Lack of Medical Device Interoperability -is there a way out?
January 2009

Lack of Medical Device Interoperability – is there a way out? : Market Insight, Healthcare Practice, Frost & Sullivan

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Market Insight, Healthcare Practice, Frost & Sullivan

It is hard to digest that keeping aside the IT enabled data transfer, the healthcare industry has minimally benefited from standards based interoperability.

The fact that patient monitoring is not a new concept in healthcare is apparent. Santorio did the first patient monitoring in 1625 by measuring body temperature and blood pressure. Rapid advancements in technology took place post World War II that has led to the development of different types of monitoring till date.

Patient monitoring today

To a large extent computer based monitoring and high acuity care systems have become affordable enough to be deployed on a large scale in many intensive care units around the world except for a few regions in Asia Pacific and Eastern Europe. With bedside becoming an imperative site of displaying data, bedside monitors have started functioning with multiple capabilities like efficient monitoring, intelligent alerts, plug and play modules, Ethernet networking and many other features that provide easy, integrated monitoring in any facility. Most bedside monitors available today can incorporate data from clinical laboratory and bedside laboratory systems. The drawbacks of these features are that they usually have proprietary communications protocols and data acquisition schemes usually governed by the respective manufacturers.

Gaps in the system – medical device interoperability

The most common problem with patient monitoring systems has always been their interoperability. Not all systems can be interfaced with other devices unless and until they are from the same manufacturer or from the ones with whom strategic alliances exist. It is tough to debate whether industry conglomerates employ this strategy to improve their market share or to maintain the brand reputation that they have been enjoying thus far. Single vendor device integration looks achievable, whereas disparate devices from multiple vendors, assembled by end users or system integrators, run into interoperability barriers.

Interoperability – today’s scenario

It is hard to digest that keeping aside the IT enabled data transfer, the healthcare industry has minimally benefited from standards based interoperability. Device connection established through leads and cables may result in electric shocks. A hazard report published by Medical Devices Safety Reports [MDSR] says patients received electric shocks when they were inadvertently connected to line power (120 VAC). These incidents occurred when electrode lead wires, which should have been attached to the patient cables connected to ECG or home apnea monitors, were instead plugged into energised detachable power-line-cord plugs. Reasons for lapses during device connectivity could be (i) device factor in the form of design error (ii) user error in the form of improper connection and (iii) support system failure due to use of inappropriate devices.

Perfect interoperability is not a mere physical connection of two systems where one device provides data to a second device, but also a functional bridge where the second device understands what it is receiving from the first and thereby respond the way it is expected to.

 

Is anything being done to address the problem?

There are multiple reasons why medical devices do not have proper interoperability when compared to many non-medical devices, which can be easily integrated. (i)There is no incentive for medical device manufacturers to interoperate with other manufacturers’ devices. (ii)The medical devices industry also runs short of interoperability standards and the ones that exist are too complex. (iii)The healthcare sector, in general, has been lagging behind other industries with respect to computerisation and networking. (iv) Interoperability solutions face complex technical and social problems, including liability and regulatory issues.

Several consortia are addressing the issue of medical device interoperability. The Medical Device Plug and Play program (MD PnP), Continua Health Alliance (Continua) and Integrating the Healthcare Enterprise (IHE) are groups focusing on interoperability. MD PnP is a multidisciplinary, multi-institutional program committed to simplifying and standardising medical device connectivity in support of improving patient safety and healthcare efficiency. In the regulatory arena, FDA is reopening discussion regarding the issue of a unique device identifier (UDI), which is one necessary ingredient for medical device interoperability.

Perfect interoperability is not a mere physical connection of two systems where one device provides data to a second device, but also a functional bridge where the second device understands what it is receiving from the first and thereby respond the way it is expected to.

Is the job done?

Establishing a perfect interoperability amongst medical devices is not that easy a task. The interoperability package should ideally have simple and user-friendly hardwares that are capable of physically integrating devices from different manufacturers. These hardwares should be governed by a versatile algorithm in order to put all the data into a single platform. This being a new approach, companies should collaborate to manufacture it.

An ideal interoperability platform

Amidst all the difficulties, it is possible to create a “customised one-off solution” to integrate all the monitoring systems. But it is complicated, expensive and could be possible only if manufacturers and the end-users join hands to bring a permanent solution for a perennial problem.

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