An interoperable clinical environment offers great potential for healthcare, but many challenges need to be overcome to make it happen, according to the new director of the U.S. Food & Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). Speaking at a recent FDA interoperability workshop, Jeff Shuren, MD, outlined what is needed from the medical device industry and FDA to achieve this clinical environment.Although interoperability is commonplace in other industries—such as computers, television, and automobiles—“the majority of medical devices are not interconnected and hence not interoperable,” Shuren noted. “In this environment, each device is represented by a single, stand-alone product or entity. These individual medical devices provided by many manufacturers are generally designed to operate independently and do not address interfacing with other devices. Data from each individual device is presented separately to the practitioner.”Shuren, who was named CDRH director in January, gave an example of a patient's ventilator that was shut off to take an x-ray. The x-ray film got jammed and the medical team worked diligently to remove it. Once fixed, nobody remembered to turn on the ventilator and the patient died.There are some advanced systems that include integrated and interoperable devices, Shuren added, but they can only interact with the proprietary product line of the manufacturer.Still, the clinical benefits of interoperability are numerous. “As a clinical device environment becomes completely interoperable, the ability for truly integrated plug and play will emerge,” he said. “The practitioner will have the ability to unplug an existing module and select a new module that may provide more appropriate functionality for the patient without the traditional restrictions of proprietary or legacy stand-alone device systems.”An interoperable system will also allow the implementation of patient-centric safety interlocks. “Interoperability could allow for automatic synchronization between a ventilator and imaging equipment designed to take a picture during the ventilator process,” he said.The FDA is examining interoperability challenges, and the first step is to ask the right questions and address these questions with balanced science, Shuren said. “Important questions to be addressed include who is going to develop and maintain the tools, who is going to implement the tools, and who will decide if the tools are adequate to ensure safety and effectiveness,” he said. “Answering these questions will help us identify what tools we need to develop.”