Few medical device makers are prepared for the next implementation phase of FDA's unique device identifier (UDI) system, according to an industry survey released last week.
FDA in September 2013 issued a final rule establishing its UDI system. The final rule calls for manufacturers to assign UDIs to medical devices to make it easier to track the devices':
- Expiration dates;
- Lot or batch numbers; and
- Manufacturing dates.
FDA is phasing in the UDI system over seven years. Manufacturers were required to include UDIs on class III medical devices starting in 2014 and on implantable, life-supporting, and life-sustaining devices starting in 2015. Manufacturers will be required to include UDIs on:
- Class II medical devices—which account for 43 percent of the market and include condoms, wheelchairs, and pregnancy tests—by Sept. 24; and
- Class I and non-classified devices by 2018.
CMS, FDA officials call for unique device identifiers on universal insurance forms
The survey, conducted by technology firms Loftware and USDM Life Sciences, received responses from 120 medical device professionals. The survey found that just 15 percent of respondents currently comply with the requirements of the UDI system's next implementation phase.
Overall, 93 percent of respondents said UDI requirements have significantly affected their current labeling processes. According to the survey, about 50 percent of respondents said they believe their existing barcode labeling software would meet UDI regulations and other requirements. The survey also found that:
- About 50 percent of respondents said they face challenges to including all necessary data on medical device labels; and
- 36 percent cited issues with understanding and applying the regulations.
According to Modern Healthcare, device makers that fail to comply with the regulations will be barred from selling products across state lines.
Josh Roffman, VP of product management at Loftware, in a statement said, "With all of the evolving FDA ... regulatory requirements, it's important for medical device companies to be able to quickly implement and maintain a validated, compliant, and sustainable labeling solution."
Jay Crowley, vice president of UDI services and solutions at USDM Life Sciences, 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" (Castellucci, Modern Healthcare, 8/3; Goedert, Health Data Management, 8/5; Loftware release, 8/1).
The evolving role of surgeons in medical device evaluation and selection
The need for hospitals to control costs is not exactly news. But since 2012, when year-over-year hospital cost growth surpassed revenue growth, the pressure to contain costs has intensified. Emboldened by recent success and continued pressure to further reduce per-case costs, many supply chain leaders are pushing ahead with expanded efforts to influence—if not dictate—physicians' product preferences and use.
The increased reliance on data transparency is only one tool highlighted in our recent survey of proceduralists, which aimed to shed light on two key areas of broad concern to suppliers: How surgeons' roles in product evaluation and selection are changing, and how their asks of vendors are evolving.
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