Gastrointestinal endoscopy clinics of North America
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Gastrointest. Endosc. Clin. N. Am. · Apr 2001
ReviewClinical presentations and complications of achalasia.
Patients with achalasia often present with atypical symptoms. If these occur in the context of "normal" morphological findings, the diagnosis may be delayed for several years. However, a careful interview and the use of modern methods that concentrate on pathophysiologic aspects always allow an early diagnosis and the initiation of therapy that affects most but rarely all symptoms. Finally, regardless of whether this therapy remains partially or totally effective, patients require some follow-up since serious and late complications may occur.
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Laparoscopy is an invaluable technique for the evaluation of ascites in subgroups of patients with ascites. Indications for laparoscopic examination include determination of the causes of ascites when routine tests fail to disclose the source, evaluation for the presence of multiple causes of ascites formation, or histopathologic verification of malignancy within the peritoneal cavity. Several reported series have illustrated the efficacy of laparoscopy for the diagnosis of peritoneal carcinomatosis, tuberculous peritonitis, or unsuspected cirrhosis, securing its role in the management of selected patients with ascites.
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Endoscopy often is required in the management of patients with chronic liver disease. Endoscopy in this pediatric population is a safe and effective diagnostic and therapeutic modality for the appropriate clinical situation. ⋯ Advances in technical innovations will expand the currently offered diagnostic and therapeutic options for management of pediatric with portal hypertension. This article reviews specific considerations for endoscopy in this demanding patient population.
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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.