AAMI_TIR14

Technical Information Report AAMI Contract s for ethyl AAMI TIR14:1997 Association for the Advancement of Medical Instrumentation terilization ene oxide & AAMI TIR14:1997/A1:2004 AAMI TIR No.14—1997 Contract Sterilization for Ethylene Oxide Approved 24 February 1997 Abstract: This AAMI Technical Information Report (TIR) provides additional guidance to augment ANSI/AAMI/IS0 11135, Medical devices—Validation and routine control of ethylene oxide sterilization for both medical device manufacturers that use contract sterilization facilities and contract sterilization operations. The TIR addresses how ANSI/AAMI/ISO 11135 applies to ethylene oxide sterilization operations for devices marketed in the United States. Keywords: documentation, medical device manufacturing, product sampling, validation program, Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 © 1997 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this draft should be submitted to AAMI. It is illegal under federal law (17 U.S.C. § 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact Kurt C. Larrick, Director, Technical Publishing, at AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-087-4 AAMI TECHNICAL INFORMATION REPORT A technical information report (TIR) is a publication of the AAMI Standards Board that has evolved during the development of a standard for a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, there is value in releasing the information because of the immediate need for it by the industry and the professions. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted upon—either reaffirmed, revised, or withdrawn—and the action formally approved usually every 5 years but at least every 10 years. For a TIR, AAMI consults with a technical committee about 5 years after the publication date (and periodically thereafter) for guidance on whether the document is still useful—that is, to check that the information is relevant or of historical value. In the event that the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI Technical Information Report may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. CONTENTS Committee representation........................................................................................................................vi Ackowledgements.................................................................................................................................viii Introduction.............................................................................................................................................1 1 Scope..........................................................................................................................................1 2 Definitions...................................................................................................................................1 3 Selection of sterilization facility...................................................................................................2 4 Written agreement between product manufacturer and contract sterilizer.......................................3 5 Validation program......................................................................................................................5 6 Handling of product samples and BI test samples.........................................................................7 7 Sterilization processing documentation.........................................................................................8 8 Controls for routine processing..................................................................................................10 9 Maintenance of contract relationship..........................................................................................12 Annexes A Sensor monitoring tables............................................................................................................13 B Protocol preparation..................................................................................................................18 C Bibliography..............................................................................................................................20 © 1997 Association for the Advancement of Medical Instrumentationvi COMMITTEE REPRESENTATION This technical information report was developed by the AAMI Industrial Ethylene Oxide Sterilization Working Group under the auspices of the AAMI Sterilization Standards Committee. The AAMI Sterilization Standards Committee, which authorized the distribution of this report, has the following members: Cochairs: William E. Young Virginia C. Chamberlain, PhD Members: Carl W. Bruch, PhD, Consultant, Hudson, WI Virginia C. Chamberlain, PhD, Quintiles Quality Regulatory Alliance, Inc. Neal E. Danielson, D’s Enterprise, Wichita, KS Judith C. Dowler, Medical Devices Bureau, Health Canada, Ottawa, ON Frank B. Engley, Jr., PhD, University of Missouri, Columbia, MO Victoria Hitchens, PhD, U.S. Food and Drug Administration Collette P. Keyser, RN, Colonel, U.S. Army (Retired), Alexandria, VA Robert F. Morrissey, PhD, Johnson & Johnson Richard Nusbaum, Pennsylvania Engineering Barry F.J. Page, Consultant, Garner, NC Marimargaret Reichert, RN, MA, Reichert Consulting, Olmsted Falls, OH Janet K. Schultz, RN, Jan Schultz & Associates, Allison Park, PA James Whitbourne, Sterilization Technical Services James L. Whitby, MA, MB, FRCP, Univ. of Western Ontario, London, ON William E. Young, Baxter Healthcare Corporation The AAMI Industrial Ethylene Oxide Sterilization Working Group has the following members: Cochairs: James M. Gibson, Jr. William E. Young Members: Lauren Andersen, H.W. Andersen Products, Inc. Krisann Anderson, St. Jude Medical, Inc. Thomas A. Augurt, PhD, Propper Manufacturing, Inc. Richard H. Bean, Zimmer Anne F. Booth, MS, Booth & Associates, Barrington, IL William C. Bradbury, PhD, Consultant, Sugarloaf, FL Lloyd Brown, U.S. Surgical Corp. Vincent A. Caputo, Quality Solutions, Inc. Virginia C. Chamberlain, PhD, Quintiles Quality Regulatory Alliance, Inc. Gary N. Cranston, Consulting & Technical Services Roger Dabbah, PhD, U.S. Pharmacopeial Convention, Inc. Douglas D. Davie, Sterilization Validation Services Richard J. DeRisio, MF, Sorin Biomedical, Inc. Randal S. Fitzgerald, Ethox Corp. James M. Gibson, Jr., JM Gibson Associates* Joel Gorski, PhD, North American Science Associates, Inc. Gary S. Graham, PhD, Abtox, Inc. * At the time this TIR was drafted, Mr. Gibson represented Special Process Services. © 1997 Association for the Advancement of Medical Instrumentation vii Arthur C. Harris, Chicago Sterilization Services Deborah Havlik, Griffith Micro Science, Inc. Paul A. Honan, Getinge International, Inc. Clark W. Houghtling, Cosmed Group, Inc. Steve Kahn, Depuy, Inc./Boehringer Mannheim Corp. Carolyn Kinsley, Becton Dickinson Michael S. Korczynski, PhD, Abbott Labs Mary S. Mayo, CR Bard, Inc. Sarah Mowitt, U.S. Food and Drug Administration John Nygard, Advanced Bio-Control Technologies Gerry A. O'Dell, Johnson & Johnson Stacey Paetschow, Pfizer Hospital Products Group Daniel L. Prince, PhD, Gibraltar Biological Labs Robert Reich, Pharmaceutical Systems, Inc. Zenius V. Seliokas, Sherwood, Davis & Geck Jon Seulean, Cobe Labs Inc. Charles P. Truby, PhD, Isomedix James Whitbourne, Sterilization Technical Services C. C. Woltz, Allied Signal, Inc. William E. Young, Baxter Healthcare Corp. Alternates: Paul Bombardier, Valleylab Inc./Pfizer Hospital Products Group James E. Conner, Zimmer Stephen A. Conviser, Allied Signal, Inc. Zory Glaser, PhD, MPH, U.S. Pharmacopeial Convention, Inc. Joyce Hansen, Baxter Healthcare Corp. Thomas L. Hansen, Sherwood, Davis & Geck Monica R. Kenyon, Cosmed Group, Inc. Ralph Makinen, CIH, Griffith Micro Science, Inc. John Masefield, Isomedix, Inc. Anna M. McLernon, PhD, Ethicon, Inc./Johnson & Johnson George Mills, MSC, U.S. Food and Drug Administration Dave Parente, MBA, North American Science Associates, Inc. Paul Sordellini, Quality Solutions, Inc. Thelma Wilcott, Becton Dickinson James D. Wilson, Pharmaceutical Systems, Inc. NOTE—Participation by federal agency representatives in the development of this standard does not constitute endorsement by the federal government or any of its agencies. © 1997 Association for the Advancement of Medical Instrumentationviii ACKNOWLEDGMENTS The AAMI Industrial Ethylene Oxide Sterilization Working Group acknowledges the efforts of the Task Group on Contract Sterilization for Ethylene Oxide which drafted this Technical Information Report (TIR). The Task Group has the following members: Chair: Gary Cranston, Consulting & Technical Services Members: Susan Carpenter, CR Bard, Inc. Joyce Hansen, Baxter Healthcare Corp. Arthur C. Harris, Chicago Sterilization Services Monica R. Kenyon, Cosmed Group, Inc. Sue Kuhnert, Sterilization Technical Services Sarah Mowitt, U.S. Food and Drug Administration Robert Reich, Pharmaceutical Systems, Inc. Bill South, Isomedix, Inc. The AAMI Industrial Ethylene Oxide Sterilization Working Group also wishes to acknowledge the contributions of former working group members Cas Woss of Fox River Grove, IL, and Dan Burgess of Napierville, IL. © 1997 Association for the Advancement of Medical Instrumentation 1 CONTRACT STERILIZATION FOR ETHYLENE OXIDE Introduction The medical device industry is using contract sterilization operations at an increasing rate. The resulting rise in the percentage of medical devices that are sterilized under contract calls for additional guidance to support this trend. A direct impact of using contract sterilization facilities is downsizing of the sterilization support and technical knowledge within the medical device manufacturer's resources. Experience indicates that contract sterilization procedures require enhanced communications between the manufacturer and the contractor to ensure a well-controlled sterilization process. As the contract sterilization industry continues to grow, it is increasingly evident that responsibility for sterility is shared by the medical device manufacturer and the contract sterilization facility. Furthermore, it is essential that the division of responsibilities be clearly defined and understood by both parties. NOTE 1 This technical report is considered "informative," and use of the terms "shall," "should," etc., should be considered within the context of this technical report only. That is, if the decision is made to use a particular method presented in this technical report, then the method should be followed in adherence with the requirements ("shall") and recommendations ("should") as set forth in this technical report. 1 Scope This AAMI Technical Information Report (TIR) provides additional guidance to augment ANSI/AAMI/IS0 11135, Medical devices—Validation and routine control of ethylene oxide sterilization for both medical device manufacturers that use contract sterilization facilities and contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135 applies to contract ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide contract sterilization guidance for health care providers is not specifically covered in this TIR. 2 Definitions For the purposes of this Technical Information Report, the following definitions apply: 2.1 bacteriostasis/fungistasis test: Test performed with selected microorganisms to demonstrate the presence of substances that inhibit their multiplication. 2.2 calibration: Comparison of a measurement system or device of unknown accuracy to a measurement system or device of a known accuracy (traceable to national standards) to detect, correlate, report, or eliminate by adjustment any variation from the required performance limits of the unverified measurement system or device. 