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Balance Medical Device Risk Analysis with Internal & External Data

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Author: Rachel Benway, Product Manager

Last month we held a webinar on the updates to ISO 14971 published fall of 2019 and the importance of using post-market data as part of any risk analysis process.  Throughout the webinar, we performed several polls and learned that over half of our audience was already using both internal and external data to complete their risk analysis. 

Risk management as a whole is a continuous process that occurs throughout the entire medical device life cycle.  Specifically, risk analysis must occur at both the beginning and end of the risk management process.  In the beginning it is the formal process of identifying characteristics, hazards, hazardous situations, and the risk estimate of each. Towards the end, we see the processes of collecting production and post-production information and reviewing for impacts to the risk profile of the device. 

As stated in section 10.1 of the 2019 standard, “The manufacturer shall establish, document, and maintain a system to actively collect and review information relevant to the medical device in the production and post-production phase.”  Production and post-production data can include data generated during the production process, user-generated information, maintenance and service requests, publicly available information, and data related to the general state of the art.  A few of these may come as a surprise to some people but are very important sources of information – such as user-generated information.  Some may feel that user-generated information is biased, but the patients and doctors are the users of these devices and their feedback is invaluable. 

This feedback could come in the form of complaints or service requests.  Additionally, there are publically available sources like the FDA’s database of adverse events, MAUDE, providing information about how devices are failing and the consequences. 

Finally, sources that provide context for the current state of the art include the FDA’s Approval and Clearance Databases.  Approvals & clearances provide data on intended use, indications for use, device descriptions, and technology used – especially when it is new technology for the medical device industry.

The standard also states in section 10.2 that “The manufacturer shall also consider the need to actively collect and review publicly available information about similar medical devices and similar other products on the market.” The FDA data is not always easy to use but it is public data and must be evaluated as part of any manufacturer’s risk analysis process. The FDA provides public access to approval and clearances, adverse events through the MAUDE database, market recalls, and warning letters to the manufacturers. When these sources are reviewed, possible changes to the safety profile of the device must be evaluated including potential changes that need to be made to the risk management plan. This means evaluating when there are new or unrecognized hazards or situations and identifying when the estimated risk is no longer within an acceptable range.

Additionally, it’s important to decide whether the overall residual risk is no longer acceptable in regards to the benefits of the intended use and assessing if the generally acknowledged state of the art has changed. Data on similar devices can be especially helpful when little is currently known about a device because it is new or otherwise has little available public data.

To further analysis of FDA data, Reed Tech has developed Navigator™ for Medical Devices, providing easy access and improved visibility into FDA Approval & Clearance data, Adverse Events (MDRs), Recalls, and Warning letters. Manufacturers can view data on their products, competitors’ products, and industry averages.

What’s Your Approach?

How are you currently tracking complaints and public data on devices, and are you treating it as an essential part of your device’s risk analysis process? We would love to hear more about your approach!

To continue the conversation, or learn more about Navigator for Medical Devices (and get a free two-day trial!), reach out to our team at 267.961.0232 or emcdermott@reedtech.com.

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