Although successful sterilization is always considered as a design input, Medin does not perform or guarantee sterilization validation for OEM products. It is ultimately our customer’s responsibility to perform sterilization validation in the configuration that the product will be used in the field. However, as long as you have followed our design recommendations, should any case system designed fail sterilization validation for reasons that are directly attributable to our case design, we will re-engineer and re-prototype the system free of charge.
- The expected life cycle of a these products varies widely depending upon the design and manufacture, number of uses, shipping & handling, and the chemicals used to clean the product. If used frequently, but properly handled and cleaned with mild detergents, these products can last longer than 5years. Medin is not responsible for the lifetime of these products unless failure is directly attributable to design or manufacture.
- Product tracking throughout the lifecycle of the product and thorough end-user training for handling, storage, packaging, preservation and cleaning are expected to increase the lifetime of these products.
The following is recommended to maintain these products in optimum working condition. Failure to follow some of these basic instructions can result in product failure or reduced product life.
Handling, storage, packaging and preservation
- It is strongly recommended that external plastic totes that are custom-designed foam lined be used to transport sterilization cases and trays from place to place. These totes are available through Medin and can be custom designed to hold your products for optimal handling.
- Sterilization cases, trays and accessories designed by Medin are made of the lightest weight material possible to ensure the maximum number of instruments and devices can be loaded into the case and still maintain a reasonable weight to strength ratio. However, if these products are dropped, dragged or otherwise abused, the lifetime of the product may be reduced.
- Many sterilization cases and trays are made from anodized aluminum. Anodizing creates a thin oxidized layer on the outside of the material which provides superior abrasion and corrosion resistance. However, anodized aluminum is prone to etching when exposed to very high or very low pH cleaners under certain conditions. Once a case has been exposed to an adverse chemical agent the surface of the aluminum oxide is compromised and will deteriorate more rapidly than if cared for correctly.
Cleaning Anodized Aluminum
- Will the pH of cleaning agents used affect the material?
- Factors such as concentration of the detergent solution, duration of exposure, thoroughness of rinsing, and temperature will influence the results. Cleaning the material at room temperature and promptly rinsing thoroughly with clean water will limit adverse effects. If cleaned at an elevated temperature or with prolonged exposure without rinsing, the cleaning solution will attack the anodized layer and etch the metal.
- Only neutral pH cleaning agents and disinfectants are recommended. Cleaning agents with pH lower than 7 or higher that 9 are not recommended.
- Mild soap is generally preferable to detergent for routine cleaning.
- How do I clean anodized aluminum?
- Use a mild abrasive cleaning technique with a gentle soap. A mildly abrasive cleaning sponge with dish washing liquid is recommended.
- Do not use harsh acidic or alkaline cleaners because they may destroy the finish.
- Use solvents with care as they may stain the finish.
- Always spot test a small area before cleaning the entire surface.
- Various instruments and implants will be provided as design inputs for OEM design projects. Care should be given to identify forgings as considerable variability is expected in these parts. If properly considered, fit will be accounted for in the design.
- The state of design of an instrument or implant is also a critical design input. Frozen designs are the easiest to account for; however, interim designs can also be used as long as the design state and design changes are clearly communicated to Medin.
- Our goal is to produce product right the first time. Frequent and clear communication is required to meet that goal.
Every effort to meet customer requirements are made during Medin’s design and development activities. This includes frequent communications and several levels of formal approvals. However, a prototype is always recommended as it provides an opportunity for you, our customer, to formally review a physical piece and significantly reduce any risks in ramping up to full production.