03 - advamed.org · industrial paint masks and automotive respirators are being transformed into...
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03 Op-Ed Real Clear Health: As Demand for Masks and Protective Gear Surges, Medtech Steps Up
11 Press Release: COVID-19 Test Availability Rapidly Scales Up
05 Letter To FEMA: Re: Recommendation to Centralize Procurement and Allocation Decision-Making of Ventilators
14 Member Company Response Effort: A Compilation of Individual Company Efforts to Combat Coronavirus
07 Press Release: Tens of Thousands of Life-Saving Ventilators On Deck To Combat COVID-19
21 Medtech on the Frontlines: Advamed Principles
09 Press Release: Advamed Applauds Congressional Passage of Cares Act
22 Op-Ed RealClear Health: COVID-19 Shutdown Reveals Telehealth Importance
23 Press Release: Non-Invasive Ventilators Offer Life-Saving Treatment for Less Severe COVID Patients
TABLE OF CONTENTS
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By Scott Whitaker
March 24, 2020
The national coronavirus outbreak has caused a ripple wave of uncertainty that leaves no
American spared from worry. The threat the virus represents to public health is real, and that is
why the first steps individuals and communities take in mitigating and preventing the spread of
this virus are critical. The U.S. medical technology (medtech) industry has quickly galvanized to
respond to this crisis, with a focus on producing and distributing the personal protective
equipment (i.e., masks, gloves, and gowns), diagnostic tests, and ventilators to communities
battling the pandemic.
Supply-and-demand dynamics change drastically in times of turmoil, and they’re often
unpredictable. This trend has extended to the medical technology industry. Hospitals and other
health care providers are asking for unprecedented numbers of personal protective equipment
(PPE), but in this instance, Americans should feel reassured that demand levels will be met.
In recent weeks, medtech companies have been working around the clock to elevate production
and meet the incredible surge necessary to help protect citizens and health care workers
throughout the United States and across the world. For example, 3M is running manufacturing
shifts 24 hours a day, and they’ve hired new workers to run additional production lines.Owens &
Minor has invested heavily in additional resources to expand North American manufacturing
capacity for its HALYARD-branded PPE, including N95 respirator masks, as rapidly as possible.
In addition, early supply chain challenges stemming from shut down facilities in China where the
coronavirus outbreak originated are beginning to resolve themselves - Medline’s Wuhan PPE
manufacturing plant is scheduled to be back up and running this week. Just last week, the Office
of the U.S. Trade Representative eased shipment of those China-based products back into the
U.S. by eliminating burdensome import tariffs.
OP-ED REAL CLEAR HEALTH: AS DEMAND FOR MASKS AND PROTECTIVE GEAR SURGES, MEDTECH STEPS UP
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These PPEs can mean the difference between a doctor or a nurse contracting the coronavirus
and remaining healthy; they can mean the difference between a fully staffed hospital and a
skeleton crew; sometimes, they can mean the difference between life and death. That’s why the
medical technology industry is committed to doing whatever is necessary to increase
production, streamline dissemination and avoid shortages at all costs.
These efforts are already proving successful and the value will only compound in the coming
weeks. Even in the event of a spike in COVID-19 transmissions, medtech is working 24/7 to help
ensure American communities will be able to access to the PPEs they need to stay safe.
Notwithstanding recent ramp-ups, the industry – in partnership with the federal government
and state and local governments – has been prepared. Medtech helps stock and maintain the
Strategic National Stockpile (SNS) – secure warehouses of pre-packed and transport-ready
containers of critical medical supplies, including PPEs. Already, states like Washington, Missouri,
Delaware and Louisiana have requested PPEs from the SNS, and their requests have been
granted.
But most recently, the medtech industry is seeking out entirely new supply chains. We’re
exploring ways to repurpose, retrofit, and reimagine the production of PPEs. Factories that
typically make shoes and underwear and diapers are being retooled to make surgical gowns and
gloves. Industrial paint masks and automotive respirators are being transformed into health
care-specific safety masks.
All of this informs more than just supply-and-demand economics. It’s proof that when we work
together, we get more done. There’s immeasurable value and strength in unity. Even once this
pandemic is under control, the medical technology industry will continue to leverage
collaboration to solve the world’s most pressing health challenges. We won’t stop adapting and
improving. And we’ll be even more prepared for our next big obstacle because of it.
