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At least 1,459 records · Page 81Linked to original sources
PubMed2000

Personal watercraft use by children and adolescents. American Academy of Pediatrics. Committee on Injury and Poison Prevention.

The use of personal watercraft (PWC) has increased dramatically during the past decade as have the speed and mobility of the watercraft. A similar dramatic increase in PWC-related injury and death has occurred simultaneously. No one younger than 16 years should operate a PWC. The operator and all passengers must wear US Coast Guard-approved personal flotation devices. Other safety recommendations are suggested for parents and pediatricians.

Adolescent↗
PubMed1990

Laser angioplasty in coronary artery disease.

At the present time all laser coronary angioplasty systems in use are investigational devices awaiting FDA approval. Preliminary results in human trials of several coronary laser angioplasty systems have been reported and appear encouraging. The technological achievement of delivering laser energy to the coronary circulation and opening occluded arteries has been accomplished. The much more difficult question of determining which patients, if any, should be offered this very expensive technology remains to be answered.

Coronary Disease↗
PubMed1980

The use of controlled and sustained release agents in dentistry: a review of applications for the control of dental caries.

Three types of sustained and controlled release dosage forms of sodium fluoride (NaF) for the prevention of dental caries are reviewed. Sustained release NaF tablets or capsules have prolonged the elevation of saliva and plasma fluoride levels in both animal and human studies when compared to conventional NaF tablets. In vitro studies have shown that aerosol application of NaF-containing microcapsules to the tooth surface may prolong the retention of a given dose of fluoride in the mouth and also increase enamel uptake of fluoride. A membrane-controlled reservoir-type intra-oral controlled release device for NaF is potentially the most effective dosage form of NaF developed to date. Devices releasing 0.02 to 1.0 mg of fluoride per day for 30 to 180 days have been prepared. Extensive testing has shown that the devices function under both in vitro and in vivo conditions and the device has been approved by the US Food and Drug administration for preliminary testing in humans.

Aerosols↗
PubMed1993

Ontario dentists: 3. Radiographs prescribed in general practice.

In February 1991, a mail survey was used to poll a sample consisting of about 10 per cent of Ontario's general dentists. The data obtained provided information about the radiographs prescribed by dentists for five different patient types, which were described to the respondents. The per cent agreement between the radiographic procedures prescribed by Ontario dentists and the ADA-approved Center for Devices and Radiological Health (CDRH) guidelines ranged from three per cent to 79 per cent, depending on patient type and disease risk. For each patient and risk type, there was considerable variation in the radiographs prescribed.

Adult↗
PubMed1977

[Injuries from hang gliding].

106 accidents in hang gliding during the years 1974--1977 are discussed. 25 pilots died, 19 of the flyers suffered severe brain damage and multiple fractures. Injuries associated with hang gliding are very often fractures of the lower extremities, of the spine and of the head. Severe burns were seen if flyers touch electric wires. Preventive safety measures consist in approved schools for flyers, better safety devices (shoes, helmet), official testing and approval of equipment; a modified parachute should be developed and used.

Athletic Injuries↗
PubMedDate not supplied

[Pulse oximeter: a component of medical computer-aided monitoring].

A nonautonomous pulse oximeter (a device) that is controlled by a personal computer (PC) is described. The division of functions between the device and PC is shown. Algorithms are presented for signal treatment and device gain control. A list of the developed softwares and an outline of the functions fulfilled are given. The prototypes of the device have been approved and are used at the intensive care units and operating rooms of the First Republican Clinical Hospital of the Udmurt Republic.

Algorithms↗
PubMed2001

Medical devices; reclassification of six cardiovascular preamendments class III devices into class II. Final rule.

The Food and Drug Administration (FDA) is reclassifying six cardiovascular pre amendments devices from class III (pre market approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the Food and Drug Administration Modernization Act of 1997. The agency is also revising the identification of one of the devices subject to this rule to simplify the classification regulation and is correcting a typographical error that was incorporated into the regulations.

