Reprocessing of Single Use Devices (SUDs) MEDEC Regulatory Conference May 9, 2016
Objective and Outline Objective: Health Canada s requirements around licensing of Reprocessed Single Use Devices (RSUDS) Content to be provided in a licence application for RSUDs Outline: Description/definition of RSUDs Regulatory approach to RSUDs Licence applications for Class III/IV devices Expectations and requirements for reprocessors Labelling Device tracking Cleaning validation Device validation
Reprocessed Single Use Devices Single-use medical devices (SUDs) are intended by their manufacturers to be used once during a single procedure and not to be cleaned and reused. Reprocessed SUDs are those that have previously been used on a patient and have been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. Devices that may be candidates for RSUDs: Surgical instruments, drills, burrs, catheters (PTA, EP), compression sleeves, hemodialysis accessories, etc.
Reprocessing Single Use Devices Reprocessing a medical device involves cleaning, reconditioning, function testing, and disinfection or sterilisation. A hospital s use of third-party commercial reprocessors may be either: A closed-loop procurement model (the hospital receives only its own devices back from the third-party reprocessor) An open-loop model (the hospital does not get its own devices back but rather buys them from a pool of reprocessed devices).
Background on Regulatory Approach will Health be held Canada to the same published a requirements as manufacturers of notice outlining the new devices. This means they must meet regulatory requirements approach for licensing, to quality commercial system management, reprocessing labelling, investigating and handling of SUDs complaints, maintaining distribution records, conducting recalls, reporting incidents http://www.hc-sc.gc.ca/dhp- and informing Health Canada mps/md-im/activit/announce- annonce/md_notice_sud_uu_avis_i in their licence application. of any changes to the information m-eng.php All RSUDs are to be licensed by September 1, 2017
Regulatory Approach Health Canada will issue medical device licences to commercial reprocessors who reprocess SUDs for healthcare facilities. Reprocessed devices will keep the same risk classification as the original equipment manufacturer (OEM) device. Reprocessors must demonstrate that the reprocessed devices they sell meet the safety and effectiveness requirements of the Medical Devices Regulations either directly, or by demonstrating equivalence to a currently licensed device. Reprocessors of licensed SUD s will not be required to demonstrate that the OEM devices meet the safety and effectiveness requirements of the Medical Devices Regulations. Reprocessors of unlicensed SUD s will be required to demonstrate, through the provision of objective evidence, that the OEM devices meet the safety and effectiveness requirements of the Medical Devices Regulations 6
Regulatory Approach In addition to the standard medical device licence application package, the reprocessor should submit: 1. An overview specifically outlining whether the device in question is appropriate for reprocessing, including: a. Description of the device b. Detailed risk analysis c. Data analysis of reverse engineering d. Performance specifications (functional specs., cleanliness, SAL, etc.) including a justification that the specifications are appropriate. 2. Complete and detailed description of the entire validated reprocessing process / procedures, including initial decontamination, cleaning, acceptance testing, refurbishing, packaging, labelling, sterilisation, and release. 7
Regulatory Approach 3. Validation of post-processing device performance, in accordance with item 1 above, up to the maximum number of cycles, including: a. Acceptance criteria b. Pre-clinical testing c. Biocompatibility, etc. 4. Packaging validation including description of sterile barrier system and stability studies. 5. Product labelling, including IFU s and product marking/etching scheme. 6. A method of tracking the number of processing cycles that have been applied to a given device. 8
Regulatory Approach Requirements for licence applications the same as any other manufacturer. Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro Diagnostic Devices (IVDDs) http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guideld/md_gd_reprocessing_im_ld_retraitement-eng.php http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guideld/md_gd_data_im_ld_donnees_ciii_civ-eng.php
Device Licence Applications - Class III and Class IV 1. Background Information Device Description Design Philosophy Indications 2. Labelling 3. Marketing History Canadian and International Incident Reports 4. Manufacturing and Quality Control Materials Biological materials Quality Plan Manufacturing Process Process Validation Studies Sterilization Validation Bioburden, pyrogen, residuals Packaging Validation 5. Safety and Effectiveness Studies List of standards Preclinical studies Bench testing, shelf life, biocompatibility, animal studies Clinical studies Literature Studies & Bibliography 6. Risk Assessment
Expectations for Reprocessors Reprocessors will be required to include their name and address on the labelling of the SUDs they reprocess and will therefore be considered the manufacturer as defined in the MDR. 11
Expectations for Reprocessors Section 9 of the MDR requires that the manufacturer ensures that its devices meet the safety and effectiveness requirements (S&E) [Sec.9(1)] and to keep objective evidence to establish that its devices meet the S&E requirements [9(2)]. Reprocessors of all risk classes of RSUD s will therefore be required to maintain objective evidence to demonstrate that their RSUD s meet the S&E requirements of the MDR. 12
Expectations for Reprocessors Clause 4.2.1 of ISO 13485:2003 requires that a manufacturer establish and maintain, for each type or model of device, a file either containing or identifying documents defining product specifications and quality management system requirements. These documents shall define the complete manufacturing process. 13
Expectations for Reprocessors Reprocessors will need to develop a complete, documented set of acceptance criteria and functional requirements for each type and model SUD to be reprocessed. This should include a documented and justified rationale for the suitability of each type and model of SUD for reprocessing. 14
