All study items will be unpacked and logged into Bonesim Laboratories electronic and paper logsheets. All items will be inventoried and photo documented with particular attention to any ROI (Regions of Interest) identified by customer. T=0 pictures will be archived. Per our quality system T=1 cycle pictures will also be archived.
The function is the first step in the reusable device lifespan test. This is where the device goes through the actual function it is meant to perform. This could be simply assembling the modular components or actual trials in surrogate substrates (Bonesim analog) . Soiling with whole or citrated bovine blood to simulate real world application can also be included in your study. The devices will be disassembled and taken to the next step or soaked in saline or enzymatic fluid until cleaning can take place.
This step performs manual cleaning or brushing in a detergent or uses high frequency sound waves to create cavitation bubbles that will agitate a liquid. This process gets into blind holes, cracks, and recesses where debris or bacteria could be hiding. A detergent and elevated temperatures (40-65C) are typically used to simulate clinical practices.
After the reusable medical device has gone through the function cycle, then it will be washed in order to remove debris and to mimic the same washing process it will go through after being used. An IFU is used to determined method and parameters for this step. If you do not yet have an IFU available we will recommend typical SPD parameters for "like kind" devices. Many standard wash cycles are pre-programmed in the facility washer disinfector and either an enzymatic, alkaline, neutral detergent (or combination) is prescribed.
After the device has been washed, it will be placed in an autoclave to be sterilized with steam to kill bacteria that may be resistant to boiling water and detergents. Most steam charge cycles are 4-18 minutes long at temperatures above 132C (270F) and below 137C(278F). A prevacuum autoclave unit is one that evacuates the chamber then pulses a steam charge several times before the timed steam charge is initiated. It then drys the devices under a high (greater than 10inhg) vacuum.
Your study includes a full certification of what the devices were exposed to including time, temperatures, chemicals and cycle count. In addition it can include a full technical detail for submittal to governing bodies, this is called a Technical Memorandum which is formatted with executive summary, background, materials and methods, results and discussion, and conclusion including references.
After your reusable medical device lifecycle testing is complete, you will receive documentation noting the process that the device has gone through, products that were used, and any Regions Of Interest. You will receive a full complement of Receiving Inspection pictures and photographs at predetermined intervals as required.
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