Why is product safety critical for respiratory ventilators during the COVID-19 global pandemic?

Over the last couple of weeks, traditional American and European manufacturers of ventilators have been ramping up production capacity by 30-50% to meet the soaring demand but are still falling short.

Source: http://www.centerforhealthsecurity.org/our-work/events/2018_clade_x_exercise/pdfs/Clade-X-ventilator-availability-fact-sheet.pdf

Industrial heavyweights such as Ford, GM, Tesla, Dyson, and others have responded to the call by governments to address the ventilator shortage problem. Many have joined forces with MedTech manufacturers to convert their production facilities to assemble parts for ventilators.

Ventilators basics and production

Ventilators are sophisticated devices that are expensive and involve supply chains spread across the world to source multiple parts. They are controlled by strict safety regulations and evaluation processes before they are placed into the market. Mechanical ventilators are conventional with more useful functions and advanced features.

New technologies in ventilators or respirators, including closed-loop modes, automated weaning features, and smart alarm systems, continue to improve patient outcomes, ease of use, and efficiency. Ventilators continue to become increasingly automated, adaptable, integrated, visual, therapeutic, and safety-driven in respiratory monitoring, data collection, and care. In general, ventilators can be grouped into:


Invasive ventilators
– used in critical care units like CCU, ICU, and step-down units.

Non-invasive ventilators – used in hospitals and homes for spontaneously breathing non-ventilator dependent patients, e.g., Bi-level ventilators.

CPAP ventilators – Continuous Positive Airway Pressure (CPAP) machines.

 

According to ResMed, a comparison of ventilators to cars would be to think of CPAPs like a chassis of the four-cylinder car. It is possible to put a V8 engine with extra motor power, additional software, and extra sensors for a CPAP to become a powerful non-invasive ventilator.

Source: https://www.nbcnews.com/news/world/coronavirus-ventilator-rush-faces-regulatory-logistical-obstacles-n1161651

More than 500 parts go into manufacturing an advanced invasive mechanical ventilator and automotive, aerospace, and defense manufacturers are offering help existing ventilator manufacturers to produce critical parts to help alleviate the parts shortage problems. In turn, the industrial companies can contribute to an increase in production lines with logistics, supply chain, and large-scale technical expertise.

Product safety and adverse events

Research and consulting firms unanimously agree that product safety is the leading concern for medical device manufacturers to address. Medical devices, such as ventilators, which are in critically high demand, are at a high risk of cyber threats and are subject to several different vulnerabilities.

Product safety is paramount to prevent cyber threats and ensure any new ventilators distributed are protected. It has been found that there are three key areas to focus on for ventilators:

  • Product reliability
  • Patient safety
  • Comfort

Sources:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

Ventilator malfunction was the most common event type reported in the FDA system. In many of the events, it was difficult to determine whether the ventilator performed appropriately given the situation or whether the ventilator itself failed.

Ventilation equipment is subject to a variety of adverse events and recalls. They range from software and hardware malfunctions, to those associated with breathing circuits, control systems, monitors, and alarms, with the top safety concern being alarm management. It is worthwhile to note that alarm systems can be suppressed unintentionally, whereas others allow clinicians to disable all alarms, including critical ones. Both cases are hazardous and can result in severe harm.

In 2019 a Class I recall, the most severe type due to the potential for severe injury or death was prompted by 14 complaints to a major ventilator manufacturer. More than 4000 ventilators were recalled because of the potential for a software error to cause the device to stop providing breathing support to the patient. The device provided breathing support for adult, pediatric, infant, and neonatal patients in intensive care. The FDA determined that the use of the equipment without a software correction could cause severe injury or death, although there were no reports of harm to patients.

So far, in 2020, out of the total list of 15 Medical Device Recalls by the FDA, three Class I recalls have been attributed to ventilators, anesthesia machines, and other respiratory accessories. They range from recalls of non-invasive and invasive ventilators due to sound alarm failure to anesthesia systems due to loss of mechanical ventilation to respiratory modules due to incorrect oxygen values.

Other common problems, such as leakage and patient-ventilator asynchrony, can usually be avoided by using a well-designed ventilator and maintaining it correctly.

FDA enforcement policy for modifications

On March 22, 2020, the FDA issued guidance for the Emergency Use Authorization (EUA) Policy for modifications to FDA-Cleared Device and Enforcement for Ventilators and Accessories and Other Respiratory Devices during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The enforcement applies specifically to five different classifications of devices:
  • All ventilator types
  • Anesthesia gas machines
  • Other respiratory devices
  • Accessories used to provide ventilation
  • Ventilatory machine support

The guidance states that wherever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators when necessary to support patients with respiratory failure or a device subject to an EUA. A policy for modifications to FDA-cleared devices has been issued to assist manufacturers in adding production lines or different sites. It also allows manufacturers to source parts from alternative suppliers (e.g., changes to motor or ventilator tubing).

Two critical observations to software modifications with caveats include:

  1. In the context of COVID-19, the FDA does not intend to object to limited modifications to the FDA-cleared hardware, software, or materials. This includes hardware and/or software modifications implementing the capability for remote monitoring and remote adjustment of ventilator parameters (i.e., adjustment of parameters by trained health care providers from outside an isolation unit to avoid unnecessary exposures). One example is the addition of wireless and/or Bluetooth capability.
  2. Due to product safety requirements for any such changes, manufacturers should develop and implement appropriate cybersecurity controls to assure device cybersecurity and maintain device functionality and safety. The FDA recommends that firms refer to the four FDA guidance documents for consideration when pursuing these design changes.

The FDA recommends following the 22 different FDA-recognized standards for specific device types when designing, evaluating, and validating changes made to hardware, software, materials, or duration of use. It also recommends labeling for EUA ventilators – ventilators that are FDA-cleared and those that are not FDA-cleared.

Source: https://www.fda.gov/medical-devices/letters-health-care-providers/ventilator-supply-mitigation-strategies-letter-health-care-providers

In conclusion, with the increased need for ventilators due to the COVID-19 global pandemic, many automotive, aerospace, and defense manufacturers are offering their help to existing ventilator manufactures to produce critical parts. Now with regulatory enforcement being relaxed and as the production of ventilators ramps up, minimal measures are being put in place to ensure product safety for ventilators used for life support of critically ill COVID-19 patients. It is a challenging time when the FDA balances safety and supply constraints experts in product security can offer insights moving forward, and hospitals can ensure that products meet the highest standards. The need for ventilator manufacturers to implement appropriate product and cybersecurity measures is critical without regulatory insight.

 

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