Low-unit-of-measure (LUM) programs can pose a challenge for
manufacturers and distributors working to comply with the Food and Drug
Administration’s (FDA) unique device identifier (UDI) rule.
With LUM programs, distributors break down product to reduce the
customer’s need to buy and hold large quantities of inventory. While the
manufacturers’ original packaging may have UDI-compliant labeling, the
smaller packages may not, risking non-compliance with the UDI rules.
no one-size-fits-all solution to this challenge. Instead, HIDA and its
partners at the Association for Healthcare Resource and Materials
Management (AHRMM) and the Healthcare Manufacturers Management Council
(HMMC) have developed a set of recommendations that distributors and
their trading partners can follow. Here is a summary of these steps:
- Initiate trading partner discussions. The
distributor needs to make sure the manufacturer fully understands the
LUM program they offer. Due to anti-trust concerns, these conversations
must be conducted one-on-one between individual trading partners.
- Share key data. The distributor must then share a list of products distributed in their LUM programs.
- Analyze. The manufacturer reviews the distributor’s
data and gathers up-to-date UDI implementation plans from their product
teams. The manufacturer then determines if there are any gaps in UDI
compliance because of the distributor’s programs.
- Dialogue. The manufacturer presents the distributor
with a plan for how products can remain UDI compliant when they are
sold via a LUM program. During this step, the manufacturer may require
additional information, and the distributor may need to gather input
from their provider customers.
- Develop a plan. In this step, manufacturers and
distributors decide on how to implement the necessary changes to comply
with UDI requirements, and how to communicate necessary information to
- Continued dialogue. Distributors and manufacturers
should maintain an open dialogue to ensure that UDI requirements are met
as customer needs change.
In addition to releasing the best practices, HIDA, AHRMM, HMMC, and
the FDA, working together as a part of a new UDI Coalition, are
developing a series of webinars through the spring and summer. Speakers
will include leading policy and industry experts who can offer practical
tips for ensuring all members of the supply chain comply with UDI
Keep an eye out for these by visiting www.HIDA.org/webinars.
The UDI compliance deadline for certain class II devices is
September 24 of this year. The deadline had originally been September
24, 2016, but the FDA extended this to give the supply chain more time
to ensure compliance. The deadline for class I and unclassified devices
is September 24, 2022. For more information on upcoming deadlines, the
best practices, or other UDI resources, please contact us at HIDAGovAffairs@HIDA.org.
In September 2014, the FDA issued its final UDI rule to identify
medical devices as they move from the manufacturer through to the
provider down to patient use. The UDI is required to include information
about the product’s origin, through a sequence of letters and numbers
you are provided with the product identifier (brand name and item) and
for class II & III devices the production information
(lot/batch/expiry date/etc.). In addition to requiring that the UDI
information is shown on the medical device packaging, device labelers
need to make sure this information is entered into the Global Unique
Device Identification Database (GUDID). The GUDID is intended to be a
public portal making product information easily available to the medical
UDI rules have been particularly challenging for all members of the
supply chain, especially since many providers receive medical supplies
as part of a low-unit-of-measure or just-in-time program. Ensuring UDI
compliance as products are separated into smaller collections is a key
challenge the best practices aim to address.