When it comes to product tracking requirements, perhaps no industry is more highly regulated than medical device manufacturing. In the United States, for example, governmental bodies like the Food and Drug Administration (FDA) have developed and enforced traceability requirements and advised medical device manufacturers on how to identify and track their equipment for decades.
Although the FDA doesn’t issue tracking orders for every kind of medical device on the market, acts of legislation like the Food and Drug Administration Modernization Act (FDAMA) do lay out traceability requirements for many kinds of medical devices, including:
Similarly, both prescription drugs and over-the-counter medicines are subject to unique labeling and traceability guidelines as well.
Depending on legislative specifics, these tracking guidelines range from mere suggestions to rigid requirements such as unique device identifier (UDI) systems, which include lot numbers, batch codes, model numbers, and serial numbers. With the aid of these identifiers, manufacturers can provide federal regulators with essential data, such as:
To ensure that devices are aligned with these requirements, manufacturers turn to industrial printers and laser marking systems to outfit their products with the necessary codes and markings. Coding technologies like thermal inkjet printers, thermal transfer overprinters, and CO2 laser marking systems enable manufacturers to label their products with markings that won’t become faint due to issues like condensation or radiation sterilization during manufacturing, distribution, and use.
If you’re on the lookout for new marking hardware, read below to learn about some of the best medical coding and marking printers and laser marking solutions available today.
Although technology has advanced medical coding and marking systems in recent years, many older systems can still be found in many manufacturing facilities due to their high-quality, robust designs. Below, we detail some of these legacy models that are still in use today, as well as some of the newer technologies that rival them.
Before delving into the latest and greatest machines in the medical coding field, it’s important to look at some old favorites that are still in use today. After all, an industrial marking system isn't designed with a quick replacement in mind—a quality system is an investment that should be able to deliver great results for extended periods. Accordingly, many systems that were first released years ago are still in use throughout the industry.
Take the Wolke m610® advanced thermal inkjet (TIJ) printer, for example. Available through Videojet, the Wolke m610 is a TIJ system specifically built for medical applications. With a max DPI resolution of 600 x 600 and a print height of 2”, the m610 is capable of making long-lasting UDIs and machine-scannable barcodes/data matrices that won’t rub off from environmental factors or physical handling. The m610’s compact dimensions (13.4” long x 10.1” wide x 4.6” high) also make it easier for users to integrate the machine into a larger production line. Domino’s G-Series TIJ printers carry similar specs and have maintained consistent popularity in the medical industry for years as well.
Although machines like the m610 and G-Series model TIJ systems are still used to create quality codes, recent advancements in the coding and marking field have made them essentially legacy products in a relatively short time. Technological improvements in marking speed, application versatility, and system build have given the edge to newer TIJ models and CO2 lasers—a topic we explore in our next sections.
Since the m610 and G-Series were first released, medical marking systems have become faster, more versatile, and capable of delivering longer periods of uptime. In recent years, one of the most talked-about medical printing systems has been Bell-Mark’s InteliJet TS.
Built with an impressive IP67 outer structure, the InteliJet TS is a powerful TIJ printer that delivers high DPI codes at quick speeds and can print on medical paper, polyvinyl, foil, and other popular medical product materials. The InteliJet TS requires no regular maintenance even when operating daily, and its intuitive label software also makes it easy to create new label designs as well as update variable data.
Compatible with up to four 0.5” printheads at a time, the InteliJet TS carries the following printing specs:
Along with the InteliJet TS, the Anser X1 has also been making waves in the medical marking field. The Anser X1 offers a maximum printing speed of 300 m/min. and a 2” print height, similar to many continuous inkjet printers, and has a maximum DPI of 600 x 600. Recently dubbed one of C&M Digest’s best thermal inkjet case coding printers for 2021, the Anser X1 is compatible with a wide range of porous and non-porous substrates, making it suitable for both primary and secondary medical coding applications.
Finally, the Anser X1 carries the unique ability to be able to control two production lines simultaneously, allowing operators to quickly increase production if necessary.
While many older TIJ medical printers are gradually becoming outdated compared to new releases, many laser systems have maintained their status as industry favorites. Laser systems are advantageous to medical manufacturers due to their fast speeds, reliable results, permanent marks, and compatibility with a diverse range of packaging forms, including;
They also can accurately mark metal machinery, making them a great fit for marking devices like defibrillators and pacemakers as well.
Within the medical laser marking system sector, Domino has been known to make excellent systems, with the D620i D-Series Laser as its top-of-the-line option. A 60-watt CO2 laser, the D620i D-Series can create unlimited text lines at 2,000 characters per second. Thanks to the system’s flexible print head, the system is capable of marking materials at any orientation, making it ideal for packages of all shapes and sizes.
For those looking to buy a laser system soon, we also suggest keeping a lookout for new releases from Solaris Laser. For more than 25 years, Solaris has supplied the medical field and the manufacturing and packaging industry with several different laser systems, and in 2020, the company was acquired by marking and coding giant Markem-Imaje. With this acquisition, Markem-Imaje is aiming to improve its selection of laser marking options by releasing innovative new solutions in the coming years.
When this occurs, tune into C&M Digest to see how they stack up to the rest of the market.
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