Medical devices; general and plastic surgery devices; classification of the nonabsorbable expandable hemostatic sponge for temporary internal use. Final order.

The Food and Drug Administration (FDA) is classifying the nonabsorbable expandable hemostatic sponge for temporary internal use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the nonabsorbable expandable hemostatic sponge for temporary internal use classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Análisis de costes sobre la utilización de cobertura quirúrgica desechable frente al algodón reutilizable / Cost analysis of the use of disposable surgical materials and dressing compared to reusable cotton

La ropa quirúrgica, batas y paños, se utilizan como método de barrera ente el riesgo de transmisión de microorganismos en quirófano, desde el equipo médico y el paciente hasta la herida quirúrgica abierta. Este artículo muestra un análisis de costes independiente, con el fin de argumentar la decisión de sustituir el algodón tradicional en los tejidos quirúrgicos por cobertura quirúrgica desechable (AU)

Surgical clothing, gowns and dressings are used as a barrier method against the risk of transmission of microorganisms in the operating theatre, and covers the medical team, patient and the open wound. This article presents and independent cost analysis, in order to give arguments justifying the decision to substitute traditional cotton in surgical materials for disposable surgical dressings (AU)

Double-blind randomised controlled trial comparing Merocel with Rapid Rhino nasal packs after routine nasal surgery.

INTRODUCTION: Nasal packing after routine nasal surgery is commonly practiced in the UK. The most popular pack appears to be Merocel, however this can be associated with significant pain on its removal. AIM: To test the efficacy of a relatively new nasal pack--the Rapid Rhino Goodman pack--introduced to our department, which claims to reduce pain and bleeding after nasal surgery. METHODS: Fourteen patients undergoing routine nasal surgery were recruited into a randomised controlled trial. One nasal cavity was packed with a Merocel pack and the other with a Rapid Rhino Goodman pack. Patients were asked to record pain levels on each side using a visual analogue scale. RESULTS: We found no difference between packs whilst in-situ, with all patients recording low to moderate pain scores. There were significantly higher pain levels associated with Merocel pack removal than with Rapid Rhino pack removal (average pain scores 5.64 vs 1.64, p < 0.001) and less bleeding overall. CONCLUSIONS: Rapid Rhino (Goodman pack) is associated with significantly less pain on removal than Merocel pack, causes less bleeding and is not more painful whilst in-situ. We therefore recommend its use in routine nasal surgery.

General and plastic surgery devices; classification of the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is classifying the nonresorbable gauze/sponge for external use, the hydrophilic wound dressing, the occlusive wound dressing, and the hydrogel wound dressing into class I (general controls). FDA is also exempting these devices from premarket notification procedures. 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 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).