15 research outputs found
Simple Capsule Pneumograph
A capsule pneumograph includes an electret microphone connected to a capsule chestpiece attached to a sleeping subject. The output of the microphone is connected to the input of a recorder or monitor in order to provide a system for the detection of respiratory movements in subjects during polysomnographic sleep monitoring. A tube connecting the capsule chestpiece to the microphone functions as a low pass filter to pass only low frequency signals in the range of respiratory movements from the chestpiece to the microphone
Fundamentals of Lung Auscultation
Chest auscultation has long been considered a useful part of the physical examination, going back to the time of Hippocrates. However, it did not become a widespread practice until the invention of the stethoscope by René Laënnec in 1816, which made the practice convenient and hygienic.1 During the second half of the 20th century, technological advances in ultrasonography, radiographic computed tomography (CT), and magnetic resonance imaging shifted interest from lung auscultation to imaging studies, which can detect lung disease with an accuracy never previously imagined. However, modern computer-assisted techniques have also allowed precise recording and analysis of lung sounds, prompting the correlation of acoustic indexes with measures of lung mechanics. This innovative, though still little used, approach has improved our knowledge of acoustic mechanisms and increased the clinical usefulness of auscultation. In this review, we present an overview of lung auscultation in the light of modern concepts of lung acoustics
Reporter\u27s Occupation and Source of Adverse Device Event Reports Contained in the FDA\u27s MAUDE Database
Introduction: A review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information.
Methods: The reporter’s occupation and source of the medical device report were determined for acquisition dates Jan 1, 1997 to Dec 31, 2018. A total of 7,766,737 adverse event records were analyzed.
Results: 96.6% of reports originated with the manufacturer. Patients (patients/family/friend) were the most frequent submitter of reports directly to the FDA, almost five times as often as physicians. Nurses submitted reports directly to the FDA 2.77 times as often as physicians. Only 0.49% of physician reports were submitted directly to the FDA, representing 0.09% of total MAUDE reports.
Conclusion: Increasing physician reporting directly to the FDA and MAUDE through the MedWatch reporting system is an imperative. Incorporating information from the perspective of the physician has the potential of increasing the quality of the data and improving the reliability of post-market surveillance