Mois : août 2016

85% of manufacturers are not prepared for upcoming UDI compliance deadline

September 24th 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 September 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.

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.

The survey polled approximately 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.

The heads of the CMS (Centers for Medicare & Medicaid Services) and the Food and Drug Administration want universal health insurance claims forms to include unique device identifiers. The UDI would improve post-market surveillance and provide for better value-based reimbursement based on device performance, they say.

CMS Administrator Andy Slavitt and FDA Commissioner Dr. Robert Califf wrote to the chair of the Accredited Standards Committee X12, or ASC X12, to ask that the organization add UDIs for implantable medical devices on claims forms. The letter reflects the FDA’s push to improve device evaluation and surveillance, as outlined in a JAMA editorial Monday co-written by Califf.

Proponents of the use of UDIs say they could more quickly identify dangerous devices, some of which in recent years have not been flagged until they hurt patients. Those pushing for the use in claims say they could inform population health by evaluating associated outcome data.

Manufacturers and distributors currently are implementing UDIs and electronic health records are being tweaked to allow providers to one day record unique device identifiers, but insurance claims forms had been the holdout. Some in the industry say the changes are costly because the technology to support the changes isn’t there.

ASC X12 will release the next version of the insurance claims form for public comment in December. That template will be released in 2021. The next update isn’t scheduled for another 10 years.