Medical Device Meaningful Use Matrix

Impact of Medical Device Systems on Meaningful Use Strategy

Meaningful Measurements with Medical Devices
A tool to help examine the role of medical devices in EHR implementation

HIMSS Medical Device & Patient Safety Task Force

It is widely accepted that there are many potential improvements in the quality of healthcare delivery and patient safety through the effective use of an electronic healthcare record (EHR).[1]

Medical devices and the data collected from these will play important roles in meaningful use.

Although the Center for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) Final Rules for Stage 1 Meaningful Use do not explicitly address medical devices, the strategic vision for EHR meaningful use was articulated by the HIT Policy Committee in its August 10, 2009 recommendations to ONC for inclusion in future stages of the Meaningful Use Objectives and Measures:

  • In 2013, as part of the priority on engaging patients and family, data from home health devices should be incorporated; and
  • In 2015, meaningful use of an EHR should include medical device interoperability.

In his presentation at the January 25, 2010 Workshop on Medical Device Interoperability: Achieving Safety and Effectiveness, Charles Friedman, PhD, from ONC highlighted the connection between the meaningful use priorities and medical device interoperability:

"I think it's pretty clear that the various policy priorities underlying meaningful use relate quite clearly and closely to the requirements that might be realized through increased and improved device interoperability.
Under improved quality, safety and efficiency, and disparity reduction of healthcare, it can be seen that accurate, complete, and automated data capture, through devices and of course everything else that feeds data to electronic health record systems, is necessary to achieve these goals.
With regard to engaging patients and families, relating this back to the theme of this meeting, home-based medical device data acquisition is important to engage patients and family participation in care. So there's a relationship there. Improved care coordination also requires accurate, complete, and automated data capture."

Patient safety issues and processes are also being looked at as a future component of Meaningful Use by ONC, and the Food and Drug Administration (FDA) has asserted that EHRs are Class 2 medical devices over which FDA has regulatory authority. The relationship between the FDA and the ONC is evolving and it is still unclear to what extent EHR systems will be regulated, yet it is important that the user devise a comprehensive program to evaluate and monitor HIT, in particular those HIT systems that integrate medical devices as part of the data collection process. It is important that one can measure the quality of care, not just the delivery.

The final rule published July 28, 2010 by CMS provides specifications for achieving stage 1 meaningful use. One of the requirements of the CMS final rule is use of computerized physician order entry (CPOE). In Stage 1 the requirement is simply to enter pharmacy orders into the EHR. But, as per the HIT Policy Committee recommendations for future stages, one can expect that the Meaningful Use requirements will eventually encompass pharmacy, radiology, lab and other systems, including the execution of orders and reporting of results as well as the order entry. With that future vision in mind, the HIMSS Medical Device and Patient Safety Task Force created a tool (Figure 2, below) that shows the link between measures of quality and the medical systems present in most hospital systems. Table 1 illustrates the Measures and Medical Data Systems that are compared using this tool.

 

Table 1


Measure

Data System

Clinical Outcomes

Medication Ordering, Management, and Administration

Efficiency

Monitoring Systems

Safety

Pulmonary Systems, including Mechanical Ventilation

Regulatory

Laboratory Systems

 

Pathology Systems

 

Radiology

 

Surgical

 

Emergency

 

Home Health

Many of the measures that a hospital will want to track can be generated by using present medical device technology. This Task Force recommends that adopters of EHR technology that is interoperable with medical device systems review this tool with colleagues to determine which data-producing systems (e.g., physiological monitoring or home-based vital signs monitoring) are present, what interoperable capabilities already exist, and what steps should be taken to safely and effectively incorporate them.


Please provide your feedback on this document by participating on the list serve by posting your message to at MedDevPtSafety@list.himss.org as you would a regular e-mail. Contact pjohnson@himss.org to be included on this list serve.

Footnotes

1. Walker JM, Carayon P, Leveson N,et al. EHR safety: The way forward to safe and effective systems. Journal of the American Medical Informatics Association. 2008; 15(1):272-277.

2Health information technology: Initial set of standards, implementation specifications, and certification criteria for electronic health record technology. Interim final rule. Federal Register. 2010;75(8):2013-2047.

3 Fernandopulle R, Patel N. How the electronic health record did not measure up to the demands of our medical home practice. Health Affairs. 2010; 29(4):622-628.

4 Koppel R, Wetterneck T, Telles JL,et al. Workarounds to barcode medication administration systems: Their occurrences, causes, and threats to patient safety. Journal of the American Medical Informics Association. 2008; 15(4):408-423.

5 Halbesleben JRB, Savage GT, Wakefield DS,et al. Rework and workarounds in nurse medication administration process: Implications for work processes and patient safety. Health Care Management Review. 2010; 35(2):124-133.

6 Ash JS, Sittig DF, Poon EG,et al. The extent and importance of unintended consequences related to computerized provider order entry. Journal of the American Medical Informatics Association. 2007; 14(4):415-423.

7 Shuren J. Testimony of Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health. Health Information Technology (HIT) Policy Committee Adoption/Certification Workgroup. February 25, 2010.

The Medical Device Meaningful Use Matrix:

One may use the tool provided in Figure 2 to connect certain medical device data systems to the quality measure of interest. For example, compliance data derived from Medication Administration Systems, including those with some level of infusion system integration, can be used to support clinical outcome improvement reporting (Figure 1).