Originally published at RealClear Health
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March 24, 2020
The Honorable Peter T. Gaynor
Administrator
Federal Emergency Management Agency
500 C Street SW
Washington, DC 20024
RE: Recommendation to Centralize Procurement and Allocation Decision-making of Ventilators
Dear Administrator Gaynor:
I write to you on behalf of the Advanced Medical Technology Association (AdvaMed). Many of
our members are manufacturers of medical devices that are critical in the diagnosis and
treatment of Covid-19, including ventilators, diagnostic tests, and other devices. We are well
aware of the Administration’s efforts to encourage industry to increase the production of
products that are desperately needed to contain the virus and treat its victims. I will be
communicating with you regarding a range of products, but the focus of this letter concerns
ventilators.
Our membership includes major manufacturers of ventilators for use by patients in the United
States. Their products have been subjected to rigorous review by the Food and Drug
Administration for safety and effectiveness. They are the finest in the world. I cannot stress
enough that the limitations on supplying ventilators are not because of decisions by these
companies to produce fewer than they can. They are trying to produce as many ventilators as
possible, including significant production increases. However, they are facing unprecedented
demand for these complex products from health care providers all over the United States and
the world.
Regarding the distribution of devices, there are two fundamental challenges. First, there are
problems in allocating devices to health care providers who need them most. Many health care
providers, as well as state and local governments, are trying to buy ventilators. Some of these
LETTER TO FEMA: RE: RECOMMENDATION TO CENTRALIZE PROCUREMENT AND ALLOCATION DECISION-MAKING OF VENTILATORS
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potential purchasers should have a higher priority than others based on the acuity of patient
needs in their areas. It is difficult for manufacturers to establish these priorities. We would
appreciate the Administration’s leadership and the advice of clinical and other experts within the
Administration in deciding how to allocate these products in the most effective way.
Second, it is difficult in many cases to determine which source of products – a particular
manufacturer, the Strategic National Stockpile, or other sources of inventory – can most
efficiently provide products to certain users. These decisions can most effectively be made by a
single federal coordinating entity that has information about possible sources of devices and the
needs of individual users.
We believe the most effective way to address these allocation issues is for the Administration to
designate a lead agency, such as FEMA, to oversee these allocation decisions with the active
input of clinical experts, including the CDC, and other stakeholders, including members of the
health care community, patient advocacy groups, and industry. Manufacturers of ventilators
would then commit to supply their production of these products for the U.S. to the Strategic
National Stockpile, which would be distributed by or under the direction of FEMA or whatever
lead agency is designated. Manufacturers would provide support to users of the distributed
devices in installation, servicing, and training of appropriate employees in the use of the devices.
I welcome any opportunity to facilitate the advancement of a centralized acquisition and
allocation framework or to dialogue on alternatives that you may be considering. Thank you for
your time and consideration. I look forward to communicating with you further on our
recommendations. Please do not hesitate to contact me at (202) 783-8700 or
[email protected] with any questions or concerns.
Sincerely,
Scott Whitaker
cc: The Honorable Michael R. Pence, The Vice President
The Honorable Alex M. Azar II, Secretary, U.S. Department of Health and Human Services
Original letter available at AdvaMed.org
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April 1, 2020
Key medtech sector pushes the limits of capacity to produce unprecedented numbers of respiratory
medical devices
WASHINGTON, D.C. – The
Advanced Medical
Technology Association
announced today that its
member respiratory device
companies have dramatically
expanded the limits of their
present production capacity
in responding to the
coronavirus outbreak,
producing on average 2,000-
3,000 ventilators per week,
collectively, according to a
recent survey of the seven
member companies. In the
coming weeks, company
officials expect to ramp
production to
unprecedented levels,
producing between an aggregated 5,000 and 7,000 ventilators per week in meeting the greatest
needs across the nation. In 2019, when tallied together, these same companies were
manufacturing approximately 700 ventilators per week for domestic distribution.
PRESS RELEASE: TENS OF THOUSANDS OF LIFE-SAVING VENTILATORS ON DECK TO COMBAT COVID-19
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“This historic response is nothing short of extraordinary,” said Scott Whitaker, president and
CEO of AdvaMed. “Across the board, our ventilator members have boosted production by more
than 285 percent to meet the demands of this global crisis. Through it all, our partners in
government agencies have worked hard alongside our industry to help where we’ve needed it
most, speeding approvals and fast-tracking the production of these sophisticated life-saving
devices so manufacturers can get them where they are needed.”
