In early July, the U.S. Food and Drug Administration proposed rules for a new ID system — called the unique device identifier — for most medical devices sold in the U.S.
Five years after Congress called for such a system, the U.S. agency said that the UDI would significantly improve its device recall efforts and boost patient safety.
While that may be true, the UDI system, if implemented properly, can have multiple other benefits, said Karen Conway, executive director of industry relations at GHX, a healthcare supply chain management company.
“The Brookings Institution has a contract with the federal government to look at building out a road map for UDI implementation and will be studying a variety of applications from supply chain, reimbursement, capturing data in EMRs, clinical information systems, post-marketing surveillance,” Conway explained.
Reduce waste through better inventory management
Conway shared an anecdote from a medical device manufacturer who told her the company has two years worth of product out in the marketplace that is set to expire in only 18 months. That is because there is no clear visibility in to how much is being used.
But if devices had a UDI, hospitals would have the data to what is being consumed at what price and in what frequency. They can then share that demand data with vendors, Conway said.
“That solves a huge problem that no one wants to talk about: inventory management. We overproduce inventory in healthcare,” Conway said. “So [with the UDI] if we can have a better understanding of how much of the product is being used, and you can share that data, we can be matching to demand better and that can take a significant amount of costs out of healthcare.”
More Visibility for Clinicians
Conway said that the FDA is in talks with the Office of the National Coordinator for Health IT to see whether the UDI can be required to be captured within electronic medical records as a stage 3 of meaningful use.
If such information were contained in an EMR, an orthopedic surgeon performing a revision surgery on a patient, for instance, would know in advance what device the patient has been implanted with instead of waiting to do the surgery.
Implementation of the UDI system will occur in various stages. For instance, high-risk devices such as implantables will need to have the UDI labeling on its packaging ready one year after final rules are proposed, which will occur after the 120-day comment period in early July. If there are no delays, that would make it early 2014. Class II devices would get three years time and Class III devices five.
But implantable and life-sustaining devices would need to bear the UDI on the product itself and Congress is requiring that to happen in two years after the final rules are issued, said Jeffry Shuren, director for the Center for Devices and Radiological Health, in a call announcing the proposed guidelines in early July.
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