Shortage of medical ventilators during COVID-19 pandemic

During the COVID-19 pandemic, a shortage of medical ventilators was expressed widely and extensively across news outlets and the media^[1], leading to investigations on the cause of the shortage^{[citation needed]}. Some findings report that unnecessary proprietary restrictions of parts and technician repairs have led to damaged and unused ventilators^{[citation needed]}, further removing access to life-saving equipment during the global pandemic.

Infection of SARS-Cov-2 works primarily as a viral infection of the respiratory tract^[2]. Depending on severity, patients who are hospitalized upon contraction of the virus may be treated with ventilators^[3], which either assists patients' breathing or takes control of the breathing process entirely^{[citation needed]}.

Given the rapid spread of the COVID-19 virus and the overwhelm of hospitals^{[citation needed]}, ventilators were quickly in high demand and short supply^{[citation needed]}. US President Donald Trump enacted the Defense Production Act to aid in the development of medical ventilators^[4], and even car manufacturers such as General Motors, Ford, and Tesla were using their assembly lines, equipment, and parts to produce more ventilators^[4][5][6][7].

The high usage of hospital equipment at this time also meant more servicing and maintenance required on existing equipment, including newer machines, forcing hospitals to use equipment that sat in storage for many years including decommissioned devices^[8].

The U.S. Health and Human Services Department (HHS) provided funding to many manufacturers to address the shortage^[4].

CEO of Medtronic, Omar Ishrak, reported a 40% increase in production of ventilators with 250 devices being manufactured on a weekly basis^[5], and in addition to partnering with manufacturers like Tesla, Inc., he stated that the company will open-source their low-end ventilators to allow others to manufacture those models^[5].

AdvaMed, a trade association of medical device manufacturers which includes Medtronic, said to have boosted ventilator manufacturing to 2,000-3,000 units per week across the various companies; meanwhile, those same companies reportedly made roughly 700 units per week before the start of the pandemic^[9].

Medical ventilators are a machine used in a hospital or similar setting to help a person breathe. They are used with severely ill patients who are sedated or in a coma. They are typically constructed of various sub-assemblies, such as a pump, and control electronics (which control breath frequency and volume, based on measurements and settings). When one sub-assembly fails, others may still be good. It is possible to connect working sub-assemblies from two compatible broken machines to make one working machine.

Some manufacturers use Digital rights management controls, to control whether they will allow a repaired device to operate. Unlocking the DRM may also require internet access, making repair difficult in emergencies, or where internet access is difficult.

Medical device manufacturers often restrict service and maintenance on the equipment they sell to hospitals, despite hospitals employing certified biomed technicians. Many of these biomed technicians are already trained to service proprietary equipment; however, some manufacturers discontinue providing certification to hospital staff and require hospitals to contact the manufacturer for all servicing and maintenance^[10].

Medical devices in general have become more complex over the years, many of them including microprocessors and software for functionality which allows manufacturers to put software locks on equipment^{[11][citation needed - weak]}.

Example Text^[8]

In his interiew on CNBC, CEO Ishraq stated that Medtronic would open-source their generic, low-end ventilators to allow other manufacturers to produce those same models. However, as stated by Ishraq, the low-end models are not equipped for acute situations^[5]. "Acute" in the medical context is defined by rapid onset symptoms of an illness such as viral infections like COVID-19^{[citation needed]}. Ishraq states that the high-end models are developed with more complex parts and are used for more critical patients.

When asked by the interviewer on the possibility of using one ventilator machine for multiple patients, Ishraq replied that it was dangerous to do so and that the machines are designed for one-person usage^[5]. However, a study in Academic Emergency Medicine described how one machine may be safely and easily used by up to four people for twelve hours during an emergency situation^[12][13].

While Medtronic promised to supply manuals for their generic, low-end models and the equipment open-sourced, repurposed, and otherwise used without restriction^[5], The American Society of Mechanical Engineers published a report stating that the Medtronic manuals provided are outdated, complex, missing core files, and simply do not qualify as quality schematics capable of remaking the product^[14]. The manual for the specific product, the Puritan Bennett 560, had been posted on the official Medtronic website but now leads to a broken webpage^[15], and the item is no longer listed on their website. Additionally, the report states that the files have not been released open sourced; instead, the permissive license will expire when the World Health Organization declares the COVID-19 threat to be over, or on October 1, 2024, depending which comes first^[14].

In August of 2020, a bill was proposed to the U.S. Senate to enable and protect technicians to repair medical equipment without the restrictions of patents and copyrighted material. The bill was intended specifically for the time of the COVID-19 pandemic

During the shortage, attempts were made to create open-source ventilators^[16]

Mindray is a manufacturer that publicly shares their service manuals for medical equipment, along with other freely available education and support for technicians^[17]

Studies and real-world application show that ventilators can be used off-label to safely treat multiple patients, by using a tube-splitter and adapter^[12][13].

• Online activation

• Part pairing