Compass Health AI Post-Market Surveillance SOP PDF 2024

Compass Health AI SOP: Post-Market Surveillance 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: Post-Market Surveillance 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-0030 Revision History Version Date Description 1.0 03-Jan-2024 Initial Release Document# QMS-SOP-0030 1 Introduction 1.1 Purpose The purpose of this document is to describe the system for collecting and critically evaluating relevant data on an ongoing basis throughout the entire post-production phase of all products manufactured by Compass Health to monitor their clinical performance. The intention behind surveillance activities is to support or rebuke—via sound evidence— all claims made by Compass Health about the performance and safety characteristics of any of its medical device products, thereby either adequately demonstrating continual compliance with applicable recognized regulations or the reverse due to the detection of sufficiently hazardous adverse elements associated with the device that may require corrective action(s) in order to re-establish compliance. The post-market surveillance (PMS) system ensures ongoing communication of information that has an important bearing on a device’s benefit-risk assessment (or would indicate a need for labeling and/or instructions for use changes regarding contraindications, warnings, precautions) between Compass Health and relevant regulatory authorities in accordance with local reporting requirements. 1.2 Scope This procedure applies to all medical products that are designed and manufactured by Compass Health. Post Market Surveillance activities encompass both Reactive and Proactive surveillance activities and involves the following QMS processes: 1. Reactive surveillance activities are conducted as part of the following SOPs: Document# QMS-SOP-0030  a. SOP: Medical Device Reporting/Mandatory Problem Reporting, SOP: Device Recall and Advisory Notices and subsequent fulfillment of the relevant reporting requirements by geographical region to which each quality procedure applies. b. SOP: Complaint Handling; and c. SOP: Corrective and Preventative Action 2. Proactive surveillance activities are conducted through post-market clinical studies, customer feedback data, and risk management activities. These activities are discussed in detail in SOP: Feedback and Customer Satisfaction, SOP: Risk Management, and product specific plans and results can be found in the product specific Risk Management File. 2 Applicable and Reference Documents 2.1 Applicable Regulations/Standards The following standards and regulations are intended to be met by this procedure: ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes ISO 14971: 2019 Medical devices - Application of risk management for medical devices Medical Devices Regulations SOR/98-282 Supporting data source - database to be used to produce product/market data in relation to incident reports of predicates and/or products of similar design and technological characteristics: o MAUDE - FDA website o Australia’s Database of Adverse Event Notifications (DAEN) o Canadian MDI (Medical Device Incidents) database TG(MD)R Sch1 P1 2, Sch3 P1 1.4(3), 1.4(5)(b)(iii) &1.4(5)(f) 2.2 Reference Documents Document Document Title Number Document# QMS-SOP-0030  SOP: Risk Management QMS-SOP-0013 SOP: Feedback and Customer Satisfaction QMS-SOP-0022 SOP: Complaint Handling QMS-SOP-0026 SOP: Device Recall and Advisory Notices QMS-SOP-0028 SOP: Medical Device Reporting/Mandatory Problem QMS-SOP-0029 Reporting SOP: Corrective and Preventative Action QMS-SOP-0031 3 Acronyms and Definitions Term Definition The term is typically used to describe the phases that follow the Post-production release of a product into the market. Generally, the term applies to phase all project/product lifecycle stages occurring after the actual end of completed project (post-release). Risk is defined as a combination of the probability of process Risk failure and the severity of the harm that could be caused by that failure. The absence of unacceptable clinical risks, when using the device Clinical Safety according to the manufacturer’s Instructions for Use. Document# QMS-SOP-0030  The assessment and analysis of clinical data pertaining to a Clinical Evaluation medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. The clinical data and the clinical evaluation report pertaining to a Clinical Evidence medical device. Any systematic investigation or study in or on one or more human Clinical subjects, undertaken to assess the safety and/or performance of a Investigation medical device. An adverse event that 1. led to a death; 2. led to a serious deterioration in the health of a patient, user, or others that: a) results in a life threatening illness or injury; Serious Adverse b) results in a permanent impairment of a body structure or body Event function; c) requires inpatient hospitalization or prolongation of existing hospitalization d) results in medical or surgical intervention to prevent permanent impairment to body structure or a body function; e) Led to fetal distress, fetal death or a congenital abnormality/ birth defect. 