Which marking technologies for medical device traceability?
Ensuring the precision and safety of healthcare through robust identification and medical device traceability
Gravotech offers advanced, non-abrasive laser and dot-peen technologies to meet the strict compliance and safety requirements for medical device traceability, designed to remain readable after sterilisation and reprocessing cycles.
In the medical industry, accurate identification of surgical instruments, tools, and parts is paramount. Marking each device with a unique ID ensures that traceability follows strict regulatory guidelines, which notably mandate that identification must not increase the potential for bacterial development on a surgical tool.
As an expert in marking solutions for over 30 years, Gravotech supports healthcare professionals and manufacturers on the road to compliance. We ensure that your medical device traceability is robust, durable, and ready for frequent sterilisation cycles.
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 Fibre, MOPA, 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.
| Technology | Machines | Applications | Advantages | Constraints | Price |
| Laser (Green, Fiber, hybrid and MOPA sources) |
|
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| Potential degradation of mark depth over time | $$-$$$ |
| Dot-peen |
|
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| Can be noisier than laser | $ |
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.
|
| 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. |
What are the main marking standards for medical traceability?
Medical Device Regulation (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.
Implementing robust marking systems is fundamental to achieving the strict compliance goals set out by the MDR for effective medical device traceability.
|
| 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. |
Unique Device Identification (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 labelled 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.
|
| 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, bio-compatibility, or structural integrity.
Additionally, the markings must withstand repeated sterilisation processes, which involve exposure to high temperatures, chemicals, or radiation, without degradation or loss of legibility.
These crucial requirements underscore the complexity of achieving reliable medical device traceability, which demands highly specialised marking technologies.
Ensuring the identification marking remains readable guarantees the proper tracking of sterilisation 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.
Accurate and compliant marking is the foundation upon which the entire system of medical device traceability is built.
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 sterilisation 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.
|
| Did you know? Sterilisation 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 sterilisation 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 sterilisation.
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.
What are the main applications for medical device traceability?
Prostheses marking
They must be very resistant. For this reason, the most commonly used materials are metal, ceramic, or highly cross-linked poly-ethylene.
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.
Achieving this non-abrasive, high-durability marking is crucial for reliable long-term medical device traceability within the body.
There are around 600 prosthesis references concerning different materials and shapes, which our marking machines and software can perfectly adapt to.
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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 customisation.
Identification of surgical instruments serves several purposes, the main one being global tracking. The marking also permits tracking of which sterilisation 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.
|
| Did you know? Sterilisation 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 sterilisation machines, as they are expensive. |
Tool containers and storage boxes marking
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 sterilisation.
The marking of these containers is a step in maintaining the integrity and compliance of the complete medical device traceability system.
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.
Contact us
| FAQ: The 4 questions most frequently asked of our experts |
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🔽Which marking technologies are best for medical-grade materials?
Laser marking is the most frequently used technology for the medical sector, primarily due to the high contrast it provides. The Green laser source is particularly favoured for its efficiency and high precision, crucial for not altering the surface or structural integrity of the device.
Dot-peen is also relevant, providing superior mark depth for long-term durability against harsh cleaning cycles.
🔽Which marking technology allows safe sterilisation?
The goal is to avoid modifying the surface state or chemical composition of the material, preventing corrosion or bacterial formation. All Gravotech technologies, including every laser sources, ensure safe sterilisation of medical devices after marking. Dot-peen was historically used first in the medical field for its marking durability and resistance to bacterial formation, as the marking did not alter the surface and mechanical properties.
🔽What is the best machine for medical device traceability?
For marking high volumes or batches of parts quickly, larger machines like the LW2/LW3 laser station are the best solutions, providing contrast and security. For flexibility and safety, the WeLase™ laser station and the Impact dot-peen station are excellent choices for low volumes. These systems are designed to be easy-to-use and to take up minimal space for surgical tool identification.
🔽Do sterilisation processes affect the readability of a medical device mark?
Repeated cycles of cleaning and passivisation can damage both laser and dot-peen markings over time, potentially requiring the device to be remarked to ensure continuous traceability. However, dot-peen marking degrades more slowly than laser marking due to its deeper physical mark. These cycles are a key consideration when choosing a marking technology, as the loss of readability directly impacts the system's ability to track unique IDs and data.
