8 Ways the FDA Unique Device Identifier System Will Impact Surgery Centers

Laura Dyrda -

The Food and Drug Administration has announced its proposal to create a unique device identification (UDI) system, which will impact both suppliers and providers. The rule itself has its genesis in a report from 1999 stating that 100,000 people die annually as a result of medical errors that could be avoided. In 2004, a law for identifying products using the NDC was created and went into effect in 2006. Pharmaceutical companies were required to print bar codes on their products so they could be scanned at the bedside and in the operating room.

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"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," says Karen Conway, executive director of industry relations at GHX. "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."

This time around, the FDA hopes to avoid pitfalls of the medication bar code system, which only 40 percent of hospitals widely use, and has enacted a 120 day comment period on the proposed rule from its publication in the Federal Register on July 10.

"The FDA can mandate that suppliers put the bar codes and identifiers on, but if we aren't actually using it on the provider side, we aren't going to get the full value," says Ms. Conway. Here, she discusses eight things to know about the rule and how providers can optimize the UDI system for increased efficiency and quality.

1. The system will help track implants.
As we have seen over the past several years, it's important to track which implants are used for patients and how patients respond to those implants. This is especially true for orthopedics cases, where in recent years providers were blindsided by complications with standard devices such as metal-on-metal hip replacements.

"Gathering data on what products you are using in which patients can help you with recall management, adverse event reporting and clinical efficacy studies," says Ms. Conway. With the UDI, the FDA hopes it will be easier for providers to capture data on products used in patient care and to identify trends related to clinical outcomes.  

Tracking implants can also have a benefit for patients who might need revision work or end up in the emergency room with an illness or traumatic injury. "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," says Ms. 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."

2. Managing supply chain will be easier.
A  UDI can also help tell providers how much they are purchasing and which products they are actually using to cut down on over-purchasing, if providers use it effectively.

"There are several benefits from supply chain efficiency," says Ms. 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."

3. Data capturing systems will be more accurate.
Whether surgery centers have an automated supplier management system, manual data entry or paper logs to keep track of their supplies, administrators should begin to think about how their system might be altered by UDI. Here are three questions to consider:

•    How can I capture this new data?
•    Can my system support that data?
•    Can I share data between our operating room system, implant log and EMR?
•    How can we capture the data at the point of use?
•    How can I share that data and compare it with the manufacturer's data?

First, think about how supply data is currently tracked; likely, there is someone from the manufacturing company in the operating room that captures data as well as a nurse and at the end of the case both sides reconcile this information. With manual data entry, there is a high chance of mistakes.

"Automating the process of capturing data on products used using UDIs could catch a lot of errors and save time," says Ms. Conway. "Everything from understanding what is being used, how to bill for it and replenish it is important. Surgery centers can help make sure they are charging effectively and better handle inventory issues with automation. If we can share information, manufacturers can start making and supplying the right amount of product, which will reduce the product that is expiring on the shelf and save money."

4. Focus on the total cost of care is renewed.
When we pay more attention to the supply chain as a whole, we get a better picture of the total cost involved in sourcing, procuring, using, documenting and paying for products. Since the supply chain is still one of the most highly manual processes in healthcare, costs are high.

"If you've got better information on how the case was scheduled, products being used and patients coming in, you'll hopefully spend less time on the front end preparing the products and less time on the back end putting away products you didn't use," says Ms. Conway. "We want to capture data more accurately so we really understand the role of specific supplies in improving the quality of care."

Understanding the total cost of care will become increasingly important in the age of healthcare reform. "Under healthcare reform we have to figure out how to deliver quality care at affordable prices," says Ms. Conway. "Being able to electronically capture data and automate those processes is going to take out a lot of costs as well as allow providers to understand the total cost for procedures better."

5. Products will be impacted at different times.
When the comment period is completed and the final rule has been released, there will be a specific timeline for manufacturers to become compliant. The first devices that will be impacted are Class III devices, which are primarily implantables. Class III devices will be required to have the labels one year after the rule is issued; Class II devices three years after the rule and Class I devices five years after the rule is issued.

However, there are some additional products that will need to comply within two years after the final rule is issued under language in the recently passed FDA Safety and Innovation Act, often referred to as the FDA user fee act. These include non-Class III implantables and devices considered "life-saving or life-sustaining," so knowing which devices will be covered at which point will be important. "The FDA is sorting out the proposed rule and overlaying it with the FDA user fee act, which outlines the timeline for implementation," says Ms. Conway. "They are also working to provide more clarification to device company manufacturers on what products are likely impacted when."

6. Providers can use the system to meet higher quality standards.
In addition to the several supply chain management benefits from the UDI system, providers may need to capture UDIs in their electronic medical records as part of Stage III meaningful use, although this is not yet required by the Office of the National Coordinator for Health IT.

"The National Quality Forum has been looking at how UDI could be used to improve quality measures," says Ms. Conway. "For example, they are looking at how to improve safety and efficacy of infusion therapy."

Capturing UDI data as part of quality measures could be adopted by the Joint Commission or CMS for reimbursement purposes. "Even though the UDI is a regulation that will be directed at manufacturers' products, I could see requirements down the road for providers," says Ms. Conway.

7. Product scanning will be technology-neutral.
One of the problems with the initial bar code system for medications was that it mandated use of a specific auto id carrier, the linear bar code.

"They want to be technology neutral," says Ms. Conway. "The manufacturers will need to label the products in a manner that is both machine and human readable, but the FDA will not require a specific auto ID carrier. They can use the linear barcodes, 2-D matrix barcodes or RFID, as examples."  

8. The system creates a UDI database.
The UDI system will create a database of information associated with each device. "Manufacturers will have to label their devices and provide additional data about the products that are associated with the UDI to this database," says Ms. Conway.

The database could include information such as who manufactured the device, the device's brand name, whether the device is required to be sterile and whether the device contains latex. "Manufacturers store different data for their products in different places," says Ms. Conway. "The manufacturers will have to maintain the data and submit it for compliance."

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