4 Process Roles Role Description Document# QMS-SOP-0030  Allocating sufficient resources, with appropriate technical Top Management background, to support surveillance activities. Reporting the status of the surveillance activities as required at the Management Review meetings conducted under SOP- Management Review Assigning proactive and reactive management activities to project team members as needed. RA Presenting a summary of surveillance (i.e. feedback) to Executive Management as needed, Advise and escalate issues as required. Responsible for reviewing the MAUDE – FDA website database for relevant incident reports and escalation of incidents as appropriate. Perform clinical evaluations in addition to post-market Medical Affairs surveillance activities 5 Process 5.1 General Compass Health shall, should a reportable adverse event be discovered during post- market surveillance operations, promptly report the incident to Health Canada and/or to the FDA via appropriate channels. Compass Health shall do so according to the protocol detailed in SOP: Medical Device Reporting/ Mandatory Problem Reporting, SOP: Device Recall and Advisory Notices, as applicable. Compass Health shall periodically perform thorough clinical evaluations —and critically examine their results—in addition to regular post-market surveillance activities conducted on all Compass Health-manufactured devices presently in the post-production phases of their life cycles. The scope, nature and frequency of the clinical evaluations shall be determined by examination of the level of risk (determined via a Product Hazard Analysis) Document# QMS-SOP-0030 associated with each Compass Health device (see SOP: Risk Management), its intended use, distribution/partnership agreements, and whether adequate scientific and/ or clinical data on comparable devices manufactured by Compass Health or another company already exists and are readily available. Compass Health shall collect relevant data using one or any combination of the following methods: 3. Literature Review 4. Clinical Experience 5. Clinical Investigation Clinical evaluation information (beta testing results, clinical studies, customer feedback and all other supporting materials, etc.) shall be documented, summarized (with trending) and presented at each Management Review Meeting by the QA/RA Lead. Resulting actionable items shall be assigned and progress shall be monitored by QA/RA Lead. Compass Health may limit their PMS clinical evaluation method for a given, low-risk Compass Health-made medical device to scientific literature review activities (clinical experience and investigation evaluation methods are thus excluded) to be performed at intervals commensurate with the level of risk associated with the device, but only if equivalence can be demonstrated by Compass Health between the device in question and the device(s) to which the data gathered from the literature review relates. Likewise, the data itself must adequately demonstrate compliance with relevant essential requirements if this approach is to be relied upon. Compass Health shall document and update regularly the data generated from the clinical evaluation process from the planning to reporting stages (including the evaluation’s outcome), and include the supporting documentation within the device’s technical documentation, or, at minimum, fully referenced therein. In the event Compass Health deems it appropriate to conduct a Clinical Investigation as part of a PMS plan, Compass Health shall do so guided by twin objectives: to verify that the device in question in fact performs under normal conditions of use the way Compass Health intended and indicated as stipulated in the device’s labeling and instructions for use; and to screen for side effects under normal conditions of use such that should emerge, the investigator may assess whether they constitute unjustifiable risks when weighed against the device’s intended purpose (see SOP: Risk Management). Document# QMS-SOP-0030 In the event Compass Health deems it appropriate to conduct a Clinical Investigation as part of a PMS plan, Compass Health shall also ensure that it executes all actions in relation to the study in accordance with the latest revision of ISO 14155 sections 1 and 2: Clinical Investigations of Medical Devices for Human Subjects. The ethical principles relating to the protection of human subjects outlined therein shall inform each step of the investigation, from first consideration of the need for—and justification of—the study to publication of the results. Compass Health shall appoint a medical practitioner or another authorized qualified person in an appropriate environment to lead any investigations, clinical evaluations, or literature reviews, who shall be granted access to any applicable technical and clinical data regarding the device, as required. Moreover, Compass Health shall be prepared to justify the choice of the evaluator(s) through reference to qualifications and documented experience. As a general principle, evaluators should possess knowledge of the following: 6. the device technology and its application; 7. research methodology (clinical investigation design and biostatistics); and 8. diagnosis and management of the conditions intended to be treated or diagnosed by the device. 