Device Recall and Advisory Notices SOP PDF

Compass Health AI SOP: Device Recall and Advisory Notices Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin...

Compass Health AI SOP: Device Recall and Advisory Notices Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver 02-Jan-2024 Baskin COO Document# SOP-QMS-0028 Revision History Version Date Description 1.0 03-Jan- Initial Release 2024 Document# SOP-QMS-0028 1 Introduction This procedure provides instructions and a system to assign responsibilities for the recall of distributed devices of Compass Health, and the issue and implementation of advisory notices. 1.1 Scope This procedure applies to all dispatched, shipped and distributed Compass Health products/devices, inclusive of investigational devices. Note: The details of this SOP are specific to recall definitions and procedures as required by FDA QSR, Health Canada CMDR and Australian Therapeutics Goods (Medical Devices) Regulations. Required actions differ from country to country and the applicable laws of each country in which the product is subject to a recall must be reviewed and adhered to respectively. 2 Applicable and Reference Documents 2.1 Applicable Standards The following standards and regulations are intended to be met by this procedure: Document Title Document Number FDA Voluntary Device 21 CFR 7 Recalls FDA Mandatory 21 CFR 810 Device Recalls FDA Corrections and 21 CFR 806 Removals Document# SOP-QMS-0028 FDA Regulatory Procedures Manual: http://www.fda.gov/downloads/ICECI/ComplianceManuals/Reg Chapter 7: Recall ulatoryProceduresManual/UCM074312.pdf Procedures FDA Recall Procedures and http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProc Model Press eduresManual/default.htm Releases Recalls, Corrections https://www.fda.gov/medical-devices/postmarket- and Removals requirements-devices/recalls-corrections-and-removals- (Devices) devices Medical Device Class https://www.fda.gov/medical-devices/medical-device- I Recalls safety/medical-device-recalls Canada Medical SOR/98-282 Device Regulations Health Products and Food Branch https://www.canada.ca/content/dam/hc- Inspectorate sc/documents/services/drugs-health-products/compliance- enforcement/information-health-product/drugs/recall-policy- Recall Policy (POL- 0016/recall-policy-0016POL-0016-2019-08-06-eng.pdf 0016) Product Recall https://www.canada.ca/content/dam/hc-sc/migration/hc- Procedures Guideline sc/dhp-mps/alt_formats/pdf/compli-conform/prob-report- – Health Canada rapport/gui-0054_recall-retrait-doc-eng.pdf Website Guidance Document https://www.canada.ca/en/health-canada/services/drugs- for Mandatory health-products/reports-publications/medeffect- Document# SOP-QMS-0028 Problem Reporting canada/guidance-document-mandatory-problem-reporting- for Medical Devices medical-devices-health-canada-2011.html Therapeutics Goods (Medica Devices) Regulation – TG(MD)R 2002 Australia Medical Uniform Recall Procedure for Therapeutic Goods (URPTG) Device Regulations Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 3 Part 1 Clause 1.4 (3A) 2.2 Reference Documents Document Title Document # SOP: Complaint Handling QMS-SOP-0026 SOP: Control of Nonconforming Product QMS-SOP-0024 SOP: Corrective and Preventive Action QMS-SOP-0031 SOP: Medical Device Reporting and Mandatory Problem QMS-SOP-0029 Reporting SOP: Control of Records QMS-SOP-0003 3 Acronyms and Definitions Term Definition Document# SOP-QMS-0028 Advisory Notices Manufacturer to report to the Sponsor or the TGA, as soon as practicable, (TGA) any technical or medical reason for a malfunction or deterioration that has led the manufacturer to take steps to recall. Action to eliminate a detected non-conformity. Repair, modification, adjustment, relabeling, or inspection (including Correction patient monitoring) of a product without its physical removal to some other location Anyone who received, purchased, or used the product being Consignee recalled An advisory notice is sent to clients issued to provide information Customer and/or advice on what actions should be taken by the customer in Notification the use, modification, disposal, or return of a medical device for the purpose of corrective action. Includes a survey of those affected by the recall (consignees) to Effectiveness verify they have received the recall notification and are aware of any Check appropriate action to be taken and may include verification of the action taken. An evaluation to assess the degree of health risk caused by the Health Hazard device deficiency or malfunction. A risk to health may result from a Analysis product malfunction, deficient labeling, or an error in device usage. Issued in situations where a medical device may present an Medical Device unreasonable risk of substantial harm. In some cases, these Safety Alert situations are also considered recalls. Market Withdrawal A firm’s removal or correction of a distributed product which (FDA only) involves a minor violation that would not be subject to legal action Document# SOP-QMS-0028  by the FDA—or—which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs (If the action may be defined as a Market Withdrawal, a recall is not required). Any action taken in respect of the device by the manufacturer or importer thereof after becoming aware that the device; 1. is or may be hazardous to health, 2. fails or may fail to conform with any claims made by the manufacturer or importer relating to the effectiveness, benefits, performance characteristics or safety of the device, or 3. does not comply with the Food and Drugs Act or Medical Devices Regulations to recall or correct the device or to notify the owner or user of the device of the defectiveness thereof Recall (FDA) The definition of "Recall" does not include a "product withdrawal" (see market withdrawal definition) or a "stock recovery". A recall is an action taken by Compass Health to address a problem with a medical device that violates FDA law. Recalls can be a correction or removal of such devices. