A new AAMI report lays out a framework for how the medical device industry and the FDA could embrace a new—and shared—way of thinking when it comes to considering the benefits and risks of products already on the market. The goal of the document is to make for a clearer and more efficient way of reaching corrective and removal decisions when a problem emerges with a device that is already being sold and used.
The challenge of postmarket actions, especially product removals, has long been a source of contention between regulators and manufacturers.
The report—Postmarket Risk Management: A Framework for Incorporating Benefit-Risk Assessments into Correction and Removal Decisions—comes as the FDA has signaled a stronger interest in strengthening the postmarket observation of medical devices and at a time when the industry says there’s a need to streamline premarket decisions so innovative products can get to patients faster.
“In this environment, it is more important than ever that we have greater understanding and less acrimony,” says Mary Logan, who recently retired as the president and CEO of AAMI. “We saw a need for fresh perspectives and insights in considering how postmarket assessments ought to work. And, we realized that we needed to bring everyone together if we were going to find a meaningful and lasting solution.”
Working with the FDA, Logan convened a diverse working group of experts, including representatives from the agency, device manufacturers, a patient, and four industry trade associations, to tackle the challenge of developing a predictable and transparent process that could be used by the FDA and industry alike.
The framework is the product of 20 months of deliberations, drafts, and debates among members of the working group who sought to develop a practical and usable document that would delineate the steps and issues involved in a postmarket benefit-risk assessment and a potential recall.
Two fundamental principles guiding the group were the belief that a consideration of benefits is every bit as important as an evaluation of risks when it comes to deciding what to do with a device that is not performing as intended, and that a recall is not always the best solution to a problem.
“There may be scenarios that arise in which a manufacturer would consider removing the medical device from the market to correct the violation,” reads the introduction to the framework. ”However, sometimes that removal could adversely impact public health.” One example of this is implanted devices.
“Currently, there is little guidance on evaluating these scenarios in the postmarket setting,” the framework notes. “This report seeks to provide guidance to manufacturers as well as increase the transparency needed between FDA and manufacturers to reach a decision that is most beneficial to patients.”
A free copy of the framework can be downloaded here.