www.fdanews.com/articles/97898-fda-gives-8216-best-practices-8217-for-dear-doctor-letters-on-icds

FDA Gives ‘Best Practices’ for Dear Doctor Letters on ICDs

August 31, 2007

Implantable cardioverter defibrillators (ICDs) are life-saving devices whose failures can cause patient deaths; therefore, the communication of these failures to healthcare professionals requires a “specialized approach,” the FDA says in a recent guidance. The guidance outlines what the agency considers “best practices” for communicating with healthcare professionals about ICD failures.

The document guides manufacturers on the content, format and risk communication principles of Dear Doctor letters regarding ICD failures, corrections or removals. It may also be used by the FDA in reviewing manufacturers’ Dear Doctor letters prior to their issuance.

When device failures involve ICDs in distribution, the manufacturer should initiate a recall, correction or removal with oversight by the FDA, according to the guidance. It should notify all consignees, including physicians, of the reason for recall and the suggested actions to correct or minimize patient risk.

Letters should lead with the name of the device and a “plain-language description” of the problem, including a clear description of deaths and serious adverse events. Recommended actions should be prominent and clearly identified.

Immediately following the description of the problem, letters should contain a bulleted list or table addressing each of the following areas in this order:

The nature of the device malfunction or failure;
The scope or likelihood of the problem;
The severity of the problem;
Whether the failure mode can be observed or predicted in clinical follow-up;
Whether the failure mode can be corrected in situ by reprogramming or upgrading the software;
The recommended treatment for patients
Advice physicians should give to patients;
What should be done with explanted devices; and
Where healthcare professionals can get additional information and updates.

The guidance, “Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs),” can be accessed at www.fda.gov/cdrh/ocer/guidance/1645.pdf.