NOV 13, 2012 5:55pm ET

Related Links

New Tools & Processes Needed as Patient Payments Rise
June 19, 2013
New Support for National Health Information Exchange
June 19, 2013
FDA Soon to Issue Drug Shortage Notification Rule
June 19, 2013
AMA Annual Payer Report Demonstrates Cost Shift to Patients
June 18, 2013
CMS Updates 2014 Clinical Quality Measures for Eligible Professionals
June 18, 2013
Three HIT Vendors Make Buys
June 18, 2013
Berwick: Public Confused and Scared about Health Care
June 18, 2013

Suppliers to FDA: Speed the Medical Device Identifier

Print
Reprints
Email

The Healthcare Supply Chain Association is asking the Food and Drug Administration to cut the timeframe for implementing a unique device identification system for medical devices from seven years to three years.

Other stakeholders in commenting on the FDA’s proposed rule also called for a much quicker timeline. Provider alliance Premier Inc., for instance, told the FDA that all classes of devices should have a UDI on the label or package in two years, and direct markings on the devices in three years.

HSCA believes a seven-year wait is too long, “because patient safety outcomes far outweigh any rationale, economic or otherwise, for such a prolonged phase-in,” according to its comment letter recently submitted to FDA. “Furthermore, the proposed phase-in period does not lessen the burden imposed on labelers by the rule, but may in fact increase the burden.” Other recommendations from the association, also mirrored by other stakeholders, include:

* Adopt the international GS1 standards for the UDI system, as GSI is one of the most widely used supply chain standards worldwide;

* Adopt a policy that if a device can be labeled, it must be labeled; and

* Adopt the International Standards Organization standard for the date format labels as yyyy-mm-dd. The rule proposed a format from Arabic numerals, such as Nov. 13, 2012.

Comments (0)

Be the first to comment on this post using the section below.

Add Your Comments:
You must be registered to post a comment.
Not Registered?
You must be registered to post a comment. Click here to register.
Already registered? Log in here
Please note you must now log in with your email address and password.
Twitter
Facebook
LinkedIn

There are well over 400 accountable care organizations in the nation now and about two dozen self-sustaining health information exchanges.

Login  |  My Account  |  White Papers  |  Web Seminars  |  Events |  Newsletters |  eBooks
FOLLOW US
Already a subscriber? Log in here
Please note you must now log in with your email address and password.