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The aim for any medical device company is always to ensure that the devices they make are safe and effective.
How do you ensure that those devices remain both effective and safe once on the market? One key way is through implementing post-market surveillance.
This is a key source of data that should be integrated with your risk management system. This data is used to keep your product risk management systems updated - perhaps adding new or previously unseen hazards, or adjusting the risk level applied to hazards previously identified.
Here’s what you should know:
Post-market data is gathered through a range of post-market surveillance activities that are expected of medical device developers.
Many medical device companies regard clinical studies and other methods of gathering data in the realm of pre-market activities, but in reality, not only are post-market surveillance activities valuable for informing the company, but they’re expected by regulatory bodies.
Here’s an extract from the FDA:
Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.
Post-market surveillance should be seen as more than just a regulatory requirement - it’s actually good business practice to keep tabs on the performance of your device once it has gone to market. Feedback is one of your best informants for maintaining product quality, keeping consumers happy and protecting the reputation of your company.
Importantly, keeping a close eye on post-market data can help you to minimize your exposure to incidents, by having effective early warning systems. It’s much better to recall a product and fix a defect prior to a really serious incident happening!
Bottom line: This approach is about being proactive instead of just reacting to events.
Post-market surveillance activities might include:
The Act authorizes the FDA to require postmarket surveillance for a class II or class III device at the time of approval or clearance of a device or at any time thereafter, in the following instances:
- Failure of the device would be reasonably likely to have a serious adverse health consequence;
- The device is intended to be implanted in the body for more than one year;
- The device is expected to have significant use in pediatric populations;
- The device is intended to be life-supporting or life-sustaining and used outside of a user facility.
Product risks can never be entirely eliminated, so continuous monitoring of post-market data helps companies adjust and manage risk to acceptable levels.
You can see from the activities listed above that post-market data might come from either proactive or reactive activities. Complaints set off reactive procedures while a survey is a proactive way of gathering data.
The challenge for post-market data and risk management is ensuring that as a company, you ensure good feeder systems are in place to bring that data into your risk management tools. It can be challenging if information is coming from different sources, being managed by different people in the company and perhaps being captured in different places.
On top of data management for your products, it’s important to monitor and review information about related competitor’s devices too. Sometimes new information is brought to light that wasn’t considered in your original risk assessment.
Any new information, from either your own product feedback or a competitor’s may lead to a re-evaluation of your original risk management data. For example you might find that;
A well-established system, integrating post-market data and risk management not only reduces risk for the end-users of your product, but benefits the manufacturer by identifying areas to improve product quality, possibly even reducing cost (especially if you can reduce returns or breakages).
There are a few different achievements that can be made by closely monitoring post-market data and integrating with risk management. These include:
We’ve talked before about risk management being a crucial activity for the entire product lifecycle - this is actually a specific requirement under ISO 14971. Risk management and post-market data should be clearly linked, although, as explained earlier this is often a challenge where different data sources need to be brought together.
This is where we suggest a cloud-based QMS that encompasses your risk management file and other crucial parts of your QMS is a good solution. Have a centralized place where all parties involved can easily access and file the information needed (one of the strengths of Greenlight Guru's QMS Software).
Your post-market surveillance should inform a few risk management points;
Do changes need to be made to your device?
Do you need to change how you label, market or educate on the device?
Do you have a systematic process for evaluating the data you collect?
Do you have objective evidence in your risk management file for any assumptions being made?
Are changes required to your risk acceptability definitions?
This is not an exhaustive list, but you probably get the idea of the importance of having a good system for managing post-market data and incorporating with risk management.
Post-market surveillance and data play a key role in risk management for the entire lifecycle of your medical device. You need to have good systems in place to not only capture that data, but ensure that it is used to monitor and update your risk management files.
What you do with the data you collect is important - you need a way to centralize information and ensure that it is reviewed regularly and action taken where needed. A truly effective program doesn’t reserve this for an annual Management Review, but frequently reviews data depending on the quantity and type received.
Is further action necessary? If so, this can be a trigger for CAPA, for updated risk management or ultimately, for changes in the device.
Jon Speer is a medical device expert with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.