Laser Marking for Patient Safety

Umbilical cord scissor with laser marked UDI-Code, marked with Foba HELP (Holistic Enhanced Process) according to UDI (Unique Device Identification) regulations. (Source: Foba)

Umbilical cord scissor with laser marked UDI-Code, marked with Foba HELP (Holistic Enhanced Process) according to UDI (Unique Device Identification) regulations. (Source: Foba)

The 17th of September was declared international Patient Safety Day, which takes place for the second time in 2016. The Patient Safety Day aims at increasing public awareness. It is organized by the German Aktionsbündnis Patientensicherheit and supported by the German Federal Ministry of Health. Focus this year is on “medication safety”. Hospitals, nursing homes and other health organizations are invited to participate as well as industries, manufacturers and consultants.

Foba Laser Marking + Engraving, manufacturer of laser marking machines, is part of MedicalMountains, a cluster initiative with over two hundred member companies, which represents quality and innovation in medical technology.

“Patients’ safety is every medical company’s final concern”, Yvonne Glienke, Chairwoman of MedicalMountains, explains. “For that reason we offer trainings and information seminars on related subjects like CE marking, bio-compatibility, technical documentation and the European medical device regulation”, Glienke continues. “All implemented measures’ target is to ensure that patients benefit from safe products and services.”

Lately extended official directives like UDI (Unique Device Identification) regulations by the FDA (U.S. Food and Drug Association) or the European Medical Device Regulation MDR are intended to better control the big variety of products on the medical market, to store information in a central data base and protect quality standards. Not only products of low risk like dressing material or stethoscopes are affected, but also middle to high risk devices like hearing aids, medical tubes, intravenous catheters, scalpels or implants.

Direct part marking (DPM) on medical devices ensures continuous traceability from manufacturer to patient and is mandatory for many industries. In this context, MedicalMountains provides support for its member companies to find adequate marking technologies.

Laser marking system Foba M2000 with integrated fiber laser markers of the Y-Series and camera system IMP. (Source:Foba)

Laser marking system Foba M2000 with integrated fiber laser markers of the Y-Series and camera system IMP. (Source: Foba)

Laser marking appears to be the most reliable technique for medical devices, which require bio-compatible and hygienic marks. High marking quality with excellent long term resistance ensures traceability throughout the whole product life cycle. In terms of medical implants for example, these marks contain data on time and place of production, further processing, attending physicians, time and place of surgery and patient data. All information can be taken directly from the product and transferred further into hospital and other documentation systems.

Manufacturers benefit from Foba’s Holistic Enhanced Laser Process HELP, a vision-based marking system that verifies parts and marking contents before, during and after marking. An efficient and nearly error-free production can thus be guaranteed and production costs can be reduced by up to 80 %.

Laser marking is most suitable for direct part marking on materials most medical devices are made of, like titanium and other metals or different plastics. Also highly sensitive silicone products can be adequately marked by Foba’s UV-lasers or the pulsed Ytterbium fiber-lasers from the Y-Series. The flexible vision-based marking systems solve the current demands of medical device manufacturers for industrial parts marking. (Source: Foba)

Links: ALLTEC GmbH, Foba Laser Marking & Engraving, Selmsdorf, Germany • MedicalMountains AG, Tuttlingen, Germany • Aktionsbündnis Patientensicherheit, Berlin, Germany

Further reading: HELP for Compliantly Marking Medical Devices, photonicsviews.com, 21 January 2016

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