The FDA has put out a warning that the daylight savings time (DST) change this weekend could have a detrimental and unpredictable impact on medical devices. The warning covers hospital networks and all manner of health IT. Sounds like Y2K all over again, but though nothing much happened in the year 2000, this is a potential problem worth addressing.
Why is this DST change any different than other years? This year begins new start and end dates for daylight savings, coming up three weeks earlier than usual and ending a week later.
The agency has warned that medical devices that are involved with medical records or logs that include time data might not operate properly unless updated by the device manufacturer.
According to the FDA, patient treatment or diagnostic result could be:
- incorrectly prescribed;
- provided at the wrong time;
- given more than once;
- given for longer or shorter durations than intended; or
- incorrectly recorded.
Some medical device companies are being proactive in addressing the problem with their customers. Siemens Medical Solutions for one has been working with customers for several months in anticipation of Sunday’s time change. The overall goal is to avoid operational inefficiencies and most importantly instances where patient safety could be jeopardized, said Marie Pettinos, senior director of global CRM (customer relationship management).
Pettinos is charged with handling the channels of communication to customers regarding needed updates in department systems such as RIS and PACS as well as clinical information environments and financial systems within hospitals.
Some Siemens customers operate under an ASP (application service provider) model which means that Siemens stores their data and manages the technology for them at a facility in Malvern, Pa. However, the more common model is one in which the customer manages their own systems and data in an ICO (in-house computing option) model. In the ICO case it is up to the customer to install the update patches not just to the Siemens systems, but also to any other vendor system in their network.
Siemens expects that most of the problems will come from ICO customers because the problem there is two-fold. Due to their persistence, generally customers will apply the patches to the Siemens systems, but the concern is whether the appropriate patches for other vendors will be applied. If they are not, then the Siemens systems can be exposed to problems as sort of a domino effect, according to Jim Delone, director customer service, Global Support, interim program manager for DST.
If an ICO customer is unable to do the updates internally, Siemens offers professional services for customers that are not able to get the updates installed in time, and this includes placing the patches on systems from other vendors.
“Ultimately an error would manifest itself in our application,” said Pettinos. The underlying infrastructure is what needs to get updated and if customers don’t do that “all of the systems in the network will be impacted.
Pettinos believes that all of the concerns from the FDA regarding possible errors with patient data and other healthcare operations definitely warrant attention. “The biggest issue would be an out-of-synch condition where a system with an order for a drug or test might have one date/time stamp and the results from another system has another date/time stamp and you are trying to reconcile these things,” she said.
Or, scheduling systems that do not match up in time or date could create havoc during medical procedures which potentially could impact patient safety.
As another check, Siemens is offering software scripts that can audit departments to assure that the patches have been correctly applied, said Delone. The goal is to get as many of these situations mitigated as possible by Sunday. This means reaching out to customers time and again if necessary to avoid problems, he added.
This weekend marks just one event in what will be a busy year in time change headaches.
There are four dates that will actually change between March 11 and October because DST begins three weeks earlier and one week later. So, the dates that come into question are March 11, and then April 1 which would have been DST without the change. The industry will then head into September and October with the same scenario, said Delone. They expect that March 11 will be the biggest challenge, but they will have to keep