While health IT has the potential to make significant improvements in efficiency in healthcare organizations, it presents patient safety risks. In November, the Institute of Medicine published a report calling for an increased focus on health IT and patient safety and recommending 10 actions for HHS. Medical devices have also garnered attention for its risks to patients. The ECRI Institute listed several medical device-related issues in its list of the top 10 health technology hazards for 2012. Fifth on the list is "inattention to change management for medical device connectivity," which can cause problems with interoperability.
However, medical device interoperability can allow different systems to share clinical data to manage patients more effectively. For example, smart pumps allow different brands of pumps to communicate with each other to ensure that a patient does not receive an overdose or incompatible medications. Other interoperable medical device possibilities include connecting alarms to electronic medical record systems and infusion pumps with a pharmacy system, according to Elliot B. Sloane, PhD, CCE, professor and director of Health Systems Engineering and founder, president and executive director of the Center for Healthcare Information Research and Policy at Drexel University School of Biomedical Engineering in Philadelphia.
To ensure patient safety while gaining the benefits of medical device interoperability, the United States needs to develop updated regulatory guidelines, Dr. Sloane says. The FDA released draft guidance on oversight for mobile medical applications in July, but it included unnecessary regulations and did not promote innovation, according to comments submitted to the FDA by the mHealth Regulatory Coalition in October.
The field is young
One of the reasons the industry needs updated guidelines is because interoperability between medical devices is a young field. "Formal IHE [Integrating the Healthcare Enterprise] profiles for patient care devices are only five or six years young," says Dr. Sloane. IHE profiles are protocols that allow different systems to share data. While profiles for blood pressure monitors and early infusion devices have been developed, they are only beginning to be implemented in alarms, according to Dr. Sloane.
An advantage of being a young field is the ability to anticipate and adapt to changing trends. For example, some companies are now manufacturing products with interoperability capabilities built in to the system. "We can look forward with a sense of awareness that tomorrow's technology will be very facile, embracing things like apps," Dr. Sloane says. In addition, medical device interoperability can pull from related, more established fields, such as clinical engineering. As a less established area, however, current regulatory processes are inadequate.
The need for a new regulatory framework
"One of the conundrums is medical devices as a category have always been highly regulated," says Jim St. Clair, CISM, PMP, SSGB, senior director of Interoperability and Standards at HIMSS. "On the other hand, the iPhone has no regulation. From a compliance standpoint, the juxtaposition of regulations and the growth of technology and wireless communications is a challenge for this year and into 2013."
Dr. Sloane suggests the need for new certification methods and safety management methods for an industry in which the HITECH Act and healthcare reform laws have spurred enormous growth in a short period of time. In fact, the IOM report recommended HHS urge Congress to establish an independent federal entity for investigating patient safety deaths, serious injuries or potentially unsafe conditions associated with HIT. "We need to develop a new paradigm of regulation," Dr. Sloane says. "The prior paradigm was based on box-level or unit-level certification — [an] infusion pump or heart monitor is certified by itself. We're evolving into an interoperable, interdependent world where everything has to work [together]."
One way to work towards a new regulatory model for medical devices is to study and test interoperable systems. "To the extent we can establish reliable interoperable demonstration platforms or case studies, we can help in the exploration of the risks and safety challenges of converging medical technology, information technology and electronic health records," Dr. Sloane says.
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However, medical device interoperability can allow different systems to share clinical data to manage patients more effectively. For example, smart pumps allow different brands of pumps to communicate with each other to ensure that a patient does not receive an overdose or incompatible medications. Other interoperable medical device possibilities include connecting alarms to electronic medical record systems and infusion pumps with a pharmacy system, according to Elliot B. Sloane, PhD, CCE, professor and director of Health Systems Engineering and founder, president and executive director of the Center for Healthcare Information Research and Policy at Drexel University School of Biomedical Engineering in Philadelphia.
To ensure patient safety while gaining the benefits of medical device interoperability, the United States needs to develop updated regulatory guidelines, Dr. Sloane says. The FDA released draft guidance on oversight for mobile medical applications in July, but it included unnecessary regulations and did not promote innovation, according to comments submitted to the FDA by the mHealth Regulatory Coalition in October.
The field is young
One of the reasons the industry needs updated guidelines is because interoperability between medical devices is a young field. "Formal IHE [Integrating the Healthcare Enterprise] profiles for patient care devices are only five or six years young," says Dr. Sloane. IHE profiles are protocols that allow different systems to share data. While profiles for blood pressure monitors and early infusion devices have been developed, they are only beginning to be implemented in alarms, according to Dr. Sloane.
An advantage of being a young field is the ability to anticipate and adapt to changing trends. For example, some companies are now manufacturing products with interoperability capabilities built in to the system. "We can look forward with a sense of awareness that tomorrow's technology will be very facile, embracing things like apps," Dr. Sloane says. In addition, medical device interoperability can pull from related, more established fields, such as clinical engineering. As a less established area, however, current regulatory processes are inadequate.
The need for a new regulatory framework
"One of the conundrums is medical devices as a category have always been highly regulated," says Jim St. Clair, CISM, PMP, SSGB, senior director of Interoperability and Standards at HIMSS. "On the other hand, the iPhone has no regulation. From a compliance standpoint, the juxtaposition of regulations and the growth of technology and wireless communications is a challenge for this year and into 2013."
Dr. Sloane suggests the need for new certification methods and safety management methods for an industry in which the HITECH Act and healthcare reform laws have spurred enormous growth in a short period of time. In fact, the IOM report recommended HHS urge Congress to establish an independent federal entity for investigating patient safety deaths, serious injuries or potentially unsafe conditions associated with HIT. "We need to develop a new paradigm of regulation," Dr. Sloane says. "The prior paradigm was based on box-level or unit-level certification — [an] infusion pump or heart monitor is certified by itself. We're evolving into an interoperable, interdependent world where everything has to work [together]."
One way to work towards a new regulatory model for medical devices is to study and test interoperable systems. "To the extent we can establish reliable interoperable demonstration platforms or case studies, we can help in the exploration of the risks and safety challenges of converging medical technology, information technology and electronic health records," Dr. Sloane says.
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