6 Post-Market Surveillance (PMS) Strategies 6.1 General Feedback related to Compass Health products shall be pro-actively monitored, managed and presented, in summary form, and/or escalated to Compass Health Top Management by the QA/RA Lead, as required, at which point relevant operational procedures may be invoked (SOP: Medical Device Reporting/ Mandatory Problem Reporting; SOP: Device Recall and Advisory Notices; SOP: Risk Management). Compass Health shall implement a number of post-market surveillance strategies as deemed required in addition to complaint handling (SOP: Complaint Handling), which may focus on one or more of the following (depending on the nature of the device) sources of data: Complaint Monitoring (through the use of defect tracking system) Document# QMS-SOP-0030  Customer (current, clinical partners or industry experts) interviews; Feedback from company representative in contact with customers; Customer surveys; Clinical site communication (directly, indirectly through verbal or written communication); Routinely checking for possible reports/ notifications issued by regulatory authorities about recalls/ adverse incidents involving comparable devices and regularly reviewing risk profile of released products Reports on PMS activities (for internal review), reviewed at Management Review meetings; Support of Customer and Partner-assisted product literature, studies and reviews; and Note: See SOP: Feedback and Customer Satisfaction and SOP: Complaint Handling for detailed instruction. 6.2 Variables affecting scope of Post-Market Surveillance The following factors shall be taken into consideration by Compass Health Inc. when choosing the scope of the post market surveillance activity for a particular product: Whether any device features or target treatment populations require special attention (e.g. special performance/ safety concerns, specific claims made by Compass Health about clinical performance/ safety of the device) Whether data from comparable devices can be used to support safety/ performance claims about the Compass Health device in question The data source(s) and type(s) of data to be used in a clinical evaluation, which shall be chosen based on careful consideration of the following factors: o Intended use/ risks associated with the device (SOP: Risk Management) o Design characteristics of the device o Proposed clinical application of that technology o Compass Health’s experience and history with specific product o Compass Health’s individual experience and history with the device in question o Customer’s expectation and political climate Document# QMS-SOP-0030  o Distributors/ partner company expectations o The developmental context of the technology (product represents minimal or drastic advance in existing technology) o Proposed clinical application of the technology Note: Clinical evaluation activities for Compass Health devices based on established technology are more likely to rely to a larger extent on literature reviews, compliance with recognized standards, and the clinical experience of comparable devices to adequately demonstrate compliance with post-marketing surveillance requirements of relevant regulatory requirements. Conversely, Compass Health-made products judged to be “high risk” (e.g. based on technology with little or no documented experience or which aim to extend the intended purpose of an existing technology) are most likely to require clinical investigation data. 6.3 Surveillance Reports for devices sold in Canada 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: 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; ▪ Complaints; ▪ Incident reportable to Health Canada ▪ Foreign Risks of injury to human health that are reportable to Health Canada o 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: Document# QMS-SOP-0030  ▪ 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 can be prepared using [QMS-TMP-2357_A] Health Canada Summary Report Template 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 the summary report. Notification methods are detailed int he Health Canada [Guidance on summary reports and issue-related analyses for medical devices]. 7 Procedure: Clinical Evaluation 7.1 General Drawing on data originating from one or more of the following sources (as deemed appropriate) Compass Health shall periodically review the performance and safety characteristics of—and the benefit-risk assessment for—the device in question through an adequate clinical evaluation, and update the clinical evidence accordingly: Safety reports, including adverse event reports; Results from published literature; Any further clinical investigations and formal post market surveillance studies Expert user groups (focus groups) Customer surveys Customer complaints and warranty claims Post-market clinical trials User feed-back other than complaints, either direct to manufacturer or via sales force User reactions during training programmes Document# QMS-SOP-0030  Experience with similar devices made by the same or different vendor Maintenance/service reports and In-house testing Failure analysis Note: Data generated from sources outside of this scope shall also be considered. Compass Health shall exercise due diligence in determining