FDA announces proposal for unique device identification system The U.S. Food and Drug Administration recently proposed a unique identification system for certain medical devices, potentially impacting both the vendor and buyer sides of the healthcare supply chain.

A report from 1999 showed that an estimated 100,000 people die annually as a result of medical errors that could be avoided if certain preventative measures were taken, which led to a law being created and finally implemented in 2006 that led to pharmaceutical products being labeled with scannable labels, according to Becker's ASC Review.

"At that time, the FDA and center of radiological health wanted to do the same for medical devices but realized there was no standard out there," said Karen Conway, executive director of industry relations at GHX, who was quoted by Becker's. "That's what led to the inclusion of the language in a 2007 act mandating the FDA establish this unique device identifier system; the FDA has been working on developing this rule for five years. I think it's a good thing they have looked at this really carefully."

The Federal Register began a 120-day comment period on the proposed rule that will gauge feedback from those who are involved in the process of establishing the new system that's expected to improve the supply chain. Becker's pointed out that the pharmaceutical scanning system has not caught on, with fewer than half of U.S. hospitals employing it. The comment period is intended to strengthen industry buy-in of this new system.

According to Conway, the FDA is allowed to control whether suppliers put the bar codes and identifiers on, but it must also deliver value to the physicians and other healthcare professionals. She suggested several things to know about the newly proposed rule and how providers can use the UDI system to their advantage.

Tracking implants

The system will allow medical facilities to track implants, allowing them to document what implants are used and how patients respond to them. Orthopedics cases are especially in need of more attention. In recent years, providers were presented with or caused complications related to standard devices such as metal-on-metal hip replacements, which could be addressed if the tracking system is adopted.

"If you have a specific UDI for a hip implant and captured it in the patient's electronic medical record, surgeons can see in advance exactly what kind of implant is already there," said Conway. "Additionally, if a patient is in the ambulance and being transferred to the ER, physicians should be able to see whether the patient has a specific kind of implant so they are more effective in the procedural suite. We don't have that capability with each case yet."

Improving the supply chain
According to Conway, managing the supply chain will be made easier through the new system, as providers will be able to tell how much they are purchasing and what products they're using to cut back on wasteful spending.

"There are several benefits from supply chain efficiency," said Conway. "For example, by capturing data on consumption, versus the more traditional focus on how much product is ordered, providers can help reduce the amount of product that might expire before use."

While this tracking technology could have a transformative impact on the healthcare supply chain, it is not the only development that could have a profound effect. According to Becker's, focusing on entrepreneurial manufacturers with FDA-approved products is one of the popular trends in the medical device industry. There has been a shift from internal new product development in larger companies to sourcing opportunities across the country, which could have a major impact on the healthcare industry.
Share To:

Strategic Sourceror

Post A Comment:

0 comments so far,add yours