Identificación y trazabilidad de dispositivos médicos
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In the medical industry, accurate medical device traceability and identification of surgical instruments, tools, and patient information are paramount.
Medical device traceability must follow strict guidelines imposed locally or by an international standards. For example, the identification must not increase the potential development of bacteria on a surgical tool.
Our advanced identification technologies offer robust solutions tailored to meet the rigorous demands of the healthcare sector. As an expert in traceability marking solutions for more than 30 years, Gravotech supports you on the road to the compliance with the Unique Device Identification (UDI) and Medical Device Regulation (MDR) standards.
Our marking solutions for medical device traceability
Our laser stations (WeLase™, LW2), thanks to their enclosure, maintain high levels of security throughout the medical device traceability process. The operator can quickly perform a contrasted and durable laser marking on several small units with the WeLase, or batches of medium sized-parts with the LW2.
Would it be logos, serial numbers or datamatrix codes, laser marking medical devices is done without touching the part, enabling identifications on hard-to-reach areas. Our Fiber, Hybrid and Green laser sources easily answer your medical device and surgical tool identification requirements.
The Impact dot peen station provides quick and deep identification of surgical instruments, medical devices and tools. The succession of impacts precisely marks the part with a highly durable code or text.
We recommend the use of an Impact m or eZ m (electromagnetic versions) to control the strength and precision of the marking stylus perfectly.
Main medical traceability and marking standards
MDR
The Medical Device Regulation (MDR) is a regulatory framework implemented by the European Union to ensure the safety, quality, and performance of medical devices.
It replaced the former Medical Device Directive (MDD) and introduced more stringent requirements for clinical evaluation, post-market surveillance, and transparency.
The MDR aims to enhance patient safety by ensuring that all medical devices meet high standards throughout their lifecycle, from design and manufacturing to post-market monitoring.
| Please inquire about your local rules and regulations regarding medical part marking and identification as various countries and regions might not follow above-mentioned international standards. |
UDI
The Unique Device Identification (UDI) system is a global standard mandated by regulatory authorities like the U.S. FDA (Food and Drug Administration) and incorporated into the EU’s MDR.
UDI requires that every medical device be labeled with a unique identifier, which can be used to track the device through its entire supply chain and lifecycle.
This system improves traceability, reduces medical errors, and facilitates efficient recalls when necessary. It also helps in the accurate recording of devices in electronic health records and supports more robust post-market surveillance.
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| Please inquire about your local rules and regulations regarding medical part marking and identification as various countries and regions might not follow the above-mentioned international standards. |
Marking constraints
Identification in the medical sector faces stringent constraints due to the high requirements in the qualification process, where every marking method must meet strict regulatory standards to ensure patient safety and product reliability. Dot-peen or laser marking medical devices must not alter its surface properties, as this could compromise their functionality, biocompatibility, or structural integrity.
Additionally, the markings must withstand repeated sterilization processes, which involve exposure to high temperatures, chemicals, or radiation, without degradation or loss of legibility.
Ensuring the identification marking remains readable guarantees the proper tracking of sterilization cycles, tool history, and future usage. These constraints faced by manufacturers and facilities are easily addressed by our laser and dot peen marking stations.
Datamatrix codification and reading
Marking guidelines
DataMatrix codes must adhere to strict guidelines to ensure legibility and compliance.
For example most standards - including the GS1-128 (for barcodes) and GS1 Datamatrix codifications - require proper contrast, quiet zones (the space around the code), and correct module sizes to maintain the integrity of the code. This guarantees that scanners can reliably capture the code without errors and regardless of the device's surface or material.
The codes need to remain clearly legible, even to the naked eye in certain cases, and are applied to medical devices across all classifications (I, IIa, IIb, III). They must be scannable without requiring invasive procedures or special operations as demanded for example by the EU’s Regulation (EU) 2017/745.
Adherence to these rules guarantees that the code is valid so the data can accurately be read, ensuring traceability and patient safety.
Want to learn more about the differences between barcodes and Datamatrix codes?
Code reading
Reading DataMatrix codes with a camera requires optimal environmental conditions to ensure accuracy and efficiency.
There are three main factors to pay attention to:
- Lighting plays a crucial role; insufficient or excessive light can obscure the code's contrast, making it difficult for the camera to capture the necessary details.
- Glare from reflective surfaces on medical devices can also interfere with image quality.
- The angle at which the camera views the code affects readability, as does the distance between the device and the camera.
Moreover, environmental factors such as dust, moisture, or residue on the device's surface can blur the code, hindering scanning accuracy. Even though these aren’t usually an issue in the medical market, these conditions can be controlled for laser marking medical devices with an exhaust system. Ensuring reliable and consistent readings.
Medical device traceability examples
Prostheses
They must be very resistant. For this reason, the most commonly used materials are metal, ceramic, or highly cross-linked polyethylene.
Mark a reference number and logo on each prosthesis based on alphanumeric series retrieved from a dedicated database with a cycle time of under a minute.
The most common solution to meet the traceability requirements of prostheses is annealing: this laser marking technique consists in locally heating the material (titanium, stainless steel, etc.), which makes it possible to obtain a highly visible and readable marking.
The advantage of annealing is that it is non-abrasive and the etching is carried out on the surface, which means that the part is not damaged, and thus avoids contamination from bacteria.
There are around 600 prosthesis references concerning different materials and shapes, which our marking machines and software can perfectly adapt to.
Surgical tool and instruments
Usually made in stainless steel, surgical tools can be marked with several methods. The most durable will remain laser and dot peen marking.
Each tool is marked with very specific reference numbers, codes and logos. This is allowed thanks to the built-in flexibility the marking software’s offers, allowing for customer-specific customization.
Identification of surgical instruments serves several purposes, the main one being global tracking. The marking also permits tracking of which sterilization cycles were performed, the room and building in which the tool is assigned.
All these help prevent instruments from being lost or misplaced and enable accurate tool count verification.
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| Did you know? Sterilization is not necessarily done in the hospital where the tool is used. It depends on the size of the hospital: the smaller the hospital, the less likely it is they have sterilization machines, as they are expensive. |
Tool containers and storage boxes
In the medical industry, marking isn't limited to tools and prostheses; containers, boxes, and trays also receive unique identifying marks to ensure comprehensive traceability.
These markings enable the tracking of entire groups of tools, ensuring that each item is accounted for and properly managed.
Identification marks help monitor cleaning cycles, distinguishing between trays with clean tools ready for use and “dirty” trays containing used tools that require sterilization.
By implementing such detailed marking, healthcare facilities can maintain high standards of hygiene, reduce the risk of errors, and ensure the correct handling and processing of medical equipment at every stage.
