Millennium bug makes a surprise appearance with early 1999 visit
FDA issues advisory; Rx2000 establishes response center
So much press has been given to the year 2000 (Y2K) transition that glitches in a few medical devices caught the health care community by surprise — in what may become known as year 1999.
"I think most people were amazed that there was the possibility of some malfunction this early," says Cassandra Junker, senior vice president of Rx2000 Institute Solutions in Minneapolis. The institute is a nonprofit, member-supported organization helping the U.S. health care system prepare for the year 2000. "January ’99 was not on most people’s radar screen."
Based on information provided in electronic messages posted on the Rx2000 listserve, the U.S. Food and Drug Administration (FDA) in Rockville, MD, issued a medical device malfunction advisory on Dec. 29. The messages raised concerns that 15 medical devices from eight manufacturers would not work correctly after Dec. 31, 1998. (For a list of products that were named in the listserve, see p. 35.)
"The FDA monitors the Rx2000 Web site and listserve so it can stay alert to what the providers are saying," explains Ronald Hanser, president of Hanser & Associates, a public relations firm in West Des Moines, IA, that works closely with Rx2000. "[After the messages had been posted], the FDA contacted the eight manufacturers of the 15 devices to confirm if there were problems."
Two manufacturers confirm devices’ problems
The manufacturers of two of the medical devices confirmed that these devices may have problems in the transition to 1999. The rest of the manufacturers, however, said their products should not have a problem with the transition. The FDA noted that inclusion on the list does not mean a problem was confirmed and that providers should keep in mind that a product may have been incorrectly identified on the listserve. In addition, the FDA said some of these products still may have problems with Y2K transition.
The two products with confirmed problems are the Palo Alto, CA-based Hewlett-Packard’s 43100A/43200A external defibrillator and the Pleasanton, CA-based Invivo’s Millennium 3500 multiparameter patient monitor.
The problems relate to the ability of the device to display, print, or store the correct time and date of the device’s operation. They still will work in direct use so immediate patient care will not be affected, the FDA said. (For more information on the confirmed problems, see story, p. 35.)
Manufacturers with products mentioned on the listserve are Datascope in Montvale, NJ; Cadwell in Kennewick, WA; Baxter in Deerfield, IL; Sequoia-Turner (now Abbott) in Abbott Park, IL; and Instrumentation Laboratories in Lexington, MA.
"I think the FDA did the right thing [in listing the products]," Junker says. Some companies were not even aware that the FDA had issued a press release.
"Manufacturers are good testers, but everything is a work-in-progress picture," she explains. Since most manufacturers are working diligently to give Y2K compliance assurances to providers about their inventory, the 1999 transition might have caught them off guard.
And why would the transition from 1998 to 1999 be a problem? "Programmers had to put some date at an end of file, or an expiration date, or a date unknown, and they seem to choose 9,’" she says. She expects more problems to arise throughout the year such as those experienced by the two products.
Rx2000 is still compiling reports on any actual 1999 transition problems that may have occurred. "Several health systems did report some events," she says. One health system had a command center where hospitals could report events that happened on any of the listed pieces of equipment. The health system could then alert its other hospitals to the possible problems.
There is a positive side to the 1999 transition problems. "They can be used as early warning systems," Junker says. The lion share of problems, however, will still take place during the Y2K date changeover.
With device problems beginning in 1999, provider and consumer concerns about the Y2K changeover are increasing. "Several of us [at Rx2000] get more than 300 e-mails a day," Junker says "Some of them are from consumers who see our Web site. They are dependent on drugs and are concerned [about Y2K]. Most of the e-mails are from providers looking for answers to all sorts of questions."
Between the focus of the media and the impending Y2K transition, Rx2000 is anticipating a tremendous demand for information and put a communicative mechanism in place to handle the volume. Therefore, it established a Rapid Response Communications Center to alert hospitals and health care clinics to Y2K and year 1999 problems identified with computers and medical devices.
Providers can call toll-free and leave a message regarding any year 1999/2000 problem they encounter. The institute then collects the information and makes it immediately available as an e-mail to its health care members and the worldwide health care community through postings on the Rx2000 message listserve and Web site. (See end of story, below, for phone number and Web site.)
If it can raise the funds, Rx2000 also wants to provide a response center for consumers.
"We are already getting input that beneficiaries don’t know where else to go [for Y2K information]," Junker says. "We’re concerned that if people are trying to take a responsible attitude and get prepared, there is no mechanism in place where they can get their questions answered."
The consumer response center, however, is a massive undertaking, she adds. "It’s on the drawing board. We know what it needs to look like; we know how it needs to be manned, and we know whom we would get to do that." Rx2000 is in the process of raising funds for it now, she says.
[To contact RX2000, call (888) 835-4478 or (612) 835-4478. Or access the organization’s Web site: http://www.rx2000.org.]
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