In a survey conducted by AdvaMed from March 25-31, member companies reported that they
have added entire new manufacturing lines, repurposed existing manufacturing lines for less
essential equipment, trained and reoriented engineers, and added new employees to meet the
enormous demand for ventilators. Still other companies have added new shift lines to
production, and others are partnering with third parties to explore opportunities to enhance
supply chains and forming creative partnerships with other industries. Analysts predict these
new capacities will yield as many as 5,000 and 7,000 invasive, COVID-related ventilators per
week during the second quarter of 2020. This estimation of production does not include
recently announced partnerships with groups such as the automotive industry.
According to the CDC, a low but significant number of patients with COVID-19 may see their
symptoms worsen with progression to lower respiratory tract disease. Many are diagnosed with
pneumonia and subsequently develop hypoxemic respiratory failure or acute respiratory
distress syndrome (ARDS). These patients are primarily treated with mechanical ventilation, both
invasive and non-invasive, often with supplemental oxygen. AdvaMed companies such as
Draeger, GE Healthcare, Hillrom, Medtronic, Philips, ResMed and Vyaire Medical manufacture
ventilators – along with other respiratory devices – in the treatment of COVID-19 patients.
###
Original press release available at AdvaMed.org
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March 27, 2020
WASHINGTON, D.C. – Today, AdvaMed President and CEO Scott Whitaker released a statement
applauding congressional passage of the Coronavirus Aid, Relief, and Economic Security
(CARES) Act.
“These are extraordinary times, and we appreciate Congress for responding in an extraordinary
way,” said Scott Whitaker, President and CEO of AdvaMed. “The latest relief package will help
keep medical technology manufacturers afloat in the face of economic turmoil, and it will enable
them to operate at the highest possible levels to combat COVID-19. Patients and the global
health care system are counting on our industry to continue delivering the tools they need to
prevent, diagnose, and treat this disease. Thanks to quick action by Congress and the
administration, we feel even more confident in our ability to do just that. Still, many small
medical technology companies may need additional help, and we look forward to working with
Congress and the administration on that front as they consider future relief legislation.”
The CARES Act includes several key provisions to aid medical technology manufacturers.
• In order to preempt supply chain and device shortages, CARES requires the strategic national
stockpile to include certain medical devices necessary for diagnosing and treating COVID-19. It
adds $16 billion in federal funding for the Strategic National Stockpile for medical supplies,
personal protective equipment and medicine.
• CARES provides permanent liability protection for manufacturers of personal respiratory
protective equipment, such as masks and respirators, in the event of a public health emergency.
• CARES extends the 50/50 transition payment amount for durable medical equipment (DME)
provided in rural areas through the end of the public emergency period and creates 75/25
transition payment amount for DME items provided in non-CBA areas.
PRESS RELEASE: ADVAMED APPLAUDS CONGRESSIONAL PASSAGE OF CARES ACT
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Additionally, CARES includes several positive tax and payment relief provisions for medical
technology manufacturers.
• CARES delays private payer data reporting for laboratory payment purposes for one year (January
– March 2022) and freezes payment rates for 2021 at the 2020 levels.
• CARES offers net operating loss tax relief; NOLs from tax years 2018, 2019, or 2020 may be
carried back five years. It also offers funding to reimburse providers for health care related
expenses or lost revenues that are directly attributable to the coronavirus.
• CARES will expand an existing Medicare accelerated payment program for the duration of the
COVID-19 emergency period.
###
Original press release available at AdvaMed.org
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March 31, 2020
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today released
the following statements by Scott Whitaker, AdvaMed president and CEO, and Susan Van Meter,
executive director of AdvaMedDx, regarding the medtech industry’s ongoing response to the
coronavirus pandemic:
“Within just the last few weeks, 17 diagnostics companies have received FDA Emergency Use
Authorizations (EUA) and are rapidly scaling up capacity for COVID-19 testing,” said Scott
Whitaker, president and CEO of AdvaMed. “All of this has happened in a matter of days since the
first commercial IVD for the coronavirus received FDA authorization on March 12, thanks to the
fast work of many of our member companies and, just as critically, FDA.
“So far, hundreds of thousands of COVID-19 tests have been performed. Millions are now
available, including several point-of-care tests that provide results in under an hour, and one
that takes just five minutes. By mid-April, monthly capacity for commercial COVID-19 tests will
be in the tens of millions. It’s an incredible accomplishment. And more are on the way.”
