Unique Device Identification (UDI)

A UDI is a unique numeric or alphanumeric code that consists of two parts: 1) a device identifier (DI), and 2) a product identifier (PI). Implementation of UDI labeling is a global regulatory initiative.

UDI Implementation-Why You Need to Begin Today

udi UDI Implementation Why You Need to Begin Today

In this blog, “UDI Implementation-Why You Need to Begin Today,” the author provides reasons why you should begin your implementation today and the benefits of doing so.

I have taken you through what UDI is, what you need to do to meet its compliance dates, and in the last few blogs, written about the steps you need to take to implement UDI in your organization. With the September 24, 2014 deadline looming, labelers of Class III devices and stand-alone software should be well on their way with implementation. But what about you who label implantable, life-sustaining, life-supporting (9/24/15 deadline), Class II (9/24/16 deadline), or Class I (9/24/18 deadline) devices? Should you wait or begin now?

UDI – Good Business Sense

There are many reasons why implementing UDI makes very good business sense. Two overriding reasons are increased revenues and lower costs. The healthcare industry has been using Automated Identification and Data Capture (AIDC) technology for a number of years. FDA has required since 2004, drug manufacturers use barcodes (NDC number) on their  labels. Now, they require device manufacturers (labelers) use Unique Device Identifiers (UDI) on their medical device labels. 

Hospitals and Group Purchasing Organizations (GPOs) have been at the forefront of persuading many medical device manufacturers to adopt UI for the devices they label. GPOs are now at the point of mandating manufacturers to implement UI to continue and/or obtain contracts to sell their devices to GPO hospital members. Even with that significant pressure, many manufacturers have resisted implementing UI. Of course, now, they will have no choice.

UDI Implementation-Why You Need to Begin Today

Manufacturers who have implemented UI have seen increased revenues and decreased costs. Their hospital/GPO customers view them as “easy-to-do” business with, resulting not only in an increase of sales of contracted devices but also of non-contracted devices. Hospitals must implement systems to reduce their costs. UDI is such a system. It will permit hospitals to manage their inventories better, reducing or eliminating product duplication, as well as realizing improved inventory tracking.

The use of product barcodes will allow hospitals to charge patients more accurately for the devices they use while hospitalized. Manufacturers have also been able to increase the speed to market for a new device compliant with UI, and by adding it to their existing GPO contracts. This can increase the new device’s exposure to the market very quickly.

Becton Dickinson Implementation

The March 2011 Edition of Healthcare Purchasing News published an article by Karen Conway that describes Becton, Dickinson, and Company (BD) Resource Optimization and Innovation (ROi) experiences implementing UI (GS1’s Global Trade Identification Number). Dennis Black (BD) and Alex Zimmerman (ROi) describe the positive impact implementing UI had on their businesses.  They were able to document a 30% reduction in accounts payable days outstanding. Other findings included:

  • 73% reduction in errors on customer orders
  • fewer stock-outs
  • greater process efficiency
  • fewer calls to customer service
  • better charge compliance

All are excellent reasons to start UDI implementation now.

Regulatory Affairs will also benefit from implementing UDIs. Improving the recall process will help reduce costs through easier tracking of which customers to contact, versus what is typically a very arduous and time-consuming process today. Starting now will also allow you to control the pace of the required changes to your organization, and collect data needed to submit to GUDID. This regulation will put your organization under a tremendous amount of pressure without having to deal with the crisis of a short implementation window.

The most common mistake I have seen organizations make is poor planning around UDI implementation. They significantly underestimate the amount of time it will take to implement UDI, the amount of change that will occur within the organization to be compliant, and being able to manage the ongoing requirements of UDI. These issues are compounded for multi-site organizations, where project planning is critical. 

Earlier in this blog, I mentioned hospitals using barcodes to charge fees for devices used by patients. This information will be added to the patient’s electronic health record. From there, this information will work its way into large population databases, such as claim data. Manufacturers will ultimately be able to use this claim data to identify new potential intended uses for products, and thereby expand their target markets.

Implementing UDI now makes good business sense. Why wait and put your organization in jeopardy?

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9 Major Steps That Should Be In Your UDI Implementation Plan

steps udi 9 Major Steps That Should Be In Your UDI Implementation PlanIn the last blog, I started the discussion on UDI implementation and how it will impact nearly every area of your company.
Successful implementation will take careful planning and coordination throughout the organization, and in some cases, outside your company. As with every other FDA regulation, you will need to have resources available to maintain and update your systems; plus, you will need resources to update and maintain the Global UDI Database (GUDID). 

 What Comes Next?

The UDI regulation is a maze. In trying to solve a maze, it is often easier to start at the end. This same philosophy should be used to implement UDI in your company. Start your implementation process with the outcome in mind. It is more than simply meeting a timeline. UDI implementation should be viewed as a way to improve your business with the processes you use every day. It should help you standardize your daily processes, especially as it relates to data gathering, label design, and communication with your trading partners. This process will yield useful marketing information, which is one of the greatest values resulting from implementing a UDI system.

