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Medical device risk management

Shared by Radhika Narayanan | 0 0 0 | about 8 days ago

Ensuring proper connectivity of medical devices is a means to protect patient safety. “Errors and inadequate interoperability, such as differences in units of measure (e.g., pounds vs. kilograms) can occur in devices connected to a data exchange system,” said Bakul Patel, associate director for digital health at FDA’ Center for Devices and Radiological Health. Thus, appropriate functional, performance, and interface requirements for devices with such interactions are essential, he added. The FDA guidance focuses on three areas that manufacturers should keep focused on to ensure “smart, safe, and secure” interoperability of medical devices and IT systems.1. Manufacturers should design systems with interoperability top-of-mind as a core objective.”In designing a medical devices electronic interface, manufacturers should consider the level of interoperability needed to achieve the purpose of the interface, as well as the information necessary to describe the interface,” according to the document. “The labelling should be in sufficient detail to allow anticipated users to connect and use the medical device and interface as it is intended.”

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