“AdvaMedDx member companies are supporting large reference laboratories, hospital
laboratories, and increasingly – with greater availability of rapid, point-of-care tests – emergency
departments, physician offices, urgent care facilities and clinics,” said Susan Van Meter, executive
director of AdvaMedDx. “All these tests complement one another across the health care delivery
system. We commend the remarkable work that health care providers and the laboratory
community are doing to perform these essential tests,” Van Meter said.
“Medtech companies on the front lines of the coronavirus crisis are working 24/7, doing
absolutely everything they can to make sure everyone has access to the tools they need to
PRESS RELEASE: COVID-19 TEST AVAILABILITY RAPIDLY SCALES UP
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prevent, diagnose and treat this disease,” Whitaker continued. “They’ve significantly increased
production of essential equipment and supplies, including personal protective equipment (PPE)
and ventilators.
“As the entire medtech industry continues to do all we can to address the COVID-19 pandemic,
we also commend the hard work and support of the White House task force, HHS, FDA, CDC,
FEMA, Congress, and other key officials. We will continue to work with them and all
stakeholders to facilitate patient access to medtech during this crisis,” Whitaker concluded.
For more information on the medtech industry’s response to the COVID-19 pandemic,
click here. For a listing of currently available coronavirus tests, see below.
Tests that have received EUAs from FDA for COVID-19 include:
• Roche’s Cobas SARS-CoV-2 Test.
• Hologic’s Panther Fusion SARS-CoV-2 test.
• Quidel's Lyra SARS-CoV-2 Assay.
• Thermo Fisher's TaqPath COVID-19 Combo Kit.
• Abbott's RealTime SARS-CoV-2 test.
• Abbott’s ID Now COVID-19 test.
• DiaSorin's Simplexa COVID-19 Direct assay.
• GenMark’s ePlex Test.
• Cepheid’s Xpert Xpress SARS-CoV-2 Test.
• Primerdesign’s COVID-19 Genesig Real-Time PCR Assay.
• BioFire Defense’s COVID-19 Test.
• Mesa Biotech’s Accula SARS-Cov-2 Test.
• Perkin Elmer’s New Coronavirus Nucleic Acid Detection Kit.
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• BGI Genomics’s RT-PCR Kit.
• Luminex’s NxTAG CoV Extended Panel Assay.
• NeuMoDx’s SARS-CoV-2 Assay.
• Qiagen’s QIAstat-Dx Respiratory SARS-CoV-2 Panel.
Additional COVID-19 IVDs that are available and being performed around the country, and in
the process of securing EUAs, include:
• BD’s and BioGx’s SARS-CoV-2 test for the BD MAX System.
• Co-Diagnostics’s Logix Smart test.
# # #
Original press release available at AdvaMed.org
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Since the onset of the coronavirus (COVID-19) outbreak, AdvaMed member companies have
donated millions of dollars’ worth of medical products and cash to hospitals, foundations and
charities around the world. Medical device companies are responding to increased demand by
ramping up production wherever possible, coordinating closely with governments to ensure the
delivery of supplies where they are most needed, and in some cases, creating new devices and
diagnostic tests to help effectively diagnose and treat sick patients.
Below is a collection of some of the efforts undertaken recently by AdvaMed member
companies based on public statements as of April 20, 2020.
View a list of companies that have developed IVDs that have received Emergency Use Authorization
from the U.S. Food and Drug Administration.
3M has ramped up to maximum production of N95 respirators, doubling their global output to a
rate of 1.1 billion per year, or 100 million per month. This includes 35 million per month in the
United States, and over just the last seven days (as of March 31) has delivered 10 million N95
respirators to healthcare facilities in states across the country.
3M plans to double their capacity to reach 2 billion globally within the next 12 months – and
some of that additional capacity will begin to come online in the next 60-90 days.
In the United States, 3M expects to be producing N95 respirators at a rate of 50 million per
month in June, a 40 percent increase from current levels. Read More.
Abbott has received emergency use authorization (EUA) from the FDA for its molecular test for
the identification of SARS-CoV-2, the virus that causes COVID-19.
