As the comment period closes on long-awaited regulations to implement an identification system for most medical devices, some providers are voicing concerns.
Sixty individuals and organizations have submitted perspectives on the Food and Drug Administration's proposed unique device identifier rule during a comment period that ends Nov. 7
. They included several providers and their advocacy groups, which pushed for various changes in final rules expected next year.
BayCare Health System, Tampa, Fla., was generally supportive of the proposed device rule, wrote Judith Lipscomb, vice president of materials management at BayCare. However, that provider was concerned about the data-collection and reporting burdens that the rule would create for hospitals, specifically in electronic health record-related infrastructure and personnel costs.
“BayCare Health System is concerned that the proposed rule does not recognize the significant financial impact on healthcare providers in the UDI system is required to pass all attributes in the EHR,” Lipscomb wrote.
Premier healthcare alliance said the seven-year implementation timeframe for the proposed UDI system is far too long, especially since the original authorizing legislation for it was enacted five years ago. Premier urged the FDA to complete the implementation of UDI labeling and packaging requirements for all affected devices within two years.
Providers also aired the common concern that the proposed rule would use as a device tracking tool the Global Medical Device Nomenclature, which charges a fee. Many commentators said they preferred the use of either the ECRI Institute's Universal Medical Device Nomenclature System or the United Nations Standard Products and Services Code, both of which are available for free.
“Why make us pay for what we get for free and the additional labor of changing what we already use?” wrote Stephen Mosher, assistant administrator of engineering/facility services for the South Georgia Medical Center, Valdosta, Ga.