Identity Verified Prints for Unique Device Identification (UDI)
Doranix Unique Device Identification Capabilities
At Doranix, we specialize in serialized data printing, especially bar coding for unique device identification. We are able to configure our printers to clearly code a variety of materials including those most commonly used in the medical device industry: Tyvek pouches, Tyvek lids, and foil/poly pouches. The configuration process involves adjusting each printer for optimal performance on the actual product/substrate a company uses for production. This process accounts for substrate thickness, surface roughness, adhesives, coatings, etc. To learn more about UDI labeling, please check out our UDI printers.
In order to ensure accurate configuration, Doranix has partnered with optical recognition companies Webscan and Cognex. Using the Webscan Omni bar code verifier, each bar code (1D or 2D) can be evaluated for quality during the configuration and validation phases of equipment construction. Bar code verification is also available as a service when using a Doranix product – send samples and we will return a bar code validation report using ISO15415/6 and ISO29158 standards.
Additionally, Cognex DM262X bar code scanner/graders can be outfitted on the ThermaPrint 64 label printer applicators to provide on-line bar code grading. Each printed piece could be checked for quality, logged, and stored in a database if required – all without decreasing printing throughput!
These capabilities allow Doranix to be the industry leader in demand, serialized, package identification – especially medical printing applications requiring UDI coding.
Summary & Guidelines for New FDA Unique Device Identification Requirements
As a result of the FDA’s final ruling on the medical Unique Device Identification System (UDI) in September 2013, and its follow-up Global Unique Device Identity Database (GUDID) Guidance document in June 2014, this publication has been prepared in order to simplify and assist in understanding the compliance requirements necessary to achieve regulatory acceptance. The UDI system has been implemented by the FDA in order to stratify and simplify the traceability of all classes of medical devices manufactured and distributed in the United States, alongside certain products registered under the Public Health Services (PHS) Act that incorporate medical devices. The outcomes of the final ruling are expected to:
Unique Device Identifiers
- Improve the quality of information which is recorded on medical devices and medical device packaging.
- Standardize the data that is presented on the label
- Simplify data analysis of medical device within data recording systems
- Assist in prevention of counterfeiting
- Facilitate rapid regulatory action following the occurrence of Adverse Event Reports (AER’s) in medical devices
- Assist in rapid, specific and targeted product recalls
- Reduce medical errors and improve patient safety
- Lead a global directive in medical device identification
The UDI label must be applied to the medical device (as primary packaging) and secondary packaging. The FDA ruling dictates that UDI must be must be provided in a plain text version and in a form that uses automatic identification and data capture (AICD) technology’. Stipulations are that is must consist of two specific and discreet aspects:
Types of Unique Device Identifiers
A device identifier (DI): This is mandatory and must identify the Labeller and specific model/version of the device.
A product identifier (PI): This is conditional and variable depending on the device, must include one or more of the following:
- Lot or batch number within which a device was manufactured o Serial number of the specific device
- Expiry date of the specific device o Date of manufacture
- Distinct Identification Code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based products (HCT/P) regulated as a medical device.
Fig 2: Fictitious example of a medical device UID label illustrating Product Identifier as proposed by the FDA
Included in the FDA ruling is the stipulation that each device supporting a UDI must be recorded on the newly constructed Global Unique Device Identification Database (GUDID). The GUDID is intended to be a central depository for traceable information for all supplied medical devices of all classes within the United States. The data provided for the GUDID will be available to the general public and should include only the DI. Submission of the PI is not required. Furthermore although the general public will be able to request and see information relating to specific devices, no personal user information will be held on the GUDID.
UDI & GUDID Implementation Dates:
The implementation programme as outlined by the FDA is set to roll out over the next 7 years to progressively incorporate all classes of medical devices for UDI application and GUDID information submission. Initially targeting Class III devices it is set to progress as follows:
Date: Requirements:
Sept 2014
All labels and packaging of devices must incorporate a UDI Dates on labels must be formatted as stipulated
Data must be submitted to the GUDID database
1 year-extension for compliance must be applied for by 23rd June 2014 Stand-alone Class III software must provide its’ UDI as required
Sept 2016
- Any Class III device intended for use more than once must bear a permanent marking UDI
- Life Supporting/Life Sustaining Devices:
Date: Requirements:
Sept 2015
- All labels and packaging of devices must incorporate a UDI Dates on labels must be formatted as stipulated
- Data must be submitted to the GUDID database
- Stand-alone software for these devices must provide its’ UDI as required
- Any Life Supporting/Life Sustaining device intended for use more than once must bear a permanent marking UDI
Class II Medical Devices
Date: Requirements:
Sept 2016
- All labels and packaging of devices must incorporate a UDI Dates on labels must be formatted as stipulated
- Data must be submitted to the GUDID database
- Stand-alone Class II software must provide its’ UDI as required
Sept 2018
- Any Class II device intended for use more than once must bear a permanent marking UDI
- Class I Medical Devices and other Devices Not Classified as Class I, II or III
Sept 2018
- All labels and packaging of ALL devices (including those previously exempt) must incorporate a UDI
- Dates on labels of ALL devices (including those previously exempt) must be formatted as stipulated
- Data for ALL devices (including those previously exempt) must be submitted to the
- GUDID database
- Stand-alone Class I software must provide its’ UDI as required
Sept 2020
- Any Class I device or and device that has not been classified into Class I, II, or 3 but
requires labelling with a UDI, which is intended for use more than once must bear a
permanent marking UDI
UDI Exceptions
The UDI rule does allow for exceptions of for the requirements of § 801.20 for certain categories of medical devices. It is possible to request an exemption or alternative for unique device identification marking if either an acceptable alternative method of identification is used, or if the exception is viewed as being in the best interest of public health. Application and assessment for this process takes place directly through the FDA.
Accrediting Agencies:
The FDA has currently allocated 3 agencies with accreditation to assign UDI’s outlined below:
- Firm Name: GS1 Website: www.gs1.org
- Firm Name: Health Industry Business Communications Council (HIBCC) Website: www.hibcc.org
- Firm Name: ICCBBA Website: www.iccbba.org
Relevant Links:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/uniquedeviceidentification/
https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device-identification-system