From the August 6, 2007, issue of "The Gray Sheet"
Manufacturers should alert doctors about a newly discovered implantable defibrillator risk before their patients learn about it through the media, FDA recommends in a newly released 1guidance document.
Getting safety information out to doctors as soon as possible "helps them to be better equipped to address patients' concerns and mitigate undue alarm," the guidelines note.
The recommendation is one of six "best practices" identified in the document, "Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs)," dated July 19 and posted on FDA's Web site July 30.
FDA emphasizes that communications with health care professionals should avoid promotional statements and concentrate on the immediate problem and recommended actions. "Health care professionals perceive letters from manufacturers as less credible when they appear to focus on minimizing company liability rather than on safety concerns," the agency explains.
FDA also recommends that "Dear Doctor" letters follow a standard format, leading with the name of the device, and a plain-language description of the problem and the adverse events linked to it. Recommended actions for the health care professional should be "prominent and clearly identified."
The letters should be formatted for easy readability with short paragraphs, tables or bulleted lists, large fonts and boldface type to highlight the most important information.
FDA also recommends that safety communications be transmitted to health care professionals through multiple channels at once, including email, fax, express mail and the Web.
ICD Risk Communication Has Been "Spotty"
The guidance is a result of FDA's own research, risk communication principles and recommendations from the Heart Rhythm Society and device regulatory authorities in the United Kingdom and Canada, among others.
Last September, HRS released its final recommendations for industry, FDA and physicians on handling malfunctions of implantable heart devices. HRS' recommendations were the culmination of an industry-wide response to the series of high-profile ICD recalls in 2005 (2"The Gray Sheet" Oct. 2, 2006, p. 3).
Within CDRH, the Office of Communication, Education and Radiation Programs, the Office of Device Evaluation, the Office of Compliance, and the Office of Surveillance and Biometrics collaborated on the guidance. "All of us were seeing, from our different perspectives, that the quality of 'Dear Doctor' letters was spotty," OCER Public Health Advisor Kris Mejia told "The Gray Sheet."
FDA decided to produce a "Dear Doctor" letter guidance specific to ICDs because "ICDs are extremely prominent life-saving devices and they capture the public eye," and because in the past there has been a widespread misconception that any ICD recall should necessitate explant of those devices, Brian Lewis, a medical reviewer in FDA's Office of Device Evaluation, explained in an interview.
HRS president Bruce Lindsay said he observed the same problem. "We felt that things were maybe a little bit discoordinated between industry, FDA and clinical medicine as to how to deal with these problems."
"I think the companies have tried to do the right things, but each company has a different approach to it. Some of them have had more information about the failure modes than others, so the amount of information that's provided could influence how a physician interprets the data," Lindsay explained.
"[For example], some companies have been very clear that they don't recommend removal of the device unless there are special circumstances that would change the recommendation, whereas other companies are very vague about what you should actually do with the information they've given."
Lindsay praised the new guidance. "It reflects the input from the Heart Rhythm Society and addresses most of the concerns that we had. Certainly I had a positive reaction to it."
- Reed Miller
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