Linda Rouse O’Neill
HIDA Government Affairs Update
HIDA, AHRMM, and HMMC to debut new UDI resources and education campaign
By Linda Rouse O’Neill, Vice President, Government Affairs
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.
There’s 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 customers.
- 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 requirements.
Keep an eye out for these by visiting www.HIDA.org/webinars.
Looking ahead
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.
Background
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 community.
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.