The company is deploying 150,000 laboratory tests immediately. Tests already have been sent
to hospital and academic medical center labs in 18 states including Illinois, California, New York,
MEMBER COMPANY RESPONSE EFFORT: A COMPILATION OF INDIVIDUAL COMPANY EFFORTS TO COMBAT CORONAVIRUS
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Massachusetts and Washington. Abbott is scaling up production at its U.S. manufacturing
location to reach capacity for one million tests per week by end of March. Read more.
Baxter is committed to working with global partners to ramp up production of PPE for health
care providers, patients, and their employees, the company reported April 2. The company has
also committed resources to relief organizations helping to promote telemedicine opportunities
and mobilize critical supplies, among other activities, and is matching employee donations to
selected nonprofit partners by 2:1. Read more.
Bayer is donating funds to Spain for hospital beds and medical equipment to fight the corona
pandemic, as well as testing equipment. The donation is worth an aggregate of about 1M euros,
the firm announced April 8. Read more. The package is one of numerous Bayer efforts
worldwide. The firm is also supporting hospitals in Lombardy, Italy, with a donation of 1M euros,
the firm announced March 18. The funds will support regional authorities in procurement of
equipment for intensive care units in hospitals with the greatest needs. Read more. Earlier this
year, the firm sent financial and material support to China valued at about EUR 1.5M to help
contain the pandemic. Read more.
B. Braun Medical announced April 13, 2020, it received FDA emergency use authorization (EUA)
for use of infusion pumps with nebulizers to treat COVID-19 patients. The alternative treatment
will allow continuous medication to be delivered into a nebulizer for critically ill COVID-19
patients while decreasing exposure to health care providers. Read the press release.
BD (Becton, Dickinson and Company) and BioGX Inc, a molecular diagnostics company,
announced April 3 they have received FDA Emergency Use Authorization (EUA) for a COVID-19
diagnostic that returns results in under three hours using the BD MAX automated molecular
diagnostic platform. The platform is already in use at hundreds of labs in nearly every U.S. state,
with each unit capable of analyzing hundreds of samples per day. Read the press release.
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BD CEO and President Tom Polen stated following a White House meeting March 13, “We are
working around the clock internally and with external partners to increase the coronavirus
diagnostic capacity in the U.S by ramping up production of our sample collection tools and
increasing access to our automated molecular platform for in vitro diagnostics.” As of March 23,
BD also reported contributing over $1M for COVID-19 response efforts, including $350,000 in
cash and company product donations for relief efforts in China earlier in the year. View the
press release.
Boston Scientific has donated more than $2M in supplies to hospitals, including PPE, to meet
urgent needs of health care providers, according to the company. In addition, Boston Scientific is
collaborating with the University of Minnesota Bakken Medical Device Center on a ventilator
alternative to replace manual respiration in emergency settings by using a robot to pump an
Ambu® bag. The firm is also collaborating with the University of Minnesota to develop a
reusable personal respirator and PPE. Read more.
BioMérieux received an EUA from FDA for use of its BIOFIRE® COVID-19 test in moderate and
high complexity clinical laboratories to detect SARS-CoV-2, the firm announced March 24. The
test uses nasopharyngeal swabs and provides results in about 45 minutes on the firm’s nearly
11,000 BIOFIRE® systems worldwide. Read the press release.
Cardinal Health is collaborating with suppliers to increase product supply, and partnering closely
with trade groups including AdvaMed, the Health Industry Distributors Association, Healthcare
Distribution Alliance, National Community Pharmacists Association, National Association of
Chain Drug Stores, and Healthcare Ready to respond to industry-wide challenges. Read more.
Cepheid’s Xpert® Xpress SARS-CoV-2 rapid molecular diagnostic for COVID-19 became the first
commercially available point-of-care test for the disease upon receipt of an EUA from FDA,
announced March 21. The test is run on Cepheid's installed base of over 23,000 automated
GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes. Read the
press release.
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Danaher Corporation: Five Danaher operating companies donated RMB 10 million ($1.4M) of
diagnostic equipment, reagents and other products to hospitals in Wuhan, China to combat
COVID-19. Included in the donation is: Beckman Coulter Diagnostics' hematology analyzers,
Beckman Coulter Life Sciences' flow cytometers, Radiometer's blood gas analyzers, Cepheid's
Xpert® Xpress Flu/RSV assay, and Hach's UV-Vis spectrometers.
