Only 15% of medical device manufacturers are currently compliant with the next phase of regulation required for unique device identification under the Food and Drug Administration's final rule, according to a report.
A Sept. 24 deadline requires labels and packages of Class II medical devices such as condoms, wheelchairs and pregnancy tests to bear UDI barcodes. Data on Class II devices also must be submitted to the FDA's Global Unique Device Identification Database. The database will serve as a reference for every device on the market. Class III devices that are reused must also have a UDI.
Class II devices comprise about 43% of the market, according to the FDA. By Sept. 24, 2017, Class III devices, which are used to sustain or support life, such as pacemakers and comprise about 10% of the market, will need to carry UDIs.
The deadlines are part of a seven-year rollout by the FDA to ensure medical-device manufacturers mark their products with unique identifiers that allow industry and the government to track device safety and efficacy.
The survey polled 120 medical device professionals responsible for regulatory and information technology labeling. It was conducted by Loftware, a software company, and USDM Life Sciences, a professional services firm.
The poll found that only about 50% of respondents felt their current barcode labeling software would meet UDI regulations and other evolving requirements. This is likely because more than 70% of manufacturers don't have a single, standardized labeling software.
About 50% of respondents admitted that they continue to struggle getting all of the necessary data on the label. Challenges with understanding and applying the regulation also affected 36% of respondents.
An overwhelming majority, 93%, also reported that UDI requirements have had a major or noticeable impact on their existing labeling operations.
In a news release, Jay Crowley, USDM Life Sciences vice president of UDI Services and Solutions said, “I can't stress enough the need to have your approach to UDI compliance be well thought through and thorough, well documented and well implemented in a way that's going to provide a path forward that can grow and evolve with your organization.”
Manufacturers found to be non-compliant will lose their right to sell devices across state lines.