Risk Communication

New US guidance on “Dear Doctor” letters for faulty implantable cardioverter defibrillators

The US Food and Drug Administration (FDA) has issued guidance for implantable cardioverter defibrillator (ICD) manufacturers on best practices when writing a “Dear Doctor” letter to inform physicians of any faults found in their devices that are in distribution¹.

The guidance, which may also be used by FDA staff reviewing the Dear Doctor letters, recommends that ICD manufacturers issue the letters in a timely fashion, so that physicians have the proper information to respond to patient inquiries generated by public warnings, including media reports. Its recommendations might also be useful in communicating risk when no recall action is being taken but new information is available about ICDs, such as labelling changes or product updates.

The composition of the letters should be as consistent as possible in order to convey information about ICDs, and to avoid unnecessary subsequent letter revisions that may cause confusion. The guidance recommends that Dear Doctor letters are concise, formatted for easy readability, begin with a succinct description of the problems and refer physicians to attachments containing more complex descriptions, if necessary. The FDA also recommends that letters include a bulleted list or table that addresses in a particular order, areas of concerns. This list addresses issues such as the nature of the device failure, likelihood of the problem, the severity of the failure and recommended advice and treatment that can be given to patients with affected devices.

The FDA says that guidance specific to these devices is necessary because the communication of ICD failures requires a specialised approach due to the fact that certain types of failures can directly result in patient death; there are risks associated with explantation of these long-term implants that may be higher than the risk of continuing to use the device; and ICDs are programmable, so that some types of problems can be fixed non-invasively through reprogramming.

In producing this guidance, the agency has drawn on its own research, risk communication principles and other efforts to standardise Dear Doctor letters, including recommendations from the Heart Rhythm Society, Health Canada and the UK Medicines and Healthcare products Regulatory Agency.

References

1. Guidance for Industry and FDA Staff: Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs), 19 July 2007, www.fda.gov/cdrh/ocer/guidance/1645.html