ExThera's Seraph®100 Microbind® Affinity Blood Filter has received FDA Emergency Use
Authorization (EUA) for treating COVID-19, the firm reported April 17, 2020. The blood
purification therapy binds and removes SARS-CoV-2 virus/RNA while improving vital signs and
laboratory parameters associated with inflammation and tissue damage, the company explains.
Read more. The device received a European CE Mark in 2019 for reduction of pathogens in
blood, and is widely available in Europe. Read more.
GE Healthcare CEO Kieran Murphy shared on March 6 that the company is accelerating
manufacturing, with plans to rapidly deliver around 1,000 pieces of technology, such as CTs,
ultrasounds, monitors and ventilators, among several other response efforts. Read more. GE
Healthcare announced March 24 that since the COVID-19 outbreak began, the company has
doubled its capacity of ventilator production and has plans to double it again by mid-year to
address unprecedented demand — independent of its recent collaboration with Ford to scale up
supplies of the devices. Read more.
Hologic created a fully automated test that detects genetic material from SARS-CoV-2, the new
coronavirus strain, in under three hours. The test recently was granted Emergency Use
Authorization (EUA) by the U.S. Food and Drug Administration (FDA). Read more.
Johnson & Johnson has earmarked $50M for COVID-19 response efforts, primarily focused on
supporting frontline health workers. This includes product donations in China, Italy, South
Korea, and more, with over $3.7M in personal protective equipment like goggles, protective suits
and masks. J&J is also working diligently to convert manufacturing lines at several facilities
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around the world to produce hand sanitizer in accordance to FDA and CDC guidelines as quickly
as possible that will help protect R&D, manufacturing and distribution employees, and to be
donated to health and community service workers on the front lines of care. Read more here.
Additionally, J&J is working with partners to develop a vaccine. Read more here and here.
The Lilly Foundation contributed $500,000 to United Way of Central Indiana’s Community
Economic Relief Fund. The fund will support human services organizations and the individuals
and families they serve who are affected directly or indirectly by the COVID-19 virus. The Lilly
Foundation is also providing a 2:1 match for Lilly employee and retiree contributions to the fund.
Lilly and AbCellera agreed to co-develop antibody products for the treatment and prevention of
COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will
leverage AbCellera's rapid pandemic response platform and Lilly's global capabilities for rapid
development, manufacturing and distribution of therapeutic antibodies. Read more.
Medtronic continues to make progress in increasing ventilator production worldwide. As of
March 18, the company reported having increased production over 40 percent, and being on-
track to more than double its capacity to manufacture and supply ventilators in response to
COVID-19. Read more. The firm’s partnership with Baylis Medical, a Canadian-based device
company, will also help produce ventilators for hospitals in Canada, Baylis announced April 7.
Read the press release.
Olympus installed endoscope systems into the Wuhan Huo Shen Shan Hospital within 10 days
to treat infected patients. In addition to monetary donations to the Red Cross Society of China
Huanggang, Olympus has donated 15 sets of laryngoscopes to the China Social Welfare
Foundation, and 25 biological microscopes to the Chinese Center for Disease Control and
Prevention, totaling approximately $500,000 in donations.
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PMT Partners announced April 13 that its small, compact, and portable Oxylator® ventilation-
resuscitation device was successfully used to treat a patient with COVID-19. Read more. Earlier
this year, the firm said it had 1,000 emergency ventilation-resuscitation devices available for
hospitals and emergency medical services.
QIAGEN received FDA Emergency Use Authorization (EUA) for its QIAstat-Dx Respiratory SARS-
CoV-2 Panel test, the firm announced March 31. The test can differentiate COVID-19 from 20
other serious respiratory infections and a provide a result in “about one hour,” according to the
company. Read more.
Quidel's Lyra® SARS-CoV-2 Assay for COVID-19 has received FDA Emergency Use
Authorization (EUA), the firm announced March 17. The RT-PCR test is intended for qualitative
detection of nucleic acid from SARS-CoV-2. Read more. The company subsequently received an
expanded EUA for use of the test on additional platforms and with expanded specimen types, as
well as CE Mark approval and Health Canada authorization for marketing overseas, the firm
announced March 25. Read more.
ResMed CEO Mick Farrell stated March 23 that over 7,500 ResMed employees are working
diligently in over 140 countries with government officials and health care workers to maximize
production and delivery of essential ventilators and other respiratory support devices. The
company is looking to double or triple ventilator output, and scale up ventilation mask
production by tenfold. Read more here. Earlier this year, the firm reported sending over 100
ventilators from its facility near Shanghai to Wuhan, with plans to send hundreds more and
thousands of masks. Read more.