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. A recall is defined as any action taken by the manufacturer, importer or distributor of the device to remove a faulty device from the marketplace or correct (on or off-site) the device, or to notify its Recall (Health owners and users of its defectiveness or potential defectiveness, Canada) after becoming aware that the device: (a) may be hazardous to health; Document# SOP-QMS-0028  (b) may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or (c) may not meet the requirements of the Act or these Regulations. The numerical designation, i.e. Class I, Class II or Class III, assigned by the FDA and/or Health Protection Branch to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. Class I: a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Class II (CAN): a situation in which the use of, or exposure to, a Recall violative product may cause temporary adverse health Classification consequences or where the probability of serious adverse health consequences is remote. Class II (USA)-a situation in which there is a reasonable probability that the use of or exposure to a violative device may cause temporary or medically reversible adverse health consequences or where the probability of a serious health consequence is remote. Class III: a situation in which the use of, or exposure to, a violative product is not likely to cause any adverse health consequences. Class I - Most serious safety-related - When there is a reasonable probability that the use of, or exposure to, the deficient therapeutic good(s) will cause serious, permanent Recall or long term adverse health consequences or death. classification (Australia) Class II - Urgent safety-related - When the use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse Document# SOP-QMS-0028  health consequences is remote. Class III - Lowest risk - when the use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences and the identified problem/s are therefore not safety related. Recall - A recall is conducted to remove therapeutic goods permanently from the market or from use when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation. Product defect correction - A product defect correction is undertaken to correct a specific or potential deficiency. In some instances, the product can continue to be used if there is robust mitigation in place until a permanent correction has been implemented. Recall Action Type (Australia) Hazard alert - A hazard alert is issued for an implanted therapeutic good with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy because implanted goods cannot be recalled. Product defect alert - Discontinuation of treatment is sometimes riskier than continued use of the deficient product. This occurs for critical therapeutic goods for which there is no alternative product or for which a recall action will result in interruption of patient treatment, a medical device supply disruption A planned specific course of action to be taken in conducting a specific recall, which addresses itself to matters such as the depth Recall Strategy of recall, need for public warnings, and extent of effectiveness checks for the recall. Recall Termination The FDA determines when to issue a recall termination upon (FDA) receiving such a request from the manufacturer (i.e. Compass Document# SOP-QMS-0028  Health). The FDA closes the recall initiation process and issues a recall termination by letter when all requirements have been met satisfactorily, including product disposition and the potential condition for harm has been eliminated. A change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of the following: (a) the manufacturing process, facility or equipment; (b) the manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of Significant Change the materials used in its manufacture; (c) the design of the device, including its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories; and (d) the intended use of the device, including any new or extended use, any addition or deletion of a contraindication for the device and any change to the period used to establish its expiry date. A manufacturer importer or distributor's removal or correction of a product that has not been distributed or that has not left the direct control of the firm. (i.e. the device is located on the premises owned or under the control of the manufacturer and no portion of the lot, mode, code or other relevant information has left the Stock Recovery premises). It is not considered to be a recall. However, if product leaves the control of a manufacturer but has not left the control of subsequent importers or distributors, the action is considered a recall at the manufacturer’s level and a stock recovery at the importer/distributor’s level. Document# SOP-QMS-0028 4 Process Roles Role Description Management Responsible for the maintenance of internal records that Representative demonstrate appropriate efforts have been made to ensure all of Recall suitable consignees have been contacted following initiation of committee the recall strategy Senior managers, Quality Assurance, and the assigned Product Executive Receives updates of all potential recall problems from Quality Assurance. These details include: the extent and nature of Top health hazard and recall classification, proposed depth of Management recall, type of notice to consignees, i.e., letter, fax, email or telephone, content of notice to consignees and the method for verifying effectiveness of recall. When the above data is available, the proper authorities are contacted with the proposed recall plan and strategies. Responsible for initiating the recall and coordinating all related activities Decide whether a recall is necessary and informs the applicable Recall case-specific regulatory body Committee Comprised of one of the CTO, VP of Engineering and QA/RA Manager/Director as a minimum but can be extended to include other multidisciplinary groups as deemed appropriate. Quality Maintaining this procedure. Assurance Participates in the recall committee to initiate and coordinate all recall activities. Document# SOP-QMS-0028  Designates a quarantine holding area for all recall products and determines product disposition as per recall committee directives. In coordination with the Top Management, Engineering and Engineering & Support are responsible to organize and conduct all recall Support activities including internal and external locations of questionable part numbers of hardware items and/or products. If included in the recall committee, Distributors will cease and Distributors desist all sales of suspect products and comply with all recall committee directives. 