par John R. Fischer
, Senior Reporter | February 24, 2020
From the January/February issue of HealthCare Business News magazine
“Devices have become smaller in size, increasing portability,” says Brittany Schmidke, national business development manager at Rigel Medical. “There is also connectivity with CMMS programs and between the testing equipment and the device being tested. Prices of the devices have actually come down. Touch screen is ever-evolving, and there are now color screens.”
Harkless notes that changes in test equipment, especially within X-ray testing, stem from greater pressure on quality assurance specialists “to get in, get the job done, and get out.” Adding that, “anything that saves time is a premium in the industry right now.”
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While most devices have evolved to the point that older test equipment can no longer provide the functions or accuracy necessary to test these more advanced devices, some types of solutions can still be sufficiently tested with equipment going back decades.
“I used to sell EKG simulators 35-40 years ago,” said O’Day. “That simulator back then will still simulate an EKG complex today just fine, but ESU generators, anesthesia monitors, defibrillators and other medical devices have evolved beyond the capabilities of older test devices.”
Different paths toward equipment validation
The guiding principle for development and efficient use of test equipment is the ability to test and repair whatever the medical device industry creates, says Jerry Zion, global training manager for Fluke Biomedical. For patient monitors this means sending patient-like signals into the medical device just the same as a patient’s real vital signs would come in during clinical use. These are called simulations or functional test information.
Increasingly, many facilities are opting to construct biomed teams to assess equipment in-house. While this requires an investment in tools and training, it removes the expense and wait-time that can be associated with depending on manufacturers for testing and repairing equipment.
“Testing and databasing test results day-by-day and year-over-year enable department staff to get a feel for the medical devices in the inventory of the medical facility and for identifying when failure rates rise. As a result, they can find problems earlier, while they are less expensive and easier to repair,” said Zion. “That makes sure that critical medical devices — especially those of which are small in numbers — are available and ready to use. Otherwise, the hospital loses money and the patient can sometimes become sicker or lose their life due to the device being broken or unavailable to provide them with treatment.”