Create an Implementation Playbook

Creating a playbook or strategic plan is a necessary step. Without one, your hope of ever successfully implementing UDI requirements will be severely reduced. Your playbook should focus on solving real business problems within your organization. Issues such as, how will you collect missing data? Create a “label brand” through standardization? Are you able to develop a cross-functional team for implementation and beyond? Can you streamline your labeling and packing functions? What can other processes be improved? The playbook you develop needs to be tailored to solving your organization’s specific issues.

Now the Specifics

Implementing the strategic plan for your organization requires coordination of UDI-related activities from all impacted areas identified in your plan. In addition to having an overall UDI leader, each area should have a designated person responsible for ensuring the tasks assigned to their area are completed. The major steps of each plan should include:

1. Acquire missing data attributes and create a data management process

o   Develop a protocol for obtaining missing attributes

o   Determine who is responsible for compiling the information

o   Determine who is responsible for managing the collected information

    • Enter into Excel spreadsheet

o   Establish a verification and validation process

o   Determine who is responsible for validating the information

    • Review source documents against gathered information

2. Amend label/packaging composition and components; order by the device compliance date

o   Develop label template for the entire organization

o   Develop label sign-off process to include all impacted areas

o   ADIC Technology will work for you? Concatenated, Stacked, 2-D Matrix? What are the technical capabilities of your trading partners? 

o   What packaging changes are required to accommodate new labels?

o   Determine what the global considerations for label changes are. Do other regulatory agencies need to approve label changes? Did will amend or new device submissions be required?

3. Compose, create, administer and verify/validate software system changes and integrations

o   Does 21 CFR Part 11 apply to these changes?

4. Acquire new or upgrade existing labeling and packaging equipment and verify/validate

o   Does 21 CFR Part 11 apply?

5. Rehearse connectivity with GUDID and verify all systems are functioning correctly

o   Does 21 CFR Part 11 apply?

6. If required, plan for Direct Marking requirements

     o   Obtain etching equipment appropriate for your devices

7. Create/revise Quality System SOPs as needed and conduct process validation

8. Determine if, as part of your strategic plan, your company should invest in building inventory levels – using the three (3)-year extension period for inventory labeled before compliance date – to create a buffer in case implementation is delayed.

9. Develop training programs to train staff on new responsibilities in maintaining the UDI system. Whether the outcome of your implementation is successful or not, it is directly tied to how well your team plans and executes. Validation of the changes becomes a significant aspect of the implementation process and cannot be taken lightly. Remember the adage – “Garbage in, garbage out.” But in this case, there are serious ramifications for “Garbage in.”

UDI – the Forever Project

UDI is not a “one and done” project. The entire system will need continual maintenance. Computer systems will need constant updating, as changes to devices or new ones are developed. You will need to appoint someone with clear responsibility for maintaining your information in GUDID. Postmarket surveillance activities also feed into the post-implementation process, as device changes are made as a result of tracking and reporting activities. And you will find that you will continually need to train your staff on UDI requirements, especially with staff turnover.

The true value is not in the barcode; it is the DATA that will be generated as a result of using barcodes.   And finally, identify the appropriate value proposition for your organization, and remember in healthcare, there is no single answer for all situations.       

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The First 4 Steps of Unique Device Identification Implementation

fda udi clock The First 4 Steps of Unique Device Identification Implementation

This blog explains the first four steps of UDI system implementation.

UDI implementation will impact nearly every area of your company. Successful implementation will require careful planning and coordination throughout the organization and, in some cases, outside your company. You will need to assign resources to update and maintain your systems and the Global UDI Database (GUDID).

The Commitment to Begin is Step 1

The first implementation step is committing to begin. Unique Device Identification (UDI) systems have been used in healthcare for many years, especially for over-the-counter products (commonly known as “UPCs”). Many companies have already implemented UDI systems, using one or more of the Issuing Agencies protocols. They understood the benefits of moving forward with developing UDI capabilities in advance of any regulatory requirements. Customers also played a role in influencing early adopters of UDI. Customers told companies to employ standardized methods, such as UDI. Otherwise, they would stop buying their products. The fear of losing a customer is a powerful incentive, but early adopters also understood the additional benefits of being an early adopter of UDI–including:

  • Ability to control the pace of implementation without having to be concerned with mandated timelines
  • Becoming “easy to do business with”
  • Reduction in transaction errors
  • Decreased order-to-cash process time
  • Help customers ensure patients receive correct products
  • Reduce costs associated with product recalls and other business processes
  • Increase patient safety and satisfaction
  • Reduce waste through better inventory management throughout the supply chain
  • Increase revenue through greater product line exposure to the customer base
  • Increase the speed-to-market of new devices

FDA regulation has now mandated UDI implementation for most medical device labelers. Compliance dates are established. If you miss the date(s) relevant to your devices, you no longer can legally sell your medical devices. Why wait? Start the implementation process now.

