff contact: cbernier@aami.org. Industrial Ethylene Oxide Sterilization Working Group - Multiple documents. Staff contact: cbernier@aami.org. Blood/Gas Exchange Device Committee - Multiple documents. Staff contact: cbernier@aami.org. Cardiovascular absorbable Implants Committee - Revision of AAMI/ISO TIR17137, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants. Staff contact: cbernier@aami.org Page 3 6

4 Upcoming Meetings AAMI Committees and U.S. TAGs Open meetings of AAMI committees and U.S. Technical Advisory Groups (TAGs) are listed here and at the AAMI website ( Agendas for open meetings are usually available from AAMI Central. (Visit find the committee or working group and look under Upcoming Shared Events or "Recently Shared Documents"). Note: If you plan to attend a meeting, please send a brief note to the AAMI Standards Department (standards@aami.org) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation. July 2018 General Criteria for Sterilization Processes and Sterilizing Equipment Working Group (open meeting), 18 July 2018, 12:30 to 13:30 h EST, GoTo Meeting. Contact: abenedict@aami.org Vaporized Hydrogen Peroxide Sterilization Working Group (open meeting), 18 July 2018, 14:00 to 15:00 h EST, GoTo Meeting. Contact: abenedict@aami.org Endoscope Reprocessing Working Group (open meeting advance registration required), July 2018, 9:00 to 17:00 h, AAMI, Arlington, VA. Contact: abenedict@aami.org Hospital Ethylene Oxide Sterilizer Working Group (open meeting), 23 July 2018, 11:00 to 12:00 h EST, GoTo Meeting. Contact: abenedict@aami.org Industrial Moist Heat Sterilization Working Group (open meeting), 30 July 2018, 11:00 to 13:00 h EST, GoTo Meeting. Contact: abenedict@aami.org August 2018 Biological Evaluation Committee (open meeting advance registration required), 30 August 2018, 9:00 to 17:00 h, AAMI, Arlington, VA. Contact: abenedict@aami.org October 2018 Allowable Limits for Leachable Substances Working Group and Sterilization Residuals Working Group (combined open meeting), TENTATIVE DATE 10 October 2018, 10:00 to 13:00 h EST, GoTo Meeting. Contact: abenedict@aami.org Sterilization Standards Week (open meeting advance registration required), October 2018, 8:00 to 17:00 h, Hyatt Regency Baltimore Inner Harbor, Baltimore, MD. Contact: abenedict@aami.org November 2018 Cardiac Rhythm Management Devices Committee (open meeting), 15 November 2018, 9:00 to 17:00 h, AAMI, Arlington, VA. Contact: jmoyer@aami.org December 2018 Luer activated valves working group (open meeting), 3-5 December 2018, 8:00 to 17:00 h (13:00 h on final day), Turin, Italy. Contact: celliott@aami.org Page 4 6

5 International Standards Information on draft international standards under ballot can be found in ANSI Standards Action: nuid=7 International Committee and Working Group Meetings Call or the indicated staff person at AAMI for more information about upcoming international standards meetings. September 2018 ISO/TC 150/SC 2 and related working groups (closed meetings), September 2018, San Diego, CA, USA. Contact: cbernier@aami.org. ISO/TC 150/SC 6 and related working groups (closed meetings), September 2018, San Diego, CA, USA. Contact: jmoyer@aami.org ISO/TC 198 and related working groups (closed meetings), September 2018, London, UK. Contact: abenedict@aami.org November 2018 ISO/TC 121/SC6, Medical gas systems (closed meetings), 5-9 November 2018, 9:00 h to 17:00 h, Prague, Czech Republic. Contact: celliott@aami.org ISO/TC 210, Quality management and corresponding general aspects for medical devices, and related working groups (closed meetings), November 2018, Seoul, South Korea, USA. Contact: wvargas@aami.org IEC/SC 62A/WG 20, Environmental protection (closed meeting), November 2018, 9:00 to 17:00 h, New York, NY. Contact: hchoe@aami.org December 2018 ISO/TC 121/SC2, Airways and related equipment (closed meetings), 5-7 December 2018, 9:00 h to 17:00 h, London, UK. Contact: celliott@aami.org. January 2019 ISO/TC 121/SC3, Lung ventilators and related equipment (closed meetings), January 2019, 9:00 h to 17:00 h, Auckland, NZ. Contact: celliott@aami.org. Page 5 6

6 Miscellaneous Introducing our new Standards FAQs page! Please visit the AAMI website at to quickly get answers to commonly asked questions. If your question and answer is not listed on the website, please complete and submit the online form and someone will get back to you within three business days. Please note that as a standards developing organization accredited under ANSI, AAMI is procedurally prohibited from providing interpretations of standards and/or interpreting whether specific actions are in conformance with the standards. We do not have the technical expertise on staff to advise about specific practices and can only point you to content in the standards that might be helpful. For questions of a technical nature, we suggest you reach out to any number of consultants in the AAMI Buyers Guide that can be found on The Buyers Guide.. Page 6 6