Hairy cell leukemia - reclassification of an old entity.
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Humans↗
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Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.
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Reclassification of negative smears as atypical squamous cells of undetermined significance in quality assurance reviews: implications and limitations.
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Carcinoma↗
Stromal tumors of the stomach. Review of our experience and reclassification of a series of patients.
OBJECTIVE: To retrospectively review a series of 12 patients operated on in our department for stromal tumor of the stomach. Clinical and morphological data, and the patients' postoperative course, were analyzed. METHODS: Medical records for 12 patients (mean age 63.3 years) were retrospectively reviewed to obtain data on clinical presentation, diagnosis and treatment. Surgical morbidity and mortality were analyzed. A pathologist reviewed the resected specimens to determine the morphological factors of prognostic value. The biological nature of the tumor was reclassified based exclusively on mitotic index, and all tumors were staged according to the TGM system. Recurrence and survival rates were also calculated. RESULTS: The most frequent clinical presentation was abdominal pain and gastrointestinal bleeding. The most sensitive diagnostic methods were computerized tomography and echographic endoscopy. Operability and resectability rates were 100% and 91.6% respectively. Local resection was done in 5 patients, partial gastrectomy in 5, and extended total gastrectomy in 1. Histologically, 6 cases were muscular tumors (2 leiomyomas, 3 low-grade leiomyosarcomas and 1 high-grade leiomyosarcoma), 2 were gastrointestinal autonomic nerve (GAN) tumors, and 4 were pure stomal tumors. The morbidity rate was 33.3% and the mortality rate was 8.3% (1 patient). All patients were followed up: 1 patient each died after 9 months and 4 years, 1 developed liver metastases after a disease-free interval of 14 months, and the other 9 patients were still alive and free of disease after intervals ranging from 4 months to 7 years. CONCLUSIONS: Stromal tumors include a group of tumors which may present muscular differentiation (the most frequent type), neural differentiation (GAN tumors) or no differentiation at all (pure stromal tumors). The mitotic index is the most valid parameter to determine biological nature, considering that classification as a benign tumor requires the total absence of mitoses. Treatment was mostly surgical, and local resection with adequate safety margins was effective. Prognosis was relatively good, but long-term follow-up is needed to assess the malignant potential of these tumors.
Adult↗
[Macroscopic intrahepatic portosystemic venous shunt: review of the literature and reclassification].
Macroscopic intrahepatic portosystemic venous shunts (IHPSS) are defined as communications between the portal and the systemic venous circulation, measuring more than 1mm in diameter, and at least partially located inside the liver. Four different types can be identified based on anatomical, clinical, and pathophysiological criteria. Type I includes patent paraumbilical veins, located in the liver, and commonly encountered in portal hypertension. Types II, III, and IV are much less common and have been reported in only 47 publications in the entire French and English literature. They include shunts, unique or multiple, between a portal branch and a hepatic vein, located either in two adjacent liver segments (type II) or in non-adjacent liver segments (type III). Type IV corresponds to any tubular communication developed between the right portal branch and the inferior vena cava. The exceptional patent ductus venosus or a patent umbilical vein should not be considered as IHPSS since their course is strictly extrahepatic.
Hepatic Veins↗
Hematology and pathology devices; reclassification; restricted devices; OTC test sample collection systems for drugs of abuse testing. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is reclassifying over-the-counter (OTC) test sample collection systems for drugs of abuse testing from class III (premarket approval) into class I (general controls) and exempting them from premarket notification (510(k)) and current good manufacturing practice (CGMP) requirements. FDA is also designating OTC test sample collection systems for drugs of abuse testing as restricted devices under the Federal Food, Drug, and Cosmetic Act (the act) and establishing restrictions intended to assure consumers that: The underlying laboratory test(s) are accurate and reliable; the laboratory performing the test(s) has adequate expertise and competency; and the product has adequate labeling and methods of communicating test results to consumers. Finally, FDA is adding a conforming amendment to the existing classification regulation for specimen transport and storage containers to clarify that it does not apply to specimen transport and storage containers that are part of an OTC test sample collection system for the purpose of testing for the presence of drugs of abuse or their metabolites in a laboratory.
Device Approval↗
Cardiovascular, orthopedic, and physical medicine diagnostic devices; reclassification of cardiopulmonary bypass accessory equipment, goniometer device, and electrode cable devices. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these devices on its own initiative based on new information. FDA is taking this action to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.
Cardiopulmonary Bypass↗
Medical devices; reclassification and codification of the nonabsorbable expanded polytetrafluoroethylene surgical suture. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to W.L. Gore and Associates, Inc., reclassifying the nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture intended for use in soft tissue approximation and ligation, including cardiovascular surgery, from class III (premarket approval) to class II (special controls). Accordingly, the order is being codified in the Code of Federal Regulations (CFR).
Device Approval↗
Medical devices; reclassification and codification of Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for peripheral iridotomy. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Intelligent Surgical Lasers, Inc. (ISL), (now doing business as Escalon Medical Corporation), reclassifying the Neodymium:Yttrium:Aluminum:Garnet (Nd:YAG) Laser for use in peripheral iridotomy from class III to class II (special controls). Accordingly, the order is now being codified in the Code of Federal Regulations (CFR) as described below.
