New FDA Standards for Unique Device Identifier Labels


Most industries around the world have strict labeling standards and regulations, but almost nowhere are the specifics of labels more scrutinized than in the medical industry. Each and every piece of equipment that is used to facilitate the treatment and care of a patient needs to carry a label. And the slightest deviation from stipulated standards can result in strict penalties.

To improve patient safety, modernize device postmarket surveillance and encourage medical device innovation, the FDA’s Unique Device Identifier labels policy was created. This policy requires a unique device identifier (UDI) to be included on device labels and packages by device labelers.

The table below outlines key compliance dates in the UDI final rule.

Compliance Date Requirement
1 year after publication of the final rule (September 24, 2014) The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).
2 years after publication of the final rule (September 24, 2015) The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
3 years after publication of the final rule (September 24, 2016) Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class II medical devices must bear a UDI.  § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18.
Class II stand-alone software must provide its UDI as required by § 801.50(b).
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
5 years after publication of the final rule (September 24, 2018) A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule (September 24, 2020) Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Compliance dates for all other provisions of the final rule.  Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
Source: http://www.fda.gov

Anatomy of a UDI Label

A UDI is a unique numeric or alphanumeric code that consists of a device identifier (DI) and a production identifier (PI) and all UDIs are to be issued under a system operated by an FDA-accredited issuing agency.

Anatomy of an UDI Label

The Unique Device Identifier (UDI) Rules & Regulations 

  • The DI is mandatory and identifies the labeler and the specific version of a model of a device
  • The PI is a variable portion of the UDI which can include the lot or batch number when a device was manufactured, the devices’ serial number, the devices expiration date and the date the device was manufactured.
  • The UDI labels should be readable – both by humans and by computers
  • The device manufacturers will be in charge of marking their equipment with UDI labels and it is the duty of the label creators or facilitators to upload device information to the Global Unique Device Identification Database (GUDID) for unrestricted access by healthcare stakeholders.
  • The GUDID which is supported by the UDI labels will allow doctors to be able to download instructions and guidelines of device use and make the most of features and functionalities for optimum patient care.

How Does Tailored Label Products Play Its Part in the UDI Revolution?

Tailored Label Products has been the gold standard in the world of labeling for years. Accurate, capable of withstanding harsh environmental conditions and always legible, vibrant and durable. Our products have been used on vials, devices and containers for the medical industry.  Our capabilities and technical expertise allow us to meet UDI rules and regulations by printing labels with the right construction for the application and required information for UDI correctly included.

Also to help maintain the integrity of the unique IDs in the supply chain, TLP offers advanced features such as a dual label verification system that allows a technician to remove the first layer of the label for documentation, while a duplicate label will remains on the product.  With variable data capabilities, specific, unique information regarding each device can also be printed onto each label.

Have a UDI Label Question? TLP can help!

 

TLP Employee Receives Global Recognition for Label Academy Achivement

TLP Label Application Engineer Recognized by Labels & Labeling Magazine for “Leading the Label Academy”

TLP-Label-Academy-ArticleMonday, May 2th, 2016 – Menomonee Falls, Wis. – Tailored Label Products, Inc. (TLP) Regional Application Engineer Lindsey Muchka was highlighted in a feature article by Labels & Labeling magazine for having”taken – and passed – more Label Academy exams than anyone globally.

“Continuing education and technical competency are core elements of TLP culture, so we are very proud to have our team members recognized by our industry for this kind of achievement, not only at a national level, but globally.” said Tracy Tenpenny, V.P. of Sales and Marketing at Tailored Label Products.

This article in Labels & Labeling can be found online in its entirety on page 80 of the Labels and Labeling | Volume 38 | Issue #2 | April 2016 – May 2016.

About Label Academy

Label Academy is a global training and certification program for the label and package printing industry. It consists of a series of self-study modules, and once a student has completed a module, they take a timed,  50-question online test. Those who pass earn a Label Academy certificate. It is expected that a Label Academy qualification will become a standard in the industry, and has been supported by label associations including TLMI, Finat and LMAI. For more information on Label Academy, visit www.label-academy.com.

About Tailored Label Products, Inc.

Tailored Label Products, Inc. (TLP) is a custom manufacturer of high-performance labels, tags, and die-cut adhesives. TLP provides custom engineered adhesive and label solutions for the electronics, automotive, aerospace, industrial, biomedical, medical equipment, hydraulic fluid and power industries. For more information, contact TLP at 800.727.1344 or visit www.tailoredlabel.com.

