Ensuring efficacy of COVID-19 treatment with Medical Devices such as Ventilators
Since it first reared its head in early 2020, the COVID-19 pandemic has caused major disruptions around the world. Governments and healthcare institutions have been forced to respond and adjust in their fight against this unprecedented global health emergency.
Meanwhile, the public health fallout from the spread of COVID-19 has also placed many healthcare systems under immense stress. One of the key areas that has been found lacking was the shortage of medical equipment, with many medical institutions finding themselves with insufficient life-saving medical equipment such as ventilators and defibrillators.
And while many countries are starting to find their footing again after the initial shockwave of the pandemic - and the global roll-out of vaccines has begun - the demand for medical equipment and devices remains high.
As a result of COVID-19, many medical equipment manufacturers are developing and manufacturing medical equipment quickly to meet market demand. But several questions remain unanswered. For one, how can we ensure quality and standards of medical devices even as manufacturers are speeding up their product research, development, and manufacturing? Another is how do we enforce quality control standards and certifications to engender continued trust and confidence amongst healthcare practitioners and patient users?
After all, amidst the high demand and rush to get to market, there can be immense pressure to cut corners in terms of quality standards for equipment design, functionality, and manufacturing, but any failure in this area can be potentially disastrous, especially for life-saving medical equipment.
Ventilators are one of the most important medical equipment hospitals have for keeping COVID-19 critical care patients alive. In the wake of COVID-19, health authorities around the world are finding ways to supply hospitals with enough ventilators to support increasing numbers of COVID-19 patients. As such, there is a need to ensure these equipment are in good order and functioning properly.
That means putting these ventilators through different tests to ensure safety and compliance with all applicable standards and requirements.
One of the ways TÜV Rheinland has stepped up to the plate during this crisis was offering safety critical type tests at its Bangalore laboratory for ventilator systems produced in India. Commenting on the initiative, Mr. Arun Deshpande, Managing Director, TÜV Rheinland India said, “We are offering testing services to ensure uninterrupted, safe medical devices in the market.”
He also noted that TÜV Rheinland India has the in-house capability to test and evaluate medical devices for electrical safety, EMC, wireless and reliability parameters according to national and international standards.
One of the ways medical equipment manufacturers can provide greater assurance to users and healthcare authorities during this period is getting their products certified under the IEC 60601-1 series. In fact, many countries around the world have strict requirements for medical electrical equipment to be tested in accordance with the IEC 60601-1 series.
The IEC 60601 safety standards mandate collateral, particular and performance standards specific to the device type, all of which are required for relevant certification schemes. Products such as battery operated thermometers, infusion pumps or MRI imaging systems including some accessories used alongside the equipment must comply with the standard.
IEC 60601 is a globally recognized standard for medical electrical equipment, devices and peripheral accessories. Securing an IEC 60601-1 certification paves the way for easier transitions into major markets as many medical products must complete compliance evaluation, testing and device approval before they can even be placed on the market.
But the testing and certification process of fulfilling the current IEC 60601-1 standard is a complex and multifaceted task. What’s more, oversight of key compliance standards can be costly to the manufacturer, especially in the areas of product redesign, compliance testing, device approval and certification turnaround time.
This makes working with a certification partner with the necessary expertise like TÜV Rheinland, a sound choice.
Our experts offer clarification on the IEC 60601 series for your desired markets, in addition to the framework in which your product design and manufacturing will be evaluated. Here at TÜV Rheinland, we are focused on accommodating the urgency and special circumstances surrounding the manufacture and approval of these products at this time.
Our services include tests based on the EN 60601 series and product-related standards for medical devices used in intensive care units (ICU) such as ventilators, defibrillators, infusion technology, patient monitoring as well as medical devices like forehead thermometer, oximeters, sphygmomanometers, and much more.
Does your company have approval for the IEC 60601-1 series?
Find out more how we can support you with your active medical device by becoming IEC 60601-1 certified today!
TÜV Rheinland helps you understand its complex requirements, on top of identifying the specific standards that apply to your product.
To get a head start in providing the best basic safety and essential performance of medical procedures, we offer the solutions,
from development all the way through the review of your risk management files, that meet your client needs and requirements.
As a leading testing, inspection, and approval services provider, our experts offer certification on the IEC 60601-1 series to expand your market access.
TUV Rheinland ensures conformity of your medical electrical equipment to the international 60601-1 safety standards with the highest level of service.
1) (www.dw.com), D., 2021. COVID-19 Special: Healthcare systems under stress | DW | 07.04.2020. [online] DW.COM. Available at: <https://www.dw.com/en/covid-19-special-healthcare-systems-under-stress/av-53053650>
2) Begg, R., 2021. Global Medical Equipment Shortage as COVID-19 Spreads. [online] Machine Design. Available at: <https://www.machinedesign.com/medical-design/article/21125385/global-medical-equipment-shortage-as-covid19-spreads>
3) Rheinland, T., 2021. TÜV Rheinland Offers Tests on Ventilator Systems. [online] Insights.tuv.com. Available at: <https://insights.tuv.com/blog/t%C3%BCv-rheinland-offers-tests-on-ventilator-systems>