In the words of a medical device industry leader, "Congress has delivered a message to our industry that we have heard loud and clear."
Alan Magazine, president of the Health Industry Manufacturers Association, was referring to a July 23 Senate hearing at which devicemakers were roundly criticized for telling too little about the fitness of their products to operate in the year 2000.
Washington-based HIMA also scrambled to head off a threat by Sen. Christopher Dodd (D-Conn.) to read off names of companies that failed to respond to requests from the Food and Drug Administration and the Department of Veterans Affairs for status reports on their equipment's year-2000 problems and solutions.
Congressional impatience with medical devicemakers followed a public splash by a VA-led healthcare alliance, sounding the alarm about a dearth of actionable information from vendors (July 13, p. 14).
After Dodd met with Magazine July 29 and saw a HIMA "action plan" demonstrating that devicemakers were not trying to stonewall or avoid the issue, he indicated he would delay his narration on the Senate floor, said Bernie Liebler, the HIMA's director of technology and regulatory affairs.
The steps include working with representatives of the National Patient Safety Partnership, the VA-led alliance, to develop an "optimum practical set" of details.
The aim is to provide "reasonable information in a reasonable way," distributing enough specifics about devices without overwhelming thousands of small manufacturers with a reporting burden that makes it difficult to do business, Liebler said.
The trade group acknowledged the need not only for facts but for faster dissemination. " `Quickly' for this issue is not like quickly normally is," Liebler said.
The HIMA also changed its tune about using the FDA's World Wide Web site to report compliance data. In an Aug. 3 memo to members, Magazine strongly encouraged participation.
That contrasted with an April 1 HIMA letter to HHS declaring that the Web site was not "an appropriate or necessary step" and that manufacturers should be encouraged to address year-2000 issues directly with customers "in one-on-one interactions discussing particular products."
"It was not the most diplomatic letter we've ever written," Liebler said. "Basically we owned up to that."