Cardiology↗
PubMedDate not supplied

Pediatric circulatory support: an FDA perspective.

The Department of Health and Human Services, at the direction of Congress, has recently begun to address concerns regarding the development of medical devices designed specifically for the pediatric population, including devices for pediatric mechanical circulatory support, as evidenced by the National Institutes of Health's (NIH) funding of several development contracts. Food and Drug Administration (FDA) approval for marketing of these devices will typically follow either of two regulatory pathways: the Humanitarian Device Exemption (HDE) or the Premarket Application (PMA). An HDE is limited both in the extent of clinical use and economic benefit to the manufacturer, but does not require data derived from a clinical trial for market approval. A PMA allows for use in a larger patient population and offers economic benefit for the manufacturer; it does, however, almost always necessitate data derived from a clinical trial. The HDE and PMA require demonstration of a reasonable assurance of safety. In addition, an HDE requires a demonstration of probable benefit, whereas a PMA requires a demonstration of a reasonable assurance of effectiveness. The evidence that can be used to support an HDE or a PMA approval may include both preclinical and clinical data. Types of preclinical tests needed depend upon the device design and its intended use, because circulatory support devices are all unique.

Child↗
PubMed2002

Regulatory aspects of noninvasive glucose measurements.

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act (the Act) established three regulatory classes for medical devices. Section 513 of the Act specifies three classes based upon the degree of control and Food and Drug Administration (FDA) oversight that is necessary to assure that the various types of devices are safe and effective. High-risk devices are placed into the most regulated device class, Class III. Under Section 515 of the Act, all devices placed in Class III are subject to premarket approval (PMA) requirements. PMA by FDA is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Advisory panel review is required of virtually all original submissions. Manufacturing facilities of devices requiring PMA approval are also subject to preapproval inspection to assure data integrity and compliance with good manufacturing practices. An approved PMA is granted for marketing a particular medical device for a particular intended use. FDA considers noninvasive and minimally invasive glucose devices that are intended to measure, monitor, or predict blood glucose levels in diabetics to be high-risk medical devices. These devices will have a significant potential impact on the medical care of people with diabetes. The technology offers potential improvements in the quality of life, enhanced blood glucose control through increased frequency of testing, or access to testing, in a broader range of patients. However, the technology is not yet well understood, and the information obtained from these devices is often different from the information that has been the traditional base for the management of diabetes. As a result, FDA requires both analytical and clinical studies to support the intended claims for these new devices.

Blood Glucose↗
PubMed2002

Medical devices; ear, nose and throat devices; reclassification of the endolymphatic shunt tube with valve. Final rule.

The Food and Drug Administration (FDA) is reclassifying the endolymphatic shunt tube with valve from class III (premarket approval) into class II (special controls). The device is intended to be implanted in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease. FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA" (the guidance) as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is based on new information submitted in are classification petition by E. Benson Hood Laboratories, Inc. (Hood Laboratories). FDA is taking this action 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 Food and Drug Administration Modernization Act of 1997. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the guidance.

Device Approval↗
PubMed1992

Role of "buttoned" double-disc device in the management of atrial septal defects.