Now what? The second step…

Since UDI implementation is a significant undertaking for any company, a UDI champion and implementation team should be created with members from all impacted departments before beginning the planning process. It is also important to involve top management because obtaining management support is critical to a successful implementation.

Step 3: Selecting an Issuing Agency

The next step of the UDI implementation process is to select an Issuing Agency that best meets your needs and the needs of your customers. The FDA accredited three organizations that assign Labeler IDs you can choose from GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA). GS1 and HIBCC assign Labeler IDs to “labelers) of medical devices, while ICCBBA is for medical devices of human origin (blood, cell, tissue, and organ products), also known as HCT/P. GS1 assigns Global Location Numbers (GLN), HIBCC uses Health Industry Numbers (HIN), and ICCBBA issues Facility Identification Numbers (FIN).

If your company is not already partnered with one of the Issuing Agencies, or still needs to select an Issuing Agency, you should survey your key customers to determine if they are implementing UDI systems, or already have UDI systems. You may find customers using all three versions of UDI labeling (GTIN from GS1, HIBC from HIBCC, and ISBT-128 from ICCBBA). If you don’t label blood, cell, tissue, and organ (HCT/P) devices, then you can rule out ICCBBA. Conversely, if you only sell HCT/P devices, you can rule out GS1 and HIBCC. Ultimately, the selection of an Issuing Agency is your company’s to make–and remember that you are allowed to enter two different Issuing Agencies for each medical device in the GUDID.

Step 4: Unique Device Identification Implementation Planning

Analyzing, strategizing, and planning are essential to determining if you will successfully implement UDI and the related GUDID submission. You need to have a full understanding of your devices, labeling/manufacturing locations, and packaging requirements. Study the UDI Regulation to comprehend which aspects you will need to comply with as you develop your plan. Specifically, these undertakings should be completed as part of the planning process:

  • Start with the end in mind. Understand the UDI maze. What outcomes do you want?
  • Create a playbook to focus on solving business problems. Standardize procedures as much as possible, and tailor solutions to your company and its needs.
  • Group your products by Device Class, Manufacturing Location, Packaging Requirements (sterile, kit, etc.) and any other criteria you need.
  • Perform gap analysis between the device information you have and what you need for submission to GUDID.
  • Determine if your data management system(s) can maintain GUDID information, and communicate UDI or DI information as required (sales orders, purchase orders, labeling, etc.).
  • Determine what changes need to be made to your existing quality system procedures.
  • Will revalidation of electronic records is required to comply with 21 CFR Part 11? (Note: Companies or third-parties using HL7 SPL for data submission to GUDID will need to validate the software used for this purpose.)
  • Determine early on what additional resources are needed (FTE or consultants).

This information gathering should be used to create a strategic plan and budget. The plan should include timelines, assignments, and identify strategic partners (outside vendors and customers). The plan should address changes required in your Product Lifecycle Management (PLM), Enterprise Resource Planning (ERP) and supply chain systems, labeling/packaging equipment and procedures. It should define the gateway to GUDID submission, and create plans of action for validation and compliance.

In my next blog post, I will discuss implementation and ongoing maintenance.

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UDI Costs: Long-Term Expenditures May Not Be Obvious

jon money UDI Costs: Long Term Expenditures May Not Be Obvious Our author says to expect UDI costs to be as much as 1%+ of annual sales. Ongoing costs and post-market surveillance factors are also discussed. This new regulation is not without its costs. Some are significant, especially to small medical device labelers. There are the obvious implementation costs and ongoing maintenance. There are also “Post-market Surveillance Factors,” which may be a cost or benefit, but Post-Market Surveillance Factors certainly have long-term implications for your company.

UDI Costs to Industry

“The [UDI] final rule may have a significant economic impact on a substantial number of small entities that label medical devices.” (Federal Register – Cost and Benefits) Eastern Research Group, Inc. (ERG), under contract to FDA, “…estimated present value of the costs to domestic labelers is $620.4 million using a 7 percent discount rate and $713.2 million using a 3 percent rate…” over 10 years. Over the same time period, the annualized costs for domestic labelers are estimated to be $82.6 million at a 7 percent discount rate and $81.2 million at 3 percent. Medical device labelers will incur most of these costs. Labelers include manufacturers, reprocessors, specification developers, repackagers, and re-labelers that induce a label to be affixed to a medical device. ERG estimated costs would not eclipse 1% of revenues annually, except for a small percentage of companies required to mark specific devices directly. Some multi-use device manufacturers required to direct mark their Class I devices could benefit from reduced total costs if all of their device labels only need static barcodes, rather than more costly variable barcodes (DI +PI).  ERG also estimated 32 firms out of 5,234 domestic medical device labelers (5,010 are small businesses) will bear costs greater than 1% of revenues, due to needing costly laser direct marking equipment. Interestingly, all 32 firms are all considered small businesses.