Roche announced on March 13, 2020 that the U.S. FDA has issued an Emergency Use
Authorization (EUA) for the cobas® SARS-CoV-2 test for qualitative detection of the virus that
causes COVID-19 disease. Additionally, Roche has donated medical supplies and financial
support for China's affected region. Read the company's statement.
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Smith+Nephew has been working to support its employees and customers in China. They are
liaising closely with the local authorities, supporting urgent cases and donating product, in
particular from their Advanced Wound Care range, and cash via the Red Cross, in aggregate
worth approximately $250,000. Chief Executive Officer, Roland Diggelmann, shared the
following statement, “Smith+Nephew has been responding to the COVID-19 outbreak for many
weeks, first in China, and now in countries across the world. Our focus is to protect the health
and well-being of our employees while continuing to serve customers. The commitment of our
employees has ensured we have kept our products and services flowing. We stand together
ready to offer assistance during this unprecedented and challenging period.” Read more.
Stryker released a statement on April 6, 2020 that the company has increased production of
hygiene, disinfecting and surgical protection products, as well as hospital beds, stretchers, and
defibrillators. This shift in manufacturing priorities reflects the company’s global dedication to
helping customers so they can focus on taking care of patients.
Additionally, Stryker has developed a low-cost, limited-release emergency response bed to
quickly aid healthcare providers with efficient care during the COVID-19 pandemic. They are
also exploring the viability of decontaminating N95 respirator masks for emergency use in
healthcare settings through their expertise in sustainable solutions. Read more.
Terumo BCT announced April 10, 2020, its receipt of an EUA from FDA for use of its Spectra
Optia Apheresis System combined with Marker Therapeutics’s D2000 Adsorption Cartridge to
reduce pro-inflammatory cytokine levels in adult ICU patients with COVID-19 in cases of
confirmed or imminent respiratory failure. The devices work together to filter cytokines from a
patient's blood. Read the press release.
Varian has donated 1 million RMB to the China Red Cross. View the press release.
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The medical technology industry recognizes its crucial role in our nation’s health care system,
particularly during an unprecedented public health emergency such as the COVID-19 pandemic.
This crisis has united us all as Americans in a global fight. The patients our industry serves have
always been our No. 1 priority, and we are working around the clock to meet their needs. We are
committed as medical technology innovators and manufacturers to working with federal, state,
and local authorities to ensure our nation’s disaster planning efforts are coordinated, efficient,
and effective. For weeks now, the medtech industry has been mobilizing to this global cause,
and we are committed to the following guiding principles in our efforts to conquer the
coronavirus.
• We will continue to increase manufacturing capacity and support policies and industry initiatives
to ensure patients have access to critical medical technologies, partnering with manufacturers
inside and outside our industry.
• We will continue to support our employees and their families in staying healthy so they can
continue to pursue their mission of serving patients and keeping the health care system strong.
• We will work with the administration to provide timely product availability information to health
care institutions and the public, partnering with GPOs, distributors, and hospitals.
• We will leverage our industry’s substantial investments in diagnostics to continue deploying tests,
support our nation’s laboratory infrastructure, and develop point-of-care tests to make rapid
testing widely available to patients.
• We will continue our work with government agencies, health care providers, and payers to
expand patient access to medical technologies, including telemedicine, and to assist with remote
training among medical professionals.
MEDTECH ON THE FRONTLINES: ADVAMED PRINCIPLES
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By Andrew Fish
April 6, 2020
In 2017, 76% of hospitals in the U.S. were connecting health care providers to patients – not to
mention health care providers to fellow providers – via video and other forms of telehealth
technology. It saves time and money, while providing the same, if not better, levels of care
satisfaction.
But in today’s health care reality, as we battle an unprecedented global COVID-19 pandemic,
telehealth has become more than just a convenient, cost-effective supplement. It has become
mission critical. It’s keeping contagious people safe in their homes, thus reducing stress on
hospitals and protecting health care workers from infection.
That’s why, as part of its coronavirus response strategy, the Trump administration has been
focused on lifting barriers to telehealth for Medicare patients: 44 million people across the
country. Rules that limited payments for telehealth visits have been removed. Regulations that
blocked the use of popular applications like FaceTime and Skype have been suspended. Thanks
to these actions and others like it, telehealth is more accessible than it’s ever been.
