Urgent call for ventilators triggers stringent need for safety

Opinion

While there is an urgent need for more ventilators currently, the need for them to be safe and effective is just as great, says  Dr JT Janssen, Chief Scientist at the National Physical Laboratory (NPL)

As the UK’s National Metrology Institute, the National Physical Laboratory’s (NPL) world-leading measurement science and engineering plays a vital role in helping to tackle the COVID-19 pandemic. In particular, we are offering support to companies developing and manufacturing ventilators in response to the UK ventilator challenge. NPL underpins the national measurement infrastructure providing confidence to all of science, technology and manufacturing and also supports industry directly by engaging in more applied areas where there is market failure or a national challenge, as is the case for ventilator support at this time.

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The principles of accurate measurement are universal and bind together confidence in all of trade and technology. We have hundreds of world class scientists whose careers are built on understanding measurement, making NPL uniquely placed to contribute in almost any area where manufacturers need support.

Ventilators are precision pieces of equipment being used in the medical sector, therefore requiring many different measurements to ensure every single one is safe and effective. Despite the urgent need for ventilators, they still need to be appropriately regulated to ensure their safety and reliability. Manufacturers need to produce sufficient evidence to demonstrate their ventilators meet all the required regulations, and NPL is helping companies achieve this.

The device’s performance and reliability is of course vital, as too is their durability. Ventilators are electrical devices and due to current demand, will be used continuously, therefore guaranteeing that they will withstand high usage is key. There are many different measurements that need to be taken and we are helping companies understand which are the most important.

If you are making 30,000 ventilators, you need to ensure the first one produced meets the design specification

We have established a test capability so that anyone designing ventilators has the ability to receive performance evaluation on it. Testing provides confidence to manufacturers looking to take their device to the Medical and Healthcare Regulatory Approvals (MHRA) for approval for use.

NPL has a broad team of experts, with vast knowledge in many of the key parameters of ventilator control and operation, on hand to work with companies developing the devices. We have been called on by industry, including those involved in the Ventilator Challenge UK consortium, to provide support and assistance in overcoming problems in meeting the MHRA requirements.

Testing for devices like ventilators is time consuming. NPL was asked recently to help identify time savings in a company’s test plan. Without compromising product performance or patient safety, NPL provided suggestions that enabled the company to confidently reduce their test plan time from 6 hours to nearly half that.

We are providing confidence in the design and testing of ventilator systems and other COVID-19 response equipment. We can perform tests to verify and validate performance of materials, instruments and sensors and in the case of the ventilator challenge, we are offering inspection services using NPL’s measurement capability. We are able to accurately measure physical parts and verify them against the original design to help validate whether it meets the design specification dimensionally. This is vitally important for companies looking to manufacture on a large scale. For example, if you are making 30,000 ventilators, you need to ensure the first one produced meets the design specification. If this check isn’t completed, you risk producing 30,000 devices that can’t be used. The First Article Inspection Report (FAIR) is important in this instance and that is where NPL can help.

Ventilators must meet regulatory requirements (Image: Wikimedia commons)

Many companies that are not normally involved in producing medical devices are now building devices with non-medical grade materials and ensuring their safety is paramount. NPL is providing expert troubleshooting advice, most recently helping a supplier to understand how to use and calibrate a weighing device at lower loads than usual to measure volatile organic compounds being liberated from the materials used. Consequently, accelerating the validation of a new ventilator design.

Due to the shortage of some components, companies manufacturing devices might need to adapt to use a different component in their ventilators. There are several protocols that they must go through to measure that the ventilator will still perform. Our expertise is vital in assisting and providing assurance in this process.

The critical thing that manufacturers need that NPL is able to deliver, is confidence. We provide confidence that the new ventilators being developed will meet the regulatory requirements. Consequently, getting the ventilators into the NHS as soon as possible to be used to help save lives.