Unique Device Identification

UDI Implementation-Why You Need to Begin Today

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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

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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 daily processes you use. It should help you standardize your daily processes, especially regarding data gathering, label design, and communication with your trading partners. This process will yield helpful marketing information, one of the most outstanding 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 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 create must be tailored to solve your organization’s 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 significant 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 a 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? 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 the 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 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. It would be best 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 due to 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 actual value is not in the barcode; it is the DATA that will be generated from using barcodes.   Finally, identify the appropriate value proposition for your organization, and remember that in healthcare, there is no single answer for all situations.       

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The First 4 Steps of Unique Device Identification Implementation

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

In this blog, the author explains the first four steps of the Unique Device Identification system implementation and why they are essential.

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 the 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 can no longer 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 your customers’ needs. The FDA accredited three organizations that assign Labeler IDs you can choose from: GS1, the Health Industry Business Communications Council (HIBCC), and the 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, selecting an Issuing Agency is your company’s to make–and remember that you can 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 fully understand your devices, labeling/manufacturing locations, and packaging requirements. Study the UDI Regulation to comprehend which aspects you must 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’s needs.
  • Group your products by Device Class, Manufacturing Location, Packaging Requirements (sterile, kit, etc.), and any other criteria you need.
  • Perform a 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 be 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 and 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), supply chain systems, labeling/packaging equipment, and procedures. It should define the gateway to GUDID submission and create action plans 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

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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?

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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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