Article originally featured in Pharmaceutical Compliance Monitor.
The demand for robust product information is pervasive. It touches every industry and comes from multiple facets – end consumers to global governments – and the healthcare industry is no exception. Patients are no longer simply recipients of care, but active participants requiring access to rich product information to make informed decisions about their health, care and wellness.
Governments are taking heed and enacting legislation to protect consumers, increase safety, and support product traceability. As a result, recent product information transparency mandates, like the Food and Drug Administration’s (FDA) Unique Device Identification (UDI) regulation and the Drug Supply Chain and Security Act (DSCSA), are causing a shift in the way that global healthcare organizations do business.
The FDA’s UDI regulation, a mandate that requires all medical devices sold in the United States to be labeled with a unique device identifier and stored in the Global UDI Database (GUDID), has laid the foundation for an industry movement. A response to increased visibility and traceability to support product recalls and improved patient safety, the regulation intends to ensure the availability of accurate and reliable information for providers, patients and members of the public, thus enabling visibility and transparency to recipients and providers of care. As a byproduct, it is driving the healthcare industry toward standardization.
The primary methodology used by the Consumer Packages Goods (CPG) industry to aggregate and distribute product information (via GS1 Standards and UPC), has encouraged leading healthcare organizations to apply these principals to the healthcare industry at a global level. Embracing the challenge, healthcare industry leaders are seizing the opportunity to streamline internal systems and integrate standards adoption and data syndication via methods like the GDSN, transforming the way the industry conducts business.
Pioneering this approach, leading global medical device manufacturer B. Braun recognized the implication the UDI regulation would have on its operations and began evaluating its systems two years in advance of the first compliance deadline. Requiring a scalable, global solution to support all medical device categories, B. Braun sought an efficient and quality product information distribution methodology via a uniform deployment. B. Braun took a leading role in the adoption and utilization of GS1 Standards and the GDSN within their organization, ensuring that their organization consistently delivered high quality product information to trading partners and the FDA. Their innovative approach to compliance, and the subsequent benefits and efficiencies achieved, has served as a benchmark and model for the healthcare industry as a whole.
Businesses must ensure they are prepared to meet global market requirements and recipient expectations, proactive and innovative strategies are required to support consistent compliance to global regulatory initiatives, such as DSCSA, as well as increased demands for supply chain efficiencies. As regulatory mandates and the demand for greater transparency become a business necessity, global organizations are utilizing solutions to ensure their systems support a consolidated approach for aggregating, managing, distributing and delivering accurate product information via a uniform and scalable model. This includes establishing organizational commitment to data governance and data quality programs that enable trusted product information exchange at a global level.
Standardized product information exchange can have a significant impact on industry enablement. As an advocate for trusted product information exchange, we strongly recommend that the healthcare industry embrace the proven and successful framework of GS1 Standards and concepts like GDSN to improve supply chain management and support product risk and compliance. The industry transformation to a value-based care model will affect foundational changes and challenges for the healthcare supply chain and organizations need to be prepared with proactive and innovative overarching strategies to successfully adapt.
- Have you started planning for UDI compliance? - April 6, 2016
- Streamlining the Global Healthcare Data Supply Chain to Comply with Safety and Traceability Mandates - February 22, 2016
- The FDA wants YOU – to be compliant - September 23, 2015
- The Power of 1WorldSync Product Information Cloud - August 10, 2015