Reduction of laparoscopic-induced hypothermia, postoperative pain and recovery room length of stay by pre-conditioning gas with the Insuflow device: a prospective randomized controlled multi-center study.
OBJECTIVE: To assess the efficacy and safety of Insuflow (Georgia BioMedical, Inc.) filter heater hydrator device in reducing the incidence, severity and extent of hypothermia, length of recovery room stay and postoperative pain at the time of laparoscopy. DESIGN: Prospective, randomized, blinded, controlled multi-center study. Patients underwent gynecologic procedures via laparoscopy; surgeons, anesthesiologists and recovery room personnel assessed the results. SETTING: Seven North American institutions. PATIENTS: Seventy-two women for safety evaluation and efficacy studies. INTERVENTIONS: Intraoperative pre-conditioning of laparoscopic gas with the Insuflow device (treatment) or standard raw gas (control) during laparoscopic surgery and postoperatively. MAIN OUTCOME MEASURES: Incidence, severity and extent of hypothermia, postoperative pain perception and length of recovery room stay. RESULTS: The Insuflow group had significantly less intraoperative hypothermia, reduced length of recovery room stay and reduced postoperative pain. Pre-conditioning of laparoscopic gas by filtering heating and hydrating was well tolerated with no adverse effects. The safety profile of the Insuflow pre-conditioned gas showed significant benefits compared to currently used raw gas. CONCLUSIONS: Pre-conditioning laparoscopic gas by filtering heating and hydrating with the Insuflow device was significantly more effective than the currently used standard raw gas and was safe in reducing or eliminating laparoscopic-induced hypothermia, shortening recovery room length of stay and reducing postoperative pain. (+info)
The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator.
The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed. (+info)
Failure of many ophthalmologists to use lasers safely.
In 1990, after the detection of impairment of colour discrimination in laser operators, the College of Ophthalmologists recommended safety guidelines for the use of lasers. We measured the effectiveness of these guidelines and their impact on ophthalmological practice in the United Kingdom. Previously, in ophthalmologists not following the guidelines, there was a deterioration in colour discrimination after a laser session. No such deterioration was found in 10 ophthalmologists tested who adhered to the guidelines, but their colour discrimination was significantly worse than that of controls. Replies to a questionnaire disclosed that one third of senior ophthalmologists were unaware of the practices recommended. (+info)
Technology assessment of medical devices at the Center for Devices and Radiological Health.
We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations. (+info)
The effect of a levonorgestrel-releasing intrauterine device on human endometrial oestrogen and progesterone receptors after one year of use.
Thirty-four women bearing a levonorgestrel-releasing intrauterine device, 20 micrograms/day (LNG-IUD-20), for 12-15 months were recruited. Endometrial biopsies were collected during the late proliferative phase of the cycle (on cycle days 10-12) before (control) and after the use of the IUD for 12 months, and assayed for oestrogen receptors (ER) and progesterone receptors (PR). An immunohistochemical technique with the peroxidase-antiperoxidase detection system (PAP method) was employed. D75 and JZB39 were the primary antibodies for ER and PR respectively. The immunostaining semiquantitative analysis was performed with a computerized microscope image processor, and expressed as 'grey value'. Both endometrial ER and PR populations were significantly lower after insertion of the IUD (P < 0.01) than in control biopsies. The intensity of nuclear staining and the percentage of positively stained cells for ER and PR in women with LNG-IUD were each about 50% of those in control biopsies. The results suggested that LNG released locally from the IUD has a depressive action on the ER and PR, which may contribute to the contraceptive effectiveness of this type of IUD and also to the possible causes of LNG-IUD-induced irregular bleeding and amenorrhoea. (+info)
Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial.
OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction. BACKGROUND: Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments. METHODS: A randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications. RESULTS: Complete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 +/- 11.5 min compared with 12.9 +/- 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS). CONCLUSIONS: Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks. (+info)
Liability of laryngeal mask airway devices to thermal damage from KTP and Nd:YAG lasers.
We have compared the liability of four laryngeal mask airway (LMA) devices (standard, flexible, intubating and reusable) and a tracheal tube to thermal damage from KTP and Nd:YAG lasers at two power densities used commonly in airway surgery: 570 W cm-2 and 1140 W cm-2. Eighty-five airway devices were tested: 24 standard LMA (silicone-based), 12 flexible LMA (silicone-based, metal wires), 24 disposable LMA (PVC-based), one intubating LMA (silicone and steel-based) and 24 PVC-based tracheal tubes. Comparisons were made during laser strike to eight different targets: the unmarked and marked part of the airway device tube; the unmarked part of the airway device tube after application of blood; the cuff filled with air or methylene blue dye; the unmarked flexible LMA tube on or between the metal wires; and the epiglottic elevator bar of the intubating LMA. The laser strike was continued for 30 s and each target was tested three times. Three different, but identical, impact sites were used for each target. There was no ignition of any airway device with either power density or laser type. The silicone-based LMA were generally more resistant to flaring and penetration than the PVC-based LMA and tracheal tube, but the intubating LMA tube flared more rapidly with the KTP laser, and the disposable LMA cuff was more resistant to penetration. Print markings, blood and the metal wires of the flexible LMA reduced the thermal resistance of the tube. Filling the cuff with methylene blue dye increased the thermal resistance of all airway devices. We conclude that the silicone-based LMA devices were more thermal resistant to KTP and Nd:YAG laser strike than PVC-based devices with the exception of the disposable LMA cuff and the intubating LMA tube. (+info)
A preliminary study of patient comfort associated with customised mouthguards.
OBJECTIVE: To compare patient perception of custom made mouthguards of ideal and less than ideal designs in terms of their comfort and "wearability". METHOD: A mouthguard of ideal design (A) and one incorporating common design faults of underextension and unadjusted occlusion (B) were provided for 22 active sportsmen and women. They were not informed of the details of the design or the status of the protector. Half the participants were asked to wear mouthguard A first and the other half wore B first, each worn for one hour on two consecutive nights. Questionnaires were used to evaluate and rate the comfort and wearability of each mouthguard. RESULTS: Eighteen people completed the study. The ideal appliance was rated as significantly more retentive and comfortable overall and specifically was more comfortable to lips, gums, and tongue. It was also recognised as being less bulky, less likely to keep the teeth apart, or to cause pain in the jaw muscles. CONCLUSIONS: Comfort is likely to be increased if mouthguards are extended labially to within 2 mm of the vestibular reflection, adjusted to allow even occlusal contact, rounded at the buccal peripheries, and tapered at the palatal edges. (+info)