Implementation Costs

Most of the costs associated with UDI are related to implementation. The following is a list of examples:

  • planning and integration of UDI throughout information systems
  • creation, review, and approval of labeling changes
  • digital printers to print the new barcodes and date formats
  • increased printing due to variable barcodes
  • joining issuing agency and obtaining labeler ID
  • requesting Global Medical Device Nomenclature (GMDN) Preferred Term (PT) codes
  • registering new barcodes
  • laser-etching of UDI barcodes on devices for direct marketing
  • compliance with the FDA’s UDI data uploading requirements
  • review and approval of procedure changes

The first item on the above list, planning, and integration, will be the highest cost of UDI implementation. The price of planning and integration includes installation, testing, and validation of barcode printing software. You will also need to retrain almost every department to understand how UDI is being integrated with existing processes. You may also need to temporarily increase your workforce to help ensure timely implementation to ensure compliance with the data attributes required for each device entered into the Global UDI Database (GUDID).

Ongoing Costs

The highest annual ongoing cost includes labor, operating, and maintenance associated with equipment for printing labels, and labor related to software maintenance and training needed to maintain the GUDID system. Other ongoing costs include paying initial and annual fees to the Issuing Agencies and/or the  GMDN agency (http://bit.ly/GMDN-Agency) for ongoing maintenance of the system. You will need to have additional personnel in most cases to manage these other requirements.

Post-market Surveillance Factors

Post-market Surveillance Factors are either a cost or benefit to the labeler, and are directly related to the Patient Safety and transparency aspects of the UDI Regulation. The goals of the FDA in enacting the UDI Regulation are:

  • reduce medical errors
  • simplify assimilation of device use information into database systems (such as Electronic Health Records and Personal Health Records)
  • provide for quicker identification of medical device adverse events; improve the speed of the development of solutions to reported problems
  • hasten and improve the efficient closure of device recalls
  • more focused and effective FDA Safety Communications
  • allow professionals and end-users access to additional product information via GUDID

In my opinion, there are other factors just as important which companies should pay attention to as they complete UDI requirements, including the ability to:

  • develop complete safety and effectiveness profiles for devices
  • reduce waste by helping to eliminate duplicate inventory at healthcare facilities
  • identify new uses for devices, which will help increase value for shareholders, customers, and end-users

Today, the identity of labelers is hidden from users and patients. Tomorrow, when the FDA’s goals are realized, labelers will be faced with increased transparency. You will need to address increased transparency by acting quickly to product performance trends. In today’s world of instant communication, you cannot afford to ignore safety issues brought to light by post-market surveillance factors. Anyone who does does so at their peril.

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What is the GUDID?

This blog, “What is the GUDID?” reviews the basics of the database, do we need a GUDID account? How data is submitted, what information is needed, and more. 

What is the GUDID?

FDA, in creating the Unique Device Identifier (UDI), was looking to improve the postmarket surveillance process, which included developing a database to be used by the healthcare community and the public to obtain critical information on the medical devices they use. The Global UDI Database (GUDID – pronounced Good-I-D) is a repository for key device identification information. It will not include any patient information. This key information – 62 different data elements (see below) – is limited to Device Identifiers (DI) and Labeler information. Every Labeler of medical devices is required to have a UDI and submit this information to the GUDID.

Changes from the proposed rule impacting GUDID

In the proposed rule, FDA did not want to use Global Medical Device Nomenclature (GMDN) Preferred Term (PT) codes. Unfortunately, the GMDN PT codes are not free, and a subscription is required to access the GMDN Database. FDA was able to negotiate an agreement with the GMDN Agency to allow Labelers access to the GMDN PT codes. These codes will only be accessible to Labelers who enter device information using FDA’s Web Interface submission process. A word of caution; the GMDN Agency is continually adding and updating these codes. Companies submitting data via HL7 SPL (see below) will need to subscribe to the GMDN Agency to gain access to these codes.

what is GUDID What is the GUDID?

Another change deals with MRI compatibility. If you claim your device is MR Safe, MR Conditional, or MR Unsafe, then this information is now required as part of the submission to GUDID.

A new version of the GUDID Implementation Specification (Version 1.2.1, released April 11, 2014) is now available. FDA Global UDI Database Web Site 

Do we need a GUDID account?

To submit medical device key information, Labelers need to request an account through the FDA GUDID website. The Labeler Organization may have more than one GUDID account. A Duns and Bradstreet (DUNS) number for the company location is used to identify each GUDID account. The labeler must also be registered with the FDA as an establishment.