5 Recall Process 5.1 General Top Management is responsible for ensuring that this procedure is understood and implemented effectively. FDA: The recall of a device is the correction or removal of a marketed device that is in violation of FDA law. Market withdrawal and stock recovery (see definitions) are not included in the recall process. A recall is necessary when it has been determined that there is: a risk of serious deterioration of the state of health or death, failure to conform to any claims relating to its effectiveness, benefits, performance characteristics, or safety or may not meet regulatory requirements. A recall includes the return of a medical device to the supplier (or manufacturer); its modification by the supplier (or manufacturer) at the site of installation or elsewhere; its exchange; or its destruction. Health Canada: A recall is defined as any action taken by the manufacturer, importer or distributor of the device to remove a faulty device from the marketplace or correct (on or off-site) the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device: Document# SOP-QMS-0028  4. may be hazardous to health; 5. may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety; or 6. may not meet the requirements of the Act or these Regulations. An advisory notice is issued by Compass Health to provide information and/or advice on what action should be taken in the use, modification, disposal or return of a medical device. Advisory notices will be sent by certified mail and include “Urgent” and “Recall” cautions; similar warnings will be included if sent by other traceable means. Market withdrawal in the case of FDA recalls only and stock recovery activities in the case of both Health Canada and FDA recalls are not governed by this procedure. These activities pertain to the removal of distributed devices that are not in violation of current regulations, but are the result of normal stock rotation, replacement or improvement of such device; and to the recovery of devices that have not been marketed or have not left the direct control of the company’s premises. 5.2 Recall Responsibilities The Compass Health Recall Committee is responsible for initiating the recall and coordinating all related activities. A recall will be initiated once the recall committee becomes aware that the device (including its labelling) is defective or potentially defective and may: a. Be hazardous to health b. Fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety c. Not meet the requirements of the Food and Drugs Act or Medical Device Regulations In an emergency, and when there is no time to assemble the full committee, the CTO/Engineering Manager or the Director of QA/RA alone is authorized to initiate a recall. Potential recall situations are reported immediately to the Director of QA/RA. Quality Assurance analyzes the product for compliance with the specifications and/or regulatory requirements, determines the extent of the problem and reports the results to the Director Document# SOP-QMS-0028 of QA/RA. The Director of QA/RA assembles a meeting of the recall committee if time permits. If time does not permit such assembly, the Engineering Manager or the Director of QA/RA can act alone in initiating a recall. Success and QA/RA are responsible for organizing and conducting all recall activities. This includes determining the location of all internal and external suspect products. In specific cases, Suppliers (or Partner Companies) are included in the recall committee; they will follow all committee directives. 5.2.1. Supplementary Recall Responsibilities: Canada-Specific Compass Health QA/RA shall maintain internal documents that clearly define complaint handling and device recall procedures (i.e. this operational procedure), to carry out the device recall process in an effective and timely fashion upon discovery of a faulty device requiring recall. The Management Representative of the recall committee is responsible for the maintenance of internal records that demonstrate appropriate efforts have been made to ensure all suitable consignees have been contacted following initiation of the recall strategy. The record shall include the following: 7. date(s) of (attempted) contact 8. response received 9. the name and title of the person contacted 10. the means of contact 11. details of the communication 12. An evaluation of whether the recall instructions have been understood and are to be carried out appropriately 13. Copies of a completed response form 14. Copies/ evidence of any related correspondences Compass Health’s recall strategy may be checked by Health Canada to verify its effectiveness. Therefore, Compass Health shall make every effort to ensure company records of customer contact and conduct checks are maintained accordingly. Documents will be maintained by designated personnel to facilitate timely retrieval. Compass Health QA shall refer to the Ministry’s recall of medical devices guidance document (GUI-0054) for additional instruction, if needed: Document# SOP-QMS-0028 https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance- enforcement/problem-reporting/medical-devices-recall-guide-0054.html 5.3 Recalls within the USA The recall committee decides whether product removal or corrective actions are necessary and, if they are, informs the appropriate FDA district office of the decision (see below). The FDA will, in turn, determine whether the action is to be classified as a recall pending determination of whether the nature of the violation is potentially subject to legal action. If the FDA indeed classifies the violative product as a recall, the recall committee shall provide the FDA with the following preliminary information: Identity of the product involved. Reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered. Evaluation of the risk associated with the deficiency or possible deficiency. Total amount of such products produced and/or the time span of the production. Total amount of such products estimated to be in distribution channels. Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts. A copy of the firm's recall communication if any has issued, or a proposed communication if none has issued. Proposed strategy for conducting the recall (see below) Name and telephone number of the firm official who should be contacted concerning the recall. The proposed recall strategy shall be prepared according to the following elements that touch upon the conduct of the recall: The extent and nature of health hazard and recall classification. Proposed depth of recall (consumer/ user level, retail level, wholesale level); Type of notice to consignees, eg., letter, fax, telephone, or email. There will be a follow-up communication in two weeks of the recall initiation if clients have not returned the suspect product. Content of notice to consignees; and Method for verifying effectiveness of recall. Document# SOP-QMS-0028 A statement specifying whether a public warning is needed and, if so, the form it shall take (see section 5.6.1; reserved for urgent cases involving defective devices that pose an elevated hazard to public health where alternative means of preventing use of the device have proven inadequate) Compass Health shall develop the recall strategy based on careful consideration of the following factors: Results of health hazard evaluation. Ease in identifying the product. Degree to which the product's deficiency is obvious to the consumer or user. Degree to which the product remains unused in the market-place. Continued availability of essential products. If Compass Health believes the removal or corrective action to constitute a market withdrawal and the device in question does not, in its present state, pose a health risk, the FDA does not require notification of the action unless uncertainty pertaining to the designation exists, in which case the FDA will assist Compass Health in determining the exact nature of the problem and its appropriate classification, e.g., recall or market withdrawal. The FDA is contacted with a proposed recall plan and strategies within 10 days of making a recall decision. The FDA may make recommendations for revision and, when incorporated by Compass Health into the plan, approve it. With that said, Compass Health shall initiate the plan as soon as it is completed irrespective of whether the FDA has yet approved it. Any recommended changes issued by the FDA shall be incorporated into the plan as they arise. Compass Health shall update the FDA on progress relating to the recall via recall status reports. The FDA shall inform Compass Health of the appropriate frequency of said reports based on the level of hazard attached to the affected device (usually at 2 to 4 week intervals). The status reports shall contain the following information: Number of consignees notified of the recall, and date and method of notification. Number of consignees responding to the recall communication and quantity of products on hand at the time it was received. Number of consignees that did not respond (if needed, the identity of non- responding consignees may be requested by the Food and Drug Administration). Number of products returned or corrected by each consignee contacted and the quantity of products accounted for. Document# SOP-QMS-0028  Number and results of effectiveness checks that were made. Estimated time frames for completion of the recall. Compass Health shall inform the FDA of recall action and submit all subsequent recall reports to the agency using the following contact information*: Andrew Lang 6751 Steger Drive Cincinnati, OH 45237 P: 513-679-2700 x2177 F: 513-679-2773 [email protected] hs.gov Melinda Ruiz 222 Bloomingdale Rd. Division of CT; DC; DE; IN; KY; Suite 406 Medical Device Medical MA; MD; ME; MI; NH; White Plains, NY 10605 and Radiological Device NJ; NY; OH; PA; RI; VA; Phone: 914-682-2826 ext. Health VT; WV 15 Operations I [email protected] hs.gov Cynthia Aycock 300 River Place Dr. Ste. 5900 Detroit, MI 48207 P: 313-393-8162 F: 313-393-8139 [email protected] hs.gov Document# SOP-QMS-0028  Lisa Warner 555 Winderley Place Suite 200 Maitland, FL 32751 Phone: 407-475-4735 Fax: 407-475-4769 [email protected] hs.gov Meredith Andress 4121 Carmichael Rd Division of AL; FL; GA; IA; IL; KS; Suite 307 Medical Device LA; MN; MO; MS; NC; Montgomery, AL 36106 Medical and Radiological ND; NE; PR; SC; SD; Phone: 334-273-4788 ext. Device Health TN; US Virgin Islands; 106 Operations II WI Fax: 334-273-4790 [email protected] hs.gov Marie Fink US FDA Metairie Center 2424 Edenborn Avenue, Suite 410 Metairie, LA 70001 Phone: 504-846-6109 Fax: 504-219-8813 [email protected] hs.gov Maria Caride & LCDR Melinda Ruiz Recall Coordinators 158-15 Liberty Avenue Document# SOP-QMS-0028 4th Floor, Room 4013 Jamaica, NY 11433-1034 Phone: 718-662-5577 (Ms. Caride) Phone: 718-662-5470 (LCDR Ruiz) Fax: 718-622-5661 [email protected] *If a discrepancy arises pertaining to the appropriate district of contact, visit the FDA District Recall Coordinators webpage for further guidance via the following link: https://wayback.archive- it.org/7993/20170110235143/http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm1 29334.htm 5.3.1 Amendments If, after submitting a report, the Recall Committee determines that the same correction or removal should be extended to additional lots or batches of the same device, the Recall committee must amend the original report by submitting an amendment within 10-working days of initiating the extension of the correction or removal. The amendment should cite the original report number assigned, all of the information required by 21 CFR 806.10(c)(2) and any information required by 21 CFR 806.10(c)(3) through (12) that is different from the information submitted in the original report. Compass must also state what required information is not readily available and a date for when it will be submitted. 