Kenneth A. Fine | President and Co-Founder | Proven Process Medical Devices
The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of medical devices, among other things. Its role includes advancing public health by helping to speed innovations that make treatments more effective, safer, and more affordable. As such, when breakthroughs in medical device design and engineering enable safety improvements, those innovations help inform the evolution of FDA standards and guidance. The FDA and the medical device industry have a symbiotic relationship, while their independent governance makes room for innovation and regulation to coexist and drive advancements in public health and safety.
Sometimes the limitations of available technology constrain the FDA’s purview. For example, recent deaths resulted from infections transmitted during medical procedures through bacterially-contaminated duodenoscopes – even though the reusable scopes had been cleaned according to protocol, using the best available technology, and in keeping with existing FDA standards.
The FDA issued new guidance for the labeling, validation and verification of medical devices a few months ago, which also covered instructions to be provided for reprocessing reusable devices. The guideline clearly states that existing reprocessing instructions “may not be consistent with state-of-the-art science and therefore may not ensure that device is clean, disinfected or sterile.” It also recommends that new 510(k) submissions address any inadequacies in current methods. This important guidance exposes the need for medical device designers to lead the way in improving disinfection protocols for the sake of patient safety.
To this end, the FDA set a standard for acceptable levels of cleanliness, measured by the amount of protein left on surfaces after cleaning. The standard requires cleaning to eliminate all but 6.4 mcg of protein per centimeter squared (6.4 mcg/cm2). None of the machines currently available can achieve that level of cleanliness without extensive additional procedures. This reality is raising the bar and driving innovations out of necessity. While med-device companies struggle to meet the standard, one company says it has developed a cleaning machine that not only meets but exceeds it. In validation studies for the FDA, the new machine, invented by Langford IC Systems and developed in partnership with Proven Process Medical Devices, reduced leftover residue to an average of 2.5 mcg/cm2, and in some cases lower than 1 mcg/cm2. The new cleaning machine dramatically improves sanitation of surgical instruments, endoscopes, and implantable devices, significantly reducing the probability of reusable medical devices spreading disease between patients in clinical settings.
The Langford “LIC” machine is but one example of how device engineering and FDA standards evolve in a parallel dynamic that improves healthcare and patient safety. The FDA develops guidance that drives innovation, and inventors and engineers work to meet and exceed those specifications while raising the bar for continued advancement.