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FDA helps manufacturers inform physicians about ICD recalls

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 27, 2007

Device manufacturers have some new guidance about what to tell doctors when they notify them of potential health hazards of recalled implantable cardioverter defibrillators (ICDs). The FDA advised manufacturers how to prepare "Dear Doctor" letters about ICD recalls, declaring such letters the "first line of communication" with physicians about such recalls. The guidance calls the wording, format, and substance of such letters critical and provides recommendations on how to issue the letters and what information to include. The guidance does not set any new legal or regulatory requirements but merely offers recommendations.

The guidance can also help manufacturers draft such letters about other implanted devices such as pacemakers, according to the FDA. The FDA also noted the guidance may assist manufacturers in communicating non-recall information about ICDs such as updates, labeling changes, performance notes, and recommendations regarding implantation.

The guidance indicates that FDA studies revealed "best practices" on how to communicate with health care professionals about ICD problems. Such communication should:

• name the device and clearly describe the problem, then explain the deaths and adverse events and prominently identify recommended actions
• use large fonts, bold type, and formatting styles that make the letter easy to read
• be distributed by multiple methods such as e-mail, web, mail, and fax
• be distributed to health care professionals before the media alerts patients to the ICD problems
• focus on discussing the problem and recommended action not minimizing liability
• exclude promotional content

The guidance notes the Dear Doctor letters should be brief and use attachments to provide additional detailed information. The content should address, among other issues:

• the nature and severity of the problem
• how to detect whether an implanted device has already failed or may fail
• whether the device must be removed or can be monitored
• whether reprogramming or upgraded software can address the problem
• what to do with removed devices
• where to get more information

To review the guidance on the FDA's web site, click here.

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