Humans↗
Gastroenterology-urology devices: reclassification of the penile rigidity implant. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is reclassifying the penile rigidity implant from class III to class II when intended to provide penile rigidity in men diagnosed as having erectile dysfunction. The special control is the FDA guidance document entitled "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants." This action is taken on FDA's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.
Erectile Dysfunction↗
Gastroenterology and urology devices; reclassification of the extracorporeal shock wave lithotripter. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness.
Device Approval↗
New classification for the composite genus Aedes (Diptera: Culicidae: Aedini), elevation of subgenus Ochlerotatus to generic rank, reclassification of the other subgenera, and notes on certain subgenera and species.
The composite genus Aedes is divided into 2 genera, Aedes and Ochlerotatus, on the basis of consistent primary characters of the female and male genitalia. Ochlerotatus is separated into 2 sections. Additional supplemental features of the female and male genitalia, 4th-stage larvae, and pupae are provided for the separation of the genera and sections as well as a discussion of exceptions and comparisons. This classification is based on a morphological examination of specimens of over 65% of the currently recognized species and all subgenera previously included in Aedes and representative material of all subgenera and genera of tribe Aedini. Published literature was examined and evaluated. All currently recognized subgenera are assigned to the appropriate genus. The proposed new generic classification provides better defined genera and a more natural arrangement of included taxa. Armigerini is formally recognized as a synonym, in part, of Aedini.
Aedes↗
Osteoid osteoma and osteoblastoma: reclassification of 43 cases using Schajowicz's classification.
Forty-three cases of benign osteoblastic tumour of bone from the University of British Columbia bone tumour registry have been reviewed and reclassified according to the classification of Schajowicz and Lemos. Their classification has the advantage that the relationship of the two lesions is recognized and overlap, both radiologically and microscopically, is allowed for. The terminology used in the new classification, however, is cumbersome and confusing and appears to be of no great advantage. We therefore recommend instead the terminology modified from that of Dias and Frost, which incorporates the observations put forth by Schajowicz and Lemos: (a) cortical osteoblastoma, (b) medullary osteoblastoma, (c) periosteal osteoblastoma and (d) multifocal osteoblastoma.
Adolescent↗
Medical devices; reclassification of the shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is announcing that it is reclassifying the shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis intended to replace a shoulder joint from class III to class II (special controls). The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the device. The special control that will apply is a guidance document entitled "Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis." The agency is classifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.
Device Approval↗
[Review of the systematic position of Actinomyces orientalis (Pittenger et Brigham) Krass. 1970 and its reclassification as Proactinomyces orientalis (Pittenger et Brigham) comb. nov].
The micromorphology, growth cycle, chemical composition of the cell walls, and the susceptibility to lysozyme and specific phages were studied with the culture of Actinomyces orientalis RIA-1074. It is seggested on the basis of these studied to transfer the culture from the Actinomyces genus to the Proactinomyces genus and to rename it Proactinomyces orientalis (Pittinger et Brigham) comb. nov.
Actinomyces↗
Medical devices; reclassification and codification of home uterine activity monitor. Final rule.
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Device Approval↗
Orthopedic devices: classification and reclassification of pedicle screw spinal systems; technical amendment. Final rule; technical amendment.
The Food and Drug Administration (FDA) is correcting a final rule that classified certain previously unclassified pre amendments pedicle screw spinal systems and reclassified certain post amendments pedicle screw spinal systems. The agency is correcting the rule to include an intended use that was inadvertently omitted from the codified language in the rule. In addition, the agency is correcting the rule to clarify that, when intended for certain uses, the device is a pre amendments, not a post amendments, device. These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Bone Screws↗
Medical devices; reclassification of polymethylmethacrylate (PMMA) bone cement. Final rule.
The Food and Drug Administration (FDA) is announcing that it has reclassified the polymethylmethacrylate (PMMA) bone cement intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone from class III to class II (special controls). The agency is also announcing that it has issued an order in the form of a letter to the Orthopedic Surgical Manufacturers Association (OSMA) reclassifying the device. The special control for the device is a guidance document entitled "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." The agency is reclassifying this device into class II because special controls, in addition to general controls, would provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls.
Bone Cements↗
Nonpsychotic personality disturbances: a re-evaluation and reclassification.
The classical notion of neurosis as the prototypical form of nonpsychotic personality disturbance must be rejected in favor of the categories of (a) personality pattern disturbance and disorder of life style, and most especially, (b) character disorder. Category (a) would include schizoid, paranoid, and cyclothymic personality pattern disturbances and compulsive and hysteroid personality as disorders of life style. Each of these would occupy one end of a 'psychotoid' continuum, at the other end of which would be a familiar type of psychosis such as paranoid schizophrenia or pseudoneurotic schizophrenia. The most numerous of the nonpsychotic disturbances (in the tens of millions in the USA alone) come under category (b), the character disorders, involving a special sort of failure to inhibit impulse and unsocialized self-seeking. Character disorders are seen by us as turning on an eccentric axis, alternating between the two foci of 'dependency' and 'aggression'.
Aggression↗