The formerly fearsome Y2K bug was a no-show on most imaging devices this New Year's, and during the first real test of compliance -- the first work week of 2000 -- reports of the pest remain few and far between.
"It looks like all the preparations and planning finally paid off," said Michael Cannavo of PACS consulting firm Image Management Consultants of Winter Springs, FL. He called the Y2K threat "overrated but necessary."
The Web page set up by technology assessment firm ECRI of Plymouth Meeting, PA, to monitor rollover problems with medical devices, at www.healthcare.ecri.org/site/y2kproblems/index.htm, found just one problem with an imaging device. An Explorer mobile x-ray unit manufactured by Picker International of Cleveland, now Marconi Medical Systems, displayed an error message when it was tested shortly after midnight on January 1.
Marconi's Web site states that there are "no known Y2K-related problems" with the Explorer model, which is no longer manufactured. A spokesman for Marconi said that while the company had no details of the reported problem, it could not have been Y2K-related because Explorer does not have a date clock.
Jim Keller, the ECRI project manager in charge of the Y2K monitoring project, said that overall, New Year's Eve at the monitoring site was just as "boring" as the organization had expected. However, he said ECRI was successful in finding the few medical device problems that did crop up, mostly "printing and display errors, and a couple of examples of device shutdown." Keller added that the site hosted at least one high-profile visitor as well.
"The FDA knew about our site, and in two cases I heard they called the manufacturer to find more information to confirm (ECRI's problem reports). They subsequently called us to say they needed more information from the reporting hospital," Keller said.
In fact, the only device alert posted on the Food and Drug Administration's Y2K monitoring site at http://www.fda.gov/cdrh/yr2000/reports.html was an ECRI posting, according to Keller. The alert concerns AK100 and AK200 hemodialysis units manufactured by Gambro Healthcare of Stockholm, Sweden. The units displayed incorrect dates and times, which the agency said could lead to shutdown of the auto-disinfection cycle. Gambro responded to the report by saying the problem could be solved by simply resetting the time and date correctly after the New Year's rollover.
There were scattered reports of imaging device problems outside the U.S., including an x-ray machine from an unidentified manufacturer that failed shortly after midnight in Norway's Hordalan province. A few minor problems were also posted on the European radiology newsgroup Eufora, at www.devolder.be/eufora. The reported problems included a minor glitch with a Hologic 2000 bone densitometry unit in South Australia, which recorded the year as 1980. While Hologic's Web site offers a Y2K software fix for the model, it could not be ascertained whether the physician who reported the problem had installed the software.
The bulletin board of the American Healthcare Radiology Administrators listed a problem with the flash ID device on a Siemens Mammomat mammography system. However, details of the problem could not be verified.
FDA spokesperson Sharon Snider said the agency had received "no reports of Y2K-related incidents with imaging devices. In fact, there were no Y2K incidents of any significance that would affect public health in the U.S. Our folks who were monitoring did see some incidents reported in other countries, but nothing in the U.S."
Keller said his best guess was that ECRI might hear about a half-dozen more problems over the next week. "I really doubt that there will be much at all that will show up after the leap year," Keller said.
By Eric BarnesAuntMinnie.com staff writer
January 7, 2000
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