Cleaning Surgical Instruments & Medical Devices?
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Cleaning Surgical Instruments & Medical Devices: European Compliant Cleaning Fluids
Kemet International serves as the exclusive distributor in the UK for NGL Nordic A/S, a distinguished provider of over 300 cutting-edge formulations tailored to address a wide array of cleaning needs. NGL’s methodology revolves around a profound understanding of materials, proactive anticipation of industry advancements, and fostering collaborative partnerships with key stakeholders across the production spectrum, including equipment manufacturers, consultants, laboratories, and consumables producers. This holistic approach enables the creation of innovative solutions that align with the stringent requirements set forth by the European Medical Device Regulations (MDR).
Adherence to the European Medical Device Regulations is paramount in the realm of medical device cleaning solutions. NGL operates under the umbrella of ISO 9001, ISO 14001, and ISO 45001, anchoring its quality management practises, supplemented by meticulous quality cheques throughout the production lifecycle. Their unwavering commitment to continuous enhancement underscores their dedication to delivering superior quality to their clientele.
The cleaning of surgical Instruments and medical devices is a pivotal process entailing the elimination of contaminants such as oils, debris, and microorganisms from instruments and implants. Stringent guidelines outlined in the MDR govern these cleaning procedures to ensure the safety and efficacy of medical devices. Central to compliance with these regulations is the utilisation of cleaning fluids that meet MDR standards.
Kemet’s range of cleaning fluids is meticulously crafted to embody efficiency, simplicity, and strict compliance with the European Medical Device Regulations. This product line is the culmination of synergistic efforts between the Research and Development (R&D), production/Health, Safety, Quality, and Environment (HSQE), and procurement departments. These teams, cognisant of the evolving challenges confronting the medical sector, adeptly harmonised conflicting requisites such as efficacy, accessibility, cost management, and regulatory conformity.
The proliferation of bacterial growth in demineralised water rinses poses a formidable challenge in medical device cleaning protocols. Water traverses intricate pathways, including bends, pipes, and pumps, where the presence of microorganisms eludes easy detection and control. Failure to address this issue can lead to the formation and dissemination of biofilm within rinse tanks, underscoring the imperative of preemptive water treatment, even in instances where water is heated to 70°C and subject to constant circulation.
A pre-treatment solution has proven highly efficacious in mitigating bacterial proliferation during the final rinse of medical devices at a leading manufacturer of medical implants and instruments in France. This innovative solution not only curtails bacterial growth but also ensures strict adherence to European Medical Device Regulations.
In addition to Aqueous Ultrasonic Cleaners, Kemet provides the following:
Vacuum Solvent Cleaning: This method ensures impeccable cleanliness while bypassing the need for ATEX-approved machinery, thereby reducing investment costs.
Passivation: Ideal for industries like aerospace and medical, this option prioritises strict regulatory compliance to uphold the highest standards of cleanliness, adhering to ISO 7 clean room standards.
Liquid Penetrant Testing: This highly efficient technique uncovers hidden surface imperfections and defects in accordance with the ASTM E1417 FPI standard. Widely adopted in aerospace and medical sectors, it guarantees compliance with rigorous quality standards.
For further insights into Kemet’s ultrasonic cleaning range, we invite you to contact us at sales@kemet.co.uk.
