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At least 1,063 records · Page 59Linked to original sources
PubMed2002

Medical devices; classification for medical washer and medical washer-disinfector. Final rule.

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. 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 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).

Device Approval↗
PubMed2002

Normal accidents: human error and medical equipment design.

High-risk systems, which are typical of our technologically complex era, include not just nuclear power plants but also hospitals, anesthesia systems, and the practice of medicine and perfusion. In high-risk systems, no matter how effective safety devices are, some types of accidents are inevitable because the system's complexity leads to multiple and unexpected interactions. It is important for healthcare providers to apply a risk assessment and management process to decisions involving new equipment and procedures or staffing matters in order to minimize the residual risks of latent errors, which are amenable to correction because of the large window of opportunity for their detection. This article provides an introduction to basic risk management and error theory principles and examines ways in which they can be applied to reduce and mitigate the inevitable human errors that accompany high-risk systems. The article also discusses "human factor engineering" (HFE), the process which is used to design equipment/ human interfaces in order to mitigate design errors. The HFE process involves interaction between designers and endusers to produce a series of continuous refinements that are incorporated into the final product. The article also examines common design problems encountered in the operating room that may predispose operators to commit errors resulting in harm to the patient. While recognizing that errors and accidents are unavoidable, organizations that function within a high-risk system must adopt a "safety culture" that anticipates problems and acts aggressively through an anonymous, "blameless" reporting mechanism to resolve them. We must continuously examine and improve the design of equipment and procedures, personnel, supplies and materials, and the environment in which we work to reduce error and minimize its effects. Healthcare providers must take a leading role in the day-to-day management of the "Perioperative System" and be a role model in promoting a culture of safety in their organizations.

Accidents↗
PubMed2002

Totally endoscopic atrial septal defect repair with robotic assistance.

BACKGROUND: The development of minimally invasive cardiac surgery has been characterized by the performance of increasingly complex operations through progressively smaller incisions. Computer (robotic) enhancement has emerged as a potential facilitator of these procedures, initially by providing enhanced endoscopic camera control and, more recently, by allowing the manipulation of surgical instruments through limited thoracic incisions. This report describes the next step in this progression, namely the performance of an atrial septal defect (ASD) repair entirely through thoracoscopic port incisions. This represents the first U.S. application of robotic technology for totally endoscopic open-heart surgery. MATERIALS AND METHODS: A 33-year-old woman with a secundum atrial septal defect underwent totally endoscopic repair through four port incisions by means of the Da Vinci (Intuitive Surgical, Mountain View, CA) robotic surgical system. Cardiopulmonary bypass was achieved peripherally (femoral Estech endoaortic balloon cannula; femoral and right internal jugular venous Bio-medicus cannulae). The myocardium was protected with antegrade cold blood cardioplegia delivered through the distal port of the arterial cannula. After port insertion, the entire operation, including pericardiotomy, bicaval occlusion, atriotomy, atrial septopexy, and atrial closure, was performed by computer-aided control of a camera and two instrument arms manipulated by a surgeon seated 15 feet away. The fourth port was used for suction and suture passage by the patient-side assistant. The aortic cross-clamp time was 43 minutes, and the postoperative transesophageal echocardiogram demonstrated normal ventricular function and the absence of interatrial shunting. The patient was extubated on the night of surgery, was ambulatory within 15 hours, and was discharged on the morning of postoperative day 3, 63 hours after the procedure. At 30-day follow-up, the patient was well and without complaints, and transthoracic echocardiogram confirmed the continued absence of interatrial shunting. CONCLUSIONS: Computer-aided robotic surgical technology can be used to perform open-heart procedures with a totally endoscopic approach. The benefits of this approach may include decreased perioperative pain, decreased recovery times, and improved cosmesis and patient acceptance. Clinical trials currently in progress will demonstrate whether this technology will be of reproducible value in the management of patients with intracardiac disease on a larger scale.

Adult↗
PubMed2002

FDA user fee and Modernisation Act.

A new law authorises the Food and Drug Administration to collect fees on medical device premarket submissions. The law also introduces important medical device regulatory reforms. This article discusses this new law and comments on the impact that it could have on the medical device industry.

Biotechnology↗
PubMed2002

Medical devices on trial, Part I.

This is the first of a two-part article exploring the place that clinical research plays in today's medical device industry. Part I looks at the differences in development processes between drugs and devices and examines future trends for increased requirements for clinical data in the device sector.

Biomedical Research↗
PubMedDate not supplied

[Certification of medical devices].

The importance and peculiarities of certification of medical devices are analysed. The attention is focused on classification of devices which are potentially risky in application. The application aspects of the EU 93/42 Directive, i.e. a fundamental document in design, elaboration, production, sale and maintenance of medical devices are detailed.

Certification↗
PubMed2003

Medical Devices; hematology and pathology devices; reclassification of automated blood cell separator device operating by filtration principle from class III to class II. Final rule.

The Food and Drug Administration (FDA) is reclassifying the automated blood cell separator (ABCS) device operating by filtration principle, intended for routine collection of blood and blood components, from class III to class II (special controls). The special control requirement for this device is an annual report with emphasis on adverse reactions to be filed by the manufacturer for a minimum of 3 years. The agency is taking this action in response to a petition submitted 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 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is reclassifying the automated blood cell separator devices operating by filtration principle into class II (special controls) because special controls, in addition to general controls, are capable of providing a reasonable assurance of safety and effectiveness of the device.

Device Approval↗
PubMed2003

Multislice/spiral computed tomography for screening for coronary artery disease.

Multislice computed tomography (MSCT) and spiral (or helical) computed tomography (CT) are designed to provide faster images with better resolution than conventional CT scanning. MSCT and spiral CT have been used to quantify calcification in the coronary arteries, in an effort to link this to coronary artery disease. Long-term studies on clinical outcomes of people screened with MSCT or spiral CT are lacking, as are comparisons with established screening modalities like risk factor algorithms. Low specificity gives rise to concern over false positive results. False positives may cause harm (and expense) due to inappropriate and invasive follow-up. One study was identified in which spiral CT was compared with electron beam CT (EBCT) to evaluate coronary calcifications in 33 asymptomatic individuals, giving a sensitivity of 74% and a specificity of 70%. There is insufficient evidence at this time to suggest that asymptomatic people derive clinical benefit from undergoing coronary calcification screening using MSCT or spiral CT scanning.

Canada↗