I recently attended the Global Post Market Surveillance of Medical Devices Conference, held on February 23rd and 24th in Alexandria, VA. Aside from chairing the event, I spoke on the topic of how to “Strengthen Supplier Relationships Through Quality Data Insights.” The event focused on bringing industry leaders together to exchange best practices for implementing effective and agile Post Market Surveillance (PMS) systems, transitioning to the new EU MDR, and remaining ahead of industry trends.
Post Market Surveillance is the practice of monitoring the safety of a pharmaceutical drug or medical device after its release in the market. Drugs and medical devices are approved through clinical trials, which involve a defined population selected for the trial. As such, Post Market Surveillance can be an important tool in gathering broader information regarding the safety of a drug or device after it is used in the general population.
PMS can employ many approaches to monitor drug and device safety, including prescription event monitoring, electronic health records, patient registries reporting databases, and record linkage between health databases. Data from all these sources can be analyzed to understands trends or issues related to the drug or device. As regulatory agencies become less tolerant of device failure, the importance of post market surveillance increases and agencies place more emphasis on manufacturers to have a clear and surveillance program in place.
Such a solution can be both proactive in the form of customer surveys, user groups, registries or reactive in the form of complaints, unsolicited user feedback, service reports, social media, and reviews. The amount of data that can be collected can be staggering and a huge challenge for companies.
The event itself had a rich agenda with speakers from industry leaders like GE Healthcare, Siemens, Baxter and Smith & Nephew. Key themes included the need to build a closed loop system, tactics for accurately capturing and analyzing data, cutting through informational “noise” to assess PMS risks, identifying reportable signals, assessing the importance of connecting complaints as a part of a robust Post Market Surveillance infrastructure and ensuring Post Market Surveillance is incorporated into the product lifecycle process of a business.
Quality Management Systems (QMS) can play a key role in PMS, as it can act as a foundational source of quality incident or complaint data and also as a workflow enabler to support investigation processes. The key is collecting data and using that data to gain insight on quality issues to resolve them before they can happen.
To learn more about the connection between Quality and PMS visit www.spartasystems.com.