The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on 06 September 2017. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field. An interoperable medical device is one with the ability to exchange and use information with another medical or non-medical product, system, or device. An electronic interface is a medium by which these systems can communicate. This type of communication or exchange between systems and devices may include transmission and/or reception, storing, analyzing, or interpreting data. Medical device manufacturers are also designing interoperable devices to perform more advanced types of data exchange such as one device issuing commands or having control over another device(s).
A common interoperable device being utilized today by medical professionals and patients alike are infusion pumps. These devices have also been reported as one of the single biggest safety concerns in hospitals. The pumps administer critical fluids such as insulin and high risk medications like chemotherapy drugs, pain relievers, and antibiotics to a patient’s body in controlled amounts. This type of distribution leaves little room for device error. Infusion pumps regulate the amount, rate, or duration at which the medication should be distributed by means of a built-in software interface where a trained user can input desired variables. From 2005-2009 the FDA received 56,000 reports of adverse events associated with infusion pumps (not related to an exclusive type of pump or manufacturer); more than any other medical technology. While some adverse events were related to user error, the most common errors were related to software defects, interface issues, mechanical, and electrical failures. The new FDA guidance provides manufacturers with instructions designed to minimize the occasion of these adverse events.
The FDA’s concern is whether the device manufacturers are considering the design and engineering inefficiencies that could result in patient safety issues or contribute to user error. The guidance suggests the following elements should be reflected in the composition of these manufacturer’s pre-market submissions:
- Purpose of electronic interface: this should include the types of data communications occurring (receiving, sending, command controls etc.)
- Anticipated users: should consider any potential users. This may include clinical user, engineers, patients, information technology professionals, researchers, etc.
- Risk management: how to mitigate risks that may potentially arise from others connecting to the interface system.
- Verification and validation: there should be an ongoing effort to ensure the medical devices are properly functioning between interfaces prior to delivery of the device, within the integration process, while in use, and through any maintenance or software updates.
- Labeling considerations: should incorporate information users could need to connect to the interface safely and what the device’s intended purposes are.
- Use of consensus standards: should be clearly related to medical device interoperability.
Without the above considerations the potential for patient safety issues can outweigh the potential advancements interoperable devices could offer. As we look to the future let us know how you think this guidance will play a role in mitigating the risk and maximizing the benefit of interoperable medical devices.