The Advanced Medical Technology Association (AdvaMed) is at odds with a recent proposal by the US Food and Drug Administration (FDA) to create a public facing electronic database for home-use medical device labels.
In October, FDA announced the proposed rule, which would require the makers of Class II and Class III medical devices intended for home-use to submit the labels and package inserts for their products electronically. These electronic labels and package inserts would then be added to a centralized, public database.
In the proposed rule, FDA says that such a system could reduce the number of adverse events involving home-use devices by making it easier for patients to locate the instructions and labeling online.
"The incidence of adverse events may be mitigated by providing users of home-use devices with the labeling information covering instructions on use, cleaning, sterilizing, storage, and handling of special waste as well as trouble-shooting suggestions and contact information for the device manufacturer. Home-use devices tend to become separated from this product labeling over time, and the absence of this information may lead to adverse events," FDA writes.
However, in comments submitted to the proposed rule, AdvaMed disagrees with the agency, arguing that the rule could even cause patient harm.
"The Proposed Rule will do little, if anything, to enhance public health and may result in unintentional negative consequences," AdvaMed writes.
According to AdvaMed, the proposed public database could lead to a situation where there are different versions of a device's labeling available through the database and the manufacturer's website.
"Should a home-use device user seek labeling information for a specific product and find labeling information on both the manufacturer's website and the proposed database, the user may not know which information is accurate in the event the labeling has been updated and FDA has not updated the database with the newest labeling information," AdvaMed writes.
AdvaMed goes on expresses skepticism that device users would seek such information directly from FDA:
"In our experience, device users—as with users of general consumer products—would first seek labeling information on the manufacturer's website or through an internet search engine such as Google."
Also, while FDA's proposal would link the labeling and package inserts for products to other types of information, including the unique device identifier (UDI), premarket submission numbers, adverse event reports and public health notifications, AdvaMed argues that these other sources are not always intended for lay-person use and may lead to users to misinterpret certain information.
AdvaMed also requests that FDA create exceptions to the rule for certain types of devices, including home-use software devices, which typically have embedded electronic labeling, and over-the-counter single use devices, which AdvaMed argues do not run as great a risk of being separated from their labeling.
Lastly, AdvaMed asks that FDA clarify which establishments are required to submit the labeling information to the database.
"The Proposed Rule does not address situations in which multiple establishments may be responsible for submitting FURLS information about the same device. For example, the Proposed Rule could be interpreted such that devices manufactured by contract manufacturers require duplicate label submissions, or that establishments performing other activities (e.g., contract sterilization or importation) also would be required to submit device labeling," AdvaMed writes.