As part of efforts to reduce an increasing number of adverse events from home-use medical devices, the US Food and Drug Administration (FDA) is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.
The shift comes as FDA reviewers claim that the agency receives reports of approximately three to five of the most serious types of adverse events (deaths, fires, explosions, etc.) each week from home-use devices.
“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 says.
The shift also comes as FDA has seen a major spike in the number of device adverse events in the last five years. In 2011, FDA says there were over 445,000 device adverse events but by 2014, this number had risen to over 800,000.
And devices used outside a professional healthcare facility are particularly vulnerable to adverse events because the users of these devices may be inexperienced in the proper use and maintenance of the devices.
FDA has proposed to create a centralized, online resource of home-use device labeling for moderate to high-risk devices (ie. Class II and Class III home-use devices).
The proposal comes as the agency acknowledges that many device manufacturers currently provide labeling on their websites, though FDA says that information can be difficult to find and limited to currently marketed devices.
“A single online labeling database would be able to exploit economies of scale and would be less expensive to establish and maintain than a collection of manufacturer-specific resources,” FDA says.
Under the proposed rule, companies would be required to submit the device labeling to FDA, initially in Portable Document Format (PDF) but later in a Structured Product Labeling (SPL) format.
Firms would incur three types of costs as a result of this rule: costs to read and understand the rule (FDA estimated at $24.6 million), costs to reformat labeling according to the rule (estimated at $290.40 per label), and costs to train personnel to comply with the rule (initial cost of $1161.60 per establishment and an annually recurring cost of $387.20 per establishment).
There are approximately 6,800 domestic and 5,900 foreign firms listing medical devices with FDA (REF. 1, Table 3-17). Of these, the roughly 1,700 firms with devices labeled for home use would include electronic labeling information when they list their Class II and Class III home-use devices
In addition, FDA says it would incur costs to establish ($5.8 million) and maintain ($1.9 million annually) the online labeling database, and the public would benefit from access to information and instructions on the proper use of medical devices in home settings.
Electronic Submission of Labeling for Certain Home-Use Medical Devices (Proposed Rule)