FDA draft recommendations cover interoperability in medical devices

The FDA has unveiled draft guidance for secure data exchange in medical devices

The FDA has published draft guidance aimed at improving  the design of medical devices for safe data exchange.

The document outlines key points regarding the design and development of devices to ensure secure interoperability.

According to the FDA “the increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost”.

However, it notes that inadequate interoperability can lead to errors, harm and in some cases be fatal.

It states: “Manufacturers’ risk analysis should consider the risks associated with interoperability, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation. Based upon these risks, a manufacturer may want to change the design of the device, the intended interoperability scenarios, or include device limitations and/or warnings to reduce risks to acceptable levels.”  

Regarding design for interoperable devices, the FDA says key considerations for manufacturers should be information model (data attributes), the functional model (role played within the interoperable system) and the architectural model (how the device is connected within the system. The “desired functional, performance, and interface characteristics of the electronic data interface” should also be taken into account.

The guidance also comes amid a time of growing concern regarding cyber security attacks. This point was highlighted by Modern Healthcare which noted that the guidance “makes a nod to the numerous cyber security attacks on the healthcare industry in 2015 and predictions that 2016 could be even worse”.

Labelling is also a key point in the guidance – it should include information on the electronic data interface so that the device can be used safely and effectively as it should. Correct labelling “should also enable users to connect to the device in the specified manner, and should give proper instruction to use the connection to the device in the ways in which it was designed”.