AAMI has released a white paper draft that will be of interest to those of you in the medical device industry. Titled “Risk Principles and Medical Devices: A Post-Market Perspective,” it is available now, with comments allowed until May 20th. It focuses in on post-market quality and safety issues of concern to industry and the FDA’s CDRH (Center for Devices and Radiological Health).
The issue is “in the headlines” for medical device manufacturers now that there are concerns raised by the Z Annexes for EN ISO 14971 (see my post from yesterday for more information). Simply put, the art and practice of risk management has moved forward a great deal in the last 20 or so years and this improved methodology has left regulators needing updates in for post-market compliance. And again, the hope of those who drafted the white paper is that the recommendations will also be heeded by the committee in charge of the standard as well as by industry and regulators.
As with the NB-Team document from yesterday, the goal is to get industry and the regulators all on the same page with regards to risk present throughout the life cycle of any particular medical device. Risk management is now being used to spot problems and potential problems with devices after product release, during what’s called the “post-market” phase.
The AAMI white paper includes a definition of risk, so essential to determining what will actually be analyzed. Also included is a discussion of what’s called the “Decision Quality (DQ) Chain.” This tool can assist you in understanding the process of high-quality decision making and support your choices with regards to risk.
Then the AAMI paper covers the foundations of risk assessment and risk management as well as risk principles themselves. Since risk is present in virtually every situation, the goal of risk management is not to eliminate risk but to mitigate unacceptable outcomes, comply with regulations, and judge what level of risk is acceptable. This section reviews the basic principles that make for good decision making. This is in contrast to the current edition of ISO 14971.
The next section of the paper homes in on factors you need to consider when putting these risk principles into practice with regards to device quality and safety in a post-market environment. Topics like severity of harm, frequency of harm, complexity, and clinical care are addressed. To support these, examples of various scenarios are presented that highlight the context for the chosen factors.
The paper draws to an end with a section called “Next Steps.” These are issues that the authors were unable to resolve in this round of discussions but feel are worthy of further work. And a “Conclusions” section briefly wraps up the document.
If you’d like a copy, contact our staff at Document Center Inc. They can be reached by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). There will be a small charge if you’d like a paper format copy of the draft white paper, but if you mention this blog they can provide you with a pdf copy at no charge. Need other AAMI standards? Order authorized copies using our Document Center online store at www.document-center.com. We’re your Standards Experts!
