How to Test Medical Devices During a Pandemic

The COVID-19 pandemic caught more than just the medical community by surprise. The rapid infection rate overwhelmed hospital ICUs with the demand for medical devices to support patients.  Ventilators and other critical medical devices saw radically increased use which meant more frequent testing.  The major challenge for technicians, however, was dealing with the strict restrictions put in place to prevent further transmission of the disease. The lessons learned from this unprecedented pandemic compelled technicians and test equipment companies to rethink how to be adaptable to changing protocols and to be creative about approaching their jobs.

Gerald Zion, global technical training manager at Fluke Biomedical knows firsthand how the pandemic affected testing medical devices. "As the world came to grips with the tsunami of COVID-19 patients requiring not only hospitalization but intensive care treatment, we were faced with increased demand for testing emergency department and ICU medical devices. These included not only ventilators but also patient monitors and infusion devices.”

The increased demand for testing extended to medical device manufacturers who were tasked with developing new products on an accelerated timeline.  The new products and tight timelines required multiple rounds of testing both in the design phase and the final product. To meet the high demand, testing was also needed at newly outsourced production facilities where training was required for employees who had never tested medical devices.

"Whether in the hospital or on the production line, these challenges required ramping [up] of supply chains and methods for delivering training rapidly; says Zion. "We are proud to have been able to have the right test instruments, at the right time, and the ability to teach the use of those key test instruments, electrical safety, infusion device testing, and ventilator/anesthesia system testing."

One Fluke testing device that has seen huge demand during the pandemic is the VT900A Gas Flow Analyzer. As healthcare facilities used more ventilators to treat COVID-19 patients, the devices were tested using an updated version of the VT900A. The VAPOR accessory was used to expand the VT900A's capability to test all medical devices that exert a gas pressure or produce a gas flow. Fluke further improved its VT900A by adding interoperability with the company's OneQA Workflow Automation Software suite. "This allowed for standardization or testing procedure workflow, minimizing sources of human error, and making the testing and documentation much more efficient than ever before," says Zion. "OneQA also already incorporates interoperability with our electrical safety analyzers and the IMPULSE 7000DP Defibrillator/Pacer Analyzer."

The impact of the pandemic experience will have long-lasting repercussions.  Jerry sees hospitals improving their supply chains for medical devices and testing equipment as well as the standardization of devices so that it won’t be as complicated to operate and test them in the future. "The pandemic 'just-get-me-anything' reaction came with the 'how-do-I-make-this-work' and 'what-needs-to-be-tested’ challenges," he says. "Reducing risk to the patient from unfamiliarity with medical devices and getting the medical devices to 'talk' to the hospital network while managing cybersecurity and interoperability remain issues.”  Safety is also a major concern that the COVID-19 pandemic has brought into intense focus. Jerry says. He is seeing "alarming volumes of incidents that should be found during periodic testing.” But he is heartened by the increased acceptance in the United States of the need for incorporating quality assurance testing into workflows.

"End-to-end interoperability with workflow automation and standardized test procedures can and does help," Zion says. Periodic testing creates inputs about failures encountered during testing over time and helps computerized maintenance management systems develop a predictive maintenance plan, instead of the current norm of reactive fixes once something has already stopped working. Medical devices sitting idle in a repair queue reduce quality patient care, and impact hospital revenue.

The challenges Jerry sees in creating test instruments include intuitive user inter­faces; rapidly and appropriately responding to medical device innovations (which, he says, occur before the minimum performance and safety standards can respond and include such testing); improving on-demand user training about the test instrument itself, and interoperability with other systems for two-way communication or information for scheduled testing, and long-term trending of failures.

Fluke Biomedical stepped up and played a major role in helping technicians keep critical care medical devices operating at top performance standards during the COVID-19 pandemic.  But, after the virus wanes, the challenges Jerry Zion described remain.  The lessons learned from the COVID-19 experience will force the industry to carefully consider and address the issues raised for the sake of patient safety.