UDI Implementation

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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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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