ROCKVILLE, Md. -- The FDA has warned all hospitals about a possible unanticipated fallout from an act of Congress -- the three-week-early shift to daylight savings time. All medical events triggered by computer clocks could chime an hour out of whack on Sunday.
ROCKVILLE, Md., March 9 -- The FDA has warned all hospitals about a possible unanticipated fallout from an act of Congress -- the three-week-early shift this year to daylight savings time.
Unless software patches are properly installed, medical events triggered by computer clocks could chime an hour out of whack on Sunday. And there could be a repetition, like clockwork, as the effect ripples through the calendar over the rest of the year.
No one believes that Sunday's premature loss of an hour reaches the critical mass of the Y2K fears of 2000, but the FDA has put hospitals on the alert for untimely bells and whistles.
In letters to doctors, hospital administrators, and patients, the FDA noted that some medical equipment "may generate adverse events" because of Sunday's change to daylight savings time at 2 a.m.
"We'll be watching it," said Jeff Stevens, section head for telecommunications services for the Mayo Clinic in Rochester, Minn., "but we think we're pretty well covered."
Stevens said Mayo has been able to install software patches for most systems, so that the change will be automatic. But some systems -- including the hospital's voice mail system -- will require the time change to be manually performed early Sunday morning.
Toronto's University Health Network is also confident there will be no problems, according to a spokeswoman. She said the information technology department has installed software patches that should make the time change seamless.
The FDA was especially concerned about networks and other systems where devices have to be synchronized, but gave no examples.
Health Canada, in a similar letter, was more specific. The Canadian agency said implanted pacemakers or defibrillators with sleep modes that can only be adjusted by physicians could be affected. So could Holter monitors and glucose monitors with storage functions.
But the agency noted that few of these effects would have an impact on patient safety.
The FDA, on the other hand, issued the warning under its MedWatch system, because officials fear that -- like the Y2K scare of 2000 -- networked devices might give the wrong information, endangering the safety of patients.
The agency said patient treatments or diagnostic results could be incorrectly prescribed, provided at the wrong time, missed entirely, given more than once, given for longer or shorter durations than intended, or incorrectly recorded.
"Any of these unpredictable events could harm patients and not be obvious to clinicians responsible for their care," the agency said.
The change in daylight savings time is the result of an Act of Congress, aimed at saving fuel. Canada followed suit.
The FDA and Health Canada said clinicians should be wary after 2 a.m. on Sunday, but also on three other days -- April 1, when the time has usually changed; Oct. 28, when daylight savings used to revert to standard time; and Nov. 4, when it will change to standard time this year.
Most medical equipment with built-in clocks installed before the congressional action may either not change properly on the new dates or change improperly on the old dates, the agency said.