Interoperability May Make Hospitals Eligible for ISO Registration (Demo)

Medical device interoperability is a hot topic in the healthcare sector, especially when no less than the Food and Drug Administration (FDA) has expressed its intent to have manufacturers follow a new draft guidance for it in the near future. Interoperability, as defined by the Institute of Electrical and Electronics Engineers (IEEE), is a technological feature, which allows various systems – in this case, medical devices – to connect and share data. As of this writing, interoperability is still on the discussion table with various health experts, with most medical devices not having the feature yet. Modern Healthcare reports on FDA’s plan in a recent published article:

“The Food and Drug Administration plans to release draft guidance this year for manufacturers seeking to make their medical devices interoperable. Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said the guidance is part of the regulator’s broader effort to evaluate and better understand efforts that would make medical devices and health information technology systems connect and share data.”

Interoperability at a Glance To better understand the concept of interoperability, imagine two soldiers wielding different guns but firing the same ammo. If one soldier runs out, the other can provide him the ammo. This was the rationale behind some of common calibers such as the 9mm. The healthcare sector wants to achieve this kind of interoperability in an effort to reduce errors and make devices compatible with each other. This involves following a proven standard that focuses on conformity assessment for every peripheral connected to the interoperable network. Conformity assessment is a key aspect in ISO registration processes. What Will Happen? Interoperability means hospitals and medical facilities all over the country can use a unified data management system instead of developing their own. Instead of buying a can of Coke for each member of the group, why not share a two-liter bottle? This saves healthcare facilities a lot, just as a two-liter bottle is more affordable when there are many of you. Advocates of interoperability, like the Center for Medical Interoperability, estimates that a unified system can save the healthcare sector around $30 billion a year. It’s costly, yes, but nothing that the industry won’t be able to recoup in a matter of years with savings generated from complying with standards. Conformity assessment, in this case, may put facilities a step closer to eligibility in the ISO 9001 registration process. Certification services like International Standards Authority will look closely into this to make sure the interoperable system is compliant with standards. (Article information from “FDA to offer draft guidance on interoperability of medical devices,” Modern Healthcare, February 6, 2014)