Emergo Whitepaper: Key Elements of a Viable Post-market Surveillance System
EMERGO SUMMARY OF KEY POINTS:
- Maintaining a post-market surveillance (PMS) system is necessary not only to address regulatory requirements but also improve risk management and potentially improve quality of a medical device.
- Post-market vigilance is a component of a PMS system, not a synonym for it.
- Four key components of a viable PMS system include risk assessment, monitoring and control, data collection and data review.
Although premarket registration and quality management system compliance garner a lot of attention from medical device companies eager to establish themselves in their target markets, successful commercialization also requires viable post-market surveillance (PMS) efforts.
In a whitepaper written by Emergo Regulatory Affairs Consultant Elizabeth Pugh, definitions of PMS according to European and US regulators are discussed, as well as four key components manufacturers should include in their PMS systems, the relationship between PMS and risk management, and the benefits of implementing an adequate PMS system.
What is post-market surveillance?
First, Pugh explains two broad categories of activities that make up post-market surveillance: proactive actions such as customer surveys and Post Market Clinical Follow-up studies, and reactive actions including vigilance and Nonconforming Material Reports.
The whitepaper emphasizes that surveillance and vigilance should not be confused, however. The latter concept exists as one aspect of PMS—not as a synonym for it. Vigilance includes field safety corrective actions (FSCAs) and recalls necessitated when a medical device or in vitro diagnostic (IVD) device fails to perform as intended.
Capabilities a PMS system should include
To meet regulatory requirements in major markets such as the US and Europe, Pugh writes that an adequate PMS system should include capabilities such as the ones below, recommended by the European Forum of Notified Bodies Medical Devices:
- Detecting device manufacturing problems
- Quality improvement capabilities
- Verifying risk analysis
- Feedback tools for indications for use and instructions for use
- Feedback tools for customer/patient satisfaction and market performance
- Identifying incident reports
According to Pugh, “A well-established PMS system helps protect the user from risk, but it also benefits the manufacturer by monitoring product performance and identifying areas to improve quality and reduce costs.”
Four key PMS system components
The whitepaper identifies four major steps and components a device manufacturer should implement in order to develop sound PMS processes and procedures. First, a manufacturer should perform a thorough risk assessment, which should include both risk analysis and risk evaluation for all phases of a device’s life cycle. The manufacturer’s risk assessment should cover hazards such as energy, biological and environmental factors as well as software and user errors, labeling and ease-of-use issues.
Second, the manufacturer should establish risk monitoring and control capabilities that allow for continual monitoring of feedback for the duration of its device’s post-market life cycle in order to properly manage risk. This step entails monitoring of PMS data—that is, any data obtained about a device once it becomes available for sale in a market, including literature reviews, post-market clinical studies, patient registries and customer complaints and surveys.
Third, the manufacturer should set up adequate data collection procedures that can capture customer or patient feedback. Such feedback can consist of user or patient complaints, control over nonconforming device materials or components, any corrective and preventative actions, and/or post-market surveillance activities.
“It is important to ensure that all applicable departments in your organization, such as customer service representatives, sales representatives, distributors and others who may be involved in the collection of this data are properly trained to ensure all information is documented,” writes Pugh regarding PMS data collection procedures.
Finally, data review and analysis procedures should be developed in order to periodically trend and review PMS data; review and analysis should occur at least annually via formal management review meetings, according to recommendations from both the FDA and the ISO 13485 quality standard.
Manufacturers should feed collected PMS data into their risk management files and clinical evaluation reports (CERs), writes Pugh; maintain documented explanations of how they collect and analyze their PMS data; and describe how they use such data to manage and reevaluate risks posed by their devices to users and patients.
“You need to show proof in the form of documentation and audit trail that medical device post-market surveillance is being performed and data is feeding into the other systems,” advises Pugh.