This past year saw a big change in how medical devices are identified.
Beginning Sept. 24, 2022, FDA regulations require a UDI direct mark for identification purposes on “any reusable and reprocessed medical devices on the U.S. market.”.
The change affects a wide variety of devices, including medical drills, surgical instruments, and dental probes. Other Class I products, as well as those in Class II and III, are affected as well.
Direct part marking is a useful tool to help meet industry standards and provide a reliable and readable ID number for each part. In order to provide the accuracy needed, medical part marking devices must meet standards and expectations set for the medical field.
When it comes to the medical industry, laser marking is ideal due to the:
- the capabilities of the machines
- the potential size marking for the part
- the fact no material is wasted during the marking process.
A laser marking device provides an accurate and reliable method of DPM for medical devices. The laser marking device partners with software that streamlines the marking experience for both novice and experienced employees.
Fitting Into the UDI System: Medical Devices
The UDI system requires all medical devices to be assigned a unique device identifier (UDI) before being placed on the market. This UDI is used to distinguish each device from others in its class and other classes. The UDI must be included on the device label, as well as reported to FDA’s Global Unique Device Identification Database.
Medical devices can be classified into:
- Life-Support Medical Devices –those that are essential to keeping a patient alive, e.g. ventilators and heart monitors.
- Life-Sustaining Medical Devices – those that are not essential to keeping a patient alive, but they improve their quality of life, e.g. defibrillators.
- General-Use Medical Devices – those that are not used specifically for life-saving or life-sustaining purposes, e.g., blood pressure monitors or cervical collars.
The classification of a medical device is important because it determines how the device must be labeled and tracked. In addition, different classes of medical devices have different medical part marking safety requirements. For example, life-support medical devices must meet more stringent quality standards than general-use medical devices.
Multi-use medical devices are those that can be used more than once on different patients, such as an endoscope. Single-use medical devices can only be used once on a single patient. An example of a single-use medical device would be a syringe.
Reprocessing is the term used to describe the cleaning, disinfection, and/or sterilization of a reusable medical device so that it can be used again.
To learn more about medical part marking:
Types of Marking for Medical Devices: Frosting vs. Black and White Marking
Medical devices must be marked in order to meet industry standards and provide a reliable and readable ID number for each part. There are two types of marking used for medical devices: frosting and black-and-white marking.
Frosting involves lightening the background, while black and white medical part marking involves the data matrix code and clear differentiation of the code areas. This increases contrast and legibility.
Rules for Marking Medical Devices
Medical devices must also be marked to provide a reliable and readable ID number for each part. Ideally, the part will clearly display its ID number in its entirety. However, if that’s not possible due to part size or other factors, then the minimum of the barcode must be shown.
The smallest size permitted for the part marking is 0.1 mm. In fact, the widely accepted guidelines are for a DMC area size of 2.5 x 2.5 mm minimum.
Direct Part Marking Exceptions
The FDA provides some exceptions for medical devices that do not require medical part marking.
The exceptions for devices to display a legible mark for identification purposes include the following:
- When marking will interfere with device effectiveness or safety
- When technical limitations to marking the device directly exist
- Single-use devices
- A permanent UDI is already marked on the device
- Use case: research, teaching, or chemical analysis
- The device is for veterinary use only
- Device to be exported from the US
- The packaging of the device bears the UDI rather than the device itself
Medical Devices and DPM: Fulfilling Regulatory Requirements
Due to the September 2022 implementation of new regulations, direct part marking for Class I and II medical devices is a must. With some noteworthy exceptions, each device produced must carry at minimum the AIDC.
Time for Action: Discuss your Medical Part Marking Needs
Technomark experts can help you determine the best way to implement laser marking as part of your production process. Consider this free resource: