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Recycling of disposable medical devices (medical device products)
Authors:H Bebensee  KD Vitt
Affiliation:Medizinischer Dienst, Krankenversicherung Schleswig-Holstein, Lübeck.
Abstract:Modern medicine uses large amounts of one-way-devices. This includes mass articles as well as technically sophisticated ones, all of them in accordance with GMP (Good-manufacturing-practice) guidelines. Recycling of selected one-way devices in technically possible and economically useful. Prerequisite for recycling is the inclusion of legal, economic and ecologic points of view. In addition the validation of processes and agreement on installation of continuous quality control is necessary to minimise risks. We suggest admission of recycling and reuse of one-way devices and suggest to proceed stepwise: 1. Principal decision to permit recycling 2. Appointment of an interdisciplinary Federal Board "Medical Devices" for coordination and channelling of activities 3. Selection of products for recycling 4. Principal decision for the systematics of the process together with: process control, product control during a pre-testing stage, random tests in prospective, multi-centre studies for the control of production and use. 5. Introduction of internal quality control systems to allow internal and external control of routine work.
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