All medical devices that are sold and distributed in the USA and increasingly on a global scale, require a Unique Device Identification, so essential information can be held on each device. Devices can then easily be tracked and traced using a UDI database. It means that if there are issues and errors then it’s easier to recall products and safeguard patient care, client safety and supply chain security. Medical devices can be anything from hip replacements and pacemakers to prosthetic limbs.

If UK manufacturers want to trade with US partners and their healthcare market then they must comply with these rules and regulations too. The NHS is also issuing guidelines in support of full UDI application, so that they too can benefit from increased traceability and identification. With the increasing demand for compliance and efficiency, which cost-efficient solutions can be identified for marking medical devices?

What is a UDI?

A UDI is a unique numeric or alphanumeric code, which can be directly found on a product or a label on a medical device. It helps to identify a medical device with a specific code and information about how the device is controlled. The device identification signifies the manufacturer name and device product code and the production identification gives the batch number, expiry date and serial number.

Prosthetic-device-echelon

Prosthetic device by Echelon

Challenges

With more stringent regulations in the medical manufacturers sector and the need to adapt to UDI requirements, there are more and more products that require marking to comply with protocols. This has an impact on a whole host of different efficiencies involved in production lines and development. Challenges such as the rising cost of production, increased wastage and the need to consistently improve product quality all have to be addressed when considering marking.

Advantages

Being able to quickly and efficiently trace and track medical devices means that the amount of medical error can be reduced and that problematic devices can be recalled in a much more rapid timeframe. This will lead to increased patient safety.

Having a globally recognised UDI means that it’s easier to trade devices with other countries and be able to track products. A global distribution chain that is safeguarded means there will be less counterfeited products that can be damaging for patients.

There can be a more uniform, standardised system so that electronic health records, clinical information systems and registries will share similar information.

Codes allow there to be an increased use of automated systems which can reduce overall costs over time and make it easier to trace and update products.

Solutions

Delivering medical device marking is of significant long-term benefit to the industry and will result in compliance with regulations, better patient safety and care over time, increased operational organisation, a standardised system and the ability to track and trace products. All of these factors will lead to a more cost-effective framework that allows problematic devices to be quickly and efficiently recalled and more data to be generated for analysis.

Device marking can be easily integrated into the product development process and existing systems, with full support and training for the application able to be provided.  UDI compliance can be costly if it is not carried out by experienced, high quality professionals who are accustomed to software and labelling system upgrades. In short, marking of medical devices is cost-effective and beneficial to patients everywhere.

Laser marking is often introduced within the medical device marking process. This is because laser marking offers:

  • – Low running costs and minimal consumables required
  • – High consistency, high clarity and permanent marking
  • – Environmentally friendly
  • – High speed of marking and the ability to integrate into existing production lines.

If you are looking for a medical device marking solution, the team at ThinkLaser can provide no obligation advice on the best way to approach your laser marking requirements.

Click here to get in touch with ThinkLaser today.