Expectations for Reprocessors This also entails a detailed risk analysis covering: the device the maximum number of reprocessing cycles acceptance criteria for incoming used SUD s the decontamination and cleaning process any refurbishment activities functional performance criteria and testing activities packaging and labelling activities the sterilization process tracking the number of reprocessing cycles identifying the device in the field as reprocessed tracking of design changes made by the OEM 15
Expectations for Reprocessors Reprocessors are expected to have documented acceptance criteria and functional / performance specifications. Preference is given to using the OEM s specifications. Reverse-engineering of specifications is possible, but this requires justification through, for example, pre-clinical validation. Monitoring for OEM changes to the device. 16
Labelling Requirements RSUD s shall be labelled as being reprocessed and shall bear the name and mark of the reprocessor as well as a device identifier specific to the reprocessed version of the SUD. The OEM s information can remain on the device and label for post-market and compatibility issues, but the reprocessor s information shall be prominent. 17
Labelling Requirements Reprocessed SUD s shall be permanently marked (indelible ink, laser etching, etc.) to indicate the number of use and reprocessing cycles the devices have undergone. RSUD s are to be labelled to not be re-used and to be returned to the reprocessor. 18
Labelling Requirements The labelling / IFU for RSUD s should include details for the initial collection, cleaning, and storage of used devices prior to their return to the reprocessor. Unless deviations are specifically addressed by the reprocessor s objective evidence, the labelling of RSUD s should include the same indications and contraindications, and instructions for use as the OEM device. 19
Manufacturing (Reprocessing) Process Collection and Tracking Cleaning Function Testing Packaging Sterilisation
Device Tracking Applications for licensing should include descriptions of the collection system and device tracking system that are used. The descriptions should relate to the safety of the device and validations performed. Tracking system Each device is marked with a unique identifier (number) The number of reprocessing cycles the device has undergone is tracked with each device s identifier Tracking will facilitate product identification in case of a recall Tracking will facilitate adverse event reporting
Device Tracking Reprocessed SUD s shall be traceable to the OEM device s control number. A recall to the OEM device should be evaluated for applicability to the reprocessed version. Reprocessors are required to have a process to ensure that RSUD s are of a known and valid version / design / configuration / revision. Changes to the OEM device may require revalidations. 22
Process Validation - Cleaning Reprocessors are required to perform a thorough validation of cleaning activities / processes. ISO 14937:2009 can be used as a model for the validation of the cleaning process, including: Cleaning agent characterisation Process and equipment characterisation Product definition Process validation, including IQ, OQ, PQ Routine monitoring and control Product release and acceptance Assessment of changes 23
Cleaning Validation Cleaning validation should be performed on worst-case scenarios using devices contaminated with artificial test soils. A measured endpoint for the cleaning process is required and should be in accordance with the risk analysis; visually clean is not an acceptable endpoint, nor is a demonstrated reduction in contamination. The validation should address residual contamination by cleaning agents. 24
Cleaning Validation The cleaning validation should extend up to the maximum number of re-use cycles that the device may be reprocessed. The cleaning validation can include any refurbishing steps or activities, if applicable. 25
Packaging and Shelf Life Validations Reprocessors are required to validate packaging and shelf life, providing the following information in licence applications: Packaging description Packaging and device shelf life Sterile barrier testing Device function testing Validation testing should be performed after environmental conditioning, aging, and transportation simulation. 26
Sterilisation Validation Sterilisation processes shall be validated in accordance with applicable standards. This validation should account for re-sterilisation up to the maximum number of re-use cycles. Particular attention should be paid to potentiation to residuals due to repeated sterilisation cycles. Pyrogen testing shall be performed on blood contact / surgically invasive devices, as applicable. 27
Device Validation Reprocessors shall have objective evidence of device validation (ref. MDR 9(2), 10-20) post-processing following a maximum number of re-use cycles. This should be in accordance with documented device and performance specifications and the reprocessor s risk analysis. Assessed after maximum number of reprocessing cycles and cycles should be fully simulated (clinical use, cleaning, sterilisation, etc) 28
Device Validation Post-processing device validation can take many forms, but should address all relevant aspects, including: Functional testing against specifications (bench testing) Pre-clinical testing (animal studies) Biocompatibility testing Materials Characterisation etc. 29
Additional Considerations for RSUDs Other information considered during scientific review: Number of intended reprocessing cycles all validations at maximum Monitoring and tracking OEM device changes Revalidating process when necessary Determining when a licence amendments is required Adverse event reporting Human factors Prions control over any infectious agent that would not be removed by cleaning and sterilisation methods (i.e. TSEs)
Summary Reprocessed devices need to meet the requirements of the Regulations and obtain a medical device licence. Emphasis will be placed on the following during review of licence applications: Cleaning validations Device validations following all reprocessing and manufacturing steps (simulated clinical use, cleaning, function testing, packaging, sterilisation, shipping, shelf life, etc) Device tracking Labelling
References Notice to Stakeholders - Health Canada's Regulatory Approach to Commercial Reprocessing of Medical Devices Originally Labelled for Single Use March 12, 2015 Medical Device Regulations (SOR/98-282) Guidance for Industry and FDA Staff Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices September 25, 2006 AAMI TIR30:2011 A Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices ISO 14937:2009 - Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices