They may seem like a cryptic pile of digits on devices that most of us might never see but will have in us, sometimes in life-saving fashion. But “unique identification numbers,” emblazoned on everything from hip implants to pacemakers, may offer a ne safety check on a burgeoning aspect of health care. They also have gotten a major boost from the federal Medicare agency.
The Wall Street Journal has reported that the agency, after years of resistance, has agreed with the federal Food and Drug Administration and patient safety advocates that the makers of medical devices should put the identifying numbers on their products, and that this information also should be recorded in patient records, particularly the new electronic versions. To be sure, this is one step in a long regulatory process.
But experts say it could be a big advance, allowing them to better detect flawed equipment, bad processes or practices, and other situations involving medical devices and harming patients’ health and safety. Some regulators and advocates for the device makers had fought this step for some time now. They contend that it adds to costs, and it hasn’t yet demonstrated a return for the investment.
Safety experts note that numbering devices in this way would, for example, help ensure that doctors could be better informed so as to avoid, say, blood filters or heart defibrillators, that may be on hospital shelves but had been recalled by their makers. Similar markers already are required in other nations, and an analogous system is in place for medications, already credited with helping to safeguard patients.
I’ve written before about terrible situations, such as those involving dirty examination scopes that have sickened and killed dozens, and how slow doctors, hospitals, and regulators were too glacial in acting to protect patients. Experts estimate that 3,000 Americans annually die due to issues with medical devices. The current system calls for makers, especially, along with institutions and practitioners to be self-policing, and, unrealistically, to be self-reporting, sharing information about devices and possible harms. It, regrettably, also has required lawsuits in the civil justice system to get remedies for patients and their families after many of these devices have caused great harm.