Working Together to Improve Reusable Medical Device Reprocessing
Inadequate reprocessing between patients can result in the retention of blood, tissue and other biological debris (soil) in certain types of reusable medical devices. This debris can allow microbes to survive the disinfection or sterilization process, which could then lead to Health care-Associated Infections (HAIs). Inadequate reprocessing can also result in other adverse patient outcomes, such as tissue irritation from residual reprocessing materials, such as chemical disinfectants.
Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among the FDA; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; and manufacturers, responsible for providing adequate instructions that are user-friendly and proven to work.
Retention of debris in reusable medical devices should not happen. We can solve this problem by engaging all stakeholders with a role in reprocessing.
Three areas of focus are:
Based on the agency's many years of experience reviewing reprocessed devices and research conducted by the agency and others, the FDA has identified designs that foster innovation in next-generation reusable medical devices. These design features facilitate cleaning, disinfection and sterilization and reduce the likelihood of retaining debris.
These design features include:
- Smooth surfaces, including smooth inner surfaces of the long, narrow interior channels (lumens)
- The ability to disassemble devices with multiple components
- Non-interchangeable connectors for critical connections (For example, tubes used with endoscopes for direct patient connection that cannot be interchanged with tubing used for waste drainage)
- Clear identification of connecting accessories, such as drainage tubing
- Clear indication and identification of components that must be discarded after patient use and cannot be reprocessed or reused
- Disposable components for the hardest to clean areas
- Designs that address how fluid flows through the device, and areas of debris build-up within devices
The FDA is also working with standard-setting groups, such as the Association for the Advancement of Medical Instrumentation and ASTM International, to develop consensus on a series of best practices. New standards and technical information reports (TIRs) will provide manufacturers with guidelines for designing devices that can be adequately reprocessed and effective test methods and criteria for validating cleaning processes for reusable medical devices.
Advancing Regulatory Science
The FDA is also taking actions to advance the science of reprocessing.
To help manufacturers improve their premarket submissions for new reusable medical devices, the FDA has issued a revised draft guidance document that provides recommendations for reprocessing reusable medical devices in health care facilities.
This guidance provides manufacturers with clarity on how to present reprocessing information for their devices, and outlines principles for adequate labeling and scientific validation (demonstrating the adequacy) of cleaning, disinfection, and sterilization processes to assure that reusable devices can be effectively reprocessed and the instructions for reprocessing are clear for health care facilities. It is critical that the cleaning, disinfection and sterilization processes must be effective and practical, taking into consideration what health care facilities can reasonably perform.
FDA researchers are working to advance our scientific knowledge of reprocessing.
To strengthen regulatory science in this area and use it to further improve the design of reprocessed devices, FDA is investigating the use of computer modeling to study the flow of fluid and debris within devices. This type of modeling may help manufacturers determine the extent to which specific design features make a device prone to debris retention, and allow them to improve their designs prior to device manufacture.
FDA researchers are investigating the relationship between device design and debris accumulation and retention over multiple cycles of soiling and cleaning. They are also developing a method to quantify particulate biological debris retained in reusable medical devices which can be used to determine if various cleaning methods are effective. Conventional test methods may underestimate the presence of debris such as tissue, cartilage, and bone. These underestimations could lead to the design and manufacture of reusable devices that are prone to retaining debris.
We can solve problems related to reprocessing medical devices by engaging all stakeholders who have a role, including manufacturers, health care facilities and staff, accrediting organizations and government agencies.
The FDA receives a lot of information that cuts across entire medical device types, such as product submissions from manufacturers and adverse event reports from health care providers. By communicating with all external stakeholders, the FDA is in a unique position to facilitate collaboration among the many stakeholders that are vital to a successful reprocessing program.
To this end, the FDA hosted a workshop on June 8-9, 2011 to bring together manufacturers, health care facilities, standards organizations, health care accreditation organizations, government agencies, and professional societies to share their experiences and work towards finding solutions for the current problems and innovative designs for new devices.
While the FDA can provide guidance documents on device design and clear instructions, a critical component of reducing infection is the implementation of a thorough Quality Assurance program by health care facilities that is specific to reprocessing devices.
One important quality assurance step is for health care facilities to make sure their staff follow the manufacturer instructions and reprocessing guidelines. Some data have shown that many facilities do not consistently follow guidelines on reprocessing and patient exposures to inadequately reprocessed devices continue to occur.1
The FDA is committed to learning more about the challenges health care facilities face in device reprocessing, including device design, manufacturers instructions, and facility oversight of the process. The FDA plans to collaborate with health care facility oversight organizations, as well as MedSun facilities to help them improve quality assurance programs for reusable device reprocessing in health care facilities.
To help health care facilities achieve their goal of improving reprocessing Quality Assurance programs, the FDA has developed the Reusable Device Reprocessing Resources for Health Care Facilities page to share existing resources that provide reprocessing guidance and best practices.
1 Rutala, WA, Weber, DJ, and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008. Centers for Disease Control and Preventtion. Web. 1 March 2011.