FDA Joins Bandwagon of Medical Device Interoperability

FDA recognized a set of voluntary technology standards last week that promotes the cause of medical device interoperability.

August 12, 2013

2 Min Read
FDA Joins Bandwagon of Medical Device Interoperability

The Food and Drug Administration has jumped on the medical device interoperability bandwagon, reports Fierce HealthIT.

In accepting a set of voluntary standards, the FDA envisions a world where a hospital room isn't filled with wonderful devices that can't communicate with each other. That siloed existence ultimately hampers patient care.

It is costly too. An analysis made by the West Health Institute shows that the lack of medical device interoperability is basically eliminating cost savings worth $30 billion annually

So what did FDA do? Specifically the agency recognized 25 specific voluntary standards in the Federal Register.

And in a blog post last week, Bakul Patel, senior policy adviser in the agency's Center for Devices and Radiological Health said that "successful interoperability among medical devices can improve patient care, reduce errors, and lower costs."  

Patel also highlighted the reason that medical device interoperability is important with a few examples:

  • An infusion pump that administers medication to a patient also connects to the hospital’s electronic health record system where the physician inputs orders for specific amounts of medication to be delivered at specific times. If the infusion pump and the electronic health record are not interoperable, with clocks that are synchronized, medication errors could occur.

  • A patient in surgery is connected to a ventilator and a central monitoring station. If the two devices are not interoperable, the monitor may send a false alarm, or fail to send a needed alarm. Either error could increase the risk to the patient.

  • Two patients with different medical conditions both have electrocardiogram (EKG) monitors attached to check their hearts’ electrical activity. Both monitors are connected to the same computer system that records the data for later review by a physician. It’s critical that the computer system and the EKG monitors are interoperable so transmission errors do not confuse one patient’s data with the other patient’s data.

Other organizations like the Medical Device Plug-and-Play Interoperability Program have been leading the charge for medical device interoperability since 2004. Continua Health Alliance is also striving after interoperability although its stated goals revolve around personal health and wellness. It aims to establish "a system of interoperable personal connected health solutions with the knowledge that extending those solutions into the home fosters independence, empowers individuals and provides the opportunity for truly personalized health and wellness management."

[Photo Credit: iStockphoto.com user Photomorphic]

-- By Arundhati Parmar, Senior Editor, MD+DI
[email protected]
 

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