Heidi West, Medical Writer, Vohra Wound Physicians04.27.20
In February, many of us could never have fathomed how aggressively the COVID-19 pandemic would spread across the nation. The immediate need for telehealth and telemedicine as key technology emerged globally as the pandemic spread from country to country, eventually being imported via travel by American citizens unaware they were the catalyst for a state of crisis medically and financially that would eventually affect all 50 states.
Healthcare systems and infrastructures across the globe began to immediately turn to telemedicine as a key technology that would provide safe and efficient communication between healthcare professionals, facilities, and the patients who desperately needed guidance and care.
The WHO Releases Guidance on COVID-19 Response
On March 25, 2020 (since updated), the World Health Organization released a document entitled “Strengthening the Health Systems’ Response to COVID-19” that contains technical guidance on mobilizing the healthcare workforce and maintaining the continuum of care for patients. The guidance specifically names telehealth as the most efficient approach to achieving healthcare delivery in light of the overwhelming surge of patients needing medical attention. The guidance covers:
How the U.S. Federal Government Responded
As it became increasingly obvious something must be done to alter the state of the nation’s antiquated infrastructure to meet the mountainous strain on the healthcare system, the federal government released a $2.2 trillion stimulus package called the CARES Act that would contain history-making alterations to the definition of healthcare delivery. Included in this bill was what has proven to be a huge benefit to the medtech and fintech industries as well as healthcare organizations, clinics, and skilled nursing facilities.
IT departments across the nation sprang into action to design and implement a platform for telemedicine. Hospitals needed to triage patients before they entered the hospital, family practitioners and specialist doctors needed to see patients virtually when possible, and financial departments needed a way to efficiently handle the flood of new patients and billing.
The FDA Monitors Medical Device Supply Chains
The FDA has begun closely monitoring any potential disruptions to the supply chain for medical devices due to the industrial impact of the pandemic on manufacturing facilities. Pre-pandemic drug manufacturers were already required to report drug shortages to the FDA, but there’s never been a requirement for reporting such shortages for medical device manufacturers.
As the virus aggressively spread across the globe, the FDA began encouraging device manufacturers to make them aware of any issue by emailing them reports of any device shortages.
Engineers, Developers, and Scientists Impacting the Frontline
There has been a seemingly constant problem coming from the frontline workers in the hospitals and healthcare facilities: a personal protection equipment shortage. The shortage of N95 masks is a prominent issue.
On March 30, 2020, researchers at Duke University announced they had developed and tested a procedure for sanitizing N95 respirator masks so they could be used again with efficacy. Using vaporized hydrogen peroxide, Duke Regional Biocontainment Laboratory found the germs on used masks can be killed.
On April 10, 2020, the FDA granted an emergency use authorization to STERIS Corporation for its sterilization systems that use vaporized hydrogen peroxide for low-temperature sterilization. The STERIS V-PRO is capable of decontaminating ten N-95 respirators at a time approximately every thirty minutes. Every N-95 respirator can be sanitized up to ten times for single user reuse.
Engineers, Doctors Tackle the Ventilator Shortage Issue
A group of engineers and doctors from UC San Francisco and UC Berkeley announced on April 3, 2020, they developed a quick and efficient technique to turn sleep apnea machines into ventilators. The high demand for ventilators stripped the supply available to hospitals, which have been overwhelmed by patients afflicted by the novel coronavirus.
The group of professionals is calling themselves the COVID-19 Ventilator Rapid Response Team. Through a collective of knowledge, they have found a way to repurpose sleep apnea devices so they work as ventilators, supplying precious oxygen to the deprived lungs of patients. They are seeking rapid FDA approval and are enlisting local and federal officials. They also need donations of CPAP and BIPAP machines some Americans may have in their home and are not using. Devices can be donated by organizations and people who want to help get ventilators to patients more readily.
OraSure Technologies Secures Federal Grant
Lehigh Valley medical device company OraSure Technologies secured a $710,000 federal contract to produce a test for COVID-19 that can be self-administered in a person’s home. The in-home self-test will make coronavirus testing available at a higher capacity, giving hospitals and labs some space to breathe in this time of extreme crisis.
The development of a test that people can do themselves at home without the need for a visit to a doctor or a lab will likely significantly impact the rate of community spread. This cannot be less urgent, especially with Dr. Fauci’s prediction that there will be a second wave of COVID-19 in September.
Once the test is developed, the device company will seek a EUA from the FDA for immediate usage.
Heidi West is a medical writer for Vohra Wound Physicians, a national wound care physician group. She writes about healthcare and technology in the medical industry.
Healthcare systems and infrastructures across the globe began to immediately turn to telemedicine as a key technology that would provide safe and efficient communication between healthcare professionals, facilities, and the patients who desperately needed guidance and care.
The WHO Releases Guidance on COVID-19 Response
On March 25, 2020 (since updated), the World Health Organization released a document entitled “Strengthening the Health Systems’ Response to COVID-19” that contains technical guidance on mobilizing the healthcare workforce and maintaining the continuum of care for patients. The guidance specifically names telehealth as the most efficient approach to achieving healthcare delivery in light of the overwhelming surge of patients needing medical attention. The guidance covers:
- Maintaining essential services while simultaneously freeing up the capacity in the flow for treating COID-19 patients
- Protect patients from contaminating one another
- Training, repurposing, and mobilizing the workforce of the healthcare industry according to a prioritization of services
- Protecting the physical health of frontline workers
- Anticipating and addressing the mental health needs that can and will arise during a time when mass casualties occur. A pandemic is not unlike a war zone behind the walls of a hospital. PTSD is to be expected when the virus is no longer a global threat.
How the U.S. Federal Government Responded
As it became increasingly obvious something must be done to alter the state of the nation’s antiquated infrastructure to meet the mountainous strain on the healthcare system, the federal government released a $2.2 trillion stimulus package called the CARES Act that would contain history-making alterations to the definition of healthcare delivery. Included in this bill was what has proven to be a huge benefit to the medtech and fintech industries as well as healthcare organizations, clinics, and skilled nursing facilities.
IT departments across the nation sprang into action to design and implement a platform for telemedicine. Hospitals needed to triage patients before they entered the hospital, family practitioners and specialist doctors needed to see patients virtually when possible, and financial departments needed a way to efficiently handle the flood of new patients and billing.
The FDA Monitors Medical Device Supply Chains
The FDA has begun closely monitoring any potential disruptions to the supply chain for medical devices due to the industrial impact of the pandemic on manufacturing facilities. Pre-pandemic drug manufacturers were already required to report drug shortages to the FDA, but there’s never been a requirement for reporting such shortages for medical device manufacturers.
As the virus aggressively spread across the globe, the FDA began encouraging device manufacturers to make them aware of any issue by emailing them reports of any device shortages.
Engineers, Developers, and Scientists Impacting the Frontline
There has been a seemingly constant problem coming from the frontline workers in the hospitals and healthcare facilities: a personal protection equipment shortage. The shortage of N95 masks is a prominent issue.
On March 30, 2020, researchers at Duke University announced they had developed and tested a procedure for sanitizing N95 respirator masks so they could be used again with efficacy. Using vaporized hydrogen peroxide, Duke Regional Biocontainment Laboratory found the germs on used masks can be killed.
On April 10, 2020, the FDA granted an emergency use authorization to STERIS Corporation for its sterilization systems that use vaporized hydrogen peroxide for low-temperature sterilization. The STERIS V-PRO is capable of decontaminating ten N-95 respirators at a time approximately every thirty minutes. Every N-95 respirator can be sanitized up to ten times for single user reuse.
Engineers, Doctors Tackle the Ventilator Shortage Issue
A group of engineers and doctors from UC San Francisco and UC Berkeley announced on April 3, 2020, they developed a quick and efficient technique to turn sleep apnea machines into ventilators. The high demand for ventilators stripped the supply available to hospitals, which have been overwhelmed by patients afflicted by the novel coronavirus.
The group of professionals is calling themselves the COVID-19 Ventilator Rapid Response Team. Through a collective of knowledge, they have found a way to repurpose sleep apnea devices so they work as ventilators, supplying precious oxygen to the deprived lungs of patients. They are seeking rapid FDA approval and are enlisting local and federal officials. They also need donations of CPAP and BIPAP machines some Americans may have in their home and are not using. Devices can be donated by organizations and people who want to help get ventilators to patients more readily.
OraSure Technologies Secures Federal Grant
Lehigh Valley medical device company OraSure Technologies secured a $710,000 federal contract to produce a test for COVID-19 that can be self-administered in a person’s home. The in-home self-test will make coronavirus testing available at a higher capacity, giving hospitals and labs some space to breathe in this time of extreme crisis.
The development of a test that people can do themselves at home without the need for a visit to a doctor or a lab will likely significantly impact the rate of community spread. This cannot be less urgent, especially with Dr. Fauci’s prediction that there will be a second wave of COVID-19 in September.
Once the test is developed, the device company will seek a EUA from the FDA for immediate usage.
Heidi West is a medical writer for Vohra Wound Physicians, a national wound care physician group. She writes about healthcare and technology in the medical industry.