the most appropriate source(s) to employ in the clinical evaluation based on the criteria stipulated in Section 6.2. Compass Health shall document the results of the clinical evaluation in a final, clinical evaluation report upon taking necessary steps to adequately minimize residual risk (if required). The report—along with the data it is based on—shall serve as the basis for the evidence that supports the marketing of the device. The clinical evidence (report and data), together with the following sources of information and documentation, shall, in turn, demonstrate compliance with the essential principles: 9. Design verification and validation documentation 10. Device description information 11. Labeling information 12. Risk analysis information 13. Manufacturer information The above documentation and information sources shall be included in technical documentation for each device and further support on-going marketing of products. 7.2 How to Perform a Clinical Evaluation (Overview) Stage 1: Identify pertinent standards and clinical data Stage 2: Appraise each individual data set in terms of its relevance, applicability, quality and clinical significance Stage 3: Analyze individual data sets and reach conclusions about the performance, safety and presentational aspects (labelling, patient info and instructions for use, etc.) of the device. Document# QMS-SOP-0030 7.2.1 Stage 1: Identify pertinent standards and clinical data One or more of the options listed below shall be implemented in the clinical evaluation for a given Compass Health-manufactured device, as deemed appropriate (see section 5.1 above). Option 1: Literature Review Compass Health shall implement a comprehensive literature review to identify published clinical data not already in possession of Compass Health that bears relevance to the Compass Health device in question, when deemed appropriate. The literature may relate directly to the Compass Health device or to comparable devices and shall be assessed with respect to its possible contribution and weighting in establishing both the performance and safety characteristics of the Compass Health device. Compass Health shall assign a qualified person to coordinate and execute the literature review. A search strategy shall be developed by the literature review coordinator and based on carefully crafted review questions, which shall, in turn, inform the protocol to identify, select and collate relevant publications to address these questions. The protocol shall address: Sources of data and justification for choice; Extent of any searches of scientific literature databases (database search strategy); Selection/ criteria to be applied to published literature and justification for choice; and Strategies for addressing potential for duplication of data across multiple publications Following the literature search, Compass Health shall prepare a report detailing the results of the review. Document# QMS-SOP-0030 Compass Health shall maintain documentation of the literature review such that the methods may be critically appraised, the results verified, and the search reproduced, if warranted. The following data/documentation from the scientific literature review, which will serve as parts of the clinical evidence, shall be made available to the designated clinical evaluator for the final clinical evaluation: The literature review protocol; The literature report; and Copies of all relevant published articles/ references—not just the abstracts—that are suitable for evaluation. The data/documentation shall be sufficiently comprehensive such that the clinical evaluator may assess the soundness of the methodology, the reporting of results, the validity of conclusions drawn by the literature review coordinator, and the degree to which the selected papers reflect the intended application/use of the device. Option 2: Clinical (Real World) Experience Analysis Compass Health shall generate data from one or more of the following examples of clinical experience should it be deemed necessary* to pursue real-world testing of a Compass Health-made marketed device as part of an adequate post-marketing clinical evaluation plan: manufacturer-generated post-market surveillance reports**, registries or cohort studies (which may contain unpublished long term safety and performance data); adverse events databases (held by either the manufacturer or regulatory authorities); data for the device in question generated from individual patients under compassionate usage programs prior to marketing of the device; and details of clinically relevant field corrective actions (e.g. recalls, notifications, hazard alerts) Document# QMS-SOP-0030  Class I devices, the manufacturer is responsible for completing the analysis and submitting it to Health Canada. Class II to IV devices, the medical device license holder is responsible for completing the analysis and submitting it to Health Canada. Note: If no corrective actions are to be undertaken, a detailed rationale must be included in the report. Section Health Canada 61(2)(c) requires the reporter to submit any actions taken as a result of the investigation, which may include, (i) increased post-market surveillance of the device, (ii) corrective and