Compass Health SOP: Medical Device Reporting PDF

Compass Health AI SOP: Medical Device Reporting and Mandatory Problem Reporting Approvals Author Position Role Signature Date DD-MMM-YYYY Tenzin Head of Author 02-Jan-2024 Yangzom QA/RA James Approver...

Compass Health AI SOP: Medical Device Reporting and Mandatory Problem Reporting 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# QMS-SOP-0029 Revision History Version Date Description 1.0 03-Jan-2024 Initial Release Document# QMS-SOP-0029 1. Introduction 1.1 Purpose The purpose of this Standard Operating Procedure is to provide a system and instructions to assign responsibilities and duties for the establishment, maintenance and compliance of Compass Health with Medical Device Reporting regulations 21 CFR Parts 803 and 820.198 (Complaint files) and the CMDR Mandatory Problem Reporting (section 59,61.1- 61.2 and 61.3), art 5, Division 5.2, Clause 5.7 of the Therapeutic Goods (Medical Devices) Regulations 2002. 1.2 Scope This procedure is applicable to (1) All Compass Health’s medical devices released for distribution in the United States, (2) All incidents occurring outside the United States for products sold by Compass Health within the United States, (3) All Compass Health’s medical devices released for distribution in Canada (4) All Compass Health’s medical devices released for distribution in Australia. 2 Applicable and Reference Documents 2.1 Applicable Standards, Guidance and Forms The following standards and regulations are intended to be met by this procedure: Document Title Document Number / Reference Sources https://www.ecfr.gov/current/title-21/chapter-I/subchapter- FDA - 21 CFR Part 803, H/part-803 Medical Device Reporting FDA MedWatch forms Form 3500: for health professionals (Form & Instructions) for FDA Safety Document# QMS-SOP-0029 Reporting (Form 3500, https://www.fda.gov/safety/medical-product-safety- 3500A and 3500B) information/medwatch-forms-fda-safety-reporting Form 3500A for industry: https://www.fda.gov/medical-devices/mandatory-reporting- requirements-manufacturers-importers-and-device-user- facilities/mdr-adverse-event-codes Form 3500B: for patients and consumers (Online Reporting: https://www.accessdata.fda.gov/scripts/medwatch/index.cf m?action=reporting.home) FDA - 21 CFR Part 806, https://www.fda.gov/medical-devices/postmarket- Removals and requirements-devices/recalls-corrections-and-removals- Corrections (FDA) devices#5 FDA - Guidance Document for Medical https://www.fda.gov/regulatory-information/search-fda- Device Reporting for guidance-documents/medical-device-reporting- Manufacturers manufacturers (November 8, 2016) Health Canada - CMDR Section 59-61.1 https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/ Mandatory Problem Reporting Health Canada - https://www.canada.ca/en/health-canada/services/drugs- Guidance Document health-products/reports-publications/medeffect- for Mandatory Problem Document# QMS-SOP-0029 Reporting for Medical canada/incident-reporting-medical-devices-guidance- Devices (June 23, 2021) 2021.html Health Canada - Mandatory Medical https://www.canada.ca/en/health-canada/services/drugs- Device Problem health-products/medeffect-canada/adverse-reaction- Reporting Form and reporting/mandatory-medical-device-problem-reporting-form- Guidance for Industry industry-adverse-reaction-reporting.html (April 2018) Health Canada – https://www.canada.ca/en/health-canada/services/drugs- Foreign Risk health-products/reports-publications/medeffect- Notification for Medical canada/foreign-risk-notification-medical-devices- Devices (January 2021) guidance.html List of regulatory https://www.canada.ca/en/health-canada/services/drugs- agencies and foreign health-products/reports-publications/medeffect- jurisdictions (updated canada/foreign-risk-notification-medical-devices- December 23, 2020) guidance/list.html Incident reporting for https://www.canada.ca/content/dam/hc- medical devices: sc/documents/services/drugs-health-products/reports- Guidance document publications/medeffect-canada/incident-reporting-medical- (effective June 23, devices-guidance-2021/incident-reporting-medical-devices- 2021) guidance-2021-en.pdf 2.2 Reference Documents Document Title Document # SOP: Complaint Handling QMS-SOP-0026 Document# QMS-SOP-0029 SOP: Device Recall and Advisory Notices QMS-SOP-0028 SOP: Control of Records QMS-SOP-0003 SOP: Feedback & Customer Satisfaction QMS-SOP-0022 SOP: Corrective & Preventative Actions QMS-SOP-0031 MedWatch Form 3500A Mandatory Reporting FORM FDA 3500A (0910-0291) form for manufacturer (FDA) Mandatory Medical Device Problem Reporting MDR Form Health Canada 110180 Form for Industry (Health Canada) (April 2018) 3 Acronyms and Definitions Term Definition A complaint that is communicated in a written, oral or electronic method alleging deficiencies in: Identity, quality, durability, Complaint reliability, safety, effectiveness or performance of a medical device after its release for distribution. A malfunction is said to occur when there is a failure of such device to meet its performance specifications or not to perform as Malfunction intended. Performance specifications include all claims made in the device labeling. A complaint that is mandatory to report to FDA as per 21 CFR Part Medical Device 803. Report (MDR) Document# QMS-SOP-0029 Reportable Events a. An event that user facilities become aware of that (US) reasonably suggests that a device has or may have caused or contributed to death or serious injury, or b. An event that manufacturer’s or importers become aware of that reasonable suggests that one of their marketed devices: i.May have caused or contributed to a death or serious injury, or ii.Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. A complaint that is mandatory to report to Health Canada as per CMDR SOR 98-282 Section 59: 59 (1) The manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring in Canada that involves the device if (a) the device is sold in Canada; and (b) the incident Medical Device o (i) is related to a failure of the device or a Report (MDR) deterioration in its effectiveness or any inadequacy in Reportable Events its labelling or in its directions for use, and (Canada) o (ii) has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were the incident to recur. (1.1) Subject to subsection (2), the manufacturer and the importer of a Class I medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes to their attention occurring outside Canada that involves the device if the conditions in paragraphs (1)(a) and (b) are met. (2) The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated, to a Document# QMS-SOP-0029  regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action. As a manufacturer, becoming aware of a reportable event is deemed to occur when: any employee becomes aware of a reportable event that is required to be reported within 30 calendar days or an event that is required to be reported within 5 working days because we (FDA) have requested reports in accordance with 803.53(b). You are also considered to have become aware when Becoming Aware any of your employees with management or supervisory duties and responsibilities over persons with regulatory, scientific or technical responsibilities, or whose duties relate to the collection and reporting of adverse events, becomes aware from any information, including any trend analysis, that a reportable MDR event(s) necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. Constitutes the date that a Compass Health personnel becomes aware of information related to a complaint. The breadth of Aware Date information of such complaint may not be fully available at the time of initial awareness. The 5 day report is for the MDR reportable event(s) that require Individual Adverse remedial action to prevent an unreasonable risk of substantial Date (Incident) 5- harm to the public health or where FDA specifies that a 5 day report day report (US) is required. This report is submitted using an electronic equivalent of Form of 3500A which is approved by 21 CFR 803.11 and 803.14. A 30 day report is required once a manufacturer receives or Individual Adverse otherwise becomes aware of information that reasonably suggests Date (Incident) 30- that a device: has or may have caused or contributed to the death day report (US) or serious injury or has malfunctioned and such or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury, if the malfunction were to Document# QMS-SOP-0029  recur. This report is submitted using an electronic equivalent of Form of 3500A which is approved by 21 CFR 803.11 and 803.14. A mandatory problem report is required under section 59 (1) of the Medical Devices Regulations of Canada for any incident involving a medical device that is sold in Canada when the incident occurs either within or outside Canada; relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labeling or in its directions for use (section 59 (1)(a)); and has led to death or Mandatory a serious deterioration in the state of health of a patient, user or Problem Reporting other person or could do so if it were to recur (section 59 (1)(b)). (MPR) *The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated to a regulatory agency of the country in which the incident occurred, the manufacturer’s intention to take corrective action or unless the regulatory agency has required the manufacturer to take corrective action An act, or omission of an act, by the user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer. Foreseeable misuse that is warned against in the instructions for use is considered abnormal use if all Abnormal Use other reasonable means of risk control have been exhausted. See Appendix I for examples of potential abnormal uses. Note: Abnormal use includes intentional use for a non-approved purpose (“off-label” use). The person who made the initial report of the incident to a representative of the manufacturer or the importer. The Complainant complainant may be the patient, the user of the device or other person. Correction Action to eliminate a detected nonconformity including the repair, modification, adjustment, relabeling, or inspection (including Document# QMS-SOP-0029  patient monitoring) of a device without its physical removal to some other location. A correction can be made in conjunction with a corrective action. A correction can be, for example, rework or regrade (International Standards Organization, ISO 13485 Medical Devices quality management systems – System requirements for regulatory purposes). A correction can also be a recall to address nonconforming devices in distribution. Note: A nonconformity may include a problem or malfunction with the device. Action to eliminate the cause of a detected nonconformity or other undesirable situation. There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence, whereas a preventive action is taken to prevent occurrence. There is a distinction between correction and corrective action (ISO 13485 Medical Devices quality management systems – System Corrective Action requirements for regulatory purposes). Note: A nonconformity may include a problem or malfunction with the device. If the corrective action meets the definition of a recall, according to the Regulations, then recall reporting requirements would apply. A person, other than the manufacturer of a device, who causes the Importer medical device to be brought into Canada for sale. In the context of mandatory problem reporting, information on the Incident incident refers to the circumstances required to be reported under section 59 of the Medical Device Regulations. Manufacturer to report to the Sponsor or the TGA, as soon as Individual Adverse practicable, if an event might have led to death or a serious Event (TGA) deterioration in health Document# QMS-SOP-0029  A failure of a device to perform in accordance with its intended Malfunction (or purpose when used in accordance with the manufacturer’s Deterioration) instructions. Malfunction is synonymous with “fault”. A person who sells a medical device under their own name, or under a trade mark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for Manufacturer designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning it to a purpose, whether those tasks are performed by that person or on their behalf. Action to eliminate the cause of a potential nonconformity or other undesirable potential situation. There can be more than one cause for a potential nonconformity. Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent Preventive action recurrence. Note: A nonconformity may include a problem or malfunction with the device. 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: Recall (HC) (a) may be hazardous to health; (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. Document# QMS-SOP-0029  A life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected Serious medical or surgical intervention to prevent such a disease, disorder deterioration in the or abnormal physical state or permanent impairment or damage. state of health (HC) Note: Serious deterioration in health also includes a serious public health threat which is any incident type, which results in imminent risk of death, serious deterioration in health, or serious illness that requires prompt remedial action. Serious risk of Where it is likely that a serious deterioration in the state of health injury to human will occur and elicits risk mitigation actions of measures to prevent health it. Act, or omission of an act, that has a different result to that intended by the manufacturer or expected by the user. Use error Use Error includes slips, lapses, mistakes and reasonably foreseeable misuse. Person responsible for the use of the device. This could be, for User example, a health professional, a family member, or even the patient (in the case of a glucose meter, for example). Death or serious injury is averted either owing to circumstances or Near Incident (HC) to the timely intervention of health care personnel. These conditions could be pre-existing or occurring during device Patient Condition use. It does not meet the requirements of section 59(1)(a) of the Regulations Patient Harmful health effect(s) from the incident, the severity of the Consequences effect(s) and any treatment required. Document# QMS-SOP-0029  “Manufacturers” or “importers” who are responsible for reporting device-related incidents under MPR system to Health Canada. Reporter (HC) Note: The device manufacturer AND importer are required to submit a preliminary and final mandatory problem report unless the manufacturer provides written documentation to Health Canada permitting the importer to report on its behalf. “Sold” (e.g. Any device “authorized for sale” in Canada (Class I devices exempt devices “sold” in from this interpretation of “sold”. Literal meaning still applies, Canada) (HC however). distinction only) Mandatory Medical A single, consolidated form used for submitting preliminary, final, Device Problem and the combined preliminary/final report to Health Canada. Used Reporting Form for for reporting updates, as well, if and when needed. Industry 4 Process Roles Role Description Document# QMS-SOP-0029  · Once a decision is made to report an event, the QA/RA team is responsible for Medical Device Reporting. · Assistance may be required by Compass Health QA/ RA subcontractors/third parties in the complaint investigation process dependent on the nature of the complaint. Oversee and manage the complaints process · Responsible for the decision to report in accordance with SOP: Complaint Handling. · Responsible to inform FDA of Compass Health’s U.S. Compass Health Agent under 21 CFR Part 803.58 and 807.40. · Any updates of Compass Health U.S. Agent will be provided to FDA within 5 days. The responsible individual(s) fulfill all obligations and responsibilities as per the US Agent designation. The following responsibilities include: Compass Health U.S. Agent Assisting FDA in communications with the foreign establishment, Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States, Document# QMS-SOP-0029  Assisting FDA in scheduling inspections of the foreign establishment and If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. Report to FDA in accordance with 803.50, 803.52, 803.53 and 803.56; Obtain necessary information from the foreign manufacturer regarding the investigation and evaluation of the event to act within the requirements of 803.50; Compass Health To forward MDR complaints to the foreign Official Correspondent: manufacturer and maintain documentation of such requirement; In accordance with Part 807, register, list and submit pre-market notifications. Note: Compass Health Official Correspondent is the same individual as Compass Health U.S. Agent 5 Process 5.1 General requirements All complaints received by Compass Health will be processed in accordance with the SOP: Complaint Handling (QMS-SOP-0035). Complaints may be received by fax, phone, e-mail, in writing or in-person from a distributor, end-user, or health care professional. All complaints are scrutinized and reviewed for potential adverse event (MDR/ MPR). Complaints arising outside of the United States alleging injury or potential injury due to malfunction of given device are subject to a Medical Device Report (MDR) when the device Document# QMS-SOP-0029 is also distributed within the United States. Likewise, complaints meeting the same conditions received outside of Canada will be subject to Canada’s Mandatory Problem Report (MPR) as well. 5.2 Medical Device Reporting (MDR) Requirements (FDA) 5.2.1 General Complaints that are potentially reportable incidents are sent to the Compass Health Regulatory team within 1 working day of reaching determination. Compass Health Regulatory team is responsible for determining when an incident is reportable. As per 21 CFR Part 803, Compass Health shall submit a medical device report to the FDA in the event of a reportable incident. Compass Health is responsible for providing the following information to the FDA: All information that is reasonably known related to the original incident, including all supplemental information pertinent to the follow-up process: Any information obtained by contacting a user facility, importer, or other initial reporter; Any information in Compass Health’s possession or; Any additional information obtained by the analysis, testing, or any other means of evaluating the device. Missing and/or incomplete information from the original reported event submitted by user facilities, importers and other initial