FDA halts expansion of network to monitor medical device safety

Despite its plans to closely monitor deadly malfunctions and misuses of medical devices through a new computer reporting system, the Food and Drug Administration has frozen the project in place well short of its goal of connecting 500 hospitals.

The system, known as MedSun, allows doctors nationwide to directly report to the FDA problems with pacemakers, stents, and defibrillators. The FDA had aimed to connect 500 of the nation's 5,000 eligible hospitals, but is stuck at 350 and won't fund further expansion for the next several years.

That means more doctors are using an older system, through which they report problems to manufacturers, who then notify regulators. Some fear the process allows device makers to downplay bad news to the FDA.

The FDA estimates that problems with medical devices cause 300,000 deaths and injuries annually. The FDA, doctors, and hospital administrators hoped MedSun would alert them more quickly to problems and uncover patterns that might otherwise take years to discover.

Critics say the FDA's handling of MedSun contradicts its pledges to step up safety monitoring. The lack of additional funding is ''consistent with the pattern of the FDA under this administration, to act in a way that is complicit with the entities they're supposed to regulate," said US Representative Maurice Hinchey, Democrat of New York, who sits on a subcommittee that sets the FDA's budget.

Last fall, the FDA said it wanted to expand MedSun in response to problems with cardiac stents made by Johnson & Johnson and Boston Scientific Corp. The idea was to use the data to give the FDA a better understanding of problems routinely reported by manufacturers when new devices are introduced.

For example, The Wall Street Journal yesterday reported that even after Boston Scientific last year voluntarily recalled some of its latest stent models, doctors said some patients were still suffering injuries during implantation of the devices, though the FDA called the rate of problems acceptable. Many of the doctors' reports were submitted to the FDA through Boston Scientific. But agency officials have also used MedSun to follow-up on the safety of stents on the market.

Earlier this year, Guidant Corp. and Medtronic Inc. ordered recalls of implantable defibrillators, forcing thousands of patients to consider replacement surgery.

Marilyn Flack, an FDA official, said the agency proposes to spend about $5.1 million to operate MedSun in the 2006 fiscal year, which begins Oct. 1, about the same as a year ago. It costs about $20,000 to add a hospital to the system, something the FDA has been doing each year until now. The goal had been to connect 500 sites, but Flack and others said 350 are enough to make it useful and technical improvements to the system are planned.

''Within my budget, this is absolutely a success story," she said.

MedSun, whose full name is Medical Product Surveillance Network, was introduced in 2002 and represents a tiny fraction of the FDA's overall budget. For the next fiscal year it has requested $1.49 billion for salaries and expenses, up from $1.45 billion in 2005. The House approved $1.48 billion in spending, but the figure must be reconciled with the Senate version of the budget bill.

''We're all affected by undiscovered, latent device problems," said Geri Amori, a Vermont hospital consultant and past president of the American Society for Healthcare Risk Management. Some medical device safety issues might go undetected if MedSun does not reach more hospitals, she said.

Pam Weagraff, principal of Acelera Consulting, a North Reading medical technology consulting firm, said data from more hospitals might have led to earlier detection of problems with Guidant's defibrillators. The Indiana company is recalling 42,000 of the devices after reports from doctors that they might not deliver a life-saving shock to the heart when needed.

A Guidant spokesman declined to comment on whether MedSun's limitations delayed the defibrillator recall.

Last year, the FDA acknowledged the need for improved oversight of newly introduced devices and said that 22 percent of the follow-up studies manufacturers were supposed to submit were not completed.

The majority of reports about health problems associated with devices are now reported to the agency by manufacturers through a computer network known as Maude, or Manufacturer and User Facility Device Experience Database. Doctors are only required to report deaths through the system. They send reports of serious injuries to device makers, who file them to Maude.

Stents are tiny wire-mesh tubes used to prop open arteries once they have been cleared of blockages through a procedure known as angioplasty. After drug-coated cardiac stents made by Johnson & Johnson and Boston Scientific were linked to deaths and patient injuries shortly after they went on the market, the FDA called for more timely reporting of such problems to help determine public-health risks.

In most instances ''we do not have a complete accounting of all cases or information on the number of devices actually in use," wrote two FDA officials in a paper published in the New England Journal of Medicine in October.

A bigger MedSun database would help solve that problem, Daniel G. Schultz, the FDA's top device regulator, said at the time, when about 300 hospitals were part of the system. In its 2006 budget request, the agency said that once MedSun is fully implemented it will ''reduce device-related medical errors."

On a small scale, that is already happening. Pete Gummere, director of materials and management at Northeastern Vermont Regional Hospital in St. Johnsbury, which uses MedSun, said that in two recent cases the system allowed doctors to notice that problems with devices at Northeastern Vermont Regional Hospital were cropping up elsewhere. In one case, an electrical generator used to cauterize tissue during surgery was overheating and failing. The manufacturer withdrew the product after MedSun users started pointing out the problem. When individual doctors report flaws, Gummere said, companies often blame them on user errors.

''Manufacturers, I don't care who they are, as soon as you tell them there is a product defect, they go into denial mode," he said.

Ross Kerber can be reached at kerber@globe.com.