The role of post-market medical devices surveillance

[Aniket Chaudhari]

Post-market surveillance is an important element for any medical device. All national and international communities associated with medical device has given stress on this study as mandatory and reporting of adverse events to authority is also mandatory.
This is continuous and helps us develop new improvement and let us compare the performance of equivalent devices in the market and lets us know the risk assessment and its rationality.
Medical devices are released based on risk benefit analysis thus all carry some residual safety and performance risk throughout their life cycle.
These risks as arise from a couple of things that include product variability, factors affecting the product’s use environment and different end-user interactions, furthermore as unforeseen device failure or misuse.
Of course, product design and development activities normally take care all above factors in design to make sure that any residual risk is suitable before product release. (Risk benefit analysis)That is why it becomes very essential to gather and analyse information both during production and post-production to form sure that residual risk remains acceptable. This activity may result within the early detection of undesirable effects and may reveal opportunities for product improvement.
To help support manufacturers, perform appropriate post-production monitoring, ISO has produced ISO TR 20416:2020 Medical devices. Post-market surveillance for manufacturers. This is technical document and not any standard or compliance document. This technical document however helps manufacturer decide proactive and systematic process of collecting and analysing data. It will also create common understanding for all for path to follow for post market surveillance.
This document thus set up best practice for conducting post-marketing surveillance. It describes the broad objective setting and planning process. This will also help in understanding what information is to be collected like safety performance, usability, labelling, adoption in market and feedback from users. It also describes responsibilities and data sources, data collection method thus developing its protocol. Data collection includes surveys, interviews, and post market clinical follow up.
The plan is important, and it requires review to verify that it is being adhered and meeting its objective. This plan must be maintained throughout product life cycle.
This document also guides through examples various data, examples of sources and its analysis method. It also provides some examples of post marketing surveillance plans.

Post-market surveillance typically links to other processes that have been established within the quality management system. (Ref ISO 13485 ) Post-market surveillance activities help make sure that available data is analysed and determinations about product safety and performance in accordance with the intended use.
As stated earlier it makes comparative studies with other devices in the market, it helps to determine whether the device in question is or is not current state of the art,
based, as an example, on comparative information from other devices used for similar purposes or from alternative medical treatment procedures. These insights can trigger a design modification, or a replacement design, or maybe removal of the device from the market.
Post-market surveillance can generate real-world information resulting in new market authorizations for the device (new markets, new indications supported by actual use of the device) or of subsequent generation of that medical device.