Patient Hardwired Device Registries

Let’s start right off by stating unequivocally that implanted medical devices are one of the real “miracles” of modern medical technology and improve the quality of life of thousands of patients every year. Like the automobile, they are a critically important technology that has changed the way we live.

According to a McKinsey Global Institute Study we spend $76B a year in the U.S. on implanted medical devices. The cost of these devices is rising faster than the cost of drugs. Jeffrey Lerner, the President and CEO of ECRI stated in the NY times last Thursday, “This is a dysfunctional market if you take the perspective of the consumer or public programs like Medicare.”

The article goes on to quote a cardiologist, saying about the medical device companies, “Why would you build a better light bulb that lasts longer if it is going to reduce your profits?” According to the same article in the times, these profits margins hover around 25%.

This is the second time we have pointed to the traditional manufacturing industry to demonstrate the need for third party collected, impartially or consumer generated quality data. The first time was asking if you would accept crash safety data generated by the car company that made the car, “Yup, we have safest car on the market!” Of course not. That is why there is a third party, the National Highway Traffic Safety Administration, that conducts crash tests and publishes the results to the public.

We have suggested that this model needs to be applied to the collection of quality data across healthcare. Third party collected patient generated data must become the gold standard of quality reporting in healthcare.

The article goes on to discuss the need for registries to keep track of what devices last longer. There are many important functions of device registries. Aaron Moskowitz, at the Biomedical Research and Education Foundation,( www.brefnet.org ), is doing important work in this area.

As these registries are developed, what is needed is the ability for patients to report consistently on their experiences with their implanted devices. It goes without saying that they are the best source of information regarding the quality of, and the experience of living with, the device. Rather than just collecting clearly important statistics regarding failure rates, replacement frequencies etc…, how much richer would this data be if it also contained a high volume of data related to the experience of actually living with each device.

This concept should be applied to all registries. As registries, combined with comparative effectiveness research, begin to guide a broader range of clinical decision making, efforts should be made to incorporate patient generated data into a broad range of registries. This would allow patients and their therapeutic partners, the caregiver, to make better informed decisions about what is going into their bodies.