I agree with the above posts regarding the strategies used in post market surveillance (PMS) as well as the benefits obtained from doing PMS. I would like to add to the conversation by describing another beneficial aspect of doing thorough PMS. Gathering information regarding product failures is the most important step of initiating a root cause investigation. When a trend is noticed in complaints received, and the complaints that were reported provide detailed information, it can help significantly narrow down the root causes and increase the speed of the investigation. It can also help you understand if your device failed because of misuse. If your company does not have a good PMS system it can be very difficult to get all the information required to do a thorough root cause investigation.

Adding to the discussion, also in EU the manufacturer is required to produce a PMS plan, specific to each of its products. This is key to the beginning of a successful.The plan must outline how to collect information from sources such as:
information from vigilance, records referring to non-serious incidents and data on any undesirable side effects, information from specialist or technical literature, databases and/or registers
information from feedback and complaints, provided by users, distributors and importers
publicly available information on similar medical devices.
A company can use existing processes, or implement new ones, to achieve the above. These could be:
complaints procedures
vigilance procedures
checking of competent authority websites for information on adverse events or recalls of similar devices
post-market clinical follow-up (PMCF) studies
setting up key-word alerts on search engines
social media
feedback from users (via email/website/surveys)
In US: Passive surveillance systems at the FDA are centered on the DMR, through which manufacturers, physicians, and consumers submit reports of device-associated malfunctions, injuries, or deaths.

For medical devices class II and class III are required to have post market surveillance. This is a required procedure for medical device companies to initiate to keep track of any complaints or device failure. Post market surveillance is necessary to keep track of consumer feedback, possible issues of the device, provide market research comparing the device to those in the market to see if improvements can be made to the device. In addition, post market surveillance also falls within regulatory because they are also interested in consumer feedback such as complaint tracking.

I would like to point out that post market surveillance can also be conducted on clinical studies. The importance of Post Market Clinical Follow Up (PMCF) studies is to try to identify and investigate any enduring risks that are associated with medical devices on the market. This may be needed because of certain risk factors, procedures, population, safety, any significant changes to the device. Granted, due to established data in terms of safety that is conducted during clinical trails and the product already being brought to market, the PMCF is not always required. However, medical device manufacturers are still required to explain the justification as to why the PMCF is not conducted or performed.

PMS is a collection of processes and activities used to monitor the performance of a medical device.PMS can improve device,provide better services to users and reduce the risk of adverse events before it happen.If manufacturer introducing new technology ,should respond with an increased monitoring program to ensure early detection of problems.Post market clinical follow up may be warranted to success of real world use of device.PMCF is an important part of PMS .PMCF is active collection of data on clinical experience after market release Pre market phasemay be too limited to identify rare events.PMCF is crucial to identify new and unknown risks.Customer complaints are the indicator of product quality.Every complaint must be evaluated ,investigated and when necessary corrected.

In thinking about PMS and detection of problems, I thought about the process of notifying FDA and I cam across a NYT article. In the article, the director of healthy policy for the National Center for Health Research in Washington said “It often takes months or even years for the F.D.A. to detect patterns of failure, post-market surveillance of medical devices continues to be dangerously slow and clearly inadequate to protect patients from risky devices.” I never really thought about FDA side of PMS. The article goes on to say that there are approximately 65,000 new adverse events every month and due to volume and number of staff, usually the analyst will review in order of importance, starting with deaths and injuries and malfunctions, but because of the volume when they go in the next day they will again start with the high level risk ones with deaths/injuries. Dr. Shuren believes director of the agency’s Center for Devices and Radiological Health called the current reporting system “passive surveillance.” In this reporting system, FDA relies on manufacturers and hospitals to notify them of injuries, infections and other adverse events linked to medical devices, as well as malfunctions. The guidelines call for alerting the FDA no longer than 30 days after an incident. Dr. Shuren says these reports will become less important as the agency moved toward a new system that he said would mine electronic health records to detect troubling patterns sooner, however, this will take several years.

Overall I think PMS is very important. Some of examples of reports to FDA included; cardiac defibrillators that ran out of batteries; the power morcellator, designed for laparoscopic surgery to remove uterine fibroids, which spread cancer through patients’ bodies; a type of breast implant that is linked to a rare cancer; and the superbug-bearing duodenoscope, whose design flaws made it virtually impossible to disinfect. Reading about these reports, its a little worrisome to me that device companies are asking for 3 month reporting instead of 30 days. I think for something high risk FDA should be alerted within 30 days.

nytimes/2017/07/11/health/fda-medical-device-problems-rules.html