2.3 contract sterilizer: Any facility that offers to provide a contractual service intended to sterilize medical devices that are manufactured by another establishment. NOTE 2 The definition may include any facility that sterilizes products manufactured by another establishment that may be within the same corporation. This establishment may sterilize its own devices as well as provide contractual services. © 1997 Association for the Advancement of Medical Instrumentation2 2.4 finished device: Device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution. 2.5 manufacturer: Any establishment, including any repacker and/or relabeler, that manufactures, fabricates, assembles, or processes a finished device. 2.6 process challenge device (PCD): Object that simulates the worst case of conditions as they are given for the sterilizing agent(s) in the items of the goods to be sterilized. NOTE 3 The process challenge device is so constituted that a biological indicator can be arranged in the place most difficult for the sterilizing agent(s) to reach. NOTE 4 The design of the process challenge device depends on the kind of goods to be sterilized and the sterilization procedure. The biological indicator should not interfere with the function of the test body. NOTE 5 In some process challenge devices an inoculated carrier may be used instead of a biological indicator. 2.7 qualification: Documented evidence that all prescribed design and performance requirements are met. 2.8 validation: Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield a product complying with predetermined specifications. NOTE 6 Validation is considered as a total program that consists of commissioning and performance qualification. 2.9 verification: Evaluation that is performed to assure current operation or applicability for use of a system. NOTE 7 For ethylene oxide sterilization, a single point evaluation of thermocouples in the range of use may be performed prior to and after performing qualification to assure correct functioning of the equipment. Verification may also be used for other pieces of monitoring equipment depending upon their use. For example, if a secondary measuring device, such as a pressure transducer, is added to a sterilization vessel prior to performing qualification, the device should be calibrated prior to use and may be verified after use and prior to removal from the vessel. 3 Selection of sterilization facility 3.1 Initially, an evaluation is required to determine whether sterilization should be performed by a contract facility or if the capabilities exist for in-house processing. The manufacturer's selection of a location for sterilization should be well thought-out. Once this evaluation has been performed and it has been determined that contract sterilization is the choice, a number of factors require assessment to identify a contractor that best suits the manufacturer's needs. Some of the issues affecting the choice of location include a) proximity of the facility to the manufacturer; b) size(s) and available capacity of chambers in relation to the expected volume of manufactured material; c) processing capability of the facility with respect to preconditioning room(s), sterilization chambers, and aeration room(s); © 1997 Association for the Advancement of Medical Instrumentation 3 d) cost of processing (includes sterilization and shipping); e) OSHA, EPA, and safety compliance; f) availability/proximity of laboratory services to the contractor; and g) facility's regulatory compliance history. 3.2 To adequately determine the contractor's acceptability, the manufacturer or a designate should perform an audit of the contract sterilization facility under consideration. Due to the importance of the audit, the personnel performing the audit should be knowledgeable of the sterilization method being considered. The audit should cover issues such as a) maintenance and calibration programs; b) installation/commissioning qualifications of the vessels and environmental chambers (if used); c) operational qualifications of the vessels and environmental chambers (if used); d) personnel training; e) management education and/or experience; f) change control and documentation procedures; g) use of quality systems; h) software validation; and i) OSHA, EPA, and safety compliance. 3.3 To facilitate the audit procedure, it is often helpful to have a predetermined audit document that reflects the domestic and international regulatory requirements. This enables the auditor to make an appropriately informed decision with regards to the contractor's compliance. Once the audit has been completed, the auditor should provide a written report stating acceptability of the contractor. This report should list corrective actions that need to be taken, if any. It is then the contractor's responsibility to address and document these corrective actions and to provide them to the auditor enabling closure of the audit process. If no corrective action is identified, a report should be issued stating an audit has been performed. Upon completion of corrective action, a letter should be issued by the manufacturer to the contractor closing the audit. If the corrective action can not be completed within a short period of time, a timetable outlining the anticipated completion date(s) should be provided to the auditor. The audit of the sterilization facility under consideration, in conjunction with logistical concerns, provide the manufacturer with sufficient information to make a well-informed selection. The final requirement for the acceptance of the location is to document the logic and criteria used in the selection process. 4 Written agreement between product manufacturer and contract sterilizer Before starting contract sterilization pr