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At least 145 records · Page 8Linked to original sources
PubMed1995

Standards of evidence for the safety and effectiveness of critical care monitoring devices and related interventions. Coalition for Critical Care Excellence: Consensus Conference on Physiologic Monitoring Devices.

OBJECTIVE: To devise alternatives to randomized, controlled, clinical trials that clinicians and research experts might find acceptable for approval of devices used in critical care medicine. DATA SOURCES: The Coalition for Critical Care Excellence (Coalition) of the Society of Critical Care Medicine organized a consensus conference in which recognized critical care researchers gave testimony to a panel of experts regarding the process for testing and approval of monitoring devices. DATA SELECTION: The expert panel used testimony from the presenters as the basis of discussions on the testing and approval process. Guiding principles and specific recommendations were made based on the testimony given. MAIN RESULTS: The panel determined the main constituents of the medical device approval process to be the Food and Drug Administration (FDA), the research and clinical community, and the device manufacturers. Distinctions were made between monitoring and interventional device categories. This document addresses only monitoring devices. Potential alternatives to randomized, blinded, controlled study designs for device testing are: a) nonblinded, randomized, management protocol-driven study; b) crossover study (n-of-one design); c) cluster-randomization (randomized by care unit); d) case-matched controls; e) mixed design; f) on/off design (before-after); and g) historical controls. CONCLUSIONS: The panel agreed on the following major recommendations: a) the FDA should accelerate publication of specific guidances for physiologic monitoring products with the assistance of the Coalition (priorities and content); b) more multidisciplinary research should be incorporated into new device studies; c) commonly accepted clinical tools may not need to be tested for clinical utility--these accepted tools should be identified by the Coalition; and d) an independent council of researchers and clinicians should make themselves available to serve as consultants to manufacturers regarding appropriate study design for the testing of devices.

Case-Control Studies↗
PubMed1998

Medical devices; effective date of requirement for premarket approval for three class III preamendments physical medicine devices--FDA. Proposed rule; opportunity to request a change in classification.

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for the following three high priority Group 3 preamendments class III devices: Microwave diathermy for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures; ultrasonic diathermy for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures; and ultrasound and muscle stimulator for uses other than treatment of select medical conditions such as relief of pain, muscle spasms, and joint contractures. The uses of these three devices do not include use for the treatment of malignancies. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of any of these devices based on new information.

Device Approval↗
PubMed1991

Early clinical results with the hydroxyapatite-coated porous long-term stable fixation total hip system.

The design and early clinical results with uncemented porous-coated long-term stable fixation anatomic and midstem total hip systems (Implant Technology, Inc, Secaucus, NJ) are described. In an ongoing Food and Drug Administration-approved Investigational Device Exemption-Premarket Approval Program, a random selection method is used to determine patients receiving implants with a hydroxyapatite (HA) coating applied to the porous surface and those receiving uncoated implants. The early clinical results with the HA-coated systems show them to appear superior to the uncoated systems. A greater percentage of patients with HA-coated systems have clinical scores in the excellent to good range, which is primarily a reflection of less prostheses-related pain. Radiographically, all components appear well fixed, with evidence of bone ingrowth. The HA-coated systems have a decreased incidence of radiolucencies, particularly in proximal zones.

Chromium Alloys↗
PubMed1990

New tools of the trade.

The author reviews the regulatory process through which new cardiovascular interventional devices reach the hands of the interventional radiologist and the cardiologist. The marketing mechanisms are outlined, as are the data requirements. The reader is taken step-by-step from device investigation conducted under an approved investigational device exemptions application to market clearance, through either a substantially equivalent 510(k) notification or an approved premarket approval application, and beyond, including how to report adverse device experiences through the Medical Device Reporting REgulation and the Medical Device and Laboratory Product Problem Reporting Program.

Clinical Trials as Topic↗
PubMed2001

New IUD approved.

Explore the source record for details and available documents.

Contraceptive Agents, Female↗
PubMed1986

Esophageal obturator airway, ET tube, and pharyngeal-tracheal lumen airway.

Prior to approval of the EOA, this device had not been documented to be effective in oxygenation and ventilation in the pre-hospital arena. The studies quoted to demonstrate its usefulness were done in the very controlled environment of the operating room or of the emergency department. Indeed, the studies on blood gases obtained immediately upon entry into the emergency department would indicate that the esophageal obturator airway is an inadequate and ineffectual pre-hospital airway. The ability of the device to obstruct the esophagus, has been questioned. In a recent review of the EOA, Smith et al state that "How the EOA gained widespread popularity for use in patients requiring CPR without any evidence of its effectiveness is worthy of investigation". The Food and Drug Administration "grandfathered" the EOA as an acceptable device. This approval was to be reviewed with time, and if complications were reported, a second evaluation of the esophageal obturator airway was to be undertaken. Unfortunately, this has never occurred. We are now faced with the pharyngeal-tracheal lumen airway, which is being marketed for use in the pre-hospital area. The Food and Drug Administration approved the marketing and use of this device based on its similarity to the esophageal obturator airway. The PTL, is a device in many respects similar to the EOA. It has been tested in the operating room and the emergency department. In a study done on unsuccessfully resuscitated patients, it was as effective as an ETT. However, no study has shown that the PTL can be used successfully in the pre-hospital setting by ambulance personnel.(ABSTRACT TRUNCATED AT 250 WORDS)

