Twenty years ago, on February 15, 2002, I sent the following email to my boss. This was the beginning of what became my 10-year journey to develop and (finally) publish the U.S. Food and Drug Administration (FDA)’s Unique Device Identification (UDI) System regulation. It is fascinating to see how many issues are still relevant and how far we still must go.
FDA, Medical Devices, Universal Product Numbers (UPNs), and Barcoding
The AHA and major group purchasers have written to Secretary Thompson recommending that “the forthcoming regulation on the barcode label requirement apply to medical devices as well as hospital-administered drugs and biologics, down to the single-unit dose.” This regulation would likely require that all levels of drug and biologic packaging contain an NDC number, expiration date, and lot number in “machine readable” format (that is, barcoding). [Note that this regulation, now known as the barcode rule, requires only NDC numbers. We would have to wait for the Drug Supply Chain Security Act (DSCSA) to see that information on a drug label and package.]
There are several issues and players, which have as there only common element the “barcoding” medical devices. (Note: Barcoding is a particular technology, as seen in UPCs on consumer products. It is not currently known which technology, if any, will be required in the regulation. I use the term generically to mean “machine readable” format.) The issues are:
From CDRH’s perspective, there are “medical error” issues that could be addressed similarly. For example, if all medical devices were “scanned” before being used on a patient, an alert would occur if a latex sensitive patient was about to get a product containing latex.
- Money – Group purchasers, and therefore their clients, are interested in barcoding medical devices for the same reasons that they support the proposed “drug” regulation, and the same reason consumer products are barcoded: the cost savings associated with efficient materials management. They need to barcode not only the “unit of use”, but all levels of packaging that the products are transported in (e.g., box, carton, case). The estimated cost savings from barcoding are close to 20% of the total cost of medical products (a cost savings of $11 billion). [From “Efficient Healthcare Consumer Response, Improving the Efficiency of the Healthcare Supply Chain,” November 1996. The estimated cost of medical products was $60 billion, with an associated process cost of $23 billion. The report estimated a cost savings of $11 billion from UPNs and barcoding.
- Preparedness – DoD, who is also a large group purchaser and so has the same cost savings issues, wants also to be “better prepared.” This means knowing how much of something is available and where. Not very different than efficient materials management, but an additional and hard-to-ignore justification.
- Cost Effectiveness – Group purchasers, and others, are also interested in cost effectiveness (e.g., which products work better and is a less expensive product as effective). They want to track and compare products—comparing one to another head-to-head—so that they can make better purchasing and use decisions. Group purchasers are looking for value added to provide their clients.
- Medication Error – CDER is trying to break the cycle; no one will buy into hospital scanning technology to reduce medical error because the products aren’t barcoded and medical products aren’t barcoded because most facilities do not have scanning technology in place. Of course, the technology infrastructure required to make this work is HUGE. You need to be able to scan the patient, the provider, and the product, and then a “computer system” needs to alert the provider if something is amiss. More importantly, CDER does not require that all drugs be packaged in “unit of use” (e.g., at the pill level, blister packs), so the system, from the medical error standpoint, has a huge hole. The pharmacist is still taking the pill out of a large container and putting it into something that makes its way to the patient.
- Better Data – We (CDRH and other HHS groups such as CMS) would like to have better information about the use of medical devices. We would like to have reliable information on the frequency or number of devices used (denominator data), and useful information about where and how devices are used (use issues, numerator data), and the problems that occur with these products. FDA would also like to be able to better track recalled products. If all devices were barcoded, and if this information were captured on electronic patient records, and if we could obtain this data, then we should be able to obtain good data about the use of devices and the problems that occur. Additionally, CMS is interested in reimbursement and cost-effectiveness issues. For example, is product A or device-type A more effective for a particular procedure than product or device-type B?
Universal Product Numbers (UPNs) and Barcoding
There are two related issues: 1) The adoption and use of the Universal Product Number, and 2) barcoding. [Note that prior to UDI, the industry term used for identifying medical devices, as coined by DoD, was UPN.]
The Universal Product Number (UPN), like its UPC or NDC cousins, is an attempt by the standards group to have each product and level of packaging have a unique and distinct identifier (number). The manufacturer applies for and is given a unique identifier/number that identifies that manufacturer. The manufacturer then assigns a unique number to each product and level of packaging (e.g., unit of use, box, carton, case). “Barcoding,” then, is the “machine readable” format of that number and also possibly other information (e.g., lot number, expiration date). But, before barcoding can be useful, we need to have standardized, correct product data that everyone can synchronize to. Currently, DoD estimates that for “medical-surgical” products they purchase (i.e., mostly disposable product such as bandages and catheters), 60% of the “unit of use” packages are barcoded, and nearly 85% of the cases are barcoded. However, the information about what those barcodes mean is not disseminated, so the data in them is useless.
