The primary reason for creating disposable devices is infection control. When an item is used only once, it cannot transmit infectious agents to subsequent patients.
One might think the most important factor in the design of single-use products is cost, but disposable medical devices require a careful balance between performance, cost, reliability, materials, and shelf life.
Plastics are often used in the manufacturing of disposables because they are relatively inexpensive and there are many different types. In a device such as a syringe that must undergo extreme pressure, polycarbonates are used because of their strength. PVC can also be used because of its flexibility. Reusable devices, on the other hand, are typically made of more costly, sturdier materials such as ceramics or steel.
Disposable-device assembly depends primarily on injection-molded plastic, assembled by bonding, gluing, ultrasonic welding or radio-frequency welding. The high production volume of single-use devices calls for an automated assembly in clean rooms to minimize human contact.
Unlike reusable devices, which are often sterilized at the healthcare facility, disposable devices are sterilized before leaving the manufacturing site. The device and packaging must be designed to accommodate sterilization.
The reprocessing of medical devices labeled for “single use” has been a standard practice in U.S. hospitals for years, because it can cut costs and reduce medical waste. But before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to original equipment manufacturers, according to FDA regulations.
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