Biomedical Engineering Reference
In-Depth Information
Figure 10.4
An example of a single wrapped nonsterile item. (Courtesy Riverside Medical Packaging Ltd)
sterilized. The whole tray, therefore, must contain your device and fit into standard washing
machines and autoclaves. There are a number of specialist tray manufacturers who can design
something special. Equally you can purchase one “off the peg ( Figure 10.5 ).” However, as
stated previously, you will have to prove that your device can be washed and sterilized in this
tray…you cannot assume that is the case.
The tray can be fitted with special stands to retain your device securely ( Figure 10.6 ); this
also helps theater staff to see if an item is missing. It is quite common to print a manifest of
the components onto the tray in their respective locations. This all makes life for the scrub
nurses, theater staff, and sterilization staff easier. One of the other benefits of the tray is that it
also acts as your protective inner pack for transportation.
Your device will probably need some transportation protection. If you use bubble wrap,
etc. make sure it comes from a source that is medical compliant and that you have not
inadvertently added a risk of animal by-product contamination.
10.3.3 Packaging Testing
The outer box is now for transportation and storage only. It must be designed to withstand
the rigors of transportation. This must also be confirmed. There are several standards for
packaging acceptance criteria that you can follow. Remember your main aim is to get “your
baby” to the end-user in the state in which it left you, i.e., pristine. Do not allow some
delivery courier to ruin your day by rough handling. I promise you that unless you deliver
something yourself you cannot guarantee the handling that you would administer. For your
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