• P S Malchesky, V C Chamberlain, C Scott-Conner, B Salis, and C Wallace.
• STERIS Corporation, Mentor, Ohio, USA.
• ASAIO J. 1995 Apr 1;41(2):146-51.

AbstractAdvances in medical science and, in particular, minimally invasive surgical and diagnostic procedures have stimulated the development of new and improved medical devices. This has been made possible because of developments in engineering and material sciences. The design of devices for reusability is particularly important in an effort to provide cost effective healthcare. Concerns and issues include the ability to safely and effectively reprocess the devices, infection prevention and control, safety of the patient and healthcare worker, environmental concerns, and effective use of resources. From an infection prevention point of view, present requirements are based upon the intended use of the devices. Critical devices require sterilization. Semi-critical devices require, as a minimum, high level disinfection. Sterilization is, however, preferred whenever possible. Before sterilization or disinfection, devices should be cleaned adequately. Device designs should be readily amenable to cleaning and sterilization. In the past, design requirements focused primarily on the clinical user and device functionality, with reuse considerations left to the user. In the current market, the customer is redefined and, for reusable medical devices, includes all those associated with the device through the reprocessing procedure. In addition, regulations require that manufacturers give detailed instructions for reprocessing medical devices. The device users have the obligation to follow reprocessing instructions. Many choices exist today in device designs, including disposable or reusable devices. The user needs to balance cost versus convenience and reprocessing requirements for reusables. Current trends are to reuse more devices, including many of which were meant to be disposable. Cost effective designs can best be achieved when the user and manufacturer work together on the design.(ABSTRACT TRUNCATED AT 250 WORDS)

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