Considerations When Using Postmarket Data in Risk Management

The following article is Part II of “The Integration of Complaint Handling and Risk Management”.

The key to integrating complaint handling and risk management is to ensure feeder processes are in place to bring data from the post-market surveillance group to the risk management tools, in the form of:

REGISTER HERE for MedTech Intelligence’s Integrated Complaint Management Conference! September 17-18, 2015 | Washington, DC. Attend in-person or VIRTUALLY. The challenges with this have to do with designing methodologies that assess the updated risk information in a way that accurately and appropriately indicates where risk mitigation action is required. Questions may arise, such as:

VIDEO: Roberta Goode discusses the responsibility of suppliers in a medical device recall at MedTech Intelligence’s conference on health hazard evaluations, risk assessment and recalls. VIEW VIDEOIn our consulting practice, we have noted that risk evaluation methodologies using post-market data should be designed to address concerns such as:

Final Thoughts

Navigating the waters of complaint handling amidst changing risk management standards and best practices can be challenging. By focusing on mitigating risk as far as possible, considering generally accepted state-of-the-art, and using post-market data to monitor risk, it is possible to strike a balance that prioritizes patient safety and minimizes organizational burden. Through our work with the technical committee and our clients, we’ve established best practices for how to balance these apparently competing elements.

Just like you, we anxiously await updates to the ANSI/AAMI/ISO 14971(2007)/(R)2010 standard. Until then, let’s carefully watch the notified bodies and FDA to see how they interpret existing Annexes Z of EN ISO 14971:2012 and implement best practices as noted herein. If you’re struggling to implement a compliant risk management solution, we can help.

Reference

  1. Rothstein, Z. A. (May 20, 2015). “Re: White Paper on Risk Principles: A Post-Market Perspective,” Official commentary by AdvaMed to AAMI.

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About The Author

About The Author

Julie Cabezas
Quality Engineering Project Manager

Julie Cabezas is a graduate of the University of Miami with a Bachelor’s Degree in Biomedical Engineering. She has worked as a quality engineer in manufacturing, transferred a manufacturing facility to Heredia, Costa Rica, and built a nationwide medical education & clinical training program for the start-up robotics company MAKO Surgical Corp, which included the design of a new training center and surgeon education courses for partial knee and total hip arthroplasty. After MAKO’s acquisition in early 2014, she joined forces with Goode Compliance International to design cutting edge risk management compliance strategies.

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