Decoding healthcare supply
traceability standards
VIEWPOINT
by Julie E. Williamson
I
n the realm of Central Service, supply and instrument track-
ing systems have been revered as a way to streamline effi- Q
Will our department be able to meet GS1 standards and
FDA requirements if we currently only have a manual in-
ciencies, improve customer service, establish quality bench- strument and supply tracking process in place?
marks, pinpoint process deficiencies, and enhance overall trans-
parency across the use cycle. A
The GS1 standards and FDA UDI indicate that the manu-
facturer will identify the supply or instrument with a
While, for many CS departments, such systems are still consid- unique identifier, which will include a catalog number, lot num-
ered a luxury and remain on their budgetary wish lists, regula- ber, serial number, and expiration date. The FDA regulation will
tory developments will soon be making instrument and supply be published sometime in the spring, so we do not know what
tracking capabilities a requirement. Although materials manag- the regulation will state, aside from the fact that it will be imple-
ers may be well-versed on bar coding standards – which will soon mented on a risk-based system similar to the Class I, II and III
be mandated by the U.S. Food and Drug Administration – many classifications. The implementation will also be similar to the
CS professionals are lacking that knowledge and are unaware of implementation of single-use device regulation of 1999. How-
how the FDA’s Unique Device Identifier requirements and GS1 ever, there are certain products, such as implantable devices,
global standards will impact them and their department. that must be tracked today, either manually or electronically.
To help bring CS professionals up to speed, Jean Sargent, We will need to build on these systems while we are looking at
CRCST, CMRP, FAHRMM, director of supply chain manage- electronic systems to capture the data.
ment for USC Health Sciences, GS1 Healthcare US Leadership
Team member, and AHRMM past –president (2007), responded
to key questions regarding the U.S. healthcare industry’s accel-
Q
Shouldn’t our C-level executives already be familiar with
GS1 and be ensuring that we’re all on target with the
erated movement to use GS1 standards to improve patient safety
standards?
and supply chain efficiency.
A
There has been education aimed at the C- level execu-
tives, which has been presented at various venues (includ-
Q
What is GS1 and why is it important for me and my CS ing a standards DVD that was placed in each attendee bag at the
department? AHA leadership summit, which took place in July 2009). The
A
GS1 is a global standards organization responsible for tool kits that were produced by GS1 Healthcare US include a
determining the standards to be used globally. GS1 US is section on how to educate the C-suite about the importance of
specific to the United States, and GS1Healthcare US is specific this subject. The success of the implementation will be depen-
to healthcare in the US, both of which are responsible for imple- dent upon buy-in from the C-Suite. The education for all of the
mentation of the standards developed by GS1 global. GS1 stan- industry will need to come from various directions in order to
dards include billions of transactions that occur daily, many of ensure success.
which we, as consumers, use. It is about bar coding and radio
frequency identification of products. Each time we go to the gro-
cery store and scan our items, we are using GS1 standards.
Q
What can/should my department do now to ensure that
we’re on track with the GS1 standards (and the looming
The healthcare supply chain has been pursuing this same type
FDA requirements)?
of activity for healthcare. In addition, the U.S. Food and Drug
Administration is working on a new regulation that will man-
A
The first thing is to become educated on what the GS1
standards are and what the FDA regulation is about, and
date the use of bar code scanning. This regulation is called the
how it will affect the facility and department. The GS1 Health-
Unique Device Identifier and will include supplies, equipment,
care US work groups developed tool kits, white papers and an
instruments, and pharmaceuticals.
educational video for manufacturers, distributors and health-
care providers, and also sponsors educational web seminars. The
Q
If my department isn’t involved in materials management FDA has also been out speaking at many venues to educate the
duties, does GS1 still affect me and my department? public. For more information, visit the GS1 website at
A
Yes. The FDA and Medicare are looking for traceability of
www.gs1us.org/healthcare, or the FDA website for the Unique
every item used for a patient’s care — from the manufac- Device Identification at
www.fda.gov/cdrh/ocd/udi/. HPN
turer to the distributor to the hospital to the patient to the medi-
cal record, and then to Medicare for billing/reimbursement. Ev- IAHCSMM will be sure to keep CS professionals informed of new de-
ery person in the hospital who has a role in producing or using velopments surrounding the FDA UDI standards requirements, as they
the goods will be involved in the tracking of these items. become available.
34 November 2009 • HEALTHCARE PURCHASING NEWS
www.hpnonline.com
0911-VIewpoint.pmd 34 10/9/2009, 5:02 PM
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