Makers of information software for hospitals are lobbying Congress to exempt them from regulation by the Food and Drug Administration in a bill aimed to update the agency's rules on medical devices.
"The FDA believes it has a mandate to regulate everything related to patient care under medical devices," said Jim Albertine, a lobbyist for Shared Medical Systems, the largest manufacturer of laboratory information systems in the United States. "Where does this stop?"
The first act of Congress giving the FDA authority to regulate medical devices was in 1976, in response to the sale of unsafe intra-uterine devices, or IUDs, to thousands of American women. Since 1987, all clinical software - from programs that maintain patient and accounting records to those embedded in pacemakers and lung machines - have been lumped together in one category. So far, the FDA has not actively regulated "laboratory information systems," the software systems that have transformed hospitals from paper mills into vast data centers.
And manufacturers want Congress to ensure that the agency doesn't start doing so. The 1997 Medical Device Regulatory Modernization Act, which is scheduled to be voted on this week by the House Commerce Committee as part of a larger FDA reform package, would update the practices of screening medical devices by the FDA. A similar bill is currently making its way through the Senate.
But software manufacturers say that as more and more hospitals digitize, all computers used in health-care facilities are not the same, and that now is the perfect time to clarify this distinction.
Albertine points to blood banks as a bad precedent for what happens when the FDA starts regulating a niche software industry. In 1994, the FDA issued regulations for software customized for blood banks because of fears that poorly designed systems could allow blood with the virus that causes AIDS to slip by. Since the deadline for regulated systems, only a handful of software programs have been approved.
"It's a very regulated, very rigid system that caused many companies to get out of the business," Albertine said.
But the FDA says there was no getting around regulating blood-bank software, and that software used by hospitals should be held to higher standards than software installed at other businesses.
"The blood-bank issue changed in recent years because of something called AIDS," said Don McLearn, a spokesman for the FDA. "With safety, there is sometimes a cost, but I think most people would agree that it's a small price for safe blood."
McLearn said that exempting any health-care software is a bad idea, and that it is all crucial to patients - whether it's the reliability of finding a patient's chart in a database or making sure a pacemaker won't malfunction.
"Of course, people who aren't regulated will start complaining about it when they [are]," he said. "But we're not doing it to be burdensome; we're just following our responsibilities."
But this better-safe-than-sorry approach doesn't wash with the software manufacturers, who say that the FDA clearly needs a better understanding of what software is.
"The FDA has to show that there is a real risk involved in using this software, and they haven't," Albertine said.
Those in Congress say that few - if any - changes to the bill will be added at this point, but that it is possible to add a technical distinction.
"It may be natural to include it in a bill, because it is something that has changed the health-care industry dramatically in the past 25 years," said Craig Murphy, spokesman for Representative Joe Barton (R-Texas), who is chairman of the House subcommittee on Oversight and Investigation.
