Adequately reprocessing medical devices is a critical step in quality patient care.
Inadequate reprocessing between patient uses 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 various stakeholders. This includes the FDA; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; and manufacturers, responsible for providing adequate reprocessing 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 that have 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 as well as effective test methods and criteria for validating reprocessing methods for reusable medical devices.
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 the “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” Final Guidance. The guidance document reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices, many of which have become highly complex in design and are more difficult to reprocess. The recommendations in this guidance are intended to improve the safety and effectiveness of devices with reprocessing labeling. Appendix E of the guidance document identifies a subset of medical devices that pose a greater likelihood of microbial transmission and high risk of infection if not adequately reprocessed. 510(k) submissions for these devices should include data to validate reprocessing methods and instructions. Data to validate reprocessing methods and instructions includes protocols and test reports that demonstrate reprocessing instructions work reliably and consistently and are able to be followed as intended.
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 have been 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 make advances in solving 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.1 In 2009, the FDA issued a joint Safety Communication with the Centers for Disease Control and Prevention and the Veterans Administration that cautioned health care facilities about the risks to patients if endoscopes and their accessories are not properly cleaned and recommended steps to reduce these risks. To help health care facilities achieve their goal of improving reprocessing Quality Assurance programs, the FDA developed the Information for Health Care Facilities page to share existing resources that provide reprocessing guidance and best practices.
In fall of 2013, the CDC first alerted the FDA to a potential association of multi-drug resistant bacteria and duodenoscopes. Upon further investigation and collaborations with federal partners, it became clear that these cases of infection were occurring despite confirmation that users were following manufacturer cleaning and disinfection or sterilization instructions. Since that time, the FDA has been working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to these infections and how to best mitigate them. For more information, visit Infections Associated with Reprocessed Duodenoscopes.
The FDA is committed to learning more about the challenges health care facilities face in device reprocessing, including ones related to device design, manufacturer’s instructions, and facility oversight of the process. FDA is collaborating with professional societies, health care facilities, including MedSun partner facilities, to better understand the effectiveness of reprocessing methodologies used in health care settings.
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.