The Food and Drug Administration has announced its proposal to create a unique device identification (UDI) system for medical devices, 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 pharmaceutical 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. There was no comparable standard such as the NDC for medical-surgical products, which set things in motion for UDI.
The proposed rule was printed in the federal register on July 10 and underwent a 120 day comment period, with a second open comment period in November on an amendment related to the FDA Safety and Innovation Act.. Here, Karen Conway, executive director of industry relations at GHX, discusses the rule and its potential impact for manufacturers and suppliers in the future.Q: What has happened since the proposed rule was printed in July?
Karen Conway: There was a UDI conference led by Jay Crowley in September and he discussed several issues of concern. That was still during the first comment period and he mentioned that issues such as the date format would be addressed. Suppliers will have to follow these regulations, but some providers express concerned about exceptions because there are some products that would not be required to carry a UDI.
There were concerns raised about direct part marking, which will be required for products that are implanted in the body longer than 30 days and those products that are re-sterilized for second use because they would need the marking directly on the product instead of on the label. If they are imprinting the UDI on the implant with special coating, will that have an impact on clinical effectiveness or create dangers related to corrosion?
For now, Class III products will need to comply with the regulation within one year after the final rule is issued. Other devices that are implantable, life saving and life sustaining must comply with the UDI rule within two years after the rule comes out. These are higher risk items; Class 2 products will need to comply within three years and non-exempt Class I devices within five years.
There is also a stipulation that the final rule has to be out within six months after the close-out period for comments. It's unclear whether that refers to the comment period that closed in November or December and whether the rule will realistically come out in May or June. My guess is that it will come out later in 2013.
Q: How can manufacturers prepare for compliance in the future?
KC: The FDA is focused on high risk devices first, so there is a lot of work for manufacturers of those products to be done through this program. They need to think about how they will label their products, make sure printing systems can handle dynamic data — the UDI will stay the same for a specific product, but the lot,serial number and expiration date will change with time.
Device companies must make sure the ink has high enough contrast and make sure the paper isn't too translucent so it is machine readable by the provider using the product. This will help streamline and improve accuracy in the operating room.
The other thing to think about is what kind of auto id carrier to use. The FDA doesn't mandate which one, so manufacturers can use a linear bar code, 2D matrix or RFID. Manufacturers should think about what providers will actually be able to read. As we know, not all hospitals and healthcare delivery organizations have all of the kinds of technology to read the different kinds of carriers. Providers and suppliers need to talk to one another throughout this process.
Q: What concerns do providers have about the rule?
KC: Providers are expressing concerns about the fact that direct part marking won't happen until later. The biggest issue we have is to make sure providers are actually able to use the UDI. If we simply require manufacturers to assign the UDI code, label their products with the identifiers in machine and human readable fashion, and populate the UDI database with information about their products and healthcare providers don't use it, all we have done is add cost to healthcare.
Q: How can providers optimize this resource?
KC: Clinicians can use it for comparative effectiveness research. Kaiser Permanente and Mercy (St. Louis) have been working on additional clinical attributes that would be most appropriate to capture in a clinical database to understand how they contribute to a better or worse product performance. GHX is looking at capturing UDIs in electronic medical records to optimize the implantable device supply chain. The ASU Health Sector Supply Chain Research Consortium has conducted research with the American Association of Hip and Knee Surgeons to understand how UDIs can help them identify implants in patients prior to revision surgery. If we are able to capture the UDI and get it in the medical record ahead of time, that will help the surgeon prepare for the case.
Additionally, if the patient is in an ambulance on their way to the emergency room, having UDIs in the medical record can alert caregivers about any implants the patient has before the ambulance arrives at the hospital.
Q: What do providers need to do to prepare for the new rule?
KC: They need to think about how their systems will use the data. They will need to capture the UDI with point of use systems and integrate that with their billing systems, operating room information systems and electronic medical records.
There are several different uses for the UDI and many systems this information must be captured in. They don't always play nicely together, so integration is an issue. Right now, providers can look at their technology infrastructure and processes and begin socializing the value of UDIs with different stakeholders in the organization.
Talk to surgeons and nurses, to financial managers who are in charge of billing and reimbursement and to quality control specialists to get a holistic view of what UDI can do for them. UDI isn't just another thing they have to prepare for; it's integral to what providers are doing to meet the requirements and objectives of healthcare reform.
Q: How do you think the UDI rule will benefit healthcare delivery?
KC: The UDI rule can help with many things. There will be a different UDI required for each unit of measure. From a supply chain perspective, this eliminates confusion and inefficiencies because now a UDI refers to a particular product in a particular package size configuration. You have a lot more clarity on what you are purchasing and using. We tend to focus on what we are purchasing and at what price, but now healthcare delivery organizations are focused on what they actually consume. Understanding what they bought and what they used is especially helpful is there is a product recall.
We need to understand the total cost of the procedure and what role each product plays in delivering better outcomes. This cost and quality determines reimbursement. The National Quality Forum has been looking at UDI in terms of how they might use the UDI in quality measures.
I wouldn't be surprised if in the future CMS required providers to provide e UDIs to receive reimbursement. There has also been talk about document in UDIs in medical records to show meaningful use.
Q: Where are the opportunities for growth and development with the UDI in the future?
KC: Other countries are looking at their own UDI regulations, and the FDA has been working with regulators in other countries to develop a globally harmonized set of guidelines. The idea being, if you are a global manufacturer, you are spending a lot of money to comply with different regulations in different countries.
The other thing you can look at if you capture information in different databases with the same UDIs, compare apples to apples and we can look at much larger repositories of data for population health to really understand how different products have an impact on patient care.
Europe issued a draft directive for UDI in September, the goal being to adopt it in the European parliament so it is used in all member states. They indicated there would be track and trace elements in that directive. You've got other countries in Asia and Latin America looking at their own UDI regulations as well.
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