Research Topic

Medical Device Sterilization and Reprocessing: Issues and Regulatory Concepts

About this Research Topic

Under the United States’ Food Drug and Cosmetics Act (FDCA), a medical device is generally referred as any product or devices which has the intended use of diagnosis, prevention, treatment, or to cure a disease in humans. The close contac of medical devices with patients have generated the need for sterilization. This has been especially necessary for semi critical or critical medical devices which enter areas within the human body that are typically sterile and easily contaminated through the presence of opportunistic pathogens. Sterilization is the chemical or physical process to eliminate 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.

The control of invasive pathogens, which are able to cross-contaminate medical devices from either patients or the hospital environment, has become a major cornerstone in healthcare safety and regulatory risk assessments. The rapidly increasing prevalence of multi drug resistant (MDR) pathogens with biofilm infecting patient groups who are not normally at risk of developing infectious disease is even more concerning. To counteract the outbreak of MDR in association with medical devices, the application of sterilization is essential to control hospital-acquired nosocomial infections.

Failure to properly sterilize medical devices from various procedures (e.g. endoscopy, bronchoscopy, cystoscopy, duodenoscopy) has led to numerous outbreaks of MDR pathogens with serious consequences to patients. This Research Topic aims to address the risks of improper sterilization in medical devices. Research and/or review articles will be welcomed proposing the alternative sterilization procedures for semi-critical and critical medical devices. More so, the key recommendations from the experts in the field will assist ensuring the adherence to the benefits of consistent sterilization in contrast to the risks of reprocessing or reusing devices.

Dr. Om V. Singh is a Senior Scientific Consultant for TSG Consulting. Dr. Thomas E. Colonna is a Consultant at Biotech Consultant LLC. All other Topic Editors have no conflicts of interest to declare.


Keywords: Medical devices, Sterilization, Reprocessing, US FDA, Drug resistance, Microorganisms


Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

Under the United States’ Food Drug and Cosmetics Act (FDCA), a medical device is generally referred as any product or devices which has the intended use of diagnosis, prevention, treatment, or to cure a disease in humans. The close contac of medical devices with patients have generated the need for sterilization. This has been especially necessary for semi critical or critical medical devices which enter areas within the human body that are typically sterile and easily contaminated through the presence of opportunistic pathogens. Sterilization is the chemical or physical process to eliminate 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.

The control of invasive pathogens, which are able to cross-contaminate medical devices from either patients or the hospital environment, has become a major cornerstone in healthcare safety and regulatory risk assessments. The rapidly increasing prevalence of multi drug resistant (MDR) pathogens with biofilm infecting patient groups who are not normally at risk of developing infectious disease is even more concerning. To counteract the outbreak of MDR in association with medical devices, the application of sterilization is essential to control hospital-acquired nosocomial infections.

Failure to properly sterilize medical devices from various procedures (e.g. endoscopy, bronchoscopy, cystoscopy, duodenoscopy) has led to numerous outbreaks of MDR pathogens with serious consequences to patients. This Research Topic aims to address the risks of improper sterilization in medical devices. Research and/or review articles will be welcomed proposing the alternative sterilization procedures for semi-critical and critical medical devices. More so, the key recommendations from the experts in the field will assist ensuring the adherence to the benefits of consistent sterilization in contrast to the risks of reprocessing or reusing devices.

Dr. Om V. Singh is a Senior Scientific Consultant for TSG Consulting. Dr. Thomas E. Colonna is a Consultant at Biotech Consultant LLC. All other Topic Editors have no conflicts of interest to declare.


Keywords: Medical devices, Sterilization, Reprocessing, US FDA, Drug resistance, Microorganisms


Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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Submission Deadlines

24 September 2020 Manuscript

Participating Journals

Manuscripts can be submitted to this Research Topic via the following journals:

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Topic Editors

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Submission Deadlines

24 September 2020 Manuscript

Participating Journals

Manuscripts can be submitted to this Research Topic via the following journals:

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