Media Contact:  Larry Harvey  |  (262) 345-6404  |  lharvey@tailoredlabel.com

Ensuring Traceability in Auto Manufacturing: Three Pointers for Success

TLP High-speed Barcode Printing  Scanning & Inline Verification Traceability in the automotive industry is becoming increasingly important – and with good reason since it impacts a manufacturer’s ability to succeed in a globally linked economy that is connected by a sophisticated and highly complex supply chain. Moreover, manufacturers that adopt the right approach to traceability stand to benefit by gaining the ability to more rapidly respond to recalls, improve regulatory compliance and ensure supplier accountability. Not to mention, of course, the ability to readily spot problems and quickly correct them to enhance product safety and speed production.

Yet the question is how to ensure the best possible traceability when using printed bar codes? The answer lies in choosing a partner who goes beyond off-the-shelf barcode solutions. Given the critical nature of traceability, a better bet is to look for a partner who brings engineering, design, quality and product development together to ensure cradle-to-grave visibility throughout the supply chain and long after the vehicle hits the road.

Here are three things to look for when sorting through potential barcode label partners:

  • High Speed Variable Data Printing and In-line Scanning and Verification Systems:
    Check to see if they offer this advanced label verification technology, which is well proven in the life sciences industry where precise labeling has long been used to identify and protect patient data. With variable data barcode labels, each individual component contains a unique serial number with part-centric information linking to large, back-end databases. Ensuring that unique ID numbers are not repeated or skipped can be critical.

    TLP invests in high-speed barcode printing, scanning, and verification technologies to ensure labels meet the strict standards of the automotive industry.

    Automotive focused label suppliers like TLP invest heavily in high-speed barcode printing, scanning, and verification technologies to ensure labels meet the strict standards of the automotive industry.

    A supplier that specializes in providing labels to the automotive industry will typically have invested heavily in technologies that can high-speed print, scan, and verify labels inline for data integrity and readability. A label supplier that employs this type of technology can provide higher quality, reliability, and cost efficiencies compared to doing it in house using more traditional method of using standard thermal transfer systems and manual inspection processes typically found in many factories.  In these instances, serial number data is entered into computers manually. The end result is a labor-intensive process prone to errors in printing duplicate bar codes.

  • Ensure Initial and Long-Term Readability:
    Ask about initial and long-term readability. Probe the supplier about the technology and methodologies used to ensure the label stays put and performs in the harshest of environments over long horizons of time. It’s critical that a label can be scanned and easily read for many years – long after a vehicle leaves the showroom.  Selecting a label supplier that has proven engineering and quality system expertise can go a long way in avoiding readability problems by specifying the right materials, manufacturing and print processes, and stringent quality checks.
  • Automotive-Specific TS 16949 Certification:
    Dig a little deeper into their certification credentials. While it’s rare for a label manufacturer to achieve ISO 9001 and the automotive industry’s stringent TS 16949 certification, doing so ensures that your supplier – and their vendors – provide the level of quality the application demands.  These standards encompass failure mode and effect analysis, material flow diagrams, and other industry best practices to improve production efficiencies and meet stringent adhesion, thickness and conformability standards time after time.

Clearly, traceability is a priority for leading automakers. There’s also much more to choosing the best barcode label and variable data printing partner than the three important pointers we’ve outlined. But it’s definitely a good place to start since it can help you quickly separate the wheat from the chaff, which is vital when the goal is to unlock the value that traceability delivers.

Contact TLP to find out more about how High Speed Variable Data Printing and In-line Scanning and Verification Systems can benefit your company.

GHS Labels

What Are GHS Labels? Inside the Globally Harmonized System of Classification

GHS LabelsThe Globally Harmonized System (GHS) of the Classification and Labeling of Chemicals is an international standard designed to ensure that the dangers of handling hazardous chemicals are understood by all participants in their manufacture, transportation, usage, and disposal.

According to the U.S. Occupational Safety and Health Administration (OSHA), the GHS labeling system is “a logical and comprehensive approach” to:

  • Defining the health, physical, and environmental hazards of chemicals
  • Creating classification processes that use available data on chemicals for comparison with the defined hazard criteria
  • Communicating hazard information, as well as protective measures, on labels and Safety Data Sheets (SDS).

