WASHINGTON - The recent problems encountered by Guidant (Indianapolis) have stimulated considerable discussion in and outside the medical device industry, and AdvaMed (Washington) has responded with a proposed set of standards for reporting “pulse generator“ performance.
While the FDA and the Heart Rhythm Society (Washington) are currently inking their own standards for such reports, AdvaMed has the advantage of its membership - which includes several major players in the defibrillator and pacemaker markets - to bolster the use of its guidelines.
Jeffrey Secunda, associate vice president of technology and regulatory affairs at AdvaMed, told Medical Device Daily, “We have four out of the five industry people involved [in the development of the proposal] and they have all bought in.“ And he noted that Guidant, St. Jude Medical (St. Paul, Minnesota) and Medtronic (Minneapolis) all currently post product performance reports on their web sites.
Based on ISO 5841's Annex B, the AdvaMed proposal seeks to “minimize areas where manufacturers are required to use judgment so that the product performance reports provide the most objective, feasible representation of device performance.“ Included in the performance reports would be all-cause device survival curves and malfunction-free survival curves, with and without compromised therapy.
However, such data will not include “induced malfunction,“ a term that includes “damage to a pulse generator caused by a lead malfunction.“ The draft also calls for reports to cease when “fewer than 500 of the total initial implants remain in service.“
On the subject of making such data directly available to patients, Secunda noted that companies can post such data on their web sites, but that such reports tend to be “lengthy“ and that it is difficult to determine “how much information they will derive from it.“
The proposal does not deal with how a firm might collect data on or communicate specific adverse health outcomes in connection with device failures.
Secunda said that such data deal with “clinical issues, and companies are not in a position to comment on the condition[s] of patients.“ He added that physicians are in the best position to address the concerns of patients and their families.
AdvaMed's March 20 press release, signed by the organization's president and CEO, Stephen Ubl, says that the intent of the proposal is to “improve communications between the manufacturers of cardiac rhythm management devices and patients, providers and the public.“
However, Secunda indicated that AdvaMed is neither engaging in nor recommending that member companies engage in a broad public information campaign in connection with the proposal.
— Mark McCarty, Washington Editor