reporters. Results of investigational work and root cause analysis Compass Health will provide a supplemental or follow-up report electronically within 30 calendar days of the aware date (see Definition section above). The supplemental information—or, the follow-up report—shall comprise the following: Indicate that the report being submitted is a supplemental or follow-up report All appropriate identification numbers of the report to be updated Any new, changed or corrected information 5.2.2 Medical Device Reports Officially, the FDA requires a Document# QMS-SOP-0029 30-day report in instances where Compass Health becomes aware of a death, serious injury or malfunction associated with one of its devices that result in—or contribute to— the death or serious injury of patients, health care practitioners or any other persons who may subsequently come in contact with the device. Although it is unlikely that any of Compass’s devices would result in-or contribute to death or serious injury, it is the company’s policy that we will meet the earlier, 5-day report submission deadline in all adverse incident cases associated with any Compass Health device that causes or contributes to death or serious injury, whether or not the incident leading to the event(s) are deemed likely to recur. The deadline for submitting a 30-day report is 30 calendar days following the day any Compass Health employee is made aware of a potentially reportable event. It is Compass Health’s responsibility to collect all data related to the serious adverse event and include such data in the MDR report. A 5-day report is required if 1) an MDR reportable event requires immediate remedial action to prevent an unreasonable risk of substantial harm to the public health or; 2) Compass Health is requested by the FDA in writing to do so. The deadline for submitting a 5-day report is 5 working days following the day after the adverse event is brought to the attention of Compass Health Top Management or any employee specifically tasked with reporting adverse events to the FDA. Compass Health shall provide any and all additional and relevant information pertaining to the event that arose following the 5-day report submission deadline in separate, supplemental reports as the new information becomes available. The original form shall be used to this end (Form 3500A). Note: The Compass Health will document internally all failed attempts to obtain pertinent information related to the adverse event. The FDA reserves the right to review said documentation to determine if a reasonable attempt has been made on the part of Compass Health to acquire the information. Malfunctions that are unlikely to result in death or serious injury need not be reported. The decision-tree in Appendix I shall be referenced by Compass Health to determine the criteria for reportable complaints. Document# QMS-SOP-0029 A report to the FDA is compulsory regardless of the geographical setting in which the reportable incident occurs when the same (or similar) product is sold in the United States. Additional guidance for submitting MDRs can be found on the FDA’s website (see https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers- importers-and-device-user-facilities/emdr-electronic-medical-device-reporting). For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: (301) 796-6670 Email: [email protected] Or write to: Food and Drug Administration Center for Devices and Radiological Health MDR Policy Branch 10903 New Hampshire Avenue WO Bldg. 66, Room 1523 Silver Spring, MD 20993-0002 5.2.3 Submitting an eMDR Compass Health's official correspondent shall be the primary method for submitting all Medical Device Reports to the FDA. Compass Health shall provide the official correspondent with all of the required information for submission and the official correspondent shall submit reports in an eMDR format on behalf of Compass Health. Alternatively, Compass Health may submit Medical Device Reports through the ESG eSubmitter, as Compass Health anticipates to be a low volume submitter. Compass Health will provide all information as required by 21 CFR 803.52 by completing the electronic equivalent of Form 3500A. To participate in the eMDR program, Compass Health shall acquire a ESG account and install the eSubmitter application. The following link provides step-by-step instructions for enrolment: https://www.fda.gov/medical-devices/emdr-electronic-medical-device- reporting/how-enroll-emdr-program Document# QMS-SOP-0029 Compass Health shall maintain and retain electronic copies of all reports submitted to FDA and all acknowledgements received from the FDA within MDR event files. 5.3 Medical Device Reporting (MDR) Requirements (Health Canada) 5.3.1 General Compass Health Regulatory team, with input from Top Management, is responsible for immediately holding a management review meeting to confirm whether the incident is indeed reportable. QA/RA must consult applicable guidance documentation (see 2.1) and the reporting criteria provided in Appendix II to aid in the reporting decision process. The same guidance documentation is to be consulted throughout the reporting process itself to help guide it in the event the incident is indeed deemed reportable. In assessing the link between the device and the incident, the reporter shall consider: the opinion, based on available information, of a health professional; information concerning previous, similar incidents; complaint trends; and any other information held by the reporter When Compass Health receives a complaint about a Compass Health-made device which requires reporting based on the decision tree provided in Appendix II, the incident shall be reported even if the device no longer holds a market authorization in Canada. Incidents determined to have been caused by the “patient condition” (see definitions) need not be reported; however, to justify not submitting a report, QA/RA shall maintain onsite documented information demonstrating that the device in question performed as intended and did not cause, or contribute to, death or serious deterioration in health and that these findings are based on the sound medical judgment from a qualified individual. If