The Unique Device Identifier (UDI) program was Congressionally mandated in 2007 with the following language: “The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use and may include information on the lot or serial number. The UDI must adequately identify the device through distribution and use; and must include information on the lot or serial number.”
The Unique Device Identifier (UDI) program was Congressionally mandated in 2007 and requires that medical devices have labels with unique identifiers that can allow following the device through distribution and use. Those identifiers should include lot and serial number.
The UDI Regulation is supported by many stakeholders, including several governmental agencies, and several associations including AHRMM, IAHCSMM, AORN, AAMI, American Medical Association, American Hospital Association, and AdvaMed, to name a few. Obviously, your peers, the physicians, the regulators, IT, manufacturers, pharmaceuticals, are all invested in the adoption of the UDI.
The intent of the program was to create a common vocabulary for use from the manufacturer thru to patient billing and records in order to improve patient safety by facilitating:
- Adverse event reporting
- Efficient and effective recalls
- Identification of medical errors
- Enhanced analysis of devices on the market
- Creation of a global, secure distribution chain
The UDI Guidance document covers the requirements under several sections including 21 CFR Part 801 (label requirements), part 803 (Medical Device Reporting), part 806 (Medical Devices; Reports of Corrections and Removals), part 814 (Premarket Approval of Medical Devices), part 820 (Quality System Regulation), part 821 (Medical Device Tracking Requirements), and part 822 (Postmarket Surveillance).
The FDA defines the contents of a label within the guidance document to include several details:
- The UDI, which is comprised of the Device Identifier (DI) and production Identifier (PI)
- Information in both human-readable and machine-readable (barcode)
- Expiration date, which for hospitals is a clear definition of when a product expires, not the first or last day of the month
Scanning of the UDI connects to the Global Unique Device Identifier Database (GUDID). The DI is the static information, such as a catalog number that does not change; and the PI is as stated, including the production information: lot number, serial number, and expiration date –as applicable.
Figure 1 demonstrates an approved label:
How the UDI Came About
A precursor to the FDA UDI guidance came from publishing studies about preventable medical errors that cause harm and/or death. The Institute of Medicine produced a book To Err is Human: Building a Safer Health System released in 1999, which demonstrated preventable medical errors and addressed the safety concerns. In 1998, close to 100,000 deaths were attributed to medical error. This number far exceeds that of deaths due to motor vehicle accidents, breast cancer, and AIDS. The errors were likely caused by faulty systems, processes, and conditions that led to failures. Estimated costs to hospitals nationwide were between $17 billion and $29 billion per year. Those numbers are from the late 90s. When we look at that same value in 2021, the numbers are far greater. Contributing factors include patients seeing multiple physicians in multiple hospitals and medical settings where the patient’s information is maintained separately with no means of correlating it.
One of the four strategies for improvement is to implement safety systems at the delivery level and develop a “culture of safety”. The Clinton administration issued an executive order instructing government agencies to implement proven processes for reducing medical errors. In 2000 Congress appropriated $50 million dollars to the Agency for Healthcare Research and Quality (AHRQ) to support a variety of efforts targeted at reducing medical errors. The familiar term “never events” is used to indicate the processes that must be in place to ensure the “never events” never occur. It puts the focus is on patient safety and paved the way for the UDI’s focus on patient safety.
The Contributions of the PEW Trust
The PEW Trust developed the Health Information Technology and Medical Device Initiatives led by Ben Moscovitch. In 2017, new leadership in the Center for Medicare/Medicaid Services (CMS) agreed that updating the billing form to include the UDI information is critical to patient safety and could save Medicare millions of dollars. Having the device information for millions of patients with millions of devices would support patient safety, and make it possible to compare effectiveness, and facilitate recalls, to name a few.
Capturing the UDI
The UDI is intended to be captured in the patient’s medical record. To do that and to provide traceability of the product, the UDI-DI (device identifier) should be captured in the Item Master. The Item Master should then be linked to the clinical systems such as OR, Cath Lab, Interventional Radiology, etc. From this point, the clinician scans the barcode. The DI (device identifier) is found in the clinical item master and captures the PI (production information) specific to that product, which is scanned to the patient’s medical record. This information is then sent to the patient’s bill. CMS is working to have patient bills updated to capture the UDI information in 2022. At a point in the near future, CMS will not reimburse if the UDI information is missing. Because the insurance companies tend to follow the CMS guidelines, it is only a matter of time before they also reject bills that are missing the UDI. Because most hospitals receive 40 to 60 percent of their reimbursement from CMS and have an overall profit or loss of +/- 3 percent, lack of this information to obtain appropriate reimbursement can cripple a hospital very quickly.
Tracking Tissue, Implants, and Instruments
Because of the strong need to track tissue and implantable devices, there are various means to capture the UDI for implantable devices, such as a direct part mark (DPM), count sheets, tabs that are perforated and removed, and laser etching. How are you currently capturing this information in your sterile processing department (SPD) and OR? Implant tracking has been going on for many years. The OR would have a logbook where the identifying label was placed, along with patient information. The information was also added to a patient’s chart. Patients were often given a card with the serial number of the implants to keep for their records. It was a hit-and-miss system. Dependably finding this information years later would be very difficult for a patient or his physician. Someone would have to comb thru the implant logs, pull a patient’s hard copy chart to comb thru pages of documentation. Often the patient has misplaced the card. The obvious need to capture this information electronically is important for many reasons:
- Failure of the device
- Need for a revision
If you are not aware of how your organization is capturing this data, it is a great discussion to have between the procedural departments, supply chain, IT, and SPD to understand its importance and develop processes to capture the data.
One of the sections that link to OR and SPD is covered under 21 CFR 801.45 that states “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.” The compliance date for manufacturers is September 24, 2020; however, the FDA will not begin to survey the manufacturers for compliance until September 24, 2022.
In plain terms, all items intended to be reprocessed shall have a UDI imprinted on the product – direct part marking (DMP) – as well as on the packaging. The European Union has required this type of marking on instruments for many years. As instruments are sold worldwide, you will find a DPM on the newer purchased instruments. As of this time, the identification does not get to a lot number level, but that is under discussion.
Instrument tracking is included in the UDI regulation because instruments can fail, can cause harm, may be complex or plain, and are used to implant devices. The inappropriate functioning of an instrument may be the cause of harm to a patient; without documentation of its use, it may be an unknown culprit of harm. The UDI is about patient safety and knowing what devices were used on the patient, not only to track harm but also to track positive outcomes.
Enter the Global Unique Device Identifier Database
All device manufacturers are required to upload data for every product that requires a UDI into the FDA Global Unique Device Identifier Database (GUDID). The GUDID is sponsored by the National Institute of Health Library of Medicine and is accessible free of charge. As mentioned above, one of the requirements of data on a device label is the ability to scan the barcode and be taken to the GUDID - see below (which houses all relevant information as required by the FDA). The data in the GUDID can be downloaded and added to a hospital’s Item Master. This is a complex process that should be completed by an analyst who is familiar with data integrity.
Part two of Jean Sargent's in-depth look at UDI will be released on Thursday, May 20th.
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To Err is Human https://www.ncbi.nlm.nih.gov/books/NBK2673/
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