FDA ADVISORY
not available for use until culture results are known.
• Healthcare facilities should assess their supply and clinical demand for duodeno- scopes when considering microbiological culturing implementation.
Ethylene oxide (EtO) sterilization following cleaning and HLD At a minimum, as per the manufacturer’s instructions, duodenoscopes should be sub- jected to high-level disinfection following manual cleaning after each use. When pos- sible and practical, duodenoscopes should be sterilized due to the greater margin of safety provided by sterilization. Sterilization is a validated process used to render a product free from all viable microorganisms. An ethylene oxide gas (EtO) sterilizer is a non-portable device that uses ethylene oxide gas to sterilize medical products. Since it does not rely on heat, EtO gas sterilization may be an effective method for heat-sensitive instruments, like duodenoscopes, that can be damaged by high temperatures. Following cleaning and high-level disinfection, EtO is an additional measure that may eliminate the presence of micro-organisms on a device through the introduction of EtO gas. Healthcare facilities evaluating potential
use of EtO sterilization following cleaning and high-level disinfection should consider the following: • It is critical that devices are meticulously cleaned and disinfected prior to EtO ster- ilization. Gas sterilization with ethylene oxide may fail in the presence of viable microorganisms after inadequate cleaning and disinfection.
• Implementing EtO gas sterilization is costly and the process may not be readily available in or accessible to all healthcare facilities.
• EtO may affect the material and mechanical properties of the duodenoscope.
• EtO may be toxic to reprocessing personnel, and to patients if residual EtO remains on the device after sterilization.
• Healthcare facilities should assess their sup- ply and clinical demand for duodenoscopes when considering EtO sterilization.
• Users should follow duodenoscope manu- facturer reprocessing instructions pertain- ing to EtO concentration, sterilization temperature, exposure time, and relative humidity.
Use of a liquid chemical sterilant processing system following cleaning and HLD A liquid chemical sterilant (LCS) process- ing system is a device that uses a chemical solution (liquid chemical sterilant) to destroy
all viable forms of microbial life. Notably, because this process requires rinsing with highly purified (but not sterile) water fol- lowing device sterilization, the device does not remain completely free of all viable microbes. The concentration, exposure time and temperature of a liquid chemical sterilant are crucial because inappropriate dilution, insufficient exposure, or inadequate tempera- ture may result in ineffective reprocessing outcomes. Healthcare facilities evaluating potential
use of a LCS processing system following cleaning and high-level disinfection should consider the following: • Meticulous cleaning is an essential part of duodenoscope reprocessing and should precede any liquid chemical sterilization and high-level disinfection of these instru- ments. Failure to perform adequate clean- ing may result in failure of the sterilization or high-level disinfection.
• Use only LCS processing systems that have been FDA-cleared and indicated for liquid chemical sterilization of endoscopes, including duodenoscopes, and adhere to the LCS processing system manufacturer’s instructions for use.
Repeat high-level disinfection Because a small number of duodenoscopes may have persistent microbial contamina- tion despite reprocessing, some healthcare facilities have implemented repeat high-level disinfection (HLD) after the first HLD cycle in their duodenoscope reprocessing proce- dures, either manually or through the use of Automated Endoscope Reprocessors (AERs). HLD involves immersing the device with a disinfectant and is expected to inactivate all microorganisms except for large numbers of bacterial endospores. AERs are devices that wash and high-level disinfect endoscopes and scope accessories to decontaminate them between uses. AERs are designed to expose outside surfaces and interior channels of endoscopes to chemical solutions in order to kill microorganisms. Healthcare facilities evaluating the use of
repeat HLD following cleaning and high-lev- el disinfection should consider the following: Repeat HLD, either manually or using
AERs, does not eliminate the need for meticu- lous manual cleaning prior to HLD. Failure to perform adequate cleaning may result in reprocessing failure. Users should refer to the AER manufactur-
er’s instructions in the labeling to determine whether a specific duodenoscope model and high-level disinfectant are compatible with the AER. In addition to consideration of the supplemental measures described above,
the FDA continues to recommend strictly adhering to the manufacturer’s reprocess- ing instructions and following these best practices: • Meticulously clean the elevator mecha- nism and the recesses surrounding the elevator mechanism by hand, even when using AER. Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.
• Implement a comprehensive quality control program for reprocessing duo- denoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
• Refer to the Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 disclaimer icon consen- sus document for evidence-based recom- mendations for endoscope reprocessing.
Background and FDA Activities: The FDA has been working with federal partners, manufacturers, and other stake- holders to better understand the critical factors contributing to bacterial infections associated with duodenoscopes and how to best mitigate them. On May 14-15, 2015, the FDA convened
the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes based on available scientific information. The supplemental reprocess- ing measures outlined in this safety com- munication reflect discussions held at the advisory panel. Ensuring the safety of reprocessed medi-
cal devices is a shared responsibility among the FDA and other federal agencies, state and local health departments, medical device manufacturers, healthcare facilities, professional societies and others. The FDA is actively engaged with many of these stakeholder groups to better understand the causes and risk factors for transmission of infectious agents associated with these de- vices and to develop strategies to minimize patient exposure. The FDA continues to actively monitor
this situation and is currently collaborating with the CDC, the American Society for Microbiology (ASM) and other endoscope culturing experts to develop a validated culturing protocol that facilities can adopt. Visit the full FDA release at http://
www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/
ucm454766.htm? HPN
www.hpnonline.com • HEALTHCARE PURCHASING NEWS • September 2015 45
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