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Questions and Answers
What defines risk in the context of medical devices?
What defines risk in the context of medical devices?
What is the main purpose of post-market surveillance for Compass Health's products?
What is the main purpose of post-market surveillance for Compass Health's products?
What is the purpose of clinical evaluation for a medical device?
What is the purpose of clinical evaluation for a medical device?
Which of the following statements accurately describes reactive surveillance activities?
Which of the following statements accurately describes reactive surveillance activities?
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Which scenario qualifies as a serious adverse event?
Which scenario qualifies as a serious adverse event?
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What role does ongoing communication play in post-market surveillance?
What role does ongoing communication play in post-market surveillance?
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Which SOPs are mentioned as part of the reactive surveillance activities?
Which SOPs are mentioned as part of the reactive surveillance activities?
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What role does top management play in surveillance activities related to medical devices?
What role does top management play in surveillance activities related to medical devices?
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What is involved in a clinical investigation of a medical device?
What is involved in a clinical investigation of a medical device?
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What is a potential outcome of discovery during post-market surveillance?
What is a potential outcome of discovery during post-market surveillance?
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Study Notes
Compass Health SOP: Post-Market Surveillance
- This document details the system for collecting and evaluating post-production data for Compass Health medical devices
- Aim is to monitor clinical performance and support/refute claims about performance and safety
- Ensures ongoing communication about benefit-risk assessment
- Applies to all medical products designed and manufactured by Compass Health
- Includes both reactive and proactive surveillance activities
- Reactive surveillance activities are part of other specific SOPs
- Proactive Surveillance involves clinical studies, customer feedback, and risk management activities
- Uses relevant SOPs like Feedback and Customer Satisfaction, Risk Management, Medical Device Reporting, Device Recall and Advisory Notices, Complaint Handling
Applicable Regulations/Standards
- Adheres to ISO 13485:2016 and ISO 14971:2019 standards for medical devices
- Adheres to Medical Devices Regulations SOR/98-282
- Relies on databases like MAUDE (FDA), Australia’s DAEN, and Canadian MDI databases for relevant data
- Adheres to TG(MD)R Sch1 P1 2, Sch3 P1 1.4(3), 1.4(5)(b)(iii) &1.4(5)(f)
Acronyms and Definitions
- Post-production phase: The period after a product is released into the market
- Risk: Combination of failure probability and resulting harm severity
- Clinical Safety: Absence of unacceptable clinical risks when using a device as instructed
Clinical Evaluation
- Assesses clinical data to verify clinical safety and performance
- Uses clinical data and evaluation report
Clinical Evidence
- Includes clinical data and clinical evaluation reports regarding a medical device
Clinical Investigation
- Any formal investigation into the safety and/or performance of a medical device
Serious Adverse Event
- Death
- Severe health deterioration (life-threatening illness or permanent body structure / function impairment)
- Inpatient hospitalization or prolongation
- Medical/surgical intervention to prevent permanent body structure/ function impairment
- Fetal distress, fetal death, or congenital abnormality / birth defect
Process Roles
- Top Management: Allocates resources for surveillance activities
- RA: Reports surveillance activity status, assigns reactive tasks to project and executive management teams, and escalates issues as needed.
- Medical Affairs: Performs pre- and post-market surveillance activities.
Compass Health Post-Market Surveillance (PMS) Strategies
- Promptly reports adverse events to Canada and FDA via relevant channels
- Compass Health conducts thorough clinical evaluations, in addition to post-market surveillance, of all devices presently in postproduction phases
- Clinical evaluations frequency depends on the device's risk level (Product Hazard Analysis)
Clinical Evaluation Methods
- Literature reviews
- Clinical experiences (clinical evaluation, beta testing reports, clinical studies, surveys, customer feedback, etc)
- Clinical Investigations
Post-Market Surveillance Reports (Canada)
- Every year (Class III or IV), or every two years (Class II)
- Includes information about adverse effects, complaints, and incidents in the previous time period (12 months for Class III, IV and 24 months for Class II)
Clinical Evaluation Report
- Outlines the scope & context of the evaluation
- Describes the technology, intended use, clinical data, and evidence of clinical performance and safety
- Includes details of analysis stages for the clinical performance and safety aspects
Quality Records
- Includes materials such as beta test results, clinical studies, surveys, customer feedback, and literature reviews.
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Description
This quiz covers the Standard Operating Procedures (SOP) for post-market surveillance at Compass Health. It includes details on how to monitor the clinical performance of medical devices, the importance of benefit-risk assessments, and relevant regulatory standards such as ISO 13485:2016. Additionally, it highlights both reactive and proactive surveillance activities essential for ongoing device safety and performance evaluation.
