Navigating the Intersection of Medical Devices, Health IT To Boost Patient Safety

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One of the many Holy Grails in health care -- trailing somewhat behind the perennial pursuit of lower costs -- is the notion of interlinking the sometimes disparate components of medical devices, clinical systems, information systems and communication platforms to streamline care and make the entire delivery universe safer for patients.

We're getting closer, but because of the notoriously fragmented arena that constitutes the U.S. health care system, progress is, well, painstakingly slow. The good news is that the parties that need to be invested in making this interconnectedness happen are talking -- and collaborating.

These parties include device makers and information system vendors, FDA, the Office of the National Coordinator for Health IT, the Federal Communications Commission, standard-setting bodies and a slew of interested independent organizations. The latter group ranges from the Healthcare Information and Management Systems Society to the ECRI Institute, and from the MD PnP (Medical Device Plug-and-Play) workgroup to the recently formed Integrating the Healthcare Enterprise (IHE) and CE-IT Community. All are engaged, separately or jointly, in efforts to propel device-and-system interoperability while improving health IT-associated patient safety.

MD PnP, based in Cambridge, Mass., is arguably leading the pack in propelling interoperability and clinical integration to improve safety. The multi-institutional program, based at Massachusetts General Hospital, is developing a new open standard called ICE (Integrating the Clinical Environment) to define ideal conditions and standards for safer device integration. The program also continues to refine interoperability contracting language that hospitals can use to more prudently procure medical devices that are or can be configured for safer integration. Medical Device Free Interoperability Requirements for the Enterprise (MD FIRE) is now used by the Department of Veterans Affairs system.

"MD Fire is really a blueprint document -- openly shared and sharable -- that health care delivery organizations can use for RFIs and RFPs to help them articulate their needs," said Julian Goldman, MD PnP's program director and medical director of biomedical engineering for Partners HealthCare System. "It's a living document that's actually a step on the journey toward safer interoperability."

Dialing down to the regulatory intersection of medical devices, health IT and other technologies, recent developments portend or are already delivering safety gains. In 2013, FDA began implementing the unique device identification system, which enhances post-market device surveillance by enabling easier identification and recall of products when things go wrong. And earlier this year, FDA moved forward with its Electronic Medical Device Data Reporting (eMDR) system to enable and expedite electronic adverse event reporting.

In April, the long-awaited FDASIA report called for FDA to focus regulatory resources on health IT products that effectively function as medical devices and therefore increase risk if they do not work as intended. That report also calls for establishing a national health IT safety center, which would also target the device-health IT intersection.

"The details [of the center] are to be determined, but we are excited to see the potential for understanding the use of medical devices through [electronic health record] systems," FDA spokesperson Jennifer Rodriguez said. "We also continue to work toward modernizing adverse event reporting and analysis, and we'll announce these enhancements as they become part of FDA's workflow."  

The UDI itself doesn't facilitate interoperability, but it's a step toward improving device-related patient safety because it will help organizations track manage and track devices in their inventory,  Goldman said. "We are making headway, and this -- the UDI phase-in -- is one piece of the puzzle," he said.

Lisa Gallagher, vice president of technology solutions for HIMSS, concurs with Goldman on the daunting complexity of the integration task ahead -- most devices, after all, are not designed to interact with other systems -- but she also is optimistic that safety gains are in the pipeline. "It's a long process, particularly the area of connecting devices and systems to the EHR, but the good news is that we're all actually working together on this now," Gallagher said. "We're starting to see organizations that, with the help of device and [health] IT vendors, are starting to make these connections successfully."

Collaborative initiatives such as IHE, Gallagher noted, "are bringing everybody to the table with device makers. That's what we want, and it's actually moving along at a pretty good pace." She cited the increased participation in IHE's annual "Connectathon," a five-day event in which systems engineers from health care supplier organizations test their systems against the interoperability standards being developed by the IHE.

Using IT To Expedite Alerts

On the private-sector side, Pennsylvania-based ECRI Institute, which provides research-based guidance on improving care safety and cost-effectiveness in medical devices, recently enhanced it Alerts Tracker system. The patient safety system, which automates the device/medical product alert and recall management process for subscribing hospitals and entities, can now be configured with the Automatch feature. This new feature compares device or supply alerts to a hospital's inventory and notifies appropriate staff, thus reducing the time required to find and address products affected by alerts and recalls.

Betsy Schulz, who works in risk management for Faxton St. Luke's Healthcare in Utica, N.Y., describes the system as an "absolute godsend" compared with the previous system, which involved generating written weekly reports and putting the onus on staff to sift through lists of alert-affected/recalled products to identify those that might be in inventory. "We're able to notify a broader range of staff very quickly -- and the individual can actually enter into the system the action they've taken," Schulz said, citing the example of potentially high-risk surgery items that can now be pulled very quickly. "Our biomedical and clinical engineering are very excited about this system."

Kerry Cummings, a clinical resource manager at Cape Cod Health in Massachusetts, cited a similar example -- following a recall notice for inadequately sterilized central lines (vein catheters), Automatch identified the items' location and notified affected staff to prevent insertion in patients. "This significantly reduces the work the team does. Now they only have to look for the affected items in inventory, not sift through 50 or 60 notifications," Cummings said.

New Inroads, Higher-Stake Risks

Expediting device safety alerts and recalls improves safety theoretically, and as IT-enhanced systems proliferate it's likely that data will confirm the safety gains. However, the safety payoff from improved data flow between devices and information systems is likely to be slow going, in part because the intersection of previously unintegrated elements raises new risks.

"Now, it's not just the device [function] we have to worry about but also the communication and the software -- and whether the information leaving the server and coming into the server is correct," Erin Sparnon, engineering manager of health devices for ECRI Institute, said, adding, "We have to be concerned about an ecosystem of [health] IT and devices."

This complexity at the intersection of devices and information systems also necessitates a change of thinking when adverse events -- whether devices or other products are involved -- occur, according to Karen Zimmer, medical director of ECRI Institute's patient safety organization.

Traditional root cause analyses and adverse event investigations have tended to focus on isolating or identifying the product or system failure, or human factor that led to the adverse event. Now, Zimmer observed, it's important for the health care industry to make the focus more encompassing of the technology interfaces that can cause problems. "We need to take a sociotechnical approach now, when things go wrong," she said.

Health care organizations that want to pursue device-system interoperability to boost safety and efficiency should be cognizant of the inherent risks, but they needn't be deterred from proceeding, provided they plan appropriately, Meghan Dierks, a Harvard clinical informatician and member of the FDASIA Workgroup, said.

Medical centers with capable medical departments are achieving good results with interfaces by planning carefully and working closely with device manufacturers," she said. "The key is to use your vendors as partners and collaborators, because they have the same objective as you do: safe use. And even if there's no regulatory obligation [regarding interfaces], organizations should follow the same principles to connect devices that are used when creating a device -- do the risk assessment, validate the data and use the standards the device-maker intended."

Source: iHealthBeat, Monday, July 7, 2014

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