One of the big cries in health care reform is the need to have our medical information transferred to an electronic data base. The theory is that is patient records are accessible immediately and there will be fewer mix-ups in an emergency and during routine medical treatment. The government is so convinced this is a good idea that it plans to spend up to $27 billion on electronic medical records systems, also called health information technology, or HIT. Every American is supposed to have an electronic medical trail by 2014. But there are problems. Over the last two years, six patients have reportedly died and several were injured when the system malfunctioned. Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health testified at a government hearing on February 18 that there have been malfunctions of the system. HIT has mixed up patients, put test results in the wrong file, and lost medical information.
Other examples include a “locking up” of data in an operating room, and a failure to display a patient’s allergies due to software errors. The system is largely unregulated and the FDA may suggest some sort of framework of federal oversight which could include requiring the system makers to register with the government and submit reports on safety issues, errors and problems that surface. The systems could even face a pre-market review by the agency before they are launched. Sen. Charles Grassley says there needs to be a national system for reporting errors and product failures. Some manufacturers are resistant to additional scrutiny arguing regulation will not necessarily make electronic medical records safer, while others favor the stepped up scrutiny. Device makers also testified suggesting a patient safety organization be created to collect reports of problems in electronic health systems. Hospitals are interested too in finding out the most they can about safety flaws before they jump forward into the electronics age. After all, patient lives are at stake.
