| Medical News : Medical Instrumentation Traceability |
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| Most instruments used during surgery are reusable product retrieval has now become a specialty, centralized in an in-house sterilization service, supervised by a pharmacist. The sterilization cycle is made up of several steps: pre-disinfection, cleaning, reprocessing, sterilization. This cycle is renewed after each use, during the instrument’s lifespan. Therefore, process-resisting traceability is inherent. French legislation today requires medical equipment traceability through results. That is, the last five patients having been in contact with a medical instrument must be identified. The means to achieve this, on the other hand, are not specified. Today, it is not mandatory to track each instrument, but nevertheless, each instrument batch must be. It is up to each establishment to find the best-adapted identification technology. « A simple, practical and foolproof instrument identification. Technifor’s DataMatrix? is the clearest solution » The organizational solution which is commonly applied offers ‘identical’ packaging re-composition. Reusable medical equipment may be reprocesses: - as a single unit, wrapped in a single-use wrapping, - in a bath (composed of various instruments related to a given intervention) in a tray using a Pasteur folding wrapping, - and finally, as a batch in a container, using a reusable A wrapping in this case The CHPL chose instrument traceability using the Micro-Percussion process- an ideal solution for optimal ‘identical’ reprocessing. During reprocessing, the unique identification code (DataMatrix?) is read on every previously marked instrument. The data bases saves and checks the data read, which guarantees perfect reprocessing of the wrappings/ Pasteur-folded trays/ corresponding container. Each package with its content is then sterilized, reused and constantly followed-up throughout future interventions. A Proven Permanent Marking Solution: Your Accounts The CHPL operated up to 100 patients a day. For these interventions, the hospital center has an instrument inventory. According to Christine Chave, CHPL sterile processing department manager, approximately 20 000 tools will be progressively marked by a machine Technifor Micro-Percussion (today, 5 000 instruments are already identified). « This represents many, many patients, many operations and a great deal of surgical instruments » Chave explains, and adds: « but it is our responsibility to sterilize and trace each article. Furthermore, our will to trace instruments gives us real production management. » « Tracking the sterilization process greatly surpasses the legal aspect, it allows a production follow-up, piloting and the related analysis: activity logbook, simultaneous inventory, unitary instrument maintenance follow-up. » says Francis Reymondon, engineer in charge of the project’s setup. During reprocessing, instruments that aren’t marked yet can be intercepted and given to the device operator, Patrick Jeandet, in charge of marking the medical instruments with a 2-dimensional DataMatrix?, or an alphabetical text with Technifor’s CN312Cm Micro-Percussion machine. « We have studied a fair amount of methods before choosing Micro-Percussion», explains Jeandet but the other alternative solutions are less adapted. Laser marking has quality-related consequences concerning corrosion after several reprocessing cycles. Other technologies are: ‘stickers’ or RFID chips, too expensive when compared to Micro-Percussion. Such chips are retailed at 4€ per instrument. When calculated, the investment return on the marking machine is reached once 40% of the instrument inventory is marked. Sterilization & Micro-Percussion Various studies about traceability techniques have been carried out: laser marking, stickers, RFID chips, Mircro-Percussion were considered. Yet, considering the constraints linked to the sterilization process (134°C for 18 minutes), Micro-Percussion proved to be the most beneficial marking technology: - No corrosion - Cost-efficient - Time-efficient - User-friendly - Easy reading with means available on the market Furthermore, Micro-Percussion meets a pharmacist’s two most important criteria: hygiene and EC medical instrument manufacturer’s warranty preservation. Therefore, no hygiene hazard is to fear: the ‘new’ marked tools are not altered. In the event where marking may somewhat physically alter tools, Micro-Percussion will not mechanically alter them. The aeronautical industry chose Micro-Percussion and that should tell us something! Never would an aeronautics engineer consider damaging his parts! Permanent Marking Even if Micro-Percussion is an impact process, even the most intricate surgical instruments may be marked. As well, since marking is 100% indelible, an instrument can be sterilized an unlimited number of times without a slight marking alteration. « A 100%-integrated solution, without external intervention, a user-friendly technology. That’s what Micro-Percussion is all about.» The decision to mark instruments in-house was taken after careful consideration. Outsourcing would have required, time after time, complex wrapping and sending. With such an important workload, the health establishment could neither afford to let its tools go, nor the extra costs associated with such a process. « Some of our instruments must be operational within hours of arrival in the sterilization department. » says Pierre Faure, engineer in charge of the project. « We didn’t want to depend on exterior factors. With the Technifor system, we are both autonomous and efficient.»
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