If You’ve Heeded the Rallying Cry for Ventilators, Here are the Government Regulations You Should Know
Learn about which government regulations have been dropped or modified to speed up design approval for ventilators.
The COVID-19 pandemic has upped the pressure on global healthcare systems. Although ventilators are in high demand, developing these devices in the past has been a long process—and rightfully so. Medical devices must pass through months of testing and regulatory processes for safe and reliable use. These high regulatory standards are essential given the demands of life-saving medical devices: the ability of 24/7 operation, battery backup systems, and so forth.
Although the core standards for medical devices must remain high, the surging ventilator shortage has prompted governments around the world to relax their laws and regulations so that if needed, simpler ventilators can be used on non-critical patients. Many electrical engineers have risen to the call with an influx of open-source ventilator projects.
An open-source ventilator from MIT. Image used courtesy of MIT
How will these decreased requirements affect electronic engineers building these devices? And will these loosened regulations allow EEs to speed up the design and verification process for ventilators? In this article, we'll aim to answer these questions by breaking down the new protocols in the UK and the US.
How the UK Has Loosened Ventilator Regulations
While the UK government has made changes to the ventilator requirements, these changes mostly concern reliability and power options. The following information is pulled from a guide on rapidly manufactured ventilator systems published on the UK's Department of Health and Social Care site.
Boiled-Down Ventilator Specifications
The UK's new regulations require that ventilators operate at 240 V and have a battery back-up system that provides power for at least 20 minutes. Ventilators should also provide optional hot-swappable batteries and must avoid RF and EMC emissions.
Design and Manufacturing Transparency
One area, in particular, that affects electronic engineers is the requirement for transparency—in design, supply chain, and manufacturer. While regulations are more lax, the ventilator will still require MHRA officials to determine if the risk of using the ventilator is enough to justify the ventilator's capability. This means that engineers should avoid close-boxed solutions and intellectual property protection (i.e. proprietary code with protection methods). They should also ensure that all components are easily sourced with a supply chain that minimizes risks.
A Strictly UK-Based Supply Chain
Another interesting requirement by the UK government is that the design must, if possible, use parts that involve the UK supply chain. The rationale behind this requirement is that the COVID-19 virus could lead to borders closing and suspended trade. In that scenario, constructing ventilators with foreign parts could become impossible.
Another requirement that may be important for engineers to consider is the need for a compact design that will allow medical staff to easily move around. This can be reflected in the circuit design by requiring a small PCB. But generally speaking, electronics are already quite small and this requirement relates more to the mechanical parts of the ventilator.
How the US Has Loosened Ventilator Regulations
Like the UK, the US's regulatory body, the FDA, has also published revised standards for ventilators. The following information is pulled from the FDA's report on policies for ventilators
and other respiratory devices during COVID-19, updated this month (March 2020).
Anyone Can Propose Designs
The first major change is that anyone can come up with a design and propose it to the FDA, which will judge the merit and risks of the design. Be sure to incorporate sensible design practices such as EMI reduction, reliable firmware, and decent circuit protection methods; the FDA may be more inclined to consider the design.
IoT Technology in Ventilators
One specific area that the FDA has mentioned (that other governments have not) is the inclusion of IoT technologies. Since medical professionals who care for COVID-19 patients are at high risk for contracting the virus themselves, the FDA has noted the value of remote monitoring systems. The ventilators can be designed to include remote monitoring and control via Wi-Fi and Bluetooth. These systems would limit contact while featuring strong cybersecurity measures to prevent remote hacking.
No More Re-checks After Component Switchouts
Usually, when a medical device replaces a component, battery, or motor with a different model, the FDA is required to perform rechecks to ensure that the modifications do not pose an increased risk. However, the FDA is dropping these recheck requirements, allowing engineers to make modifications to components and materials so long as the engineer performing the changes does his or her due diligence disclosing the risk of the modification.
Labeled Disclosures of Changes
The designer must include a label on the device that mentions which components were changed along with a disclaimer that the modified device has not been FDA approved. This will make patients and medical providers aware of the risks of the device.
Advice on Submitting Ventilator Designs
Creating a ventilator is no small feat. Before you've laid the basic groundwork for your design, you should be aware of your local government's regulations on ventilator devices to ensure your end product will operate safely. When designing the circuitry for such a device, there are some simple rules you can follow to ensure that the circuit in question is safe, reliable, and practical. Here are a few pointers to keep in mind:
- Use circuit protection: inputs, outputs, and power systems
- Implement alarms: have software routines that check all aspects of the design
- Implement basic RF and EMI control: ground planes, stitching via, small track lengths
- Use RoHS compliant parts: avoid those containing lead, mercury, and cadmium
- Supply components locally: avoid oversea suppliers if possible
- Minimize software tasks: don’t create overly complex software routines
- Minimize hardware: try to keep component count at a minimum
- Build on pre-existing foundations: open-source software and hardware may reduce development time and use proven foundations
An EEs Hand in Patient Care
Medical equipment requires the highest standards of engineering. Many EEs have risen to the challenge to disinfect, diagnose, and treat COVID-19 patients alongside healthcare professionals through their medical device designs. When a global pandemic threatens human life on a grand scale and pushes engineering to its limits, it's amazing to see how devices that would normally be subjected to months or years of regulations can not only do the job but can also save lives.
Engineers and doctors at Vanderbilt University are teaming up on an open-source ventilator. Image used courtesy of Vanderbilt University
As Robert Keim notes in his article on the ethics of engineers designing medical devices, EEs in medical manufacturing should be aware of their hand in patient care, especially during COVID-19. While engineers designing these ventilator systems may have more freedom in their designs, it is essential that they understand that if push comes to shove, their device may be responsible for someone's life.
very good article who put thing into perspective ,
We have develop ,design (hardware) , programmed (software) and manufactured medical ventilator machines for hospitals and personal use (CPAP , BPAP ) for a medical companies in several countries(UK,USA,JAPAN…).
It took us 5 years to accomplish the task of designing & manufacturing , as the medical regulation (FDA,CE,UL,PMDA…) was not an easy test to pass.
We have put many innovation into the machines, from breath learning algorithms(ML), to innovation in hardware , task process and maintenance as ventilator breath machine is not a new invention and available for the last 70 years.
Interesting quote: “FDA has mentioned (that other governments have not) is the inclusion of IoT” -
We at iotleaf are offering remote control of ventilators & oxygen concentrators.