5.4 Recalls within Canada The recall committee decides whether a recall is necessary (see section 5.2) and, if it is, shall follow the below protocol for reporting to Health Canada—and advising appropriate parties, such as device owners, of—the decision and all applicable elements pertaining to the recall process. Within 24 hours, the recall committee shall inform Health Canada of the decision to issue a recall via telephone at 1-800-267-9675. Compass Health shall inform Health Canada at this time—based on available data and according to the following risk classifications—of the level of hazard associated with the pending recall: Document# SOP-QMS-0028  Type I: There is a reasonable probability that use of, or exposure to, the affected device will cause serious adverse health consequences, which includes—but is not limited to—death Type II: The use of, or exposure to, the affected device may cause temporary adverse health consequences in its current state, or where there is not a significant probability of serious adverse health consequences Type III: It is unlikely that use of, or exposure to, the affected device will lead to adverse health consequences Note: In contrast to FDA regulation, under Canadian regulation, it is up to the manufacturer itself, Compass Health—not the regulatory agency—to assign an appropriate level of hazard to the affected device. For reporting purposes (see below), a Health Risk Assessment (HRA) using the following criteria will be conducted by appropriate Compass Health personnel to determine an appropriate risk type to assign to the malfunctioning device: hazard identification hazard characterization exposure assessment risk characterization Note: Type I and Type II recalls apply to instances wherein the device is taken out of service as a safety precaution by the owner or as per recall instructions and thus cannot be used to facilitate treatment, thereby putting patients at risk of experiencing adverse health consequences. The recall committee will submit to the inspectorate an initial report, which shall include details of a proposed recall strategy plan (see ix below), within 3 business days of initiating the plan. The start date of the recall is when the recall notifications are sent out (ie. The date on the recall notification letter). Compass Health may permit the importer (if applicable) to prepare and submit the report on Compass Health’s behalf in the event each party—the manufacturer and importer—share identical document submission requirements. If the 3-business-day notification deadline cannot be met, the recall committee is to provide the Ministry with a rationale for the delay. Document# SOP-QMS-0028 The contents of the initial report—and of any subsequent reports—will be compiled using the guiding parameters outlined in this procedure manual below. The Medical Device Recall Reporting Form – Initial (FRM-0360) will be used to complete the initial recall report. (https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp- mps/alt_formats/pdf/compli-conform/prob-report- rapport/frm_0360_medical_device_initial_recall_reporting-eng.pdf) The initial report shall contain the following information: 15. The device name and its identifier, including the names of any additional devices and their corresponding identifiers that belong to the same medical device family as the affected device. 16. The name and address of the manufacturer (Compass Health Technology) and importer, if applicable, in addition to the name and address of the location where the device was manufactured if different from those of the manufacturer itself. 17. A rationale for the decision to issue a recall, including the nature of the (possible) problem and the date on—and circumstances under—which the defectiveness was discovered. 18. A risk type assigned in accordance with Health Risk Assignment (HRA) protocol (see above and definitions table) and a detailed evaluation of the risks associated with the discovered device defectiveness. Include therein information that pertains to: a. The nature and degree of the risk b. The nature of the particular population at risk c. The size of the population at risk d. Whether any disease, injury or death has resulted from the affected device e. The level of user awareness of the problem f. The degree of competence associated with the use of the device g. The probability that the issue will happen again h. The user’s ability to detect the problem 19. The number of devices in the marketplace subdivided per: a. Those manufactured in Canada b. Those imported into Canada (manufactured elsewhere) c. Those sold in Canada 20. The period during which affected units were distributed in Canada. 