Medical Device Daily Executive Editor

If “security” is the new watchword in computer technology and U.S. homeland defense, “transparency” appears to be the most-referenced word — and need — in U.S. healthcare these days.

The word is being used more and more frequently on the business side to describe the best practices between manufacturers and their customers, and it was the key word in a presentation made recently to a government panel looking at issues of post-market surveillance of implantable cardiac devices.

Last week during an FDA meeting to look at a variety of device and post-market issues, Dwight Reynolds, MD, president of the Heart Rhythm Society (Washington), issued a call for “greater transparency in post-market surveillance, analysis, reporting and communication” as the key to bolstering confidence in implantable cardiovascular devices. And he charged that the agency’s current system for collecting and disseminating adverse event information isn’t doing that job very well.

Physician and patient confidence in the sector took a major hit in 2005 with the recall of thousands of implantable devices. And the fallouts from those recalls have been a slowing of that market and an acceleration of product liability suits, mostly vs. Guidant/Boston Scientific (Natick, Massachusetts), Guidant acquired by Boston Scientific last year and then subsumed as its rhythm management division.

And the halting way in which the recalls were announced and the word spread concerning the device malfunctions certainly increased the level of litigation facing Boston Scientific, with most of the personal liability suits charging significant patient “anxiety.”

That anxiety may remain a burden, since Reynolds in his testimony emphasized the inadequacies of MAUDE, an FDA system established to collect and disseminate adverse event information, and he issued a call to the FDA to design a system that would make up for what he called MAUDE’s “shortcoming.”

Reynolds acknowledged that MAUDE puts adverse event reports on the Internet, thereby making them publicly searchable. But he described these reports as “often cryptic or incomplete [and] difficult to determine if a true device malfunction or patient injury has occurred.

“Poor organization and retrieval tools within MAUDE frustrates the user’s ability to retrieve useful information. It is particularly difficult to distinguish multiple reports about he same adverse event from several sources — from the manufacturer, physician and patient — and recognize updated information.”

And he said that others have identified “inherent problems with MAUDE, including “under-reporting, out-of-date information, and having inadequate resources to meet the current needs for medical device surveillance.”

The result, he said, has been the creation of registries by physician groups to fill the “gaps” in these efforts.

“The FDA needs to acknowledge that the Sentinel Network cannot be a ‘one-size’ fits all database or program,’ Reynolds said, and that it would have to feature “a variety of systems and databases.”

Reynolds also reviewed the collection of data in the Implantable Cardioverter Defibrillator Registry but said it too had “limitations,” including “being mandated only for Medicare patients receiving ICDs for primary prevention, focused only on ICDs, not on pacemakers or leads, and a focus on short-term patient “length of stay” and not “long-term device performance data.”

Perhaps especially noteworthy for other sectors of the med-tech and cardiovascular side of healthcare, Reynolds emphasized that the FDA should make increased use of “remote monitoring” for the collection of adverse event information into a large database.

He noted the recent growth in the number of remote monitoring systems used to keep track of pacemaker and implantable defibrillator activity, thus providing “a mechanism for collecting data on a long-term basis. The data obtained remotely are identical to those collected in a physician office or clinic.”

And FDA, he said, “should work with industry and the physician organizations such as HRS to identify how to integrate the enormous potential of the current and future remote monitoring technology and data in the Sentinel Network.

Some of the other specific recommendations made by Reynolds included:

• Use of a specialized form for cardiac rhythm management devices to permit better and more precise reporting of adverse events;”
• Tracking of devices that are returned to manufacturers for analysis and updating “so as to create facilitate root cause analyses;”
• Inclusion in this database “the adjudication of root cause analysis;”
• Data links to international sources for faster adverse event determination;
• Use of standardized data elements and definitions for each device malfunction, “such as manufacturer model and serial numbers, dates of implant and failure, signs of failure and clinical consequences;”
• Development of “user-friendly formats” and a search engine that will improve use of the network by the public.

Though with somewhat less emphasis, Reynolds also pushed for improvement in the reporting of the adverse data collected.

“In our experience,” he said, “we have learned the hard way that often times the communication of post-market surveillance information is just as critical as the actual collection of such data.”

Thus, he said that HRS was recommending the development of a Physician Advisory Panel to assist FDA in interpreting and data and providing recommendations on action and communication of data concerning adverse events.

And Reynolds noted that HRS is asking Congress to provide “the resources and funding necessary to provide improved post-market surveillance of implanted cardiac devices” — an entreaty that will add to the number of similar outcries for beefing up the agency’s budget.