HAVE QUESTIONSGet Support from
Fluke Biomedical representatives.
The Advantage Training site provides free and instant access to both basic and advanced medical device quality assurance training courses. With Advantage Training, you can stay up-to-date on all the latest techniques and tools from Fluke Biomedical and RaySafe.
No-cost BMET biomedical technician training for medical device testing, including:
Medical Device Quality Assurance (MDQA) program development and procedures, performance and safety testing, documenting for regulatory compliance, productivity improvement ideas and demonstrations, and using test instruments effectively.
What can I find in the Training Center?
The training center is organized into courses and curriculum about MDQA and can be filtered by category, or keywords/phrases. Select a category to view courses and curriculum available to you any time—at no cost.
Advantage Training offers:
Types of training materials:
Advantage Training from Fluke Biomedical/RaySafe includes scheduled, on-location training events that happen around the world. These training events offer the unique opportunity to learn from experienced instructors and coaches in actual testing situations often with hands-on learning. The scope of training can be customized to fit local needs. Tuition fees may apply, so ask your local Fluke Biomedical/RaySafe representative for more information.
Defibrillators include many more patient parameters, modes of operation and innovative designs than ever before. Among these are temporary transcutaneous pacemakers, AED-like automatic assessment of arrhythmias, and algorithms and circuitry that ensure defibrillation-therapy-energy delivery based on the settings. Older test instruments may not be able to test these newer design capabilities.
Electrical safety testing was the first mandate of biomedical engineering, and why biomedical engineering was brought into the hospital as a functional area in the 1970’s. Today there are many electrical safety standards, most of which have been harmonized with the IEC standards found under IEC 60601.
The basis standards (IEC 60601-1 and IEC 62353) are constantly under review and revision. Not only is it hard to keep up, it is also not easy to understand how to apply testing methodologies, or testing limits.
Medical gas flow and pressure are produced by many more kinds of medical devices besides ventilators and anesthesia systems. While ventilators and anesthesia systems have specific requirements for complete quality assurance testing, the basics of flow, pressure, and time are fundamental.
Endoscopic insufflators, tracheal and wound suctioning devices, side-stream-sampling gas concentration monitors, flow meters, vacuum pressure gauges, and more are in the inventory of every hospital, clinic, and doctor’s office.
While small hospitals and clinics may include a manageable quantity of infusion pumps, including enteral feeding pumps, syringe pumps, infusion controllers, larger medical facilities often include as high a quantity as 3 infusion devices per bed. This number can reach seemingly un-manageable quantities compared to the biomedical engineering department staff available to perform medical device quality assurance testing.
Recently the high incidence of failure across all makes and models of infusion devices has caused the US FDA to focus its attention on reducing the un-managed risk to the patient posed by these failures. Batch-testing may provide a more economically acceptable method for completing tests.
Patient monitors were among the first electronic technologies to be brought into the hospital. Though patient monitor designs have dramatically improved reliability, the frequent failure of patient-connected sensors still makes it important to perform quality assurance testing. Innovative technologies that have improved NIBP-measurements during patient movement, and brought diagnosis formerly available only after clinical laboratory analysis of blood samples cannot be tested with older test instruments.
Patient monitor testing is far from routine. The patient monitor testing courses introduce new concepts for patient monitor quality assurance (performance and safety testing, documenting for regulatory compliance, productivity improvement, and using test instruments effectively).
Everywhere that diagnostic imaging or endoscopic surgeries are performed in the hospital, or clinic, and everywhere video cameras are used to see the patient from a distance (neurological ICUs, isolation rooms, etc.) there is the potential for time-chain problems requiring an oscilloscope to troubleshoot.
Balancing 3-phase power coming into the power supplies of diagnostic imaging systems, renal dialysis systems, a multiple channel oscilloscope and digital multi-meter finds labor-saving use. Troubleshooting power line transients (previously requiring a line transient recorder) may be another use for a recording-oscilloscope to capture not only the numerical fact and instance of the transient, but how it looks on the voltage waveform or current waveform.
Diagnostic X-ray system quality assurance testing is done by radiographic engineers (who may report to biomedical engineering, radiology, health physics or medical physics department in hospitals or independent contractor companies). Safety and effectiveness for clinical use is determined by medical health physicists who may also serve as radiation safety officers.
While physicists are generally well trained on testing tools needed for dose assessment and image quality, they leave the assurance of performance and safety of the X-ray systems to radiographic engineers. Both these groups are ultimately trying to reduce risk to the patient from detrimental, accumulative effects of exposure to ionizing radiation.
Biomedical engineering departments are well advised to make sure that staffing, training, test instruments and other testing tools (including phantoms) are available before jumping into full maintenance responsibility for X-ray systems. An easier entry point is first-call troubleshooting, and so both first-call and full maintenance responsibility are included in the scope of training.