A typical GHS label includes six standardized elements that warn workers that a chemical container (such as a steel drum) contains a specific chemical that may be hazardous under certain circumstances.

The six elements, as detailed by the Environmental Protection Agency, are:

  1. Product identifiers: Names or numbers used on a hazardous product label or in a safety data sheet. 
  2. Signal word: One word used to indicate the relative severity of the hazard: “Warning” for less severe hazards; and “Danger” for more severe hazard categories.
  3. GHS Pictogram(s): A symbol inside a diamond with a red border, denoting a particular hazard class.
  4. Hazard statement(s): Phrase assigned to each hazard category that describes the nature of the hazard.
  5. Precautionary statement(s): Phrases that describe recommended measures that should be taken to minimize or prevent adverse effects.
  6. Supplier identification: The name, address, and telephone number of the manufacturer or supplier.
NiceLabel software , available from TLP,  includes a powerful graphical label designer that allows business users to easily design GHS compliant label templates.

NiceLabel software , available from TLP, includes a powerful graphical label designer that allows business users to easily design GHS compliant label templates.

In the United States, the chemical industry generates $450 billion per year, with $80 billion of that coming from exports. OSHA anticipates the GHS standard could prevent 43 fatalities and 585 injuries annually, with a net savings of over $500 million a year, according to MSDSonline, an industry resource.

TLP specializes in Warning and Safety Labels, such as GHS labels, which must meet rigorous third-party requirements. Contact us to see how we can TLP can assist you in meeting your safety labeling needs.

UL Labels Engineered for Performance in Harsh Environment Applications

Our labels are used in a variety of applications. From outdoor power equipment to scratch-off labels, we can customize our products to suit whatever the customer requests. Amidst the “green” initiatives in the country, a few of our clients requested products tailored to their eco-conscious products. For some, it’s not just about the idea of being eco-conscious—it’s about making “green” products, such as solar panels, and we’re more than happy to oblige.

Regardless of where in the U.S. solar panels are used, companies must adhere to safety standards, electrical codes, and fire codes, which must be displayed on their product. In a previous blog post, we broke own the various safety labels and their meanings for you. All products in the energy industry (light bulbs, lamps, motors) require a degree of certification. While the solar panels themselves have a strict degree of certification, our labels must pass and earn a UL969 certification.

The UL certification is one of the most prestigious and important markings to earn, and there are strict requirements of the product. Not only does the UL969 certification cover label adhesives, but it branches into unprinted materials, inks, and overlamentations. Typically, these labels have a bright red background with white text and must withstand any environmental elements. In this particular usage, many outside vendors prefer the wording to be engraved—but still visible and durable.

For more information on our safety labels and other products, head over to our website.

State of the U.S. Automotive Industry

One of our specialties at Tailored Label Products is industrial labels for the automotive industry. As a business that serves this industry, we’re happy to see that the current state of the automotive industry is quite healthy considering the economic downturn of recent years past. In fact, reports regarding the state of the industry have painted an optimistic future for automobiles well into the next two years.

The outlook for the automotive industry has remained positive since the start of the year. In January of 2013, sales numbers for 2012 indicated that automakers sold 13% more cars than in the previous year. That percentage translates to more than 14 million vehicles. Individual car makers such as GM and Ford were especially successful, reporting numbers up to 43% higher than 2011.

As 2013 draws to a close, it’s clear now that sales in the auto industry have maintained an upward trend.  According to a number of news outlets including the Wall Street Journal and Quartz, U.S. car sales are soaring.  In September, sales reached its best annualized rate in six years, at 16.1 million. Polk, an automotive information and marketing company, previously predicted that U.S. light vehicle registrations would not hit 16 million until 2015.

Experts attribute the renewed success of the auto industry to an improving economy and housing market, as well as increased construction. That success is expected to extend into the near future.

References:

http://qz.com/124641/one-chart-that-explains-why-the-us-auto-industry-is-booming/

http://www.upi.com/Business_News/2013/01/06/Auto-Outlook-Auto-industry-still-powering-US-economy/UPI-85771357468200/

http://online.wsj.com/article/SB10001424127887324123004579054710542279716.html#articleTabs%3Dinteractive

http://www.reuters.com/article/2013/08/26/fitch-us-auto-abs-losses-rise-as-softer-idUSFit66795020130826