I think it is a bad sign when a publisher thinks that U.S. hospital care has become so risky that consumers of healthcare will buy a self-help guide to surviving their in-patient stay, don’t you? But there’s a new book out and the title alone will probably tell you the mood of the country: The Essential Hospital Guide To Get Your Loved One Out Alive. As disturbing, perhaps, is that this self-help book seems to be decidedly focused on health information technology devices. A few days ago here we wrote about the possibility the Food and Drug Administration (FDA) may start to train its eye on healthcare IT, including software, as a device. This news of a consumer guide for self-defense when in the presence of health IT devices probably won’t moderate the FDA’s apparent growing interest. In fact, the news release about this new guide provides the following which quotes an FDA source:
Currently, the FDA has authority to regulate health IT software as a medical device but has not fully exercised that authority. “To date, FDA has largely refrained from enforcing our regulatory requirements with respect to health IT devices,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.
Again, all this merely points to the need for the right prescription: work with proven partners and get solutions that are known to perform as advertised, whether for the operating room, the bedside, or the manufacturing facility where products and devices are made and corrected labeled to meet unique device identification mandates looming on the horizon.
The press release about the new survival guide is here.