Cassopolis, Michigan 49031, United States

(574) 551-9814 ~ support@bonesim.com

BoneSim Laboratories CRC™ (Clinical Reprocessing Cycles)

steps and services

Receiving Inspection

Repeat Manual Cleaning or Ultrasonic Cycles

Repeat Functional Cycles

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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.

Repeat Functional Cycles

Repeat Manual Cleaning or Ultrasonic Cycles

Repeat Functional Cycles

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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.

Repeat Manual Cleaning or Ultrasonic Cycles

Repeat Manual Cleaning or Ultrasonic Cycles

Repeat Manual Cleaning or Ultrasonic Cycles

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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.

Repeat Wash and Disinfect Cycles

Lab Certification or Technical Memorandum Provided

Repeat Manual Cleaning or Ultrasonic Cycles

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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. 

Repeat Autoclave Cycles

Lab Certification or Technical Memorandum Provided

Lab Certification or Technical Memorandum Provided

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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.

Lab Certification or Technical Memorandum Provided

Lab Certification or Technical Memorandum Provided

Lab Certification or Technical Memorandum Provided

Your study includes a full certification of what the devices were exposed to including time, tempera

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.

Sample Lifecycle Testing Report Documentation

Sample Lifecycle Testing Report Documentation

Sample Lifecycle Testing Report Documentation

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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.