Example use cases and understanding the regulatory challenges of incorporating wireless connectivity into medical devices – White Paper
Author: Pelle Svensson Product Marketing Manager, Product Center Short Range Radio, u-blox
Abstract: This paper discusses some use cases as well as the challenges related to achieving certifications and approvals for medical devices that contain wireless modules, and how manufacturers of such devices can save efforts when using modules with pass-through certifications.
Background / Executive summary
With the advent of wireless technology in medical applications, new possibilities open up for medical diagnostic and monitoring equipment in a hospital, health care facility, or for care in the home environment. Medical device manufacturers need to understand the complex regulatory requirements, which cover several interrelated topics, such as radio/wireless compliance, medical device approval, hazard analysis, quality management and overall product safety.
Compared to a wired connection, wireless connectivity provides easy mobility for both staff and appliances, in addition to removing the hazards due to tripping on cables such as in a busy emergency (A&E) department. Developers of health care appliances and monitoring equipment have many key design decisions and considerations to make in provisioning wireless communication. Factors such as which wireless protocols to use, regulatory approvals to be gained, and how the design will be powered are all important. Ever increasingly, patient electrocardiography (ECG) monitoring sensors, blood pressure sensors and infusion pumps transfer data wirelessly to the hospital’s servers. This approach not only facilitates intervention-free vital sign monitoring, but also provides validating mechanisms.