Safe to Handle? Comparing Manually and Machine-Washed Medical Devices.

Abstract

The goal of medical device reprocessing is to ensure that a given device is ready for safe use on the next patient. Effective cleaning of devices is critical to achieving this goal. Device cleaning also has had an ancillary goal: rendering the device safe for handling with ungloved hands by sterile processing personnel. Such personnel are tasked with preparing the device for further reprocessing steps, such as packaging for sterilization. This raises the question: Are manually cleaned devices as safe to handle as machinewashed medical devices? The current study sought to gather data to help answer this question. Further, this study sought to evaluate the effectiveness of a relatively new tool in the area of decontamination in healthcare settings—ultraviolet (UV) disinfection—and whether UV disinfection could effectively and efficiently be used to render manually cleaned devices safer to handle. Mechanically washed reusable medical devices generally are considered to have a more reliable and effective level of cleanliness, as supported by the limited research available in this area.1 The underlying logic for this assertion is that mechanical methods are more robust and reliably repeatable compared with manual methods.2 Machine washing allows for the use of cleaning solutions at much higher temperatures. These higher temperatures typically include a detergent wash at 60°C (150°F), followed by thermal disinfection at 82°C to 93°C (180°F to 195°F) for one minute or longer.3 Further, the cycle settings are programmed into a machine and are repeated cycle after cycle. Conversely, manual cleaning depends on the individual performance of the person conducting the cleaning. These assertions do not devalue the importance of reprocessing staff. To the contrary, even the most simply designed medical device requires proper and effective precleaning by manual means. Typically speaking, the more complex the device, the more important the manual steps to prepare the device for further cleaning by mechanical means. Further, a substantial number of medical devices cannot undergo mechanical cleaning. This is due to the material used in construction (i.e., thermolabile, nonsubmersible) and/or the complexity of the design.4 Effective cleaning of these devices is wholly reliant on manual processes. By design, sterile processing departments typically have a physical separation between the area where items are cleaned (the “dirty side”) and the area to which they are transported for further processing, such as sterilization (the “clean side”). Mechanical cleaning equipment typically is designed with a dual door design, where the loading door is located on the dirty side and the unloading door on the clean side. For manually cleaned devices, and for passing items back from the clean to the dirty side for recleaning, sterile processing departments typically have a “pass-through” window. Safe to Handle? Comparing Manually and Machine-Washed Medical Devices