Gastrointestinal endoscopy clinics of North America
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The Food and Drug Administration (FDA) relies on guidance documents, such as voluntary consensus standards and professional practice standards when reviewing the manufacturer's endoscope reprocessing instructions included in the instructions for use manual. The FDA does not perform endoscope reprocessing validation studies. The device manufacturer must certify that the reprocessing instructions included in the user manual have been or will be validated. This article discusses the regulatory review of gastrointestinal endoscopes and endoscope reprocessing instructions required prior to marketing.
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Gastrointest. Endosc. Clin. N. Am. · Apr 2000
ReviewThird-party reprocessing of endoscopic accessories.
Third-party reprocessing of medical devices labeled for single use is a safe, FDA regulated practice that helps hospitals reduce costs without compromising patient care. Simply because a device is labeled as single use does not mean it cannot be safely reprocessed. To the contrary, the single use label is chosen by the manufacturer, sometimes for economic gain, as there are no formal FDA regulations or standards to distinguish between reusable and single use devices. The current FDA regulatory framework for third-party reprocessors, which emphasizes compliance with FDA quality assurance requirements, is presently under review, and the agency is in the process of developing a new regulatory scheme for reprocessing.