Internet of Medical Devices (IoMD)
September 24, 2015 § Leave a comment
Tens of millions of Americans live with medical devices implanted in their bodies today. Currently, the advances in medical technology and growth of the Baby Boomer population in America (26% of the total U.S. population) requires systems like the (UDI) initiative to improve patient safety, modernize device post market surveillance, and facilitate medical device innovation. That said, the FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When the new system is fully implemented, the labels on devices will include a unique device identifier (UDI) in human and machine readable form. The (UDI) system will be phased in over several years starting with (all) Life-sustaining and Life-supporting devices, regardless of device class in 2015 and concluding with Class I Medical Devices in 2020.
The goal is to improve the identification of medical devices by making it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use. This will facilitate more accurate reporting of adverse events (AEs) by making it easier to pinpoint the device at issue in any submitted report.
The FDA, Healthcare Providers, and Medical Device Manufacturers may then more rapidly and precisely extract useful information from adverse event reports and thereby gain a better understanding of the underlying problems and improve the ability to take immediate and better focused corrective action.
Examples of Class III devices that currently require a pre-market notification include implantable pacemakers, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.
Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps and surgical drapes.
Finally, Class I devices, subject to the least regulatory control include products like elastic bandages, examination gloves, and hand-held surgical instruments.
Moving forward, the emergence of the Internet of Medical Devices (IoMD) will improve the ability of the industry and it’s patients to have better insight into the products enabling and impacting their daily lives.