applying a unique combination of disciplines consulting, preclinical, toxicology,

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1 NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA's MRO Approach plays an important role in translational research, applying a unique combination of disciplines consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality to move client s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.

2 Steven Elliot Director, Quality Control & Sterility Assurance NAMSA B.S. in Microbiology from Auburn University Over 20 years of experience in the contract laboratory business. Prior to his current role Steven held the position of Principal Medical Research Manager for NAMSA s Clinical and Consulting Division, where he oversaw the development and execution of reprocessing validation studies and custom Microbiology studies. Currently, as Director of Quality Control and Sterility Assurance, he oversees all US Microbiology testing for NAMSA and is Site Director for the Irvine facility. He has also worked in a variety of microbiology-related fields including multiple medical device contract laboratories, food microbiology at Kraft-General Foods and virology research at Emory University. Has been a member of several working groups associated with the Association for the Advancement of Medical Instrumentation (AAMI), was the former co-chair of working group (WG) 13 for Washer-Disinfectors and has represented the United States as a delegate at the technical committee meetings of the International Organization for Standardization (ISO). 2

3 Current Regulatory Thinking in Reprocessing

4 Overview Standards and Guidance FDA Guidance Document Insights into the development and validation process Managing new validation studies Summary 4

5 Standards and Guidance AAMI TIR 12:2010 Designing, testing and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers AAMI TIR 30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning medical devices ANSI/AAMI ST79:2010, A1:2010, A2:2011, A3:2012, A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1ed 5

6 Standards & Guidance FDA Guidance Guidance for Industry and Food and Drug Administration Staff Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Draft of this document issued May 2, 2011 Final Document issued on March 17, 2015 Supersedes Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. Understanding and following this guidance will be critical to your success with FDA submissions and reviews on processed / reprocessed medical devices

7 FDA Guidance Key Points Specific criteria to be addressed/ met by reprocessing instructions, including content and format Six (6) criteria for reprocessing instructions Human Factors Specific recommendations on the validation of reprocessing instructions (particularly cleaning efficacy) Justification/ rationale for worst-case challenge/ validation parameters Justification/ rationale for selected validation study parameters and methods 7

8 FDA Guidance 6 Criteria for Reprocessing Instruction 1. Labeling should reflect the intended use of the device What level of patient contact is expected? To what bodily surfaces or components will the device be exposed (i.e., intact skin, mucosal, normally sterile tissue or other fluid, etc.) If device is non-patient contact, can it be exposed to organic soil? 2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device How 2 little words can derail your submission

9 FDA Guidance 6 Criteria for Reprocessing Instruction cont. 3. Reprocessing instructions should indicate the appropriate microbicidal process for the device Sterilization;; high-, intermediate- or low-level disinfection Based on intended use and the Spaulding Classification Critical / Semi-Critical / Non-Critical Compatibility of the device with the selected reprocessing method(s) and the ability of that (those) method(s) to reprocess the device should be validated 9

10 FDA Guidance 6 Criteria for Reprocessing Instruction cont. 4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marked Can your end-user easily and reproducibly execute your reprocessing instructions? Is the end-user s equipment able to (approved to) execute your instructions? This extends to autoclaves, sterilization wrap, autoclave tape, automated washers, disinfectants, lubricants, etc. 5. Reprocessing instructions should be comprehensive Details, details, details Times, temperatures, water quality, disassembly/ re-assembly, visual inspection, microbicidal process, point-of-use processing

11 FDA Guidance 6 Criteria for Reprocessing Instruction cont. 6. Instructions should be understandable Clearly stated, logically ordered and grammatically correct Diagrams/ graphics can be helpful, but should be accompanied by clarifying text

12 Validation Process One important thing to recognize and understand about each processing/ reprocessing step when it comes to the FDA guidance Cleaning It is important to recognize that the most comprehensive instructions in the FDA guidance for validation of a process are for cleaning efficacy Disinfection It is important to understand the Spaulding Classification of your device when worst-case use or foreseeable misuse is considered Sterilization It is important to know the FDA-cleared cycles, including the specified dry times

13 Validation of Reprocessing Instructions/ Methods All validations of reprocessing instructions provided to the end-user by the manufacturer should be conducted under the direction of a comprehensive validation protocol All validations, in their own way, must address worst-case conditions when determining the challenge that will be presented to the reprocessing procedures and the parameters of the study that will be conducted to validate those procedures.

14 Validation of Reprocessing Instructions/ Methods Worst-case devices, with regard to difficulty to clean, difficulty to disinfect, difficulty to sterilize and the likelihood of greatest contamination (based on use), should be included in the respective validations Rationale and justification for the selection of the worst-case device(s) used for each reprocessing validation should be provided in an assessment conducted in accordance with AAMI TIR 12:2010, Section and/or the associated validation protocol 14

15 Validation of Reprocessing Instructions/ Methods Worst-case conditions, with respect to least rigorous application of the cleaning process, least rigorous application of the disinfection process or sub-lethal parameters for the sterilization process, respectively, should be applied. Each reprocessing step should be taken to worst-case condition (i.e., shortest soak time, shortest rinse time, lowest temperature, etc.) and explanation/ justification to support worst-case designation should be provided. For sterilization validations, the validation method selected (e.g., half cycle overkill, full cycle overkill, etc.) should be stated and supported in the parameters applied.

