FDA, INDUSTRY RESPOND TO FINAL HRS GUIDELINES

Regulators and devicemakers pledged to implement many of the Heart Rhythm Society (HRS) recommendations released Sept. 28 that ask the FDA, industry and physicians to do a better job of tracking heart device malfunctions and communicating device adverse event information.

The HRS' draft recommendations, issued in April, called for a new approach to postmarket surveillance of pacemakers and implantable cardioverter-defibrillators. Specific recommendations included:

The FDA should stop using the word "recall;"

The FDA should establish a more efficient tracking system and a public notification process for device adverse events;

Devicemakers should expand their use of remote monitoring and wireless technologies to identify potential device problems early; and

Physicians should return devices whether they are removed for routine replacements or because of malfunctions.

The final recommendations are "largely in line with the draft recommendations [the HRS] released in April," AdvaMed President and CEO Stephen Ubl said.

AdvaMed fully endorses the recommendation that the FDA stop using the term "recall" in its public communications on device malfunctions or potential malfunctions, Ubl said, adding that the word is "often inappropriate and routinely misunderstood." (http://www.fdanews.com/ddl/33_40/)