21. The names of each person to whom affected devices have been sold in addition to the number of affected devices sold to each. If a company is the recipient, include the names and contact information of individuals within the company who received the affected device(s). Document# SOP-QMS-0028  22. A copy of any communications issued with respect to the recall, such as written notices to consignees, public notices, press releases, notices to professional associates and the like. 23. A proposed strategy for conducting the recall, which shall include: a. Date of commencement b. Information detailing how and when the minister will be informed of progress related to the recall c. The proposed date of completion The proposed recall strategy shall also consider: 24. Results of the risk evaluation 25. Risk type assigned 26. Ease of identifying recalled device(s) 27. Extent to which device defectiveness is obvious to the consumer and/or user 28. Extent to which device remains unused in the marketplace 29. Continued availability of comparable, alternative products In addition, address the following: 30. Depth of recall (how “deep” into the distribution chain does the recall extend?) and this should be consistent with the level of risk associated with the affected device 31. Timeliness of initiation and completion 32. Recall communications methods (see section 5.7) 33. Notification of users not readily identifiable (see section 5.7) 34. Effectiveness of action 35. Initiation date and progress reports to HC (reporting interval to be agreed upon by HC) 36. A proposed action plan for preventing recurrence, which shall include an analysis of the root cause (if known) and the scope of affected production. 37. The name, title, email, telephone and fax number of the designated Compass Health Canada Inc. representative who the Ministry may contact in the event supplemental information concerning the recall is required. The representative will be aware of all developments concerning the recall and shall be accessible on a 24 hour basis for Type I hazards. Document# SOP-QMS-0028 *Health Canada may deem necessary to reevaluate the HRA Protocol. Be as accurate as possible. Note: If the recall is anticipated to be more than three months from initiation date, a rationale detailing the cause of the delay shall be provided to the Inspectorate. The Compass Health Recall Committee shall submit to Health Canada progress reports as needed that chart any new developments pertaining to the recall that come to light at any point following the last report submission and are yet to be reported to the Ministry. The number of required follow-up reports is determined on an as-needed basis, depending on the unique circumstances of the recall process and any new information that should arise throughout the course of the recall action. Normally, progress reports contain the following: The number of consignees notified to date of the recall The date and method(s) of notification The number of respondents and the number of affected devices in possession of each The number of non-respondents The number of devices returned, corrected and/or destroyed in addition to the number of devices accounted for The number and results of the effectiveness checks Expected recall completion date if different from the original The recall committee shall submit a final report to Health Canada (see section 5.9) following completion of the recall process. The Medical Device Recall Reporting Form – Final (FRM-0360) will be used to complete the final recall report. (https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp- mps/alt_formats/pdf/compli-conform/prob-report- rapport/frm_0360_medical_device_final_recall_reporting-eng.pdf) The report shall include: 38. Results of recall; and the number of recovered units the number of units used by consignees the number of units destroyed by consignees (as requested in the recall notice) the number of units corrected (modified, repaired or retrofitted), either on site or off site, and returned to consignees Document# SOP-QMS-0028  the number of units that were not located the recall’s final date of completion how recovered units or stock units will be disposed (evidence of disposition will be provided to Health Canada upon request) assurance that all consignees received the recall information (evidence will be provided to Health Canada upon request) 39. Action taken to prevent recurrence Compass Health shall notify Health Canada of recalls as well as submit to it all related reports via the following address*: Contact Health Canada: For medical devices: [email protected] Toll free number (Regulatory Operations and Enforcement Branch): 1-800-267-9675 Ontario Region: Medical Devices Compliance Program 2301 Midland Ave. Toronto, Ontario M1P 4R7 Phone: 416-973-1600 Fax: 416-954-4581 E-mail: [email protected] * Discrepancies regarding the appropriate region of notification may be resolved by calling 613-957-3836. Document# SOP-QMS-0028 5.4 Recalls within Australia Compass Health is required to inform the TGA or the Australian Sponsor as soon as practicable if Management is considering steps to recall devices that have been distributed in Australia. -It is the information that has led to a decision to conduct a recall (proposed recall) that is to be reported to the TGA or the Sponsor as soon as practicable, as soon as the manufacturer is aware, not after investigations, corrections and corrective actions have been implemented and concluded. The conduct of a recall within Australia is the responsibility of the Sponsor in accordance with the Uniform Recall Procedure for Therapeutic Goods (URPTG). To estimate the recall severity for Australia, the following tables to help with the recall classification: Source: Uniform Recall Procedure for Therapeutic Goods (URPTG) Document# SOP-QMS-0028 Recall and non-recall actions Compass Health Shall notify the TGA/Australia sponsor as soon as a recall is being considered to correct or remove a product from the Australian market. Important: TGA requires notification of non-recall actions before any action is taken. Compass Australian sponsor will present recall information and a recall letter to the Australian recall coordinators, who will then approve the action. Below are the basic steps you should follow in reporting recall/non-recall actions in Australia: Inform your Australian sponsor if a recall or non-recall action is necessary. Your sponsor will submit the required information — including your Health Hazard Evaluation, distribution list and customer letter — to the TGA on your behalf. Once the TGA approves, the action can proceed with notification of customers, etc. Complete TGA-required follow-up recall reports at two weeks and six weeks, and the closure report at three months (if classified as a recall action). Add all reports to ISO 13485 or other quality system records. Document# SOP-QMS-0028 Source: Uniform Recall Procedure for Therapeutic Goods (URPTG) Document# SOP-QMS-0028 Please refer to the guidance document Uniform Recall Procedure for Therapeutic Goods (URPTG) for the latest links to templates and the details of every steps including the required information to be provided to the Sponsor and the regulator as part of the recall package to be emailed to the Sponsor. 