uncertainty regarding the appropriateness of filing an MPR remains, consult Health Canada’s “Guidance Document for Mandatory Problem Reporting for Medical Devices” to provide additional clarification (refer to 2.1 for referencing details). When doubt remains, Compass Health shall report the incident anyways per the instructions provided in this procedure. Document# QMS-SOP-0029 If any aspect of Health Canada’s “Guidance Document for Mandatory Problem Reporting for Medical Devices” is not adhered to, adequate justification shall be provided in the applicable report (preliminary, final, combined preliminary/final). Refer to the Appendices in this procedure for additional guidelines to aid in the reporting process. A Mandatory Problem Report shall not be submitted to Health Canada when: 1. the malfunctioning device is not “sold” (see definitions) in Canada; 2. the incident did not cause death or serious injury to patients, clinical practitioners or any other persons; 3. the incident will not lead to death or serious injury should it recur (e.g., “Near incident” per Health Canada definitions (see definitions); or 4. the incident occurred outside of Canada and Compass Health Technology has not been requested by an external regulatory body to take corrective actions, nor has Compass Health Technology demonstrated the intention to do so voluntarily. Note: Incidents which did not lead to death or to serious deterioration in health because a design feature protected against a malfunction becoming a hazard, qualify as incidents which do not need to be reported to Health Canada. 5.3.2 Preliminary, Final and Preliminary/Final Reports In Canada, both a preliminary and final MPR report using the identical form (https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp- mps/alt_formats/pdf/medeff/report-declaration/md-mm_form-eng.pdf) is to be submitted for reportable events – that is, unless the full results of the investigation as part of a comprehensive corrective action plan are available within the 10 or 30-day report- submission timeframes (whichever applies), as discussed below. If such is indeed the case, a combined preliminary/final report is submitted to Health Canada using the single, prescribed form (see definitions section). Regardless of what reporting pathway is chosen, the specific protocol for each report – preliminary and final – is to be nevertheless adhered to as stipulated in this procedure. The preliminary report shall be submitted by QA/RA according to the following timelines: Within 10 calendar days of aware date, in the event of death or serious injury if the incident occurs on Canadian soil Document# QMS-SOP-0029  Within 30 calendar days of aware date, if death or serious injury does not occur as a result of an incident that occurs on Canadian soil, but may occur at a later date should the malfunction recur. Within 48 hours of the foreign incident after Compass has informed the foreign regulatory agency of the intention to take corrective action, or, as soon as possible after the foreign regulatory agency has required Compass to take corrective action. The preliminary and final reports shall be completed according to the instructions provided within “Guidance Document for Mandatory Problem Reporting for Medical Devices” and the Mandatory Problem Reporting Form itself (See Section 2.2 & the definitions section for reference details) with all applicable fields/sections appropriately populated. The reporter shall supply within the “Investigative Actions and Timeline” box of the prescribed form a list of action items designed to resolve the issue along with the proposed dates for implementing those action items. The proposed date for submitting the final report and any updates shall be defined within this section of the form. When no corrective actions are deemed necessary, the reporter shall enclose a detailed rationale for the decision in the preliminary report. 5.3.2.1 Preliminary Report The preliminary report shall contain the following information: 5. the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family 6. if the report is made by a. the manufacturer, the name and address of that manufacturer and of any known importer, and the name, title and telephone and facsimile numbers of a representative of the manufacturer to contact for any information concerning the incident, or b. the importer of the device, the name and address of the importer and of the manufacturer, and the name, title and telephone and facsimile numbers of a representative of the importer to contact for any information concerning the incident, 7. the date on which the incident came to the attention of the manufacturer or importer, Document# QMS-SOP-0029  8. the details known in respect of the incident, including the date on which the incident occurred and the consequences for the patient, user or other person, 9. the name, address and telephone number, if known, of the person who reported the incident to the manufacturer or importer, 10. the identity of any other medical devices or accessories involved in the incident, if known, 11. the manufacturer’s or importer’s preliminary comments with respect to the incident, 12. the course of action, including an investigation, that the manufacturer or importer proposes to follow in respect of the incident and a timetable for carrying out any proposed action and for submitting a final report, and 13. a statement indicating whether a previous report has been made to the Minister with respect to the device and, if so, the date of the report. Further, as part of the preliminary report, the reporter shall capture within the “details of the incident” block, information collected in response to the following questions (when applicable): What happened (where, when, how, to whom)? Is this the first time the device was used by the hospital? The health care worker? The patient? The user? If not, how long has the device been in use? When was it used previously? Have there been any previous problems with the device? If so, how often have these problems occurred? Was the device used according to directions? What were the environmental conditions surrounding the incident (if applicable)? What were the parameters or control settings at the time of the incident? How many other units of the device were involved in the incident? Was the device misused in any way (for example: reuse of a single-use device)? What method was used to clean, sterilize or re-sterilize the device? Was this consistent with the manufacturer’s recommendations? How was the product stored or maintained? Document# QMS-SOP-0029 *If the investigation is still in a very preliminary state (e.g.: for a 10-day report), it may be that the timeline only indicates the immediate actions taken (or to be taken) and the proposed date(s) for the submission of any updates and the final report. 