With the onset of Daylight Savings Time (“DST”) on March 11, 2007, the federal Food and Drug Administration (“FDA”) has issued a public health notification about risks that might be associated with changing the clock.
On March 1, 2007, FDA issued a preliminary public health notification alerting health care practitioners, hospital directors and safety managers to the possibility that certain medical devices, hospital networks and associated information technology systems may generate risks to patients because of the change in date for DST. The Agency also suggested actions to prevent any such adverse occurrences. This bulletin addresses the warnings and recommendations raised by the FDA with regard to the DST date changes.
Pursuant to the Energy Policy Act of 2005, DST will begin this year March 11, three weeks earlier than in previous years, and will end Nov. 4, one week later than in previous years. Medical devices and systems with clocks, timers, and other clockrelated features usually change automatically for DST based on values set internally or interactions with other devices (such as servers). The FDA expressed concern that devices sold prior to the DST rule changes may rely on incorrect values for DST start and end dates, and medical devices and medical device networks that operate together or interact with other network devices could be at risk. The FDA emphasized that the new DST dates could potentially result in a patient treatment or a diagnostic result that is: (a) incorrectly prescribed; (b) provided at the wrong time; (c) missed; (d) given more than once; (e) given for longer or shorter durations than intended; (f) incorrectly recorded.
In order to prevent any adverse results because of the new DST dates, the FDA recommended that health care practitioners, hospital directors and safety managers take the following actions:
- As soon as possible, check with manufacturers for available patches or fixes for medical devices, hospital networks and associated information technology systems
- Advise patients who use medical devices in their home to check with manufacturers for available patches or fixes for their devices
- Consider providing patients who use medical devices in their homes with a copy of the FDA release entitled Advice for Patients: Change in Daylight Savings Time May Affect Your Medical Equipment in an Unpredictable Way, March 1, 2007
- Assess medical devices, hospital networks and associated information technology systems for the correct time for the following four critical DST times:
- March 11, 2007 (New start date of DST)
- April 1, 2007 (Original DST start date)
- October 28 (Original end date of DST)
- November 4 (New DST end date)
- Be vigilant with clinical decision-making and use of medical devices during both the new and the original DST dates
- Report unpredictable medical device events or DST medical device-related problems to an in-house biomedical engineer, the device manufacturer, and the FDA
If a hospital or other user facility suspects that a reportable medical device adverse event was related to the DST change, the entity should promptly report such event to the FDA. FDA also encourages entities to report—either to the device manufacturer or to MedWatch—adverse events related to the DST change which do not require mandatory reporting.