There are three (3) levels – Organization (which may also be a Labeler), Labeler, and Third-Party (entity authorized to submit GUDID information on behalf of Labeler). Each GUDID account must have:

  • One (1) Regulatory Contact
  • One (1) Coordinator (manages Labeler Data Entry users)
  • One (1) Labeler Data Entry user (day-to-day data entry)
  • One (1) Labeler DUNS number

Labeler DUNS number must match name and address on the device label.

Production Identifiers (PI) are not entered into the Database (just PI flags to indicate which PI are on the label). 

How data is submitted to GUDID

There are two standard-based methods to submit data: 1) structured input via a web interface, and 2) the Health Level 7 Structured Product Labeling (HL7 SPL) process. The first method, using a web-based interface, will work well for up to 200 total records. If you attempt to input more than 200 records, the input becomes overwhelming, and you will need to use the HL7 SPL process. HL7 SPL is in XML format and uses the FDA Electronic Submission Gateway (ESG) as the pathway to upload data into GUDID. Both submission methods are one DI record at a time. There is no batch option available.

You are also able to use third-parties to submit data. GS1 GDSN (Global Data Synchronization Network) is one example; there are others as well. Or you could build your submission tool.

There are three (3) states of entry –

  • Draft DI – only available via Web interface (Draft DI will be available for 180 days)
  • Unpublished – has passed all the business rules
  • Published – is now searchable

Currently, the GUDID search and retrieval options are not currently operational, as FDA is waiting until sufficient data has been entered to turn this feature on.

What information do I need?

There are 60-plus data attributes that need to be provided. Some of the fields are automatically filled in by the GUDID system, based on information that is entered. For instance, the Labeler Name and Address are pulled from the DUNS database, based on the DUNS number entered. An entry can have more than one Device Identifier. This is usually the case if you have used different Issuing Agencies. Attributes on label/package and the values submitted should match. GUDID also has controlled vocabulary and built-in business rules that will continually check what data is input.

A controlled vocabulary is DUNS #, GMDN code, and FDA Product Codes. 

Examples of Business Rules are:

  • All required data elements must be provided
  • Validating specific elements – FDA Listing #, etc.
  • Data constraints on specified elements – Publish date must always be >= TODAY
  • There are other additional business rules

Also, a DI can never be reused, even if it is discontinued. It will remain in GUDID, but marked as “Not in Commercial Distribution.”

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6 UDI Implementation Deadlines You Need to Remember

The first of the UDI implementation deadlines for the FDA’s Unique Device Identifier (UDI) Regulation is approaching fast. Do you know when your medical devices must be labeled with a UDI?  Read on to find out.

Screen Shot 2014 04 29 at 7.25.40 PM 6 UDI Implementation Deadlines You Need to Remember

FDA requires higher risk devices to be brought into compliance with the UDI regulations first. Compliance starts with Class III devices and devices licensed under the Public Health Service (PHS) Act (http://bit.ly/PHS-Act).  Lower risk devices will follow.

1. June 23, 2014, is the compliance deadline for Class III and PHS Act device labelers to file a one-year extension. FDA requires extension requests be written (§801.55), documenting the number of labelers and devices subject to the request and explaining why an extension would be in the best interest of public health. FDA may also request additional information to help the Agency make a decision on this request. Federal Register – Class III Compliance Dates

2. September 24, 2014, is the first compliance deadline for labels and packages of Class III devices, Class III Stand-alone Software and devices licensed under the PHS Act to be “compliant.” These devices must have a UDI on its packages and labels, and human-readable dates must be formatted as YYYY-MM-DD (§801.18) and information submitted to the Global UDI Database (GUDID) (§830.300) by this date.

3. September 24, 2015, is the compliance deadline required for labels and packages of Implantable, Life-Sustaining, and Life Supporting Devices to have a UDI and corresponding data submitted to GUDID.  Life-Sustaining and Life-Supporting devices are also required to have UDI as a permanent direct mark if they are to be used more than once and reprocessed before each use (§801.45). Stand-alone software that is life-sustaining or life-supporting must have a UDI per §801.50(b). Human readable dates on these labels must be formatted as YYYY-MM-DD.

4. September 24, 2016, is the compliance deadline required for Class II devices and Class II Stand-alone Software to be compliant. As with the device classes above, this means having the UDI on the device label and package (human-readable date in YYYY-MM-DD format) and data submitted to GUDID.  Class III devices intended to be used more than once and reprocessed between uses must have their UDI permanently marked on the device by this date.

5. September 24, 2018, is the compliance deadline for Class I devices and Class I Stand-alone Software, as well as devices not classified into Class I, Class II, or Class III. This date requires devices to have a UDI on their labels and packages, and the human-readable dates on labels must be in YYYY-MM-DD format. Class II devices intended to be used more than once and reprocessed between uses must be directly marked with their UDI.

6. September 24, 2020, is the compliance deadline for Class I devices, and devices that have not been classified as Class I, II, or III intended to be used more than once and reprocessed between uses, must be directly marked with their UDI.