5.6 Receipt of Recalled Devices Quality Assurance designates and prepares a specific area (or specific software work/test environment) for the receipt and holding of recalled devices. Devices are logged to include the quantity returned, lot number (revision number) and source of the return. This log is used to verify that all suspected devices have been located and returned. The log is reviewed regularly and the data is utilized to prepare the required reports. A decision is made by the Recall Committee regarding the disposition of the recalled devices at the conclusion of the recall (refer to SOP: Control of Nonconforming Product). 5.7 Issue of Advisory Notices: FDA The issuance of advisory notices is determined by the recall committee. The process for making this determination is comparable to the recall initiation process (refer to Section 5.2 and 5.2.1 of this procedure). All advisory notices (letter and envelope) are sent via certified mail and are noticeably marked with “Medical Device Recall” in bold red type. Recall communications will be also marked: “Urgent” for Class I and Class II recalls, and when appropriate, for Class III recalls. Compass Health shall convey in the recall letter: That the product in question is subject to a recall. That further distribution or use of any remaining product should cease immediately. Where appropriate, that the direct account should in turn notify its customers who received the product about the recall. Instructions regarding what to do with the product. Additionally, the recall letter shall be prepared according to the following guidelines: Document# SOP-QMS-0028  Be brief and to the point; Identify clearly the product, size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive information to enable accurate and immediate identification of the product; Explain concisely the reason for the recall and the hazard involved, if any; Provide specific instructions on what should be done with respect to the recalled products; and Provide a ready means for the recipient to report to the recalling firm whether it has any of the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place a collect call to the recalling firm. 5.6.1 Public Warning In case of failure to prevent, via alternative means, the continued use of dysfunctional devices that pose a high level of health risk to the public, a public warning shall be issued and take the following form: General public warning through the general news media, either national or local as appropriate, or Public warning through specialized news media, e.g., professional or trade press, or to specific segments of the population such as physicians, hospitals, etc. Compass Health will determine which level of effectiveness checks is to be conducted based on the recall depth specified in the recall strategy –and categorized as follows: Level A – 100% to be contacted Level B – between 10.1 and 99.9% to be contacted (decided on a case-by-case basis) Level C – 10 % to be contacted Level D – 2% to be contacted Level E – No effectiveness checks Note: FDA will assist in this task where deemed necessary and appropriate. Document# SOP-QMS-0028 5.8 Issue of Advisory Notices: Health Canada The issuance of advisory notices for affected products sold and/or manufactured in Canada is, as with in the USA, determined by the recall committee. All advisory notices are sent via certified mail. All recall communications (including notifications, cover sheets and envelopes) will be clearly marked with “Medical Device Recall” in bold, red font and, if a Type I or Type II hazard, “Urgent”. Advisory notices pertaining to defective devices shall be issued to consignees per the following guideline: 40. Type I Recalls require initial contact within 2 working days of initiating recall strategy 41. Type II Recalls require initial contact within 5 working days of initiating recall strategy 42. Type III Recalls require initial contact within 7 working days of initiating the recall strategy Note: The reason behind any delays in making initial contact per the above timeframe must be provided to the Ministry in a written rational. Every effort shall be made by designated Compass Health personnel to contact appropriate individuals relative to the recall. As with FDA requirements, Compass Health will determine which level of effectiveness checks to conduct based on the recall depth stipulated in the recall strategy and categorized as follows: Level A -- 100% to be contacted Level B -- between 10.1 and 99.9% to be contacted (decided on a case-by-case basis) Level C – Less than 10 percent to be contacted Level D – No effectiveness checks Phone, in-person, fax, email and special deliveries are all appropriate means of communicating with consignees. Recall Communications shall contain the following: A brief statement indicating that the device in question is subject to recall Document# SOP-QMS-0028  A description of the device to enable immediate and accurate identification of the device The reason behind the recall, with a clear description of any risks associated with using the device in its present state A statement indicating that further use and/or distribution is prohibited, if appropriate A list of steps specifying how to return, dispose of or correct the device (whichever appropriate) A statement requesting a prompt response to confirm receipt and understanding of the recall situation. A response mechanism shall be provided by Compass Health. In instances where users of Type I and Type II recalls are not readily identifiable, Compass Health shall issue public advisories via one or any combination of the following notification formats: specialized media, professional trade or ethnic press, or direct correspondence with specific segments of the population and their corresponding institutions including physicians, hospitals or clinics. 