Last week, the FDA announced plans to take a more aggressive approach to reporting medical device safety warnings to the public. The initial notification was delivered via an email announcement, and stated that FDA intends to increase the speed with which evolving information is shared with the public. The email was followed by a draft guidance entitled, “Public Notification of Emerging Postmarket Medical Device Signals (‘Emerging Signals’),” published on December 31, 2015.
According to the draft guidance, “an emerging signal is new information about a medical device used in clinical practice: 1) that the Agency is monitoring or analyzing, 2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device, 3) that has not yet been fully validated or confirmed, and 4) for which the Agency does not yet have specific recommendations.”
The FDA recognizes that all medical devices have both benefits and risks. When a device is approved or cleared, an accompanying benefit-risk profile is provided to health care providers, patients, and consumers for use when making treatment decisions. After the device is on the market, new information, such as unanticipated problems, may become available. This information could alter a device’s benefit-risk profile, and it is important that these emerging signals are communicated as timely as possible.
Issuing Public Notifications about Emerging Signals
In the draft guidance, the FDA states that it “considers many factors in the course of evaluating and communicating about medical device emerging signals,” which include (but are not limited to):
- Seriousness of the adverse event(s) (e.g., severity and reversibility) relative to the known benefits of the device;
- Magnitude of the risk (e.g., likelihood of occurrence);
- Magnitude of the benefit;
- Strength of the evidence of a causal relationship between the use of a device and the adverse event;
- Extent of patient exposure (e.g., how broadly is the device used, is the device still actively manufactured and distributed);
- Whether there is a disproportionate impact on vulnerable patient populations (e.g., children, pregnant women, elderly, cancer patients, chronically ill, at-home/unmonitored);
- Potential for preventing, identifying, monitoring or mitigating the risk;
- Availability of alternative therapies;
- Implications for similar or related devices (e.g., multiple models from multiple manufacturers);
- Anticipated time for completion of initial FDA assessment and development of recommendations;
- Accuracy and availability of information already in the public domain.
The FDA’s decision to share information will presumably be made to provide health care providers, consumers, and patients with the most current information, in cases where timeliness is an issue. In addition, the Agency states that its “decision to communicate about a medical device emerging signal may be affected by information the public has received from sources other than FDA, such as in the mainstream or social media.” It is possible that the public may question the safety of a medical device based on information and/or data that is incorrect, incomplete, or misleading. “In such cases, FDA may issue a statement or engage in other methods of communication to clarify or correct information and respond to public interest.”
The draft guidance advises FDA staff to strongly consider reporting medical device safety warnings to the public “when all of the following statements apply:
- The information represents a new, potentially causal association, or a new aspect of a known association (e.g., increased rate or severity of event or reduced benefit), between a medical device and one or more adverse events or clinical outcomes;
- The available information is reliable and supported by sufficient strength of evidence; and
- The information could have important clinical implications for patient management decisions and/or could it significantly alter the known benefit-risk profile of the device.”
An initial assessment will be conducted by FDA staff within 30 days of receiving new information. At this time, the Agency will determine whether or not it is necessary to notify the public.
Format of Communication
For purposes of consistency, the document states that FDA will communicate all medical device emerging signals using the format described in the draft guidance. Furthermore, once the emerging signal has been communicated, FDA may provide updates that:
- Provide new information related to the emerging signal collected since the initial public notification;
- Update the public that no additional substantive information is available and/or that no known change in the benefit-risk profile of the device has occurred since the last posting;
- Notify the public of additional actions being taken or completed by FDA and/or the manufacturer(s).
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