FDA’s UDI final rule will be phased in over time to ensure that labelers would have adequate time to build and test systems and create the infrastructure needed to implement the regulation’s many requirements. FDA believes a phased approach will spread the cost and burden of implementation over a number of years.  This approach, according to the FDA, should promote “the efficient and effective implementation of the final rule.”

On-hand inventory labeled and packaged prior to the above deadlines has been extended a 3-year grace period in the Final Rule.  This inventory does not need to be relabeled/repackaged with their UDI until three (3) years past the compliance date of their product Class compliance date. FDA considers consignment inventory to fall under this provision. This requires companies to track consignment inventory, ensuring it is used before the three-year grace period expiring. Any inventory – on-hand or consignment – remaining past the grace period will need to be relabeled and/or repackaged to be compliant. Federal Register – Existing Inventory

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What is UDI and Why It Matters

udi 2 300x162 What is UDI and Why It MattersIn this blog, “What is UDI and Why It Matters,” the author reviews the fundamentals of UDI, FDA’s Final Rule applications, and its global significance. 

FDA’s Final Rule (Federal Register – UDI Definition) states a Unique Device Identifier (UDI) is a code that sufficiently identifies a medical device throughout its distribution and use. The UDI is comprised of a static component, “Device Identifier” (DI), and a dynamic component, “Production Identifier” (PI). 

The DI itself is made up of your Labeler Identification Code and a code that pinpoints the specific version or model of that device. PI, on the other hand, includes manufacturing information for that specific device, such as lot or batch number, serial number, expiration date, or manufacturing date (both in YYYY-MM-DD format).

Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a medical device requires the use of the ISBT-128 format UDI. The UDI Final rule requires medical device labels to contain a UDI, unless exempt or provides for an exception or alternative placement. The UDI must be both human-readable and in a form that uses automatic identification and data capture (AIDC) technology. 

Reprocessed and Single-Use Devices

Medical devices that are both used more than once by intention and reprocessed by intention must have the UDI directly marked on the device. The Final Rule details exceptions to this requirement (Federal Register – Direct Marking Requirement). UDI does not need to be on individual single-use devices. Instead, it needs to be located on the next higher package. For example, non-sterile exam gloves would require a UDI on the box label, not each glove. 

This section of the rule stipulates individual single-use devices, all of which are the same version or model, must be distributed together in a single device package, is intended to be stored in that device packaging until removed for use, and is not intended for individual sale.  However, it does not apply to implanted devices, which require a UDI on the package of the individual device. Federal Register – Single-use Device 

Stand-Alone Software

Stand-Alone Software that is regulated as a medical device, must also bear a UDI. The software version should be included in the production identifier. If the software is downloaded from a website, the UDI must be in plain text (i.e., not in AIDC format) and displayed whenever the software is started and/or in the plain text displayed through a menu command, such as the “About” screen. If Stand-Alone Software is sold in a package, the package must have the UDI on its label. However, the DI of packaged software may be identical to the downloaded version. Federal Register – Stand-Alone Software

Why Now? Why Does It Matter?

Some medical device companies, especially distributors, obscure manufacturers’ names and item codes on device labels. Different devices might have the same item code, while the same device might have different item codes. These inconsistencies confuse healthcare professionals—especially during recalls and adverse event reporting. Therefore, FDA and other regulatory agencies are implementing UDI regulations to:

  • Improve patient safety by reducing medical errors.
  • Strengthen the Electronic Medical Records initiative by providing a standard method for recording the identity of each device during use in clinical information systems, claim data sources, and registries.
  • Address counterfeiting and diversion
  • Prepare for medical emergencies and disasters
  • Provide a foundation for a global, secure distribution chain. 

The most important reason for UDI regulations is the need to improve the accuracy and timeliness of Post-Market Surveillance (PMS) data. More accurate and timely PMS data will indirectly improve patient safety by helping facilitate more accurate reporting, reviewing, and analyzing of adverse event reports, so problem devices can be pinpointed, corrected, and removed faster. 

Impact of UDI Regulations Globally

FDA hopes the UDI regulations will lead to the development of a globally harmonized medical device identification system that is recognized around the world. The European Union and regulatory agencies around the globe are drafting their versions of a UDI regulation. In addition to the benefits of implementing a UDI system in general, a global UDI system would:

  • Allow companies to create globally harmonized labeling with a single UDI worldwide
  • Promote worldwide tracking and tracing of devices for easier recalls
  • Provide another risk control to prevent counterfeiting and diversion of medical devices

To that extent, the International Medical Device Regulators Forum (IMDRF) published their UDI Guidance document IMDRF UDI Guidance Document, which has many similarities to the FDA Final Rule.