DoD and the group purchasers are primarily interested in seeing a unique UPN placed into a barcode on each level of packaging. However, from our perspective, a traditional UPN (like the UPC) tells you just what the product is (e.g., a 12-ounce can of Safeway sliced peaches), not who actually manufactured it, where, or when, or any other details. We know that Safeway does not produce its own cans of peaches. They probably have a number of manufacturers of peaches that change all of the time. If all you want to do is to be able to manage the material (for example, sell the can of peaches, know how many peaches have been sold, or how many cans are left on the shelf) then a simple UPN works fine. But if you want to track a particular can of peaches (e.g., recall), or be able to track complaints, spoilage, and sickness to a particular lot, manufacturer, or a particular date of manufacture then you need a barcode. On consumer food products, this information is embedded on the package, not in the barcode.
From CDRH’s perspective, we would like to know specifically which product is being used. The more specific and detailed the information we want about the device (e.g., serial number) and version numbers (e.g., of software), the more complex the barcode becomes, and the more difficult and expensive it is to implement. Another significant challenge to FDA for barcoding is understanding how we get this information. Much of this presupposes that health care facilities have some means of capturing this information in a dynamic enough way as to be useful. For example, just knowing that 15 widgets were used this month is somewhat interesting, but we would really like to know how they were used. Were they used in the ICU or in the operating room? Were three used on the same patient because the first two broke? Were they all used on women? How long did one last before it had to be replaced? Did they use the recalled one or the replacement?
Some of the challenges and issues for the device industry include:
- Many device manufacturers are small and the industry is still very fragmented
- Device companies tend to change frequently – they get bought, sold, acquired
- There are many different manufacturers and distributors
- There is often both one manufacturer who has many distributors, and one distributor with many different manufacturers.
- Product lines get bought and sold
- Products and lines change without changing names (like cars, lots of different models with the same name) and the products are not “interchangeable”
- The owner of the 510(k) or PMA may not be the manufacturer or distributor
- Any one product may have many different accessories some made by OEM, some not
CDER is many steps in front of us. Their Registration and Listing regulation (207) requires, and manufacturers actually comply, that manufacturers submit their NDC numbers to FDA prior to marketing. So, for drugs, FDA has a valid and unique set of NDC numbers. CDER does not currently require, but requests that the NDC numbers appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer. The new regulation will require the number be on all labels.
If we want to work toward barcoding devices, we would need to:
- Create an up-to-date, valid database of manufacturers and their devices
- Have unique and distinct UPNs for each device and its various levels of packaging
- Define “unit of use”
In general, the device industry has been diligently working toward UDI implementation (that is, barcoding devices), but how far have we come in accomplishing the three tasks I put forward?
With respect to creating an up-to-date, valid database of manufacturers and their devices, FDA and device manufacturers (labelers) have progressed in creating and maintaining the Global Unique Device Identification Database (GUDID), but many devices are missing and there are a lot of missing and incorrect data attributes for existing device records. There are also new use cases and issues that were not considered in GUDID’s original development (for example, functional equivalence, non-homogeneous and variable packaging configurations, and parent-child relationships), that need to be discussed and addressed.
Regarding unique and distinct UPNs (UDIs) for each device and its various levels of packaging, we can see many UDI-compliant labels and packages on the market; however, there is a lot of incorrect and inaccurate information and formatting in the automatic identification and data capture (AIDC [barcode]), incorrectly formatted human readable interpretation (HRI), and a general mismanagement of changes to the device identifier (DI) and the introduction of new DIs.
On the issue of unit of use, I think we are still far from a common understanding of what constitutes a specific device’s unit of use. The notion of “unit of use” DI still confounds many users and there are many errors in GUDID.
As healthcare continues its digital transformation (which COVID-19 has certainly accelerated), the importance of accurate and consistent device identification and associated clinical data will become even more critical in providing the necessary foundation for effective digital health. We must all work together to identify and improve the way in which UDI is implemented and used through the healthcare system, and to improve and expand the use cases and data attributes associated with medical devices. Healthcare is going digital and medical devices are central to this paradigm shift; we have no choice but to get this right.
How USDM Can Help
USDM Life Sciences is the industry leader in UDI regulatory compliance solutions for the medical device industry. We have well-established relationships with the most prominent IT vendors in the world and an experienced team of subject matter experts led by Jay Crowley, who developed the framework and authored key requirements for the FDA’s UDI system.
Contact us to learn how we can help your organization execute a program to support your UDI efforts.
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