title: [Recycling and reuse of disposable products in radiology].
abstract: Legitimacy and appropriateness of recycling and reuse of single-use disposable medical devices is a common issue in many areas of medicine. Advocates of reprocessing claim economic savings and environmental benefits. From the manufacturers' point of view, the single use is a characteristic property of their products. Moreover, they warn that using of recycled instruments makes the procedure more difficult and increases the rate of adverse events. As comparative tests demonstrate, reused products are sometimes inferior to the genuine ones with respect to mechanical properties, but these differences may have relatively little consequence for the performance of the products and the success rate of the interventions. With rigorous cleaning and sterilizing of the instruments, patients do not run an increased risk of infection. Sterile single-use products are subject to the German Medical Products Act (1994) and the German Medical Devices Ordinance (1998). New legal provisions (in force since January 1st 2002) have restricted professional recycling of used devices further. Companies reprocessing medical products for the original users are free from certification liability. CE can no longer be issued for devices newly placed on the market. Lawyers controversially discuss whether patients must be informed about the use of recycled products. In view of the otherwise strict regulations concerning the information given to patients, it seems imperative to obtain a written informed consent when reprocessed devices are used. This might interfere with the confidential relationship of patients and physicians. The combination of increased risk, strict legal regulations, ethical concern and adverse publicity demand to refrain from reprocessing and reusing disposable equipment in diagnostic and interventional radiology.
authors.affiliation: Institut für Klinische Radiologie, DRK Kliniken Berlin, Westend. radiologie@drk-kliniken.westend.de
authors.forename: W
authors.initials: W
authors.lastname: Golder
mesh_terms: D004209:Disposable Equipment / Q000592:standards; D017743:Equipment Reuse / Q000191:economics / Q000331:legislation & jurisprudence; D005858:Germany; D006801:Humans; D007239:Infections / Q000209:etiology; D007258:Informed Consent; D011871:Radiology / Q000331:legislation & jurisprudence; D012307:Risk Factors