AAMI Seeks Feedback on Postmarket Benefit–Risk Framework

Posted June 15, 2016

A special AAMI working group is asking the medical device industry—and the wider healthcare community—to comment on a draft framework that seeks to clarify how the concept of benefit should factor into decisions made after a product has gone on the market.

The draft framework comes at the same time as the Food and Drug Administration's (FDA) own development of draft guidance focused on the use of benefit–risk analysis in compliance decisions, a tacit recognition of the need to take a fresh look at a subject with enormous practical implications for the makers of medical devices. Separately, the FDA is seeking comments on that document as well.

The AAMI working group’s draft, Postmarket Risk Management: A Framework for Incorporating Benefit-Risk Assessments into Postmarket Decisions, is part of a broader effort by the group—which includes more than 60 representatives from the medical device industry, the FDA, and industry trade associations—to better align industry and the FDA when it comes to postmarket risk management. AAMI convened the informal working group in collaboration with the FDA’s Center for Devices and Radiological Health in 2014 to address key postmarket issues related to quality and safety.

“Significant resources have helped guide industry and the FDA when assessing benefit and risk in the premarket phase of a product’s life cycle,” said AAMI President Mary Logan, a member of the working group. “Less work has been done on assessing benefit and risk in the postmarket.”

Most in the industry look to ISO 14971, Medical devices—Application of risk management to medical devices, to apply risk management processes across the total product life cycle. However, ISO 14971 only devotes one clause to postmarket risk assessment, indicating that manufacturers should conduct this activity as part of their quality management process and initiate action when appropriate. The standard does not go into detail about how this assessment should be done. For the working group, the key was to make “benefit” a foundational principle and emphasize its role in postmarket considerations.

“14971 actually uses ‘benefit’ very infrequently, although it is there implicitly,” said Chuck Sidebottom, a medical device standards consultant and editor of the AAMI report. “The framework provides a way to assess benefit in a more informed, structured way, for example, by balancing a loss of benefit when a device is removed from the market against the increased risk caused by a safety issue.”

The framework—which members of the working group hope will, in its ultimate form, be used by both the medical device industry and the FDA—is presented as a flow chart. It maps the necessary steps to include in a postmarket benefit–risk assessment, from the first appearance of a postmarket problem through implementation of a solution. The report also includes several additional tools, such as a new risk assessment form intended to promote a shared discussion of risk and direction for using quantitative decision analysis tools to improve decision quality.

“The working group hopes that industry and the FDA will use the framework in their own independent analyses and processes, as well as in the discussions that occur between them,” Logan said. “If the FDA and medical device companies consistently use the same framework to do their assessments—and if the process that the FDA and industry use is predictable and transparent—then it’s much more likely that both will arrive at a decision that clearly meets the public’s best interests.”

The FDA’s document—Factors to Consider Regarding Benefit–Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions—was informed by the working group’s discussions, although the guidance is broader in scope. According to the FDA, the guidance aims to bring transparency, consistency, and predictability to its decision-making processes and ensure that decisions about the availability of devices are ultimately in the best interest of patients.

“In certain situations involving risks of patient harm, FDA and industry, individually or collaboratively, can help maximize benefit and reduce risk to patients by assessing the situation, considering patients’ perspectives, evaluating any regulatory noncompliance or device nonconformity in light of the benefit–risk profile of the device, factoring in alternatives, where available, considering the benefit–risk tradeoffs for patients of each decision option, and determining the most appropriate next steps,” the FDA wrote in its draft guidance.

In the draft, the FDA identified the factors it may consider when assessing benefit and risk, as well as other factors involved in product availability, compliance, and enforcement decisions. The agency went on to explain how it considers benefit and risk to make patient-focused decisions, providing examples of how this process could be applied to five hypothetical or simplified real-world situations.

Logan said that the working group’s framework and the FDA’s draft guidance can be seen as complementary. “Reading both documents together provides a much clearer picture and makes each document more useful,” she said.

Logan added, “Now that both documents are published it’s up to the community—both industry and the FDA—to read them and offer feedback on how this approach can be improved. AAMI is very interested in hearing what the community thinks will work well and what might not work at all.”

How to Comment

To comment on the AAMI working group's draft benefit–risk framework, download and complete the public reviewer form. Comments submitted without using the electronic public reviewer form will not be accepted. Commenters should provide their contact information, as well as the title of the report: Postmarket Risk Management: A Framework for Incorporating Benefit-Risk Assessments into Postmarket Decisions. All comments should clearly reference the line number in the document to which they apply. Once completed, the form should be sent to csidebottom@aami.org. All comments must be received by Aug. 11, 2016.

Comments on the FDA’s draft guidance can be submitted through www.regulations.gov until mid-September.