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What are reprocessed medical devices?
Reprocessed medical devices are medical devices that have been previously used, cleaned, disinfected, sterilized and returned to clinical use on a subsequent patient. These devices are often used by hospitals as a more cost-effective alternative to new devices. Some common examples of reprocessed devices include biopsy forceps, surgical scissors, suturing equipment and various orthopedic devices used in hip and knee replacement surgeries.
Regulation of reprocessed devices
The regulation of reprocessed medical devices varies worldwide. In the United States, the FDA sets standards for reprocessing under the Quality System Regulation. The FDA requires that reprocessors be registered, list their reprocessed devices, and comply with Quality System requirements. Reprocessors must validate that their cleaning and sterilization processes can adequately remove bioburden and ensure sterility. They must also establish processes to identify recalled devices and take appropriate corrective actions. Many other countries like Canada and members of the European Union have also established regulations for reprocessing.
Cleaning and disinfection process
The first major step in reprocessing involves cleaning and disinfection of the used devices. Upon retrieval from the operating room, devices are immediately disassembled, if applicable. They are then submerged in enzymatic cleaners, detergents or other solutions designed to break down organic debris like blood and tissue residue. Ultrasonic cleaners and brushes are often used alongside the cleaning solutions. The devices are then thoroughly rinsed to remove all cleaning residues before moving to the next step. High-level disinfectants like glutaraldehyde or hydrogen peroxide vapor may be used at this stage to kill viruses and bacteria.
Sterilization
After cleaning and disinfection, reprocessed devices must undergo sterilization to eliminate any remaining microorganisms and ensure the devices are safe for reuse. The most common sterilization methods used include steam sterilization in an autoclave and hydrogen peroxide gas plasma sterilization. Autoclaves use steam heated to 121-134°C for 5-50 minutes to sterilize devices. Hydrogen peroxide gas plasma sterilization employs a plasma of hydrogen peroxide to penetrate porous device materials and achieve sterilization. Other less commonly used options are ethylene oxide gas and dry heat sterilization. Reprocessors must validate that their sterilization processes achieve a sterility assurance level (SAL) of 10-6 or greater.
Inspection and packaging
Following sterilization, reprocessed devices go through extensive inspection and testing. Devices are visually examined under magnification for any corrosion, material degradation, incomplete cleaning or other defects. Packaging is inspected for integrity. Functionality testing is performed on applicable devices to ensure full range of motion and intended use. Only fully intact and functional devices passing all quality control checks are officially released for redistribution and resterilized if needed. The sterilized devices are then sealed in tamper-evident packaging along with sterilization indicators before distribution.
Benefits of reprocessed devices
The reprocessing of medical devices offers key benefits to hospitals and healthcare systems. It allows for significant cost-savings compared to purchasing new devices. Reports indicate reprocessed devices can save hospitals 30-70% of the original device manufacturer costs. Since many devices are approved for multiple uses, reprocessing extends device life and prevents premature waste of resources. It promotes sustainability by reducing medical waste volumes. Reprocessors argue sterility and performance are maintained as long as the device design allows for effective cleaning. This provides a safe and effective alternative to mitigate the rising costs of healthcare.
Concerns regarding reprocessed devices
While reprocessing aims to offer cost advantages, some concerns have also been raised regarding patient safety and device performance:
– Risk of residual contamination: Some critics argue it may not be possible to thoroughly clean all residue from lumened or creviced devices using current reprocessing technologies. Residual organic debris or microbes could potentially infect subsequent patients.
– Material degradation: The mechanical wear and tear from initial use and repeated cleaning/sterilization cycles could degrade the structural integrity of device materials over time in unknown ways. Fatigue fracture has been a reported issue.
– Lack of traceability: It is difficult to trace the use-history of a reprocessed device and number of times it has been reprocessed. More uses than design lifetime could impact performance.
– Manufacturer non-approval: Original equipment manufacturers have not validated or approved the specific reprocessing methods used, raising questions on maintaining the same safety and efficacy as new devices.
– Human errors: Process deviations during cleaning, inspection or sterilization introduc human error risks from technicians that could compromise sterility assurance. Quality is dependent on proper procedural adherence at reprocessing facilities.
– Information asymmetry: Patients are often not informed that a device being used is reprocessed with unknown prior use-history instead of new, which raises ethical questions about informed consent.
Despite these concerns, proponents emphasize that with strict adherence to regulations and AST guidelines, quality reprocessed devices provide an important solution to promote healthcare sustainability and reduce costs when alternatives to new devices are not required by the original manufacturer’s specifications or clinicians’ needs. Continued research is assessing the balance between cost-savings and patient safety risk for various device categories and number of approved reuses.
In summary, reprocessed medical devices offer a strategy to extend device life and reduce healthcare expenditures through rigorous reprocessing. However, certain device characteristics may cause more uncertainties than others regarding material integrity and sterility over multiple reuses. Ongoing research aims to establish more data around best practices maximizing benefits while mitigating risks on a device-specific basis. Further regulations could enhance transparency for patients regarding reprocessed device use. Overall, proponents argue reprocessing should remain an option if shown to reliably maintain safety and effectiveness at lower costs.
