Helping manufacturers meet the demand with devices that are safe, reliable and of high quality.
When the COVID-19 pandemic took hold, so too did the demand for ventilators. With patient safety at its heart, ISO’s committee for respiratory devices rapidly got to work on a new standard to support the manufacture of new, high-quality medical equipment that could help.
Now, as publication of this standard draws near, we talk to two experts about the role of this and other related standards in the current crisis and what difference they could make.
Bob Kopotic is a Critical Care Manager of Clinical and Medical Affairs for Edwards Lifesciences. He is a licensed critical care registered nurse and respiratory therapist.
Dr Sandy Weininger is a Senior Regulatory Engineer in the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA).
Both are members  of ISO’s subcommittee ISO/TC 121/SC 3 on respiratory equipment.
When COVID-19 engulfed the world, ISO quickly made a number of ventilator-related standards freely available. What value could they add?
Bob: We are in a period where ventilators are used perhaps more than ever before. Not only are more ventilators of various kinds required, but more medical staff need to be brought up to date with how to use them correctly.
Internationally agreed upon standards such as those offered by ISO not only help manufacturers produce this kind of equipment more quickly and to high levels of quality and performance that comply with all necessary regulations, but they also help to ensure it is used appropriately and as intended.
Sandy: Making these ventilator-related standards freely available helps manufacturers to easily incorporate design elements to support safe device construction. It also gives them up-to-date and standardized specifications and information that are well understood and accepted, as well as testing methods to verify performance.
It seems there are many types of ventilators used in hospitals, some of which are more suitable for COVID-19 patients than others. Can you explain?
Bob: For patients who are seriously ill and can’t breathe on their own, there are ventilators that basically “act” as their lungs. These are life-support ventilators.
However, early 2020, it was also identified that there were a number of patients who just needed some support in breathing without necessarily having to be on life support. There is a category of non-invasive ventilators that can do that and were therefore seen as hugely useful. They have fewer side effects than intubation and can provide just the support these patients need at a time when they are straining for every breath.
Sandy: And they aren’t new. Some of them have been used for many years for other indications, such as sleep apnoea, but when their usefulness for COVID-19 patients was recognized, demand for them exploded.
At the same time, the FDA in the US issued an emergency use authorization for certain ventilators and related devices that “may be effective” in treating individuals during the COVID-19 pandemic. This means, for example, that ventilators such as certain ones used for sleep apnoea are authorized for use on COVID-19 patients.
How did the market respond to the increased demand for these non-invasive ventilators?
Bob: It became a serious issue. Hospitals were running out of these devices because the traditional supply chains weren’t functioning properly. Many manufacturers had closed down. So medical services were resorting to other less appropriate devices and methods that still required intubation, which is highly invasive and carries significant risks. They were also turning to similar devices used for sleep apnoea that came under different regulations.
Sandy: It was a time when existing products were being adapted to new clinical uses, and the potential of these ventilators to treat many COVID-19 patients was soon recognized. As a result, these and other emergency use resuscitator systems were rolling out of engineering shops across the world.
Bob: But they didn’t meet the exact requirements for a hospital setting where someone could be conscious, still breathing spontaneously but with very great effort. What’s more, they weren’t classified as medical devices under the same regulations.
Where did the idea for a standard for these ventilators come from?
Bob: Patient safety is the driving force behind the standards that we develop. When we saw what was happening in the field, our first thought was: How can we help medical services to reduce the breathing difficulties of COVID-19 patients without compromising their safety?
Sandy: The ISO subcommittee saw that established, internationally agreed upon safety criteria could go a long way to helping ensure these new devices were developed correctly. That is, for their intended purpose, with agreed levels of performance and quality and to help meet any regulatory requirements. This would then make it easier for manufacturers to produce the devices in this way and give healthcare staff the reassurance that they worked as they should.
How can this standard help with the COVID-19 pandemic?
Bob: This type of respiratory aid can help significantly because it has proven to be effective in treating moderately ill COVID-19 patients, i.e. those needing oxygen therapy but not full life-support ventilation. There is an extremely large number of patients in this category and only a limited number of life-support ventilators available.
This type of equipment is essential as it frees up other equipment for more serious cases, while giving all patients the lifesaving care they need. As far as we and other experts are aware, there are no other national or international standards for this modality.
Sandy: Standardization can bring consensus on what constitutes a safe device so that manufacturers can concentrate on production and not on what is the best way of meeting safety criteria.
Can this new standard help beyond COVID-19?
Bob: The good news is, yes! The standard’s development was an opportunity to improve and standardize the quality and specifications of these devices in general, as they are useful for lots of other respiratory problems such as asthma attacks. They fit all populations and can really help to support fragile patients.
How quickly can it be published?
Sandy: A typical standard takes three to five years to develop, but these are not typical circumstances. We have had meetings day and night to get it done. With experts volunteering in 21 different time zones, this unfortunately means someone is always attending an online meeting at an uncivilized hour.
Bob: This standard will have been developed 100 % virtually, which is a first! It helps that all the experts of this working group know each other well as we have been working together on other standards for more than ten years. This has been really useful in the virtual development process and we expect the standard to be available later this year.
Pulse oximeters were another device that saw a surge in demand, and production. What are the risks and benefits of such devices?
Bob: It is true that oximetry was highlighted as a means for assessing the severity of the disease. Pulse oximeters are used regularly in hospital settings and, as medical devices, they are expected to adhere to regulations. But there were also other products that some considered “general wellness products” (which did not meet the medical device requirements), that people used when doing sport or on the plane; these didn’t have the same performance or meet all of the same requirements. The surge in demand for these meant that there were suddenly many more companies all over the world making them, but to varying levels of quality and performance.
Sandy: The question was (and still is): Can you repurpose a general wellness product to assess COVID-19 symptoms? ISO has a number of standards related to oximeters. Use of these helps manufacturers meet any applicable regulatory requirements and ensure their devices are of an agreed minimum level of quality and performance. Assuming they meet regulations, this then gives reassurance to medical staff that the device will work as intended, at a time when, more than ever, they need effective and reliable equipment.
Are there any other standards the committee is currently working on that could help?
Bob: We have a whole host of standards in the pipeline related to various types and aspects of respiratory equipment, as well as plans for updating many others that already exist.
Sandy: The work never stops! We are constantly assessing market and patient safety needs to see what is required and we also assess our own standards regularly to ensure they are as up to date as possible.
The secretariat of technical committee ISO/TC 121, Anaesthetic and respiratory equipment, subcommittee SC 3, Respiratory devices and related equipment used for patient care, is held by ANSI, ISO’s member for the USA.
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