dismiss

Clean Sweep Live Auction on Wed. May 1st. Click to view the full inventory

DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Pediatrics
SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

More Industry Headlines

Rural hospitals require better 'end of support' equipment solutions Sometimes replacing equipment is simply not an option

Philips Medical Systems sues ex-employee over alleged secrets theft Suit claims X-ray tube trade secrets were stolen before erasing hard drive

Peeling back the Medicare Advantage onion Understanding the high growth rate of MA plan coverage

New 'roadmap' paves the way for AI innovations in radiology Aims to advance foundational AI research for imaging

FDA finds duodenoscope contamination risk still too high Up to 5.4 percent of properly collected samples has 'high concern' organisms

Israeli researchers develop first 3D heart from patient's biological materials A first — complete with blood vessels, ventricles and cells

Air medical transportation: How a 15-minute ride may cost $30,000, and how we can change it Reducing sky-high transport expenses

Using comic illustrations to support patient understanding of cardiac catheterization Making patients more satisfied, less anxious and more informed

X-ray sheds new light on ancient mummy The Everhart Museum in PA tapped Geisinger Radiology for help

Breaking barriers in Alzheimer’s disease with focused ultrasound Researchers at Sunnybrook in Toronto are closing the therapeutic gap

Get ready: UDI rule could affect providers, too

by Brendon Nafziger , DOTmed News Associate Editor
After half a decade of conferences, workshops, pilot studies, the lobbying for legislation and the passage of legislation, and even angry letters from long-serving U.S. senators against a seemingly obstructionist executive office, the unique device identifier (UDI) rule has, at last, arrived.

The Food and Drug Administration released proposed rules for tracking medical devices Tuesday, ahead of the December 31 deadline it would have been given by a clause in a new FDA user fee renewal bill, which Congress passed last month and President Obama is expected to soon sign.

Story Continues Below Advertisement

RaySafe helps you avoid unnecessary radiation

RaySafe solutions are designed to minimize the need for user interaction, bringing unprecedented simplicity & usability to the X-ray room. We're committed to establishing a radiation safety culture wherever technicians & medical staff encounter radiation.



Proponents of the new device identification system say it could have far-reaching effects on U.S health care by allowing easier tracking of recalled products, as well as helping hospitals better manage their inventories and keep expired items off their shelves. They also say it could improve clinical care by, for instance, letting paramedics know the kind of implant someone has before they even reach the hospital.

But while the expense, and hassle, of implementing UDIs will now primarily affect suppliers, who will have to tweak their production processes, if they haven't already, many of the program's predicted benefits can only be realized once providers start incorporating UDIs into their workflow. And it's possible, too, that the government will not wait for providers to do this on their own.

"In an early version of the Affordable Care Act, there was language that would have required capturing UDI in electronic medical records," said Karen Conway, executive director of GHX, a supply chain automation company that has been working with the FDA to test aspects of UDI implementation. Although she said it was later struck from the law, Conway maintains that the Office of the National Coordinator and the FDA are still having conversations about the matter.

"If I were a betting person, I would say it could happen down the road," she said.

HOW THE UDI WORKS

The UDI is essentially a number that identifies a particular medical device. As Conway explains, it would be graphically represented on an item in the form of a barcode, RFID or other machine-readable identifier. The identifier in turn will point to a database that lists different attributes of the product that could have regulatory or even clinical significance, such as its size and whether it's sterile or contains latex.

The database is, in many ways, the key to the whole endeavor, but it still has to be forged. GHX, along with its partners, worked on a pilot test of a prototype database for the FDA in 2009. The problem is the distributed nature of medical device data. The attributes needed for the database are often kept on different systems -- some clinical, some supply chain -- and they have to all be pooled into one place. GHX is also currently working with the Global Data Synchronization Network, an FDA partner organization, on external User Acceptance Testing for the agency -- that is, to see if the database works as intended and meets its users needs. Later, the FDA would likely work with the Association for Healthcare Resource & Materials Management (AHRMM), the supply chain wing of the American Hospital Association, to test how hospitals and others access data from the database, Conway said.
  Pages: 1 - 2 - 3 - 4 >>

Related:


You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2019 DOTmed.com, Inc.
ALL RIGHTS RESERVED