16 Key Points of Cleaning Efficacy Validation Test soil selection Simulated use conditions Inoculation/ Soiling sites Selection of test for detection of residual soil markers

17 Cleaning Efficacy Validation Test soil selection Test soil(s) that is relevant to the clinical use conditions of the device should be selected Comparison of test soil components to typical organic soil components to which the device will be exposed during normal use should be provided The test soil should include at least two (2) physical markers selected to demonstrate the efficacy of the cleaning procedures being validated

18 Cleaning Efficacy Validation Simulated use conditions The FDA guidance indicates the need to use devices that have undergone at least some simulated use in the validation of the cleaning process Repeated application of the selected test soil and repeated exposure of the test devices to multiple reprocessing cycles will help determine whether soil accumulation on/in the device may occur over time. The number of simulated use cycles used should be scientifically justified. Simulated use may also refer to the method by which a device is soiled or inoculated Application of the test soil in a manner that simulates how the device would be soiled during clinical use (e.g., articulation of moving parts while in contact with the test soil to mimic clinical use)

19 Cleaning Efficacy Validation Inoculation/ Soiling sites Test soil should be placed in the most difficult to clean ( worst-case ) locations on the device Test soil should be applied in an amount and manner that mimics typical use and organic soil contamination (e.g., articulation of moving parts in test soil to simulate clinical use).

20 Cleaning Efficacy Validation Selection of test(s) for detection of residual soil markers The selected method should be a validated, quantitative method FDA recommends including at least two (2) test methods in a cleaning efficacy validation The selected method should be sufficiently sensitive and specific enough to produce results that meet associated acceptance criterion

21 Cleaning Efficacy Validation Selection of test(s) for detection of residual soil markers Common physical markers used for cleaning efficacy validation studies can be found in AAMI TIR 30:2011 NOTE: Bioburden is no longer accepted by the FDA as a marker for determining cleaning efficacy Test methods should include appropriate controls Negative device control unsoiled, cleaned Positive device control soiled, not cleaned Negative sample control extraction with no device Positive sample control known amount of soil, extraction with no device

22 Cleaning Efficacy Validation Visual Inspection Regardless of the test soil and/or markers selected for use in the validation study, visual inspection of both internal and external surfaces should be performed, documented and reported

23 Key points of Disinfection Efficacy Validations Although cleaning and disinfection have often been co-mingled in instructions for use in the past, the processes (and expected outcomes) are different Cleaning is considered the physical removal of organic soil Disinfection is considered to be a process intended to kill microorganisms Because the goal of each process is different, the FDA expectation is that cleaning and disinfection processes be validated separately

24 Disinfection Efficacy Validation The Spaulding Classification of your device should be stated and supported with specific rationale, based on device use. Critical Semi-critical Non-critical

25 Disinfection Efficacy Validation The appropriate microbicidal process for your device, based on classification, should be identified and stated in the validation protocol. High-level disinfection Intermediate-level disinfection Low-level disinfection

26 Disinfection Efficacy Validation When disinfection is recommended, harmful residues may be left on the device. Therefore, particular consideration/ attention must be given to appropriate rinsing to reduce or remove those residuals to an acceptable level Validation studies should address the potential for these residues either through direct testing (which is preferred) or through sound justification based on peerreviewed published literature (an approach that carries more risk of rejection).

27 Key points of Sterilization Efficacy Validations The validation should be conducted in accordance with a specific, defined method (e.g., half cycle overkill method) Worst-case locations on/ in the device or instrument tray (i.e., the most difficult to sterilize) should be identified, justified and challenged For devices marketed in the U.S., the validation parameters should comply with the FDA-cleared parameters provided in Appendix C of the Guidance

28 Sterilization Efficacy Validation Validation of primary sterilization processes in health care facilities (i.e., steam and EO) has changed very little with respect to the test methods and approach (i.e., overkill method) One nuance of interpretation has emerged with many FDA reviewers regarding the challenge population of Geobacillus stearothermophilus allowed for use in the validation of steam sterilization parameters AAMI TIR12:2010 and ISO guidance allows for the variation of the challenge population of Geobacillus stearothermophilus used for validation, based on the population s D-value (i.e., resistance). However, some FDA reviewers have required a minimum population of 1 x 10 6, regardless of the D-value

29 Sterilization Efficacy Validation Locations for challenge organism inoculations should represent the most difficult to sterilize locations in or on the device(s) or instrument tray Lumens, mated surfaces, pinch points and occluded spaces, in particular, should be addressed Photos of inoculation sites and descriptions may be helpful, particularly with complex devices and/or with complex mechanisms

30 Sterilization Efficacy Validation Sterilization parameters included in reprocessing instructions must comply with FDA-cleared cycles provided in Appendix C of the Guidance Cycles not listed in this appendix are considered not technically feasible because sterilizers in the healthcare setting were approved for the market using only these specific cycles Dry time validations are required and also must comply with the FDA-cleared cycle dry times

31 Summary When validating reprocessing procedures/ methods for reusable medical devices, remember to consider: A validation protocol that specifies and justifies the worst-case conditions that will be used in the validation process and includes the concepts of simulated use Selection of test soils and inoculation sites/ methods that are clinically relevant to the use of the device, simulate the typical use and exposure to the greatest extent possible and are defined, justified and supported in your validation protocol

32 Summary When validating reprocessing procedures/ methods for reusable medical devices, remember to consider: Selection of test soil markers that are relevant to the test soil and that can be quantitatively detected by a validated method with appropriate sensitivity and specificity to meet established acceptance criteria Selection of test soil markers and acceptance criteria that can be justified and/or supported in peer-reviewed published studies

33 Summary When validating reprocessing procedures/ methods for reusable medical devices, remember to consider: The Spaulding Classification of your device and the microbicidal process required, based on intended use The importance of using FDA-cleared sterilizers and accessories and validating FDA-cleared sterilization cycles (and associated dry times, when applicable).

34 Thank you. For additional information, questions, or to request a proposal, please contact NAMSA: (toll free) (outside of USA) (fax) communications@namsa.com