Recently, the U.S. Food and Drug Administration issued draft guidance to manufacturers of medical devices in its efforts to enhance efficient data transfer and safety. Essentially, the FDA has put a strategy in place due to the continuing technological advancement in interconnected medical devices. The goal is to help improve the efficiency and safety of Medicare devices that are interoperable and exchange data.
According to news reports, patient care could be greatly improved and health care decisions made easier by the use of interconnected devices such as ECG (electrocardiogram) waveforms, patient-specific data, and UDIs, or unique device identifiers. Another advantage of interoperable devices is the ability to fill electronic health records.
The FDA’s guidance in design and medical device labeling specifics will help manufacturers implement changes. According to the agency, “Medical device interoperability is not limited to unidirectional patient data but includes more complex interactions, such as exerting command and control over a medical device(s).”
Some of the design elements manufacturers should consider in terms of a device’s electronic data interface include utilization of standards (interface, transmission, data format, etc.), whether time synchronization is necessary, method of transmission of data, the types of devices an electronic data interface is to connect to, the purpose of the device (issuing command, receiving or sending, controlling data), and how the manufacturer anticipates the interface will be used, among other factors.
As far as labeling of interoperable devices, the FDA has issued guidance that labeling should be explicit and detailed, clearly stating which medical devices are meant to connect with specific devices listed, and which non-medical device technologies or medical devices the interoperable device should not be used with.
Labeling should also include recommended architectures or connections, settings, configurations for electronic data interface, reference relevant standards used, state whether the data is meant for access by anyone, or by a specific user, whether the connection is meant to control another device’s operation, and much more.
In order for medical device manufacturers to achieve interoperability, employing standardized architectures and communication protocols is key. Proper labeling is critical for many reasons that are primarily technical; for instance, what types of devices can be connected, the software being used, even the use of the data.
While it sounds extremely complex, guidance issued by the FDA will be extremely helpful in the design and labeling of interoperable medical devices. Medical device manufacturers can find the FDA Draft Guidance here.
REA JET is a trusted supplier of reliable, quality industrial printing equipment for coding and marking of labels, packaging, barcodes, and more in many industries including pharmaceutical, building materials, plastics, packaging, non-woven goods, steel, and more. For all of your industrial coding and marking solutions, we provide real solutions for the most pressing demands in your industry.