Interoperable medical devices already play a critical role in the transfer of important patient information, but they can do much more.

Meaningful use does not yet have a final definition, but it already has a deadline. As the healthcare industry works with President Obama's administration to further develop the meaning, some healthcare executives have expressed uncertainty about meeting it. A survey released by PriceWaterhouseCoopers in June found that 80 percent of hospital chief information officers are “concerned or very concerned” with their organization's “ability to meet meaningful-use requirements within the specified time frame.”

The final regulations for meaningful use issued by the Department of Health and Human Services on July 13 provided some increased flexibility, but the pressure to match still-evolving standards by 2015 remains a major challenge for providers.

For device manufacturers, this presents a significant opportunity to offer solutions. To do so, though, device makers must help contribute to the final definition of meaningful use and must demonstrate how devices can help hospitals reach meaningful-use goals faster.

Aiming for a more inclusive final definition
Meaningful use will be defined in three stages, tied to incentive payments in 2011, 2013 and 2015. The first stage already has been determined. To meet the requirements, healthcare providers must be able to:
•    Demonstrate use of certified health information technologies in a meaningful manner.
•    Validate that certified information technology is connected, or interoperable, in a manner that provides for electronic exchange of health information to improve the quality of healthcare.
•    Use certified technology to submit data to the government on specific clinical quality measures and performance metrics.

Each of these requirements focuses on use, and not on simply having health IT in place. While adopting electronic health records has been at the center of discussions about clearing these hurdles, other health information technologies, including interoperable medical devices, already play a critical role in the transfer of important patient information. But only health IT components that are certified by CMS and the Office of the National Coordinator for Health Information Technology (ONC) will qualify for meaningful use. And those are the technologies that providers will invest in for the next few years.

Device technology could make many providers meaningful users now
The PriceWaterhouseCoopers survey also found that one-third of CIOs are “concerned or very concerned” about vendor readiness. This underscores the fact that hospitals and other providers are relying on IT vendors to help them take the critical steps that will improve healthcare quality and safety and to meet the designated timelines.

A key area for improvement in quality of care is eliminating medical errors. The Institute of Medicine's (IOM) 2006 statistics revealed that each year more than 1.5 million people are harmed by medication errors and 400,000 preventable drug-related injuries occur in hospitals; many more occur in outpatient clinics and long-term care settings. Incorporating infusion devices in “closed-loop” medication delivery — the process to automate all the steps from the ordering to the administration of medications — can help eliminate some of these errors. This involves ensuring that interoperable safety software can electronically transfer a patient's medication administration information through a hospital's network to a smart infusion pump, using bar-code medication administration (BCMA). This connectivity helps medical professionals check the “five rights” of medication administration: the right patient is receiving the right medication at the right dosage, through the right route at the right time. The “five rights” verification has been shown to generally reduce medication errors by 65 to 86 percent.

The Hospira Plum A+ Infusion System provides precise delivery of multiple therapies across the general spectrum of clinical care.

The closed-loop medication administration process will be included in the 2013 standards for meaningful use, and many hospitals already have some of the needed technology in place. However, while BCMA systems are certified for meaningful use, the smart-pump device technology that helps deliver the closed-loop benefit is not. Certification of smart pumps, along with the certification of the integrated systems, would mean many hospitals could demonstrate one form of meaningful use immediately. It also would accelerate the pace at which other providers implement these technologies, enabling them to receive incentives that could be used toward earlier adoption of other health IT. Ultimately, providers could even achieve the final stage of meaningful use — and improved patient care and outcomes — much sooner.

A new age for devices as a means to quality care
Many of the device functions mentioned so far are possible only if the medical devices are interoperable with other tools or with a healthcare facility's larger IT network. The push for interoperability is gaining momentum and it ultimately will drive innovation, enabling manufacturers to introduce new products faster and more cost effectively. The final definition of meaningful use will do the same.

For instance, the requirement that providers “use certified technology to submit data to the government on specific clinical quality measures and performance metrics” could lead to the development of new reporting tools, as well as new uses for existing devices. One example: Software surveillance tools that monitor data and use alerts to help hospitals identify and isolate infections also could provide an easy means for reporting on meaningful-use metrics.

Other medical devices offer similar potential, and meaningful use could usher in a new age for devices as a means to higher-quality care. But first, device makers must demonstrate to providers and policymakers that they can help add meaning to meaningful use.



Symeria Hudson is vice president, medication management systems, U.S., Hospira.
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