5.7.1 Follow-up Communication Efforts for Non-Responders Compass Health shall choose an appropriate course of follow-up communication with non-responders according to the level of hazard attached to the affected device: 43. Type I – personal visit by company representative* 44. Type II – two follow-up methods of differing mean of contact. Records of each follow-up attempt will be kept. 45. Type III – one additional follow-up method (different than the original) * If contact is still not made, written justification shall be provided to the Inspectorate 5.8 Issue of Advisory Notices: Australia The issuance of advisory notices for affected products sold and/or manufactured in Australia is, as with in the USA and Canada, determined by the recall committee. The recall committee shall be responsible for informing the TGA or the Australian Sponsor as soon as practicable if Compass Health proposes to take steps to recall devices that have been distributed in Australia. The report shall include information relating to any technical or medical reason for any malfunction or deterioration in the characteristics or performance of the kind of device that has led Compass to take steps to recall devices of that kind that have been distributed. Document# SOP-QMS-0028 Compass Health shall inform the TGA or the Australian Sponsor as soon as they become aware that a recall is to be conducted. All information that has led to a decision to conduct a recall (proposed recall) shall be reported to the TGA or the Sponsor as soon as practicable, as soon as the manufacturer is aware, not after investigations, corrections and corrective actions have been implemented and concluded. The conduct of a recall within Australia is the responsibility of the Sponsor in accordance with the Uniform Recall Procedure for Therapeutic Goods (URPTG). 5.9 Recall Closure: FDA If all requirements of the recall order have been complied with, and if the FDA has not deemed the recall initiation closed and has not issued a recall termination letter to Compass Health, the Director of Operations shall write to the FDA to request termination of the recall order. All pertinent and documented information will be enclosed as per FDA requirements. This information will include: a copy of the most recent status report sent to FDA (see Section 5.3), a statement indicating that he has complied in full with all requirements of the order, and a description of the disposition of the recalled device. 5.10 Recall Completion: Health Canada The recall committee shall submit a final report to Health Canada following completion of the recall process. Included in the report shall be: 46. The number of units recovered 47. The number of units used by consignees 48. The number of units destroyed by consignees (as requested) 49. The number of units corrected on or off-site 50. The number of units returned to consignees 51. The number of units not located 52. A statement specifying the (intended) method of disposition of all affected recovered and in-stock devices* 53. Completion date 54. Assurance consignees received all necessary recall information 55. A detailed plan specifying how Compass Health shall prevent recurrence (I.e. design change, process validation, increased quality control) 56. Evaluation of significant change (see definitions) if Class III or Class IV device Document# SOP-QMS-0028 * Compass Health shall maintain records of instances of disposition in the event the company is requested by the Ministry to produce evidence of their occurrence. 5.11 Recall Closure: Australia TGA will review Interim and Close-out reports (see Uniform Recall Procedure for Therapeutic Goods (URPTG) guidance for content of each report) to verify, Compass has: completed all the agreed actions with documented evidence justified any discrepancies or inconsistencies provided evidence that the agreed action for the affected goods has been implemented determine whether the following are satisfactory: implementation of the recall action the investigation of the problem or hazard that prompted the recall action and the root cause identification CAPAs implemented to prevent or minimise recurrence of the problem in the future assess the effectiveness of the recall action and assess ongoing compliance with regulatory requirements. Recall closure Actions and information provided is satisfactory, TGA will issue close-out letter stating that the recall action has been satisfactory and no additional actions are required at this stage the information submitted will be used to inform upcoming manufacturer inspections and for trending purposes in post-market or other product reviews Note: In the event a previously non-responding customer contacts you after a close out letter has been issued by the TGA, Compass Health is still responsible for undertaking any corrective actions for the life of the good (i.e. the service life of the device). Document# SOP-QMS-0028 5.12 Record Keeping Reports of Corrections and Removals shall be maintained in accordance with the SOP: Control of Records. 5.12 Device Recall and Advisory Notice Forms for FDA, Health Canada and Australia’s TGA Device Recall and Advisory Notice forms submission packages should be used for comprehensive interactions with FDA, Health Canada and TGA. 6 Quality Records Records/ Notices Description Copies of advisory notices and list of customers to whom the Advisory notices notices were sent Minutes of meetings, memoranda, and other communication and Recall records documents established in the course of planning and implementing a device recall A file will be maintained on each product correction or removal Note including recalls and market withdrawals two years beyond the lifecycle of the recalled product. Document# SOP-QMS-0028