Posted December 19, 2016
The Food and Drug Administration (FDA) intends to issue earlier warnings to patients and healthcare providers about potential safety issues with medical devices under final guidance released last week.
“Timely notification about … emerging signals based on the factors described in this guidance document is intended to provide healthcare providers, patients, and consumers with access to the most current information concerning the performance and potential benefits and risks of marketed medical devices so that they can make informed patient management decisions about their treatment and diagnostic options,” the agency wrote.
The FDA has defined an “emerging signal” as “new information about a marketed medical device: 1) that supports a new causal association or a new aspect of a known association between a device and an adverse event or set of adverse events, and 2) for which the agency has conducted an initial evaluation and determined that the information has the potential to impact patient management decisions and/or the known benefit-risk profile of the device.”
According to the guidance, “information that is unconfirmed, unreliable, or lacks sufficient strength of evidence is not an emerging signal.”
The FDA’s plan to publicly release information about emerging signals related to medical devices drew criticism from industry after the draft was published in late 2015. For example, in its public comment, the 510(k) Coalition wrote that “by publishing emerging signals as described in the draft guidance, FDA would be acting based upon preliminary information that is not scientifically verified and of unknown significance.” The coalition, which is made up of medical device companies, also cautioned against “unnecessarily” alarming the public and confusing consumers.
Similarly, AdvaMed, a medical technology trade association, called the publication of emerging signals “confusing and misleading.”
Patient safety advocates, on the other hand, applauded the FDA’s effort to get information about adverse events into the hands of consumers faster. “The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming evidence that the FDA would like to have before making recommendations. But in the months or even years during that delay, patients can be and too often have been seriously harmed,” wrote members of the Patient, Consumer, and Public Health Coalition.
According to the FDA, information about emerging signals may come to its attention through a variety of sources, including medical device reports (MDRs), MedSun Network reports, data from postmarket studies, epidemiological research, and investigations conducted by other global, federal, or state health agencies. Once receiving this information, the FDA said it will conduct an initial assessment within 30 days and decide whether a public notification is needed.
The agency will “strongly consider” notifying the public when:
- The information supports a new causal association, or a new aspect of a known association, such as an increased rate or severity of event or reduced benefit, between a medical device and one or more adverse events or clinical outcomes.
- The available evidence is of sufficient strength.
- The information could have important clinical implications for patient management decisions and/or could significantly impact the known benefit-risk profile of the device.
“The decision to provide public information about an emerging signal is intended to give healthcare providers, patients, and consumers access to the most current information about a device that may help inform their patient management decision making,” the FDA wrote. “It does not mean that FDA has definitively concluded that there is a causal relationship between the medical device and the emerging signal; nor does a public notification about the emerging signal mean that FDA is advising healthcare providers, patients, or consumers to limit their use of the device.”
The FDA acknowledged that “risk information provided without context may alarm patients,” but said that “in some circumstances … the benefits of providing early information to the public outweigh these risks if the information is communicated carefully and thoughtfully.”
As a result, the FDA said it does not plan to issue a public notification unless:
- Credible scientific evidence supports a new causal relationship, but the agency needs additional time to reach a more definitive conclusion.
- The agency has concluded a causal relationship exists, but it needs additional time to develop recommendations.
The FDA noted it intends to reach out to medical device manufacturers before publishing such a notice, “unless time does not permit because of the risk of patient harm or it is not feasible.”
– See the FDA Document HERE