Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Midwest Hospitals Prepare For Stent Unique-Device-Identifier Demo

This article was originally published in The Gray Sheet

Executive Summary

The FDA-funded effort out of the Mercy health care system, consisting of 31 hospitals and 200 outpatient facilities in Missouri, Arkansas, Oklahoma and Kansas*, is intended as a demonstration project to help troubleshoot UDIs before a mandatory nationwide system is launched. It is one of two UDI demos in the works in advance of FDA regulations.

You may also be interested in...



Questions Remain On Incorporating UDIs Into Health Care System

As part of implementation of unique device identifier requirements, hospitals will need to capture the unique codes in electronic health records and claims forms, but the logistics of doing so are still being worked out.

Long Road To Unique Device Identification: FDA’s ‘Mr. UDI’ Offers Peek Behind Curtain

The man who coined the term “Unique Device Identification,” Jay Crowley, opens up in an interview about hurdles FDA faced in setting up the system; anxiety he felt when Congress set a deadline for the final rule to be published; and why he believes UDI would have eventually happened organically anyway, among other UDI-related topics. “Sometimes people call me Mr. UDI … I think that name might stick for a while,” jokes Crowley, who planted seeds in 2002 for FDA’s new regulation to track and trace products. Since then it has mushroomed into an emerging program that has the backing of a majority in industry.

Regulatory Briefs: U.K. Trials Database; Hospitals Seek UDI Rule; FDA Workshops

The U.K.’s National Health Service is requiring all U.K. trials to be registered in a clinical trial database. Five influential hospital systems urge the White House to release the UDI final rule. FDA schedules metabolic disease workshop. More regulatory news.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT031139

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel