Podcast
Questions and Answers
What defines risk in the context of medical devices?
What defines risk in the context of medical devices?
- The manufacturer's claims regarding device safety.
- The combination of process failure's probability and the severity of potential harm. (correct)
- The evaluation of clinical testing solely.
- The potential for process failure only.
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?
- To increase production efficiency and reduce costs.
- To finalize product design and manufacturing processes.
- To continuously monitor clinical performance and comply with regulations. (correct)
- To enhance marketing strategies for new medical devices.
What is the purpose of clinical evaluation for a medical device?
What is the purpose of clinical evaluation for a medical device?
- To assess the device's aesthetic appeal.
- To assess the market potential of the device.
- To verify the clinical safety and performance when used as intended. (correct)
- To determine the financial viability for production.
Which of the following statements accurately describes reactive surveillance activities?
Which of the following statements accurately describes reactive surveillance activities?
Which scenario qualifies as a serious adverse event?
Which scenario qualifies as a serious adverse event?
What role does ongoing communication play in post-market surveillance?
What role does ongoing communication play in post-market surveillance?
Which SOPs are mentioned as part of the reactive surveillance activities?
Which SOPs are mentioned as part of the reactive surveillance activities?
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?
What is involved in a clinical investigation of a medical device?
What is involved in a clinical investigation of a medical device?
What is a potential outcome of discovery during post-market surveillance?
What is a potential outcome of discovery during post-market surveillance?
Flashcards
Post-Market Surveillance (PMS)
Post-Market Surveillance (PMS)
The process of collecting and critically evaluating data about a medical device after it's been released to the market.
Post-Market Surveillance System
Post-Market Surveillance System
A system for gathering information about a medical device's performance and safety after it's been released to the market.
Reactive Surveillance
Reactive Surveillance
Actions taken in response to adverse events related to a medical device, such as device recalls or reports of malfunctions.
Proactive Surveillance
Proactive Surveillance
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Benefit-Risk Assessment
Benefit-Risk Assessment
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Risk
Risk
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Clinical Safety
Clinical Safety
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Clinical Evaluation
Clinical Evaluation
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Clinical Investigation
Clinical Investigation
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Serious Adverse Event
Serious Adverse Event
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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.