5.3.2.2 Final Report The final report shall contain the following information: 14. a description of the incident, including the number of persons who have experienced a serious deterioration in the state of their health or who have died. All new information obtained since the submission of the preliminary report must be included and discussion of whether device was repaired or replaced, if applicable, 15. a detailed explanation of the cause of the incident and a justification for the actions taken in respect of the incident, and 16. any actions taken as a result of the investigation, which may include o increased post-market surveillance of the device, o corrective and preventive action respecting the design and manufacture of the device, and o recall of the device 5.3.3 User-Related Incidents QA/RA evaluates all reportable incidents to determine the extent to which the adverse outcome was rooted in use error. Examples of Use Errors are provided in “Guidance Document for Mandatory Problem Reporting for Medical Devices” (refer to Section 2.1 of this procedure for reference details). The evaluation should include principles of risk management, usability engineering, design validation, and corrective and preventive action processes. QA/RA aids the importer (if any) in coordinating with Compass Health its own evaluation into the incident to ensure that the elements listed above (5.3.2) are addressed. “Use Errors” resulting in death/serious injury or shall likely do so should they recur must, as with all other device-related incidents, be reported per the instructions provided in this procedure. “Abnormal use” (e.g. “off-label” use) shall not be reported by QA/RA to Health Canada under mandatory reporting regulations. Document# QMS-SOP-0029 Note: Deficiencies of devices that would always be detected by the user, and where death or serious deterioration in health has not occurred, do not need to be reported 5.3.4 Serious Risk of Injury to Human Health Compass shall submit to Health Canada information in respect of any serious risk of injury to human health that Compass receives or becomes aware of and that is relevant to the safety of the device, regarding (a) risks that have been communicated by any regulatory agency that is set out in the List of Regulatory Agencies for the Purposes of Section 61.2 of the Medical Devices Regulations, published by the Government of Canada on its website, as amended from time to time, or by any person who is authorized to manufacture or sell a medical device within the jurisdiction of such a regulatory agency, and the manner of the communication; (b) changes that have been made to the labelling of any medical device and that have been communicated to or requested by any regulatory agency that is set out in the list referred to in (a); and (c) recalls, reassessments and suspensions or revocations of authorizations, that have taken place within the jurisdiction of any regulatory agency that is set out in the list referred to in (a). The information shall be submitted to Health Canada within 72 hours after Compass receives or becomes aware of it, whichever occurs first. 5.3.4.1 Summary Reports For devices sold in Canada with a medical device license (Class II-IV), Regulatory in collaboration with relevant stakeholders, shall prepare a summary report on an annual basis (Class III or IV devices) or biennial basis (Class II devices) A summary report is required for each medical device license. Devices can be grouped into medical device family, group family or system. A rationale shall be provided to combine certain devices that are not included in the same license. The summary report content is described in Section 61.4 of SOR/98-282 and Health Canada [Guidance on summary reports and issue-related analyses for medical devices], and shall cover the following matters: Document# QMS-SOP-0029  o Information that Compass Health received during the previous 12 months (Class III and IV devices) or 24 months (Class II devices) regarding: ▪ Adverse effects; ▪ reported problems relating to the performance characteristics or safety of the device, including any consumer complaints, received by the manufacturer after the device was first sold in Canada; ▪ Incident reportable to Health Canada ▪ Serious risks of injury to human health that are relevant to the safety of the medical device ▪ Critical analysis of the information received and a conclusion, based on this analysis, whether what is known about the benefits and risks associated with the medical device has changed as described in any of the following situations: Any of the benefits could be less Any of the risks is more likely to occur, or its consequence for the health or safety could be more serious; A new risk has been identified. The summary report is part of the device's technical documentation. Notifying Health Canada If, in preparing the summary report, Compass Health concludes that what is known about the benefits and risks associated with the medical device has changed, Compass Health shall notify the Minister, in writing, within 72 hours after having to reached the conclusion. Methods to notify Health Canada include submission of an application for medical device license amendment, notification of a recall or submission of the summary report. Notification methods are detailed in the Health Canada [Guidance on summary reports and issue-related analyses for medical devices]. Health Canada may request (a) summary reports; or (b) information on the basis of which summary reports were prepared. Compass shall