Background
 
This past year, FDA’s (Center for Devices and Radiological Health CDRH) has dealt with several widely-publicized public health issues related to medical devices. The agency has also been roundly criticized by some for the timing and/or nature of its communications to the public regarding these events.
 
Criticism comes from both sides and requires a delicate balance by the agency. On one hand, alerting the public too early of a potential safety issue that has not been confirmed or is not fully understood can create unnecessary panic and can result in inadvertent adverse consequences. On the other hand, delaying notification until the information has been fully investigated and recommendations have been developed could result in patients who are harmed in the interim period. Companies deal with these same types of questions:  when to alert FDA and/or customers of unconfirmed reports that may or may not represent a safety issue.
 
As an example, in February 2015, FDA released a safety communication regarding reports of infections related to a type of reprocessed endoscope used in hospitals.1 As the agency scrambled over the ensuing months to investigate and develop recommendations for handling the issue of infections transmitted by reprocessed and reused medical devices, it was criticized in the press for delaying in reporting this information to the public.2
 
2015 also saw CDRH continuing to deal with the issue of power morcellators, a surgical tool used to grind tissue during laparoscopic surgery, which were reported to be associated with isolated cases of spreading undetected cancer cells when used in hysterectomy and uterine fibroid surgeries.3 While FDA did not outright ban the devices, the agency issued a strong warning against their use in the vast majority of women. Recently, FDA has been criticized by certain doctors for essentially “jumping the gun” with this recommendation and forcing women into more risky open surgery.4

Guidance
 
On December 31, 2015, CDRH issued a draft guidance document intended to address the issue of when to initially alert the public to potential safety issues, titled Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals). The guidance signals the agency’s intent to err on the side of earlier reporting, in contrast to the current practice of waiting until analysis of the data is complete and recommendations have been developed.

FDA indicates in the draft guidance that such early communications would be intended to allow doctors and patients to better make risk-benefit decisions regarding treatment options, and also states that they may increase levels of reporting to FDA so that the agency can better understand the issue.

The draft guidance advises FDA staff to “strongly consider public communication” when all of the following are true regarding a potential safety issue associated with a medical device:

  1. “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
  2. the available information is reliable and supported by sufficient strength of evidence; and
  3. 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.”

It also provides a list of factors FDA should consider in determining whether to communicate a risk, including the magnitude and seriousness of the risk, the availability of alternative therapies, the timing of FDA’s investigation, and whether there is information in the media that FDA wishes to correct.

The draft guidance prescribes that FDA staff should conduct an initial assessment of information within 30 days, and a reassessment within 30 days of receipt of new information if the initial decision is not to communicate. The guidance also proposes a format for such “Early Communications” (which would precede the more formal “Safety Communications”), which includes warnings that the agency has not completed its investigation, has not determined a causal link to the device, and is not recommending changes in device use. The guidance also states that any such communications should be updated periodically, at least twice a year, even to state that there is no new information.

However, according to the Federal Register notice, FDA intends to notify the public about emerging signals “even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations.”5  In fact, the definition of an emerging signal in the guidance includes that it “has not yet been fully validated or confirmed”, which could be seen as a contradiction with the statement in the guidance that the information must be “reliable and supported by sufficient strength of evidence.”

While certainly public disclosure of reliable safety information regarding medical products is desirable, the approach described in the draft guidance could very well lead to unnecessary alarm and adverse consequences in the event the “emerging signal” turns out to be incorrect, the preliminary nature of the information is not effectively communicated, or if resulting changes in patient management are not vetted prior to implementation. The medical community, media and public take public statements by FDA very seriously, and it is not clear that the subtle-sounding, but very important, difference between an “Early Communication” about safety and a “Safety Communication” will be fully understood or recognized. Serious and thoughtful consideration by FDA regarding when and how to communicate messages regarding “emerging signals” will be critical to avoid ensuing panic. Whether or not the agency is able to achieve this balance remains to be seen if and when this approach is implemented.

Comments

FDA has opened a public docket for comments on this draft guidance and will be accepting comments until February 29, 2016. Electronic comments on Docket No. FDA-2015-D-4803 can be submitted atwww.regulations.gov. Written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.