Posted 06 April 2015
By Alexander Gaffney, RAC
US regulators plan to launch a new study of medical device labeling in the hopes of determining if a standardized format could help healthcare providers to better understand the risks and benefits of a device prior to its use.
If you purchase a pharmaceutical product in the US, you can be almost certain that the label on that product will look identical to every other drug product you've ever purchased. That's because the US Food and Drug Administration (FDA) has the authority to extensively regulate pharmaceutical labeling, including the layout of information, the information that must be included and even the font size used to convey the information. The result is that drug labels are (for the most part) standardized, which makes them easy to read and understand.
But if you thought medical devices were subject to the same type of labeling standardization, you'd be wrong. In fact, medical devices are subject to very few requirements compared to their pharmaceutical counterparts. Under 21 CFR 801, medical device manufacturers are required to label their products with certain information, but the format and layout of that information is for the most part left up to the discretion of the manufacturer.
This discrepancy has not gone unnoticed by FDA officials.
In fact, there is a growing recognition among FDA staff that a lack of device labeling standardization may be harming patients. There is a "growing need for medical device labeling to be delivered in a clear, concise and readily accessible format so that patients, caregivers and healthcare providers may access and utilize device labeling as efficiently and effectively as possible," FDA wrote in a 4 January 2013 Federal Register announcement regarding device labeling. Physicians may inadvertently skip over important information or be unable to find information in an emergency, for example.
Another problem: There's no single repository for medical device labels. While such information is easily available for all pharmaceutical products, differences in device labeling formats make it difficult to collect and compare such information. That's bad news for patients, FDA has explained in the past. Unlike pharmaceutical products, which typically have a shorter shelf life, the longevity of medical devices may mean that their instructions for use and warning labels are damaged or illegible after a few years. If these labels are unavailable, patients may be harmed as a result.
A New Study Underway
Faced with these challenges, FDA has for some time been considering ways to move toward a more consistent, standardized medical device labeling format or formats.
For example, in April 2013 FDA held a meeting to discuss labeling standardization issues, including the potential to use symbols in medical device labels. FDA has also floated the idea of creating an online labeling database of devices used in home healthcare settings.
The medical device industry, meanwhile, has characterized some of FDA's efforts and proposed solutions as a "solution in search of a problem," and has urged FDA to work through several perceived issues with its standardized labeling proposals.
In response, in September 2014, FDA proposed to begin studying 12 potential device labeling standards in a small-scale pilot assessment involving two hospitals and several dozen healthcare practitioners.
"Given a sample of 6 devices with 2 different labeling types, there will be 12 different labeling types to be tested," FDA explained in its Federal Register notice about the study. Twenty-four people will test each type of device label, FDA added.
And now, after a lengthy comment period, FDA says it is finally moving forward with its proposed study, which has been sent to the Office of Management and Budget (OMB) for final approval.
FDA says the study should be useful to determine "if healthcare practitioners can find what they need in a consistent and easy way."
The study is being coordinated by FDA's Entrepreneurs-in-Residence (EIR), the agency noted.
Federal Register announcement