The Unique Device Identifier Final Rule is more than just a new FDA regulation—it is also good business practice. Healthcare customers are embracing the use of unique identifiers. In past experiences with implementing GTINs (another form of UDI from the UDI issuing agency GS1), customers demanded implementation of GTINs, or they would find a new supplier. Manufacturers may choose to ignore one or two customers. Still, eventually the number of customers demanding UDI will be significant, and they will need to act quickly—regardless of FDA deadlines.

What is UDI and Why It Matters Read More »

Unique Device Identifier Final Rule-FAQs-Part II

Screen Shot 2014 04 03 at 10.24.33 PM Unique Device Identifier Final Rule FAQs Part II

Did you know that September 24, 2014, is the first UDI DEADLINE for Class III devices, Stand-Alone Software, and devices licensed under the PHS Act? 

Who is an Issuing Agency?

FDA has accredited three (3) agencies for the operation of a system to issue unique device identifiers. They are GS1 (www.gs1.org), Health Industry Business Communications Council (HIBCC) (www.hibcc.org), and International Council for Commonality in Blood Bank Automation (ICCBBA) (www.iccbba.org).  GS1 and HIBCC are for medical devices, while ICCBBA is for medical products of human origin that are regulated as medical devices.

We sell single-use devices; do we need to label these products?

A UDI does not need to be placed on each single-use device (i.e., primary packaging). Instead, the UDI is to be placed on the secondary packaging (e.g., outer box). For example, exam gloves. The UDI label goes on the box, not each glove. This rule requires the package:

  • Have a single version or model
  • Be distributed together in a single device package
  • Are intended to stored in that device packaging, and
  • Are not intended for individual sale

Placement of the UDI on the secondary packaging for single-use devices does not apply to implanted devices. While implants are technically “single-use” devices, implants (defined as devices placed in the body for 30 days or longer) must have a UDI on the primary packaging.  Federal Register – Single-use Devices

I understand there are implementation deadlines; what are they?

There are several deadlines related to this new regulation based on device Class. For example, Class III devices, Stand-Alone Software, and devices licensed under the PHS Act must be “compliant” and have a UDI on its package label, and information submitted to the Global UDI Database (GUDID) by September 24, 2014. There is an opportunity to file for a 1-year extension for these classes of devices under §801.55. The deadline for filing this extension is June 23, 2014.

Other implementation deadlines are (includes submitting data to GUDID):

September 24, 2015,           Implantable, Life-Sustaining & Life Supporting Devices

September 24, 2016            Class II devices and Stand-Alone Software

Class III devices intended to be used more than once and reprocessed between uses must be directly marked with UDI

September 24, 2018            Class I devices and Stand-Alone Software

Devices not classified into Class I, II or III

Class II devices intended to be used more than once and reprocessed between uses must be directly marked with UDI

September 24, 2020            Class I devices, and devices that have not been classified as Class I, II or III, intended to be used more than once, and reprocessed between uses, must be directly marked with UDI

On-hand inventory labeled before the deadline does not need to be relabeled with a UDI for up to three (3) years past the deadline. FDA considers consignment inventory to fall under this rule. This requires that you track consignment inventory, as well as ensure the inventory is used before this three-year exception expiring. Federal Register – Implementation Dates

Our device is packaged one unit per package; do we need to label the device itself?

This is a “unit of use” issue. If you sell ten individually packaged devices ONLY in an outer pack, the individual devices do not require a UDI. Generally, labeling the outer pack with the UDI is sufficient. This assumes the device is stored and used that way.

I heard the information on our devices needs to be submitted to a “database.” Please explain?

UDI has been implemented to facilitate postmarket surveillance activities, including the identification of medical devices through its distribution and use. FDA believed a significant part of this was the ability for healthcare professionals and users to “search” a database to locate information about devices. This resulted in the creation of the Global Unique Device Identification Database (GUDID) system, which is a repository for 60-plus attributes for each Device Identifier and its corresponding Labeler information.  Federal Register – GUDID Information

How do we submit data to the Global UDI Database?

There are two standard-based methods to submit date to the Global UDI Database (GUDID) – structured input via an FDA web interface, or using the Health Level 7 Structured Product Labeling (HL7 SPL) process. HL7 SPL is in XML format and uses the FDA electronic submission gateway as the pathway to input data into GUDID. To submit data to GUDID, you first need to request a GUDID user account from the FDA. Data is submitted one record at a time for both methods. There is no batch process.  Federal Register – GUDID Submission

What additional information needs to be printed on a label under this new rule?

Medical devices must also follow labeling requirements detailed in Title 21, Subchapter H, §801, in addition to the new requirements per the UDI rule. Required information printed on the labels is also dictated by other regulatory agencies, such as the EU. Specifically, the UDI regulation requires a UDI be printed in easy-to-read plain text, and an Automatic Identification and Data Capture (AIDC) format and placed on the device label. The AIDC format is dictated by the format of the issuing agency you have chosen. The other label element FDA requires is the date format when a date is used on a label. The date format is YYYY-MM-DD, and a day must always be used.  Federal Register – UDI Format

When do I need a new Device Identifier?