Sixteen patients seen over a 9-month period ending in August 1990 were offered transcatheter closure of their ASD with a custom-made "buttoned" double-disc device. The study was approved by the Institutional Review Board and informed consent was obtained in each case. The device consists of an occluder, a counteroccluder, and a loading wire and is delivered to the ASD site via an 8F sheath. Parents of two children elected surgical closure. In five children the stretched diameter of the ASD was too large (greater than 20 mm) and transcatheter closure was not attempted. These seven children underwent elective surgical closure without incident. In one child the defect measured 5 mm and the Qp:Qs was 1.4:1 and therefore ASD closure was not recommended. In the remaining eight children transcatheter closure was attempted. In two of the children the occluder pulled through the ASD and was successfully retrieved and the children later underwent uneventful elective surgical closure. The device was implanted across the ASD in six children. In one child the device dislodged from the ASD site within minutes after implantation and the child was sent to emergency surgery, where the device was removed and the ASD was closed. In the remaining five patients, aged 7 months to 45 years (weight 3.6 to 50 kg), with a Qp:Qs range of 1.3 to 2.3 and a stretched diameter of 10 to 19 mm, the ASD closure was successful with 25 to 40 mm size devices. Repeat echo-Doppler studies 2 weeks and 3 months after the procedure in all patients and 6 months later in two children did not reveal any residual shunt. It is concluded that (1) the custom-made "buttoned" double-disc device can be implanted across the ASD safely and effectively via an 8F sheath, thus making transcatheter ASD closure feasible even in very young infants; (2) measurement of stretched diameter of the ASD in the catheterization laboratory is a useful guide for selection of an appropriate-sized device; and (3) additional clinical trials are warranted to confirm the efficacy and safety of the device.

Adolescent↗
PubMed1996

Is it possible to file and approve a new antihypertensive without ambulatory blood pressure monitoring?.

Clinical research into the efficacy and safety of antihypertensives has used non-invasive automated ambulatory blood pressure monitoring (ABPM) for the last two decades. Different national validation requirements have standardized the equip;ment and the clinical use thereof. The European Standardization for Medical Devices (CEN/CENELEC) organization has recently approved requirements for new ABPM devices in most European countries. For the approval process of new antihypertensive drugs, ABPM today has a supportive role to play in the documentation. Increasingly, national regulatory bureaux demand ABPM data. For the US Food and Drug Administration (FDA) ABPM is still not a prerequisite for approval but the value of peak: trough evaluation has recently been debated by major advisory boards. A US-based Cooperative Research and Development Agreement (CRADA) has been established to evaluate ABPM data from controlled trials with versus without placebo controls. In major clinical trials it has been documented that the ABPM technique reduces sample size, reduces the number of placebo-controlled trials, provides detailed information concerning the first-dose effect, documents the duration of action and dose-response relationship and allows documentation of antihypertensive therapy throughout 24 h, including the night-time period. ABPM data are recommended to support the documentation of 24 h efficacy and safety of new antihypertensive dose regimens. ABPM has been discussed for the documentation of new drugs to treat angina pectoris, heart failure and arrhythmia.

Journal Article↗
PubMed1991

Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.

Equipment Safety↗
PubMedDate not supplied

The Filshie clip for laparoscopic adnexal surgery.

BACKGROUND: Gynecologic endoscopic procedures are increasingly common and require the ability to control large vascular structures. METHOD: The Filshie clip is a silicone-lined, titanium occlusive device, originally designed and Food and Drug Administration (FDA) approved for surgical contraception. This device also has the potential for occluding vascular structures during laparoscopic surgery. EXPERIENCE AND RESULTS: We describe a salpingectomy, an excision of bilateral hydrosalpinges, and a salpingo-oopherectomy. We performed all procedures laparoscopically using this device as the primary modality for assuring hemostasis. CONCLUSION: The Filshie clip is a useful and economical device for assuring hemostasis during gynecologic endoscopic surgery.

Adnexa Uteri↗
PubMed2003

Robotic resection of pancreatic neuroendocrine tumor.

Computer-assisted surgical devices, or "surgical robots," have recently been approved for general surgical use. The device allows the surgeon remote control of multi-articulated instrument arms with a three-dimensional view. Here we report the first known case of pancreatic resection with use of a computer-assisted, or robotic, surgical device. A 46-year old woman presented with back pain and a complex cystic mass in the tail of the pancreas. The daVinci surgical robot was used to remove the lesion en bloc with the tail of the pancreas and spleen. The patient did well and returned to full activity promptly. In summary, robotic technology may enhance advanced laparoscopic procedures. Pancreatic resection is feasible, and future experience will determine the true benefits of this technique.