preventive action respecting the design and manufacture of the device, and (iii) recall of the device. Note: Section 61(2)(c) (ii) is interpreted to mean the following: corrective action on the device to prevent recurrence of the issue respecting the design and manufacture of the device, and may also include preventive action taken on similar product lines / devices to prevent occurrence of the same issue. Increased post-market surveillance: If increased post-market surveillance is required, the final report must present an action plan for increased monitoring and trending of incidents associated with devices already on the market, including the following details: Which users will be monitored and by what method(s)? How long will the increased post-market surveillance continue? The provisions for the timely reporting of the surveillance results to Health Canada. Compass Health, if it chooses to evaluate clinical experiences as part of a comprehensive clinical evaluation plan, shall ensure that the reports / collations of data it relies upon towards this end will: enable Compass Health to pursue a rational/ objective assessment of the information; and Document# QMS-SOP-0030  enable Compass Health and the designated clinical evaluator to make conclusions about the significance of the information with respect to the performance and safety characteristics of the Compass Health device in question *for example, the generation of long-term information or assessment of end-user learning curve data involving a Compass Health-made device may provide reasonable assurance of both its clinical safety and performance depending on the nature of the device in question. **Compass Health shall take into consideration the individual circumstances of the geographical regions from which post-market surveillance reports originate since the extent of reporting may vary considerably between different countries. Option 3: Clinical Investigation Compass Health shall make every effort to ensure that the environment in which the investigation is performed reflects the normal conditions the device operates in. Again, if Compass Health chooses to pursue a clinical investigation as part of a thorough clinical evaluation of a Compass Health-made, post-marketed device, it shall be designed, implemented and reported in accordance with the latest version of ISO 14155 sections 1 and 2: Clinical Investigations of Medical Devices: Clinical Investigations of Medical Devices for Human Subjects* –and local regulations. Where Compass Health sources clinical investigation data reported in the scientific literature (e.g. investigations of either the device in question or comparable devices that are undertaken by a third party), Compass Health shall seek out any documentation relating to the investigation beyond the published paper itself (though it shall also be included) and maintain it internally such that it may be made available upon request. Documentation relating to the design, ethical and regulatory approvals, conduct, results and conclusions of the investigation needed for the clinical evaluation shall also be maintained such that they may be made available for consideration in a timely fashion. Examples include: the clinical investigation plan; the clinical investigation plan amendments and the rationale for these changes; the relevant Ethics Committee documentation, opinion(s) and comments for each Document# QMS-SOP-0030 investigation site, including a copy of the approved informed consent form(s) and patient information documents; case report forms, monitoring and audit records; Regulatory Authority approvals and associated correspondence as required by applicable regulations; and the signed and dated final report. Compass Health shall prepare a clinical investigation plan that shall be based upon the latest scientific and technical knowledge in the field relating to the device in question. The data accumulated throughout the investigation shall adequately, upon analysis, be able to confirm or rebuke the manufacturer’s claims about the device, particularly those involving its performance and safety characteristics. Within the clinical investigation plan, Compass Health shall describe: how the study is intended to be performed; the design of the study, for example: The selection and assignment of participants to treatment; o Whether patients shall be masked (blinding of participants and investigators); o The measurement of responses to treatment; o intended participant follow-up approaches; and o approaches to statistical analyses and methods for recording outcomes The final clinical investigation report shall be signed by its author and appropriate reviewers to provide assurance to relevant authorities that the final report is an accurate reflection of the conduct and results of the clinical investigation. *if the clinical evaluator finds that aspects of the clinical investigation violate one or more of the ethical principles set out in this standard, those affected data sets shall be discarded and justification for their elimination shall be duly noted in the clinical evaluation report. Document# QMS-SOP-0030 7.2.2 Stage 2: Appraisal of Clinical Data Compass Health shall take steps to evaluate the merits and