Every instrument has an identity.
From manufacturing to the hospital cycle, individual identification is the starting point of instrument traceability. MEDLANE masters the laser marking and DataMatrix identification of its instruments in-house.
30932P
Pince Dissection Standard Norma 180 mm Ss Griffes
An identity at instrument level
MEDLANE has a process allowing GS1-format DataMatrix marking and individual identification directly on the instrument: every marked instrument carries its own identifier, recorded in a traceability database.
- 01
Instrument
A MEDLANE catalogue reference, manufactured and controlled in-house.
- 02
DataMatrix
Machine-readable identification applied directly onto the instrument.
- 03
Digital identity
An individual identifier, distinct for every marked instrument.
Machine-readable identification is the link between the physical object and digital traceability systems.
The exact content encoded in the marking is defined case by case with the hospital or distributor; it is not published here.
34906P
Pince Hémostatique Halstead 120 mm C. sans Griffes
Detail — same catalogue photograph
MEDLANE laser marking
Marking is performed in-house by laser, using a thermal annealing process: the marking contrast is obtained without machining or removing material from the instrument surface.
- 01
Surface
Finished stainless steel
- 02
Localised thermal interaction
Annealing, no machining
- 03
Contrast
Surface oxidation
- 04
Marking
Legible and stable
Thermal annealing: the laser interaction remains localised at the surface and does not proceed by material removal.
Applicable marking parameters are managed reference by reference within the quality system in force; they are not published.
This documented MEDLANE process — localised thermal annealing, with no material removal — differs from laser engraving methods that proceed by ablating the surface. Laser marking methods do not all behave in the same way: the observations described here concern the MEDLANE process only.
MEDLANE documentation · Documentation process laser MEDLANE · 2021-12
04104P
Ciseaux Dissection Metzenbaum nelson 180 mm Courbe
Detail — same catalogue photograph
A qualified, monitored and documented process
MEDLANE's marking process has been covered by a qualification protocol and report: behaviour of the marking on several steels and finishes, then after sequences simulating hospital reprocessing.
- 01
Marking
- 02
Passivation
- 03
Cleaning / decontamination
- 04
Steam sterilization
- 05
Visual / readability inspection
- 06
Recorded result
MEDLANE's technical archives document the qualification of the process and its robustness testing. The applicable production parameters are managed within the quality system in force.
MEDLANE technical archive · marking process qualification · 2014-2016
This documentation is presented as a technical archive: it evidences a qualification methodology, not current regulatory conformity. No former certificate, former declaration or detailed parameter is published here.
40204P
Porte Aiguille Mayo Hegar 200 mm Tungstène
Designed for the life cycle of a reusable instrument
A reusable instrument goes through the same cycle hundreds of times. Individual identification allows a compatible hospital traceability system to link the physical instrument to the events recorded in its own workflow.
- 01Use
- 02Collection
- 03Cleaning
- 04Inspection
- 05Set assembly
- 06Sterilization
- 07Storage
- 08Re-use
MEDLANE does not itself record these events: they belong to the hospital's workflow. Cleaning, disinfection and sterilization instructions are governed by the current MEDLANE instructions for use supplied with the devices.
42805
Rongeur KERRISON BAYONETTE 230 X 2 MM 40° HIGH
Designed to fit into hospital environments
DataMatrix identification, readable by a 2D scanner, is designed to make it easier to integrate the instrument into the hospital's digital workflows, subject to the compatibility of the system in use.
- 01
MEDLANE instrument
DataMatrix identification
- 02
2D scanner
Optical reading of the marking
- 03
Hospital traceability system
Solution chosen by the hospital
- 04
CSSD / operating room
The hospital's own workflow
MEDLANE supplies the identification carried by the instrument. MEDLANE does not supply CSSD traceability software: the hospital retains the choice and control of its own system.
Traceability starts in our workshops
Laser marking is one of MEDLANE's industrial capabilities, alongside instrument manufacturing and inspection.
LASER MARKING
Laser marking
Performed in-house, using a thermal annealing process.
DATAMATRIX IDENTIFICATION
DataMatrix identification
GS1-format DataMatrix marking, unique for each instrument.
REFERENCE-BASED PARAMETERS
Reference-based parameters
Applicable marking parameters are managed reference by reference within the quality system.
PROCESS VERIFICATION
Process verification
The marking process is qualified, monitored and checked.
QUALITY RECORDS
Quality records
Marking operations are documented through records.
Marking, surface condition, material and quality system are related subjects: the surface that carries the identification is also the one exposed to reprocessing. These domains are covered separately, each with its own sources.
See also: MEDLANE quality · Materials · Knowledge & Quality
On product pages
When the identification status of a reference is validated in our data, the corresponding product page carries a “Traceability ready” note. No reference displays this note without validated data.
Example of the display