What do the new EU Medical Device Regulations mean for designers and manufacturers?
In May 2017, prompted by dated regulations, the breast implant crisis and hip replacement issues, new more restrictive EU Medical Device Regulations (MDR) were introduced. The new MDR allows for a 3-year grace period and will go into full effect May 26th 2020. Some of the key changes in the regulation include the reclassification of devices, requirements for more clinical evidence, material traceability and post market surveillance.
Medical device manufacturers will need to invest greater oversight into the selection and tracking of raw materials and components used for manufacturing their device, ensuring their devices are not only safe and clinically proven for the intended use but also implement robust product surveillance to track and address operational questions and uses of their devices.
The mandatory requirements will fall under stricter oversight by national regulators and could dramatically alter the operations of medical device OEMs.
Design engineers can reduce risk and delays on new products by selecting suppliers who can verify that raw materials and components have been independently tested and proven safe for end use in medical devices. In addition, to help with more stringent post-launch surveillance and protocol monitoring, there is an opportunity to automate manual hygiene protocols to include data logging and compliance monitoring.
One of the ways that medical device manufacturers can add value to their products and achieve the above is by incorporating proven and quantifiable UVC disinfection at critical activities on hygiene processes and point-of-care products.
Klaran HC Series UVC LEDs, which have been independently tested and verified compliant to ISO 10993-5, are proven effective in surface, water and air disinfection. These devices deliver repeatable, quantifiable and trackable UVC dosage at point-of-care. Adding UVC disinfection capabilities in conjunction with approved hygiene protocols is proven to reduce the spread of healthcare-associated infections (HAIs).
As the medical device community works diligently during the current MDR grace period it should not give way to the urgent and pervasive need to address the major threat that HAIs pose in the EU. According to a recent ECDC surveillance report, millions of European citizens are impacted each year in the Intensive Care Unit (ICU) alone with pneumonia, bloodstream infection and urinary tract infections as the most prevalent nosocomial infections.
To strengthen product offerings, medical device manufacturers should consider incorporating on-demand disinfection at point of care and in the surgical suite for enhanced patient safety and improved clinical outcomes. Irradiating the surfaces of surgical instruments, vascular access points or treating the air flow in medical ventilators are some examples of applications suited for the immediate adoption of UVC hygiene.
To request more information about Klaran HC Series UVC LEDs and adding disinfection capabilities to your medical device, contact Klaran today.