The Healthcare Supply Chain Association (HSCA) recently wrote to the U.S. Office of Management and Budget (OMB) to express its support for the guidelines to implement the regulations establishing a unique device identification (“UDI”) system for medical devices. Responding to OMB’s request for comments, HSCA highlighted the direct benefits to patient safety of adopting a UDI system, and pointed out that the proposed system would help products move more efficiently and reduce costs across the supply chain.
In its comments, HSCA stated that “a UDI system, properly aligned with the GS1 standards so widely recognized worldwide, will not only achieve the numerous health benefits sought by the FDA in its proposal and its preliminary regulatory impact analysis, but will also yield huge savings to the healthcare system that will far outweigh any costs incurred by manufacturers, suppliers, or providers.”
Product tracking is vital
As products pass among manufacturers, distributors, suppliers, and healthcare providers, a UDI system would make tracking those products easier. Product tracking helps ensure that the right products are delivered to the right purchaser at the right time. Efficient tracking can also help prevent products from being lost or misplaced along the supply chain, and would protect against counterfeit devices that pose significant patient safety concerns. Clearly, effective tracking is vitally important for ensuring accurate, efficient product recalls.
Without standards, various actors along the supply chain often develop their own system for identifying products and recording data, resulting in numerous proprietary “standards” that healthcare suppliers and providers must manage. Numerous standards lead to inefficiencies and inaccurate data, which lead to unnecessary costs. A 1996 study, Efficient Healthcare Consumer Response, estimated that $11 billion is wasted in the healthcare supply chain each year as a result of inefficiencies and errors attributable to the absence or under-utilization of data standards. Global standards promote simplicity, consistency, and accuracy in supply chain communications.
GS1
The GS1 system is one of the most widely used supply chain standards in the world. GS1 standards have been used in a wide variety of industries in the United States and globally for over 35 years. Recently, a number of hospitals, healthcare suppliers, and healthcare-related organizations have begun moving toward adopting the GS1 system of standards to help improve supply chain efficiency and patient safety. In fact, many of our current business partners (e.g., Johnson & Johnson, Cardinal Health, 3M, McKesson) have already started using these standards. Presently, the U.S. healthcare industry is working toward implementing the full range of GS1 standards by Dec. 31, 2012. We believe that the GS1 system represents an excellent model for how the UDI system will work upon implementation.
The GS1 system employs a series of Identification Numbers to identify physical things, such as trade items, assets, logistic units, and locations; as well as logical things, such as corporations or service relationships between provider and patient. These GS1 Identification Numbers include Global Location Numbers (“GLN”) and Global Trade Item Numbers (“GTIN”), which are published to the GS1 Global Data Synchronization Network (“GDSN”). Every Identification Number, whether GLN or GTIN, provides a link between the object and the information pertaining to it.
Summary of HSCA’s comments on proposed rule
HSCA’s primary goal is to improve patient safety through a UDI system. Our comments on this Proposed Rule related to the Paperwork Reduction Act of 1995 focus on the following areas of particular interest to the healthcare supply chain:
- The OMB and FDA should incorporate into the cost-benefit analysis the value of the benefits of the UDI system to patients, providers, and the overall healthcare supply chain.
- The OMB and FDA should exclude costs already incurred by labelers as they prepare to comply with the market’s demand for GS1 compliance by 2012 when determining the burdens imposed on labelers by the proposed UDI system.
- The FDA should shorten the proposed seven-year phase-in to three years, because it does not lessen the burden imposed on labelers by the rule. We believe OMB will determine that the seven-year phase-in period may in fact increase the burden while also unduly delaying the benefits to patient safety.
- The FDA should eliminate the proposed labeling exceptions to ensure that all devices in the United States healthcare supply chain are labeled with UDIs that are published in the Global Unique Device Identification Database, or GUDID. We believe the OMB will determine that the benefits to patient safety provided by UDI labeling outweigh the nominal additional burdens on labelers.
HSCA believes that an effective UDI system has the potential to facilitate the identification of device compatibility problems, ensure that the correct device is used with the correct patient, and improve methods for recording device-related patient information in the patient’s electronic health record, including relevant device-related allergies. Furthermore, device tracking in the UDI system will facilitate comparative effectiveness research by helping to compare devices in the supply chain. Similarly, healthcare providers will benefit from the more accurate, efficient inventory management capabilities provided by the UDI system as well as improved invoice accuracy and reduced ordering mistakes.
The appropriate implementation of the UDI system is a unique opportunity for the healthcare supply chain to move forward.
Curtis Rooney is president of the Healthcare Supply Chain Association, www.supplychainassociation.org.
