Redefining Post Market Surveillance: A Necessity in Disguise

Post market surveillance (PMS) is a regulatory requirement set in place by the US Food and Drug Administration (FDA) and other regulatory bodies to monitor the continued safety and effectiveness of medical devices once they are in use in the market. This is important to ensure that these devices do not pose any unknown danger or cause harm to patients.

Every medical device is checked for quality, safety, performance and malfunctions during the pre-market review process. However, this process is carried out within a selected sample of people. Once out in the market, medical practitioners, nurses, patients (when the device is used in the patient’s home) and others use a device under conditions that may not have been subjected to during the review process. These altered conditions may cause the device to malfunction and injure a patient severely or even cause death. What if you as a manufacturer, came to know about it only at a later stage of the device’s life cycle? Tracking of such incidents during a device’s life cycle is imperative to enhance its safety and performance features. Timely tracking of such events can help companies to decrease the number of warning letters they receive from the FDA and other regulatory bodies. Proper collection, storage, tracking, monitoring and analysis of vital stats generated by these devices and the users can provide useful business insights and product enhancement ideas.

Today, companies should look at post market surveillance not only as a regulatory requirement, but also as a good business practice. This will help them to continually improve and enhance device safety, and grow their businesses with a more customer-centric approach. However, to derive maximum benefit companies should redefine their post market surveillance system to make it more proactive, include monitoring of a device’s entire life cycle and take an integrated risk-based approach.

By redefining their post market surveillance, medical device companies can help:

Increase timeliness to compliance through proactive monitoring of market, regulation updates and acting in time
Deliver MDRs consistently through continuous collection and analysis of PMS data
Improve product quality and safety features based on the insights derived from the data
Initiate appropriate product recalls on time
Utilize effectively post market data for business benefits

Share with us benefits that you have realized from your post market surveillance data. What are the other business advantages that can be derived from post market data?

About the Author

Pavan Kumar Garikapati is a Regulatory, Quality and IT Compliance professional with about 20 years of experience. Pavan currently heads Regulatory domain practice for Medical Devices business unit at Wipro. He has expertise in US, Europe and emerging market medical device regulations. Pavan is a Six Sigma Master Black belt and Certified Lead Auditor. He has spoken at various conferences and authored papers on these topics.

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