A new UDI is required when there is a change to a version or model. If you are calling the device a new version or model, and the users think the same, then it is a new device and requires a new Device Identifier (DI) and label changes. If the number of units in a device package changes – for instance, going from 5 to 10, then a new DI is required. This aspect often confuses people, as they think it has to do with changes in package artwork.  Federal Register – New UDIs

Need More Information on how to design and implement a compliance plan for the Unique Device Identifier Rule? 

FDA UDI Regulation on Medical Device Labelers is a complimentary webinar and PowerPoint training. To access – CLICK HERE

Unique Device Identifier Final Rule-FAQs-Part II Read More »

Unique Device Identifier Final Rule-FAQs-Part I

Screen Shot 2014 04 03 at 10.23.51 PM Unique Device Identifier Final Rule FAQs Part IThis blog,Unique Device Identifier Final Rule-FAQs-Part 1,” answers questions, such as, what is a UDI? Who is responsible for applying the UDI label? Etc. 

What is a “UDI?”

The Unique Device Identifier (UDI) adequately identifies a device throughout the supply chain and while in use. It is constructed of two main sections – a device identifier and a production identifier. The device identifier is comprised of a permanently assigned product code (model or version) and a labeler identification code. The production identifier is a dynamic component and made up of a lot number, serial number, manufacturing date, expiration date, etc. The device identifier and production identifier together make up the UDI.  Federal Register – Unique Device Identifier definition

Who is responsible for applying the UDI label? 

FDA has defined the “Labeler” to be the entity responsible for applying the UDI label. This entity may or may not be the actual manufacturer. The Labeler is defined as the entity that causes a label to be secured to a device and who places the device into commercial distribution with the expectation the label will not be replaced or modified in any way. Additionally, should an entity replace or substantially modify the original label, and then place the device into commercial distribution with the expectation the label will not be replaced or modified in any way is also a Labeler. Distributors who simply add their name and address to the package are not defined as a Labeler under this definition. 

Private label devices present a situation where the actual manufacturer or brand name holder can be the Labeler. This would be a business decision between the manufacturer and the brand name holder. The Labeler may also be the specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.  Federal Register – Labeler definition

What does a “standardized” date format mean? 

FDA has decided for all human-readable dates (manufacturing date, expiration date, etc.) printed on labels must follow a YYYY-MM-DD format. The DAY is an absolute requirement. For example, March 31, 2014, must be presented as 2014-03-31. This requirement applies to ALL medical device classes that use a date on their label. Federal Register – Date format definition

I have kits that are comprised of several devices; how does this rule apply to me?

There are many types of kits. Kits can be made up of one or more medical devices, packaged together with one or more combination products, drugs, or biologics, to expedite a single surgical or medical procedure. §801.30(a)(11) states when a device is packaged within the “immediate container of a combination product or convenience kit, the label of the device will not be required to bear a UDI,” as long as the label on the kit has a UDI. Should your kit have a National Drug Code (NDC) number on its label, it does not also need to have a UDI.  §801.30(b)(3) clearly states devices that are included in a combination product with an NDC number on its label and does not have a UDI; the device components must bear a UDI on its label. Federal Register – Kits Exemption

What does reprocessing mean? 

FDA uses the term “reprocessing” in conjunction with a direct marking of a unique device identifier. Devices intended to be used more than once must have the UDI permanently marked directly on the device (with a few exceptions), and will be reprocessed between each use. However, the FDA has not yet defined what “reprocessing” means. I have asked FDA this question, with their response being they will “shortly” issue additional guidance on this matter. When they do, I will let you know via this blog. Until they do, use the following definition of “reprocessing” – clean, clean plus disinfected, or clean plus sterilized. Federal Register – Direct Marking and Device Reprocessing

We sell software that is considered a medical device; how do I label these devices?

Stand-Alone Software (SAS) regulated as a medical device must also have a UDI. SAS that is downloaded from the web and/or sold packaged must use the version number (as the lot number) in its production identifier. The full version of the UDI must be displayed in easy-to-read plain text, following the rules of the issuing agency you have selected, on the start-up screen and/or a menu command screen, such as the “About” screen. The UDI on the SAS packaged form may have the same device identifier. Federal Register – Stand-Alone Software

What is a device package? 

A device package is a package that contains a fixed number of a specific version or model of a device. The use of this term has often confused people who think it has something to do with the package design. Federal Register – Device Package definition

Do I need to label our shipping containers? 

A shipping container, for this regulation, is defined as a container used to ship or transport devices in which the items within may change from one shipment to another. The rule does not require a UDI label for any shipping container. Federal Register – Shipping Container

Unique Device Identifier Final Rule-FAQs-Part I Read More »

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