submit to the summary reports or information, or both, requested not later than the day specified in the request. Records of the Summary Reports shall be maintained and the information on the basis of which those reports were prepared. These records shall be maintained for seven years after the day on which they were created. Document# QMS-SOP-0029 5.3.5 Foreign Incidents Medical device licence holders and importers of Class II to IV devices must notify Health Canada when there’s a serious risk of injury to human health concerning a device authorized for sale in Canada and when: 1) a notifiable action is taken by a foreign regulator of a certain jurisdiction or 2) the licence holder and importer take notifiable actions in certain foreign jurisdictions (Reference: List of Regulatory Agencies for the purposes of Section 61.2 of the Medical Devices Regulations) When the decision has been made to report a foreign incident to Health Canada, a preliminary report be submitted as soon as possible upon informing the foreign regulatory agency of the intention to take corrective action, or, as soon as possible after the foreign regulatory agency has required the manufacturer to take corrective action. (In this case, Health Canada interprets "as soon as possible" to mean within 48 hours after the decision.) A foreign risk notification (FRN) report must be provided within 72 hours of Compass receiving or becoming aware of a notifiable action. This will allow Health Canada to consider the situation and determine whether adequate risk mitigation measures have also been taken in Canada. Reporting can be submitted online using an electronic form. This form will be available on Canada.ca The specific foreign incident which resulted in the decision to undertake corrective action should be reported in the preliminary report to Health Canada in the same manner as incidents occurring on Canadian soil. 5.3.6 Submission Methods Completed risk notification / reporting forms should be emailed to: Document# QMS-SOP-0029 [email protected] or mailed to: Canada Vigilance - Medical Device Problem Reporting Program Marketed Health Products Directorate Health Canada Address Locator 0701E 200 Tunney's Pasture Driveway Ottawa, Ontario K1A 0K9 Telephone: 613-957-0337 Facsimile: 613-954-0941 Once assigned by Health Canada in the letter confirming the receipt of the preliminary report, all subsequent correspondences with Canada Vigilance – Medical Device Problem Reporting Program shall include Health Canada’s file number and the Reporter File Number. 5.4 Medical Device Reporting (MDR) Requirements (Australia TGA) Compass Health Regulatory team, with input from Top Management, is responsible for immediately holding a management review meeting to confirm whether the incident is indeed reportable. QA/RA must consult applicable guidance documentation (see 2.1) and the reporting criteria provided in Appendix III to aid in the reporting decision process. The same guidance documentation is to be consulted throughout the reporting process itself to help guide it in the event the incident is indeed deemed reportable. In assessing the link between the device and the incident, the reporter shall consider: the opinion, based on available information, of a health professional; information concerning previous, similar incidents; complaint trends; and any other information held by the reporter Document# QMS-SOP-0029 When Compass Health receives a complaint about a Compass Health-made device or determines that reporting is required based on the systematic review of post-production experience as outlined in SOP: Post Market Surveillance, the incident shall be reported even if the device no longer holds a market authorization in Australia. Investigation shall take place in a timely manner as the following is to be reported to the TGA or the Australian Sponsor, as soon as practicable, that is, as soon as Compass becomes aware of the information to ensure that reporting timeframes for adverse events or the implementation of advisory notices (recalls) may be met by the Australian Sponsor. This includes information relating to: (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or (ii) any inadequacy in the design, production, labelling or instructions for use of the kind of device, or in the advertising material for the kind of device; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device; that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health. Note: Adverse events may be reported on-line to the TGA, by the Manufacturer or Sponsor, at https://www.tga.gov.au/reporting-problems. Note: Compass shall not delay contact with the TGA or the Sponsor until after a recall has been conducted / completed. In Australia the conduct of a recall within Australia is the responsibility of the Australian Sponsor in accordance with the Uniform Recall Procedure for Therapeutic Goods (URPTG). 5.4.1 Australian Sponsor The conditions of marketing authorization (ARTG inclusion) specifically impose some applicable regulatory requirements to the Australian Sponsors including; - providing information to the TGA, when they are aware of the specified information, and within specified timeframes, about; adverse events or near adverse events, when the manufacturer is taking steps to recall a device, non-compliance with the Essential Principles, or the validity of a conformity assessment document used to support an ARTG inclusion, Document# QMS-SOP-0029 -provision of information to the manufacturer related to customer complaints, adverse events or near adverse events, events leading to a recall (by the Sponsor), non-compliance with the Essential Principles, or related to the validity of a conformity assessment document that was used to support an ARTG inclusion, when the Sponsor is aware of the information, -provision of a 120-day follow-up report related to adverse events and near adverse events, ensuring that the Sponsor stores and transports a device in accordance with the manufacturer’s instructions whilst the Sponsor has control over the device, - the keeping and retention of: - records of the information provided to the manufacturer; including complaints or problems, information about