Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions
Every year when January rolls around, there’s a cultural shift toward new beginnings and starting the year off right. Countless articles are published about making New Year’s resolutions, and gyms are packed with athletic hopefuls. People resolve to make self-improvements, even in their daily work lives.
A new year can signify the beginning of new projects or initiatives in the workplace, too. This typically includes setting goals to be more effective, efficient and productive than the prior year.
In the Quality world, the dawn of 2015 brings us closer to key regulatory deadlines and highlights the need to plan for these changes. One important area to prepare for is the FDA’s establishment of the unique device identification (UDI) system to adequately identify medical devices through their distribution and use. It is anticipated that UDI implementation will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.
So without further, ado, I wish you a very happy and prosperous 2015. To get you out the starting gate, I’ll share some UDI resolutions with you.
Resolve to review the latest FDA guidance to understand deadlines and requirements.
Do you understand the basics of UDI? Are you manufacturing class I, II, or II devices? Is your device implantable or life-sustaining? Do you know your deadlines? Make it your goal to thoroughly understand and track your timeframe for meeting the requirements. You can see an infographic with the compliance dates here.
Resolve to establish a relationship with a UDI issuing agency.
You will need to establish a relationship with one of the issuing agencies to obtain your UDI assignments for your devices and ensure you are compliant with the final rule. You can find UDI issuing agencies here. Additionally, having an established relationship will make it easier for you to address any future UDI changes. That is, what happens if a customer complaint forces a design change and you need to update your device identifier? Having a relationship with an issuing agency will allow you to more seamlessly handle such situations. It will also be valuable when you are ready to release a new product version or launch a new device.
Resolve to setup an account with the Global Unique Device Identification Database (GUDID).
Labelers must submit information to the GUDID, and the first step is to establish an account. A labeler organization may have one or more GUDID accounts. As part of the application process, you will need to provide your company’s headquarters’ or parent company’s DUNS (Data Universal Numbering System) number. This is a unique nine-digit identification number provided by Dun & Bradstreet (D&B) for each physical location of a business. DUNS numbers allow the FDA to use a uniform standard and process for identifying medical device labelers, and businesses that interact with the U.S. Federal government for contracts or grants require a DUNS number.
The second step is to identify your regulatory contact, as only one per labeler may exist (21 CFR 830.320).
Also, you will want to understand and familiarize your organization with the two submission options for feeding your device identifier data to the FDA’s global database — either through Web Interface or HL7 SPL. You will need to indicate your preferred option when setting up the GUDID account. Be sure to familiarize yourself with the guidance document for GUDID, as it is a key component of UDI.
Resolve to leverage UDI to drive continuous quality improvements.
In the Quality world, we often speak of the importance of nurturing a culture of quality. When it comes to UDI, resolve to leverage its benefits — and the clear ties to specific products — to further improve your quality initiatives.
For example, leveraging data on nonconformities can help you isolate potential issues and identify areas on which to focus product design improvements. Use the data to motivate your team to improve quality. Remember, quality is everyone’s responsibility.
Resolve to maximize your UDI investment by leveraging it in your quality system.
Tracking product UDI as part of your quality system will allow you to isolate all specific products involved in complaints, CAPAs, or nonconformities. Leveraging enterprise quality management software (EQMS) to track UDIs throughout your quality system will allow you to:
- Connect related components and processes to the complaints, CAPAs and nonconformities associated with a particular UDI.
- Incorporate the unique device identifier into your quality system records, directly tying device data to specific quality records.
- Improve identification and control of data for specific product models and versions involved in complaints, CAPAs, or nonconformities.
- Continue to comply with regulations specific to the quality system.
Resolve to see the future benefits of UDI.
Because improved patient care is a UDI benefit, let’s project its potential growth and impact. Imagine a fully populated global unique device identification database (GUDID); that is, the FDA’s database will eventually be filled with data on all medical devices on the market. Combined with reports on adverse events and recalls, the FDA and medical device industry will be able to more quickly notify any affected patients of potential issues related to their specific device. In other industries, similar controls have long been in place. If someone steals your car, the VIN number or the license plate can be used to notify you when it is located, or if it ends up involved in an accident.
With the UDI final rule now in effect, the FDA can better track and trend on data from the GUDID and its other databases to mitigate risk for patients. Access to UDI data and adverse event trends gives the FDA an enhanced ability to access data tied directly to patient records, and thereby to notify each person who may be affected by an adverse event or recall.
Have you made any of these or other resolutions for 2015 relating to UDI? Please feel free to share in the comments.
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- Unique Device Identifier System FAQs
- Introduction to the Unique Device Identification System
- Global Unique Device Identification Database (GUDID) Guidance for Industry and Food and Drug Administration Staff
- Unique Device Identification System: Small Entity Compliance Guide
- Benefits of a UDI System
- UDI Issuing Agencies