December 14, 2017 Source: massdevice 575
The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. 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 used 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:
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.
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