Abstract
The emergence of multidrug-resistant (MDR) bacteria threatens humans in various health sectors, including medical devices. Since formal classifications for medical device sterilization and disinfection were established in the 1970's, microbial adaptation under adverse environmental conditions has evolved rapidly. MDR microbial biofilms that adhere to medical devices and recurrently infect patients pose a significant threat in hospitals. Therefore, it is essential to mitigate the risk associated with MDR outbreaks by establishing novel recommendations for medical device sterilization, in a world of MDR. MDR pathogens typically thrive on devices with flexible accessories, which are easily contaminated with biofilms due to previous patient use and faulty sterilization or reprocessing procedures. To prevent danger to immunocompromised individuals, there is a need to regulate the classification of reprocessed medical device sterilization. This article aims to assess the risks of improper sterilization of medical devices in the era of MDR when sterilization procedures for critical medical devices are not followed to standard. Further, we discuss key regulatory recommendations for consistent sterilization of critical medical devices in contrast to the risks of disinfection reusable medical devices.
Highlights
Within the framework of the United States Food Drug & Cosmetics Act (FD&C Act), a medical device is defined as “An instrument apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessary which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man or other animals, or intended to affect the structure or any function or other animals.” The sterilization of a medical device is the chemical or physical process of eliminating all forms of microbial life and associated spores through a variety of methods, such as autoclaving with heat/pressure, hydrogen peroxide vapor, radiation, ethylene oxide (EtO) gas, and other processes
Some hypothesize that S. epidermidis may account for ∼80% of bacteria involved in medical device infections [43, 44]
Due to the emergence of MDR bacteria and biofilms on different classes of medical devices, we recommend that requirements for terminal sterilization and high level-disinfection of reprocessable medical devices should be unified globally, devices should be critically evaluated before clearance into the market for patient use
Summary
Within the framework of the United States Food Drug & Cosmetics Act (FD&C Act), a medical device is defined as “An instrument apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessary which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man or other animals, or intended to affect the structure or any function or other animals.” The sterilization of a medical device is the chemical or physical process of eliminating all forms of microbial life and associated spores through a variety of methods, such as autoclaving with heat/pressure, hydrogen peroxide vapor, radiation, ethylene oxide (EtO) gas, and other processes. Infection in patients groups at low risk of contracting infectious diseases from medical devices are rapidly increasing. This is due to the increased prevalence of multidrug-resistant (MDR) pathogens with biofilm-forming potential. Due to the rapid spread and development of MDR bacteria in hospital environments, there is a need to update regulatory guidelines to reflect the modern evolution of microbiota These shifts require additional efforts to explore the effective means of sterilization for a wider range of semi-critical and critical medical devices. The presented article aims to discuss the risks of improper sterilization of medical devices, given the facts of rapid microbial evolution and development of biofilms to resist disinfection in hospital settings [14]. The key regulatory recommendations in this article would ensure the benefits of consistent sterilization of critical medical devices, in contrast to the risks of reprocessing or reusing devices without high sterilization protocols
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