Emergencies↗
PubMed1998

Medical devices; retention in class III and effective date of requirement for premarket approval for three preamendments class III devices--FDA. Proposed rule; opportunity to request a change in classification.

The Food and Drug Administration (FDA) is proposing to retain in class III, three preamendments class III medical devices, and is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for these devices. FDA believes that the suction antichoke device, the tongs antichoke device, and the implanted neuromuscular stimulator device should remain in class III because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury. The agency is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request the agency to change the classification of any of the devices based on new information.

Airway Obstruction↗
PubMedDate not supplied

Regulatory approval of peripheral endovascular revascularization devices in the United States: is the horse still in the barn?

The regulatory processes by which industry obtains approval for marketing and sales of medical devices from the United States Food and Drug Administration is distinct from the drug approval pathways, poorly understood by clinicians, and widely criticized by clinical investigators and industrial sponsors of new technology. This paper reviews the most common pathways for obtaining such approval for endovascular devices used in the treatment of peripheral arterial disease. Unique issues pertinent to clinical trials carried out in this area are highlighted. Future directions for evolution of the regulatory process consonant with the mandated requirements for demonstration of safety and efficacy are discussed.

Angioplasty, Balloon↗
PubMed2000

Medical devices; effective date of requirement for premarket approval for a class III preamendments obstetrical and gynecological device. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices.

Device Approval↗
PubMed2003

Application of models for multivariate mixed outcomes to medical device trials: coronary artery stenting.

The approval process for some medical devices involves a single-arm trial in which the outcomes associated with the new device are compared to the expected outcomes associated with approved devices, the latter denoted the objective performance criterion (OPC). In this paper, models for multivariate mixed outcomes are applied to derive the OPC for a medical device to be used in clinical evaluations of the same type of device. We illustrate the techniques by determining the OPC for coronary artery stents, metal cages used to widen blocked coronary arteries in patients with coronary artery disease, using data from seven randomized trials of stents approved for use in the U.S.A. involving 5806 patients. The OPC is based on two 9-month endpoints: target lesion revascularization, a binary outcome, and proportion diameter stenosis, a continuous outcome. To account for the correlation between mixed outcomes we consider factorization of the likelihood into marginal and conditional components, or adoption of a latent variable model. Because the models have different structural forms, standard methods for model comparison (such as the AIC and BIC) cannot be used. We discuss how model identifiability and valid inference are achieved, and then adapt the deviance information criterion (DIC) and the pseudo-Bayes factor (PSBF) to select the best model. Nine months post-stenting, we find that the average posterior probability (standard deviation) of target lesion revascularization ranges from 0.086 (0.008) for non-diabetics with one diseased vessel to 0.163 (0.022) for diabetics with three diseased vessels. When considering proportion diameter stenosis, the corresponding posterior means are 0.375 (0.020) and 0.427 (0.030). The correlation coefficient of the components of the OPC lies in the range 0.042 to 0.116.

Bayes Theorem↗
PubMed2006

Clinical trials evaluating endoscopic GERD treatments: is it time for a moratorium on the clinical use of these procedures?

Perendoscopic treatments of gastroesophageal reflux have been used in clinical practice following FDA approval of the first two devices in 2000. A number of clinical trials predominantly short-term have been performed almost uniformly demonstrating patient improvement in GERD symptomatology and reduction or elimination of antacids. However, only two of these endo reflux treatment trials have included the essential elements of strict patient entry criteria, randomization, attempts at blending, and intention-to-treat analysis. Two new endoscopic antireflux trials are published in this issue of the journal. The first study compares the EndoCinch sewing device to the Enteryx copolymer injection procedure. The second report compares the EndoCinch technique to the laparoscopic fundoplication procedure. Unfortunately, both studies lack a sham-control population and have other important flaws in design. Basically, all these techniques improved GERD symptoms and well-being and decreased the patients PPI requirement during follow-up period. However, none of the endoscopic procedures reduced acid reflux impressively or improved lower esophageal sphincter tone, a consistent negative outcome with all these techniques. Morbidity was associated with all the procedures and Enteryx has been withdrawn recently from clinical use by the manufacturer because of significant complications. The efficacy durability and safety of these devices in treating GERD patients is in question. A moratorium on the continued use of the procedures in clinical practice seems appropriate at this time.

Device Approval↗