Reporting Medical Device Events: From Observation to Action
The Food and Drug Administration (FDA) is responsible for protecting public health by regulating medical devices, radiation-emitting electronic devices, drugs, biologics, food, tobacco, and cosmetics. After a product reaches the market, the Agency continues to evaluate a product's safety by monitoring adverse events. FDA's Center for Devices and Radiological Health facilitates reporting of medical device events and complaints by manufacturers, importers, healthcare facilities, and the general public to help FDA identify potential safety signals and/or improve medical device performance. FDA has established 2 reporting mech...
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: FEATURE ARTICLES Source Type: research
Impact of Post–Refractive Surgeries on Corneal Biomechanics—A Review
A stable shape for the human cornea prevents complications of post–refractive surgeries. Variation in corneal lamellae and collagen fibers is induced by recent laser refractive surgical procedures utilizing laser ablation and disruption techniques. Noninvasive prediction of corneal biomechanics and structural strength is not quite accurate pre– and post–refractive surgery despite the great advance in assessment methods. This is due to the alteration happening to the corneal structure post–refractive surgery. Many different methods have been developed to measure corneal and subcorneal biomechanics. In this article, ...
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: FEATURE ARTICLES Source Type: research
2020 Clinical Engineers Salary Survey
Given the low number of Clinical Engineering professionals in the country, it is often difficult for healthcare organizations' human resources departments to determine appropriate salary ranges. This work aims at providing more visibility around actual salaries for specific Clinical Engineering positions in different geographic areas. More than 100 responses were received and analyzed, taking into consideration cost of living and seniority associated to each data point. Starting salaries were obtained for each position, allowing the reader to calculate—adjusting for tenure and local cost of living—their personal salary...
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: Surveys, Studies, & Reports Source Type: research
Survey: Open Positions and Untapped Diversity for Healthcare Technology Management
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: AAMI News Source Type: research
American College of Clinical Engineering
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: ACCE News Source Type: research
Xenter Launches Xenter Therapeutics
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: Technology and Trends Source Type: research
OSN European Agreement Inked
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: For Your Information Source Type: research
Will Things Ever Be “Normal”?
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: Accreditation & Clinical Engineering Source Type: research
Centers for Medicare & Medicaid Services
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: Risk Management & Safety Source Type: research
FDA Issue Slew of Premarket Approvals
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: Washington Scene Source Type: research
Honeywell Secures ISO13485 Certification for Spectra Medical Grade
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: In The News Source Type: research
Wild World
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - September 26, 2021 Category: Medical Devices Tags: DEPARTMENTS: From The Editor's Desk Source Type: research
Ten Lessons Learned During the Pandemic From the Healthcare Technology Management World
No abstract available (Source: Journal of Clinical Engineering)
Source: Journal of Clinical Engineering - June 25, 2021 Category: Medical Devices Tags: FEATURE ARTICLES Source Type: research
Time-Motion Study to Evaluate the Impact of Purchasing within Clinical Engineering
Biomedical equipment technicians and clinical engineers order medical device parts in most hospitals because of the technical nature, knowledge, and expertise associated with medical equipment. But biomedical equipment technicians/clinical engineers can sometimes fail to source high-quality parts at the lowest prices, fill out work orders properly, or follow up when parts are not delivered on time. Moreover, the hours they spend on parts ordering could be better utilized on repairs to increase the uptime of critical equipment. Solutions include hiring specialized buyers within clinical engineering departments or contractin...
Source: Journal of Clinical Engineering - June 25, 2021 Category: Medical Devices Tags: FEATURE ARTICLES Source Type: research
The Clinical Engineering–Information Technology Professional Practice Interface: The Core Professional Task of Clinical Informatics and Its Relation to Clinical Engineering
Clarifying the professional roles between clinical engineers and clinical informaticists potentially will reconcile the clinical engineering and information technology divide, yet the applied science of informatics lacks a defined core task relative to engineering design. Presenting a case study about the design and deployment of a clinical decision support system, we define a core task of informatics. Analyzing this case study given the complexity of clinical systems, we conclude that informatics seeks to solve problems at a hierarchical level above clinical engineering. Attention to the systems complexity of solutions to...
Source: Journal of Clinical Engineering - June 25, 2021 Category: Medical Devices Tags: FEATURE ARTICLES Source Type: research