limitations of each piece of data generated throughout the clinical data collection process (stage 1), whether from a literature search, clinical experience, clinical investigation, or any combination thereof. Specifically, the data shall be appraised in terms of: Quality and relevance vis-à-vis the device/ intended use (data should be based on a comparable device or the device itself); The method used to generate/ collect the data; the contribution of each data subset to establishing the safety and performance of the device; and the extent to which the observed effect is attributable to: o device intervention; o confounding influences such as natural development of a medical condition/ concomitant treatments; or o bias Compass Health shall categorize the data for separate analysis into performance and safety-related data sets and weigh them according to their respective contributions. 7.2.3 Stage 3: Analysis of Clinical Data The Compass Health-designated evaluator shall next examine the appraised sets of data (compiled during stage 2) and determine if they collectively produce enough evidence to support claims about the performance and safety characteristics of the Compass Health- manufactured device in question based on its intended use. Given the context within which most medical devices are developed (i.e. limited need for clinical investigations due to incremental changes in device design and therefore high use of literature and experience data), it is most likely that qualitative (i.e. descriptive) methods shall be employed by Compass Health towards this end. Compass Health shall utilize the evaluation criteria established in stage 2 to identify data sets most pivotal to demonstrating the performance and safety characteristics of the device. Document# QMS-SOP-0030 As a final step, the Compass Health-designated evaluator shall consider the basis on which it can be demonstrated that the combined data shows: the device performs as intended by the manufacturer; the device does not pose any undue safety concerns to either the recipient or end- user; and any risks associated with the use of the device are acceptable when weighed against the benefits to the patient (SOP: Risk Management and relevant Product Risk Management File) Note: In instances where the opposite findings are reached in any of the above considerations, MDR/MPR and/or Device Recall and Advisory Notices protocols (SOP: Medical Device Reporting/ Mandatory Problem Reporting, SOP: Device Recall and Advisory Notices) shall be immediately invoked, as applicable. When entertaining the above considerations, the Compass Health-designated evaluator shall take into account the following factors: number of patients exposed to the device; type/ adequacy of patient monitoring; number/ severity of adverse events; the adequacy of estimations associated with each risk for each identified hazard (see SOP: Risk Management and relevant Product Risk Management File). the severity and natural history of the condition being diagnosed or treated; the availability of alternative diagnostic modalities or treatments; existing standards of care; extent to which the product literature/ instructions for use are consistent with the data; and hazards/ other clinically relevant information have been identified appropriately If, following the evaluation, the Compass Health-designated evaluator identifies residual risks associated with the device in question that may impact its risk/benefit ratio (SOP: Risk Management; relevant Product Risk Management File), the Clinical evaluation report shall be put on hold until the level of risk involving the product’s safety and performance characteristics have been reduced to within an acceptable range and the post-market clinical follow-up protocol shall be activated. Document# QMS-SOP-0030 7.2.4 Clinical Evaluation Report The Compass Health-designated evaluator shall produce a Clinical Evaluation Report once a determination has been made that the device conforms to relevant Essential Principles of safety and performance of medical devices based on data collected from clinical experience, an investigation, a literature review, or from any combination therein. The report shall outline: The scope and context of the evaluation; the appraisal and analysis stages; the technology on which the medical device is based, the intended use of the device and any claims made about the device’s clinical performance or safety; the nature and extent of the clinical data that has been evaluated; and how the referenced information (recognized standards and/or clinical data) demonstrate the clinical performance and safety of the device in question. The final written report shall be signed and dated by the medical practitioner or another qualified person responsible for the investigation and be accompanied by Compass Health’s justification of the choice of evaluator. The level of detail in the report content shall vary according to the scope of the clinical evaluation. 8 Quality Records Record type Description Clinical Including beta testing results, clinical studies, surveys, customer evaluation feedback and all other supporting materials, literature reviews, clinical information evidence etc. Document# QMS-SOP-0030