Reusable Device Cleaning Validation – Three Cycles or One Cycle?

                  Vince L performing a cleaning validation on a medical device

                  Vince L performing a cleaning validation on a medical device

Pacific BioLabs have been performing reusable device cleaning validations for over a decade.  Traditionally, PBL has performed cleaning validations by testing three devices over three different cleaning cycles giving a total of nine data points.  This strategy was modeled after steam sterilization validations in which three separate cycles are performed independent of how many devices are in each cycle.  This article explains why PBL now offers one cycle cleaning validations.  

In the case of cleaning validations, a test cycle is defined as soiling three devices, cleaning the devices and then extracting any residual protein, hemoglobin or carbohydrates from each device.  The amount of residuals present must be below prescribed AAMI limits.  It is important not to confuse these test cycles with soil accumulation cycles which are meant to account for soil build up by simulating the device’s clinical function and thereby soiling the device.  The devices are then cleaned but residuals are not extracted.  In the current FDA guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, the FDA states, “Your validation studies should incorporate multiple full use cycles and should be designed to assess the accumulation of soil over time.”  The guidance does not give an exact number of soil accumulation cycles but states that the number of soil accumulation cycles should be scientifically justified. 

Because PBL performs three test cycles after the soil accumulation cycles, prospective clients had noticed that PBL prices were three times higher than competitor prices.  After some investigating, PBL learned that several competitors were only performing one cycle on three devices rather than testing three devices in three separate cycles. 

PBL believes that testing three separate cycles provides a much better validation process than testing one cycle. In fact, many clients prefer the extra security of testing three cycles with nine data points versus one cycle with three data points.  PBL has seen devices pass two of the three cleaning cycles and then fail the last cycle indicating the robustness of the process was not sufficient and most manufacturers would much rather learn that the cleaning process specified for their device is not robust at this early stage rather than have to face accusations of an insufficient cleaning process after their device has been used in the field.  However, PBL understands the cost issue and the importance of giving customers options, therefore PBL now provides both a one cycle cleaning validation method as well as a three cycle method.  If you are interested in reusable device cleaning validations please contact PBL and we would be happy to walk you through the details of the validation process.