adverse events, near adverse events, or the validity of certification documents used to support ARTG inclusion; - records of distribution of the product that was associated with a complaint, problem, adverse event, near adverse event or invalid certification and that has been distributed by the Sponsor, -the annual reporting of information (complaint, problem, adverse event, near adverse event or validity of a certification document) related to high-risk devices (Class III, Class IIb implantable, Class 4 IVDs) for a period up to three years post-ARTG inclusion. -the availability of documentation that substantiates compliance with the essential principles and application of conformity assessment procedures by the manufacturer, -conducting recalls in Australia (Part 4-9), -ensuring that the name and address of the Sponsor is provided with the device. To the extent that these activities that have been specifically imposed on the Sponsor by the TGA they are not the responsibility of the manufacturer. Complementary requirements may be specifically imposed on a manufacturer under a conformity assessment procedure. For example, the requirement to have a post-marketing system that informs the TGA or the Sponsor as soon as practicable about adverse events that have occurred in Australian or when the manufacturer has taken steps to recall product that has been supplied in Australia. It is likely that the Sponsor will need the assistance of the manufacturer to fulfill many of their responsibilities. To the extent of the imposed requirements, these activities are not to be included in the scope of an MDSAP audit of the manufacturer. The legal entity that is the Australian Sponsor may however be included in the scope of the manufacturer’s audit for other activities if, for example: -the legal entity is within the scope of the manufacturer’s QMS and is performing activities under the QMS other than the activities that have been specifically imposed on the Sponsor. (Although a Sponsor is within the QMS of the manufacturer it should not be presumed that Sponsor Document# QMS-SOP-0029 requirements automatically become auditable manufacturer requirements); or - the manufacturer outsources processes that the manufacturer is responsible for and that affects product conformity to requirements, including, but not limited to, installation, servicing, the provision of labelling and instructions for use in part of in whole (Essential principle 13) or the provision of patient implant cards (PICs), and patient information leaflets (PILs) (Essential Principle 13A). 6 Process Monitoring QA/RA shall maintain engagement throughout the entire mandatory problem reporting process to ensure that all forms are being submitted within the specified time for each jurisdiction. QA/RA shall also ensure that the MDR/MPR Records are filed and stored separately from other complaints. 7 Quality Records Record type Description Includes all preliminary and final reports submitted to the regulatory authorities. MDRs and MPRs are filed MDR/ MPR Records separately from other complaints and maintained in accordance with SOP: Control of Records. Appendix I: Medical Device Report Decision Tree (FDA) Document# QMS-SOP-0029 *Note that the FDA requires a report for incidents outside the USA if that product is also sold in the USA. *Note as well that the above diagram reflects Compass Health’s own company policy wherein deaths and serious injuries will be reported to the FDA within 5 days of “becoming aware” irrespective of whether it has been determined internally that the likelihood of a recurrence is remote. However, should Compass Health be met with unavoidable, extraneous circumstances that make the 30-day report submission timeframe the only viable option, Compass Health may choose to go this route, but only if death or serious injury is unlikely to recur—and—Compass Health can prove this to be true using valid data as per FDA requirements. Appendix II: Medical Problem Report Decision Tree (Health Canada) *Health Canada requires a report for incidents outside of Canada if the Manufacturer intends –or is requested by the applicable foreign regulatory body—to take corrective actions. Document# QMS-SOP-0029 Appendix III: Medical Device event Reportability (Australia TGA) Adverse event An adverse event is an occurrence involving a medical device that meets the following criteria: death of a patient, health care provider, user or other person; or a serious injury or serious deterioration to a patient, health care provider, user or other person, including: o a life-threatening illness or injury o permanent impairment of a body function o permanent damage to a body structure; or Document# QMS-SOP-0029  o a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure. Near Adverse event A 'near adverse event' is an occurrence involving a medical device that might have led to a death or serious injury if, for example, the timely intervention of a healthcare practitioner is the only reason a death or serious injury did not occur. For an event to be defined as a near adverse event, it is sufficient that: an event associated with the device occurred; and if the event occurred again, it might lead to death or serious injury as outlined above. Exemptions from reporting There are eight exemption rules that can apply to the requirement to report an adverse event. However, the exemption rules do not apply when: a device, event or issue specifically identified by the TGA as an issue that requires close monitoring - sponsors of devices that are affected will be notified by the TGA when this occurs an adverse event normally subject to a reporting exemption, where a change in trend (usually an increase in frequency) or pattern is identified adverse events associated with user error, as the TGA may use this data to identify trends with similar products that may lead to recommendations for: o corrective action for the device o revising the labelling or Instructions for Use o identifying a need for increased user education. If a sponsor/manufacturer believes an exemption rule applies to reporting an adverse event, the reasons for not reporting the event should be documented. Document# QMS-SOP-0029