Carcinoma, Neuroendocrine↗
PubMed2003

Complications associated with global endometrial ablation: the utility of the MAUDE database.

OBJECTIVE: To investigate the number and type of complications associated with global endometrial ablation using public-access governmental databanks. METHODS: MEDLINE (PubMed) and the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) databases were searched for entries for the four US Food and Drug Administration-approved global endometrial ablation devices. RESULTS: Traditional MEDLINE and bibliography searches yielded reports of two cases of hemorrhage, one case of pelvic inflammatory disease, 20 cases of endometritis, two cases of first-degree skin burns, nine cases of hematometra, and 16 cases of vaginitis and/or cystitis. A search of the US Food and Drug Administration MAUDE database yielded reports of 85 complications in 62 patients. These included major complications: eight cases of thermal bowel injury, 30 cases of uterine perforation, 12 cases in which emergent laparotomy was required, and three intensive care unit admissions. One patient developed necrotizing fasciitis and eventually underwent vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee amputations. One of the patients with thermal injury to the bowel died. CONCLUSION: Use of the US Food and Drug Administration MAUDE database is helpful in identifying serious complications associated with global endometrial ablation not yet reported in the medical literature.

Databases, Factual↗
PubMed1993

Report on a conference on motor prostheses for workplace mobility of paraplegic patients in North America.

On May 18, 1992 a symposium at Case Western Reserve University in Cleveland, Ohio, USA had the goal of defining the tasks needed to reach clinical utility of investigational neural prosthetic ambulation devices. The characteristics and stage of development of four systems were detailed: the Louiiana State University reciprocating gait orthosis (LSU-RGO) with muscle stimulation; the modular hybrid functional neuromuscular stimulation (FNS) orthosis; the Cleveland VA-Case Western Reserve University (VA-CWRU) implant system; and the Parastep system. Multicenter clinical trials are underway for the Parastep system and are planned to start within the next 2 years for the LSU-RGO with muscle stimulation, the VA-CWRU 8-channel system, and the floor reaction orthosis component of the modular hybrid FNS system. Current investigational systems provide little advantage over the standing wheelchair in some occupations but they do expand social, recreational, and exercise capabilities. Disabled people and some leading rehabilitation physicians are willing to test basic ambulation devices but the regulatory approvals must first be obtained for multicenter clinical trials. Corporate partners are central to the development of devices, their clinical testing, and their subsequent marketing. A key requirement for developing and disseminating motor prostheses is the education of clinicians so that they will participate in trials and be prepared to prescribe the prostheses when they reach the market.

Electric Stimulation↗
PubMedDate not supplied

An overview of the regulatory aspects of medical devices from the viewpoint of research and device manufacturing.

PURPOSE: To review the Food and Drug Administration's regulatory requirements for bringing a new or substantially changed medical device to market in the United States, noting the history and current requirements for the continuous spinal catheter. METHOD: The relevant laws and guidelines for classifying, testing, and submitting a device to Food and Drug Administration approval are reviewed. RESULTS: The Food and Drug Administration categorizes medical devices into three classes, based on potential risk for illness or injury presented by a malfunction or failure. Class III devices are the most critical ones, and require a Premarket Approval that includes clinical trials before market introduction. Classes I and II usually require a 510(k), or premarket notification, which usually does not need any clinical data. Testing requirements include biocompatibility testing; physical, functional, and packaging testing; and sterility testing. The continuous spinal catheter (25-32 gauge) was marketed under a 510(k) claiming substantial equivalence to the Bizzarri-Giuffrida 24-gauge catheter, which was a pre-Amendment device. After incidences of cauda equina syndrome were reported with use of the continuous spinal technique, the Food and Drug Administration reclassified the small-gauge catheters as Class III devices, which require a Premarket Approval before being marketed.

Equipment and Supplies↗