But to continue to see the benefit of that accessibility, even after this pandemic is under control,
it’s important lawmakers consider a few additional, more permanent steps.
First, as lawmakers expand Medicare beneficiaries’ access to telehealth, they should also expand
Medicare’s existing benefit structure. Medicare’s current benefit structure largely reflects the
time Medicare was created – 1965 – well before smart devices, algorithms, and apps had
entered the public health lexicon. For that reason, many digital medical technologies, including
telehealth technologies, do not fit clearly into existing Medicare benefit categories, posing
significant challenges to gaining coverage and payment. Once Medicare’s outdated benefit
OP-ED REAL CLEAR HEALTH: COVID-19 SHUTDOWN REVEALS TELEHEALTH IMPORTANCE
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structure is modernized, patients will see new technologies available to them, and Medicare will
see cost savings from improvements in care delivery and reductions in inefficiencies.
Second, lawmakers should remove geographic restrictions imposed on Medicare coverage of
telehealth services, so all patients, regardless of their zip code, have the access to telehealth
they deserve. Right now, only patients living in specific rural health professional shortage areas
can take advantage of telehealth services, and most of those patients’ homes are not considered
covered sites. Instead, patients must travel to a clinic, hospital, or health center to receive their
telehealth care, which often eliminates the convenience patients sought in the first place.
Without these unnecessary obstacles to telehealth, all patients – rural or urban; from home or
from a doctor’s office – can benefit from telehealth care.
Finally, just as many states are allowing licensed out-of-state medical professionals to practice in
their communities during the COVID-19 crisis, medical professionals in one state should be
allowed to provide telehealth care in other states during the crisis and beyond. Such a simple
solution could help relieve the strain of specialist shortages across the country. Another
solution: invite all health care providers into the telehealth community. Right now, telehealth
services covered by physical therapists, occupational therapists, speech audiologist, and other
specialists are not covered by Medicare. It’s a huge hindrance for people looking for specific
care.
The coronavirus pandemic has made it increasingly clear: telehealth is the future of health care.
But in order to usher that future in efficiently and effectively, the telehealth regulatory system
needs improvement. We hope that the steps the Trump administration has taken in recent
weeks are only the beginning, and that real, meaningful, permanent reform is on the way. We
stand ready to help make it happen.
Originally published at RealClear Health
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April 9, 2020
WASHINGTON, D.C. – New clinical evidence produced in recent weeks has shown the benefits
of non-invasive ventilators for use in less severe cases of COVID-19-related respiratory
problems, which constitute the majority of cases nationwide. In a series of white papers,
published evidence, and case studies from both China and Italy, experts say many coronavirus
patients with less-severe respiratory distress could benefit from non-invasive ventilation
therapy, thus freeing more invasive ventilation devices for the most critically ill patients
nationwide.
“This could be a game changer in the race to get as many ventilators in the hospitals as we
possibly can,” said Scott Whitaker, President and CEO of AdvaMed. “A large majority of COVID
patients could benefit from these respiratory devices, easing pressure on our critical care system
in hospitals and offering another lifesaving option for tens of thousands of people suffering
from respiratory problems.”
According to the Centers for Disease Control and Prevention (CDC), patients with mild
symptoms of COVID-19 may not initially require hospitalization; however, their symptoms could
worsen and require oxygen supplementation, which can be delivered through non-invasive
ventilation (NIV). NIV is a form of mechanical ventilation where air is delivered to the patient
through a mask or mouthpiece. Invasive ventilation is used when sufficient ventilation cannot be
achieved using non-invasive methods, so oxygen is delivered through a tube inserted into the
trachea either through intubation or tracheotomy. As governments and health administrations
around the world respond to the global demand spike for ventilators, many have now issued
guidance documents on the use of bilevel or BiPAP devices that deliver NIV in patients with
confirmed or suspected COVID-19.
PRESS RELEASE: NON-INVASIVE VENTILATORS OFFER LIFE-SAVING TREATMENT FOR LESS SEVERE COVID PATIENTS
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“There is an increasing amount of clinical guidance coming out of China, Europe, and the U.S.
that positions non-invasive ventilation and invasive ventilation as appropriate, along the
spectrum of patient presentation and care,” said ResMed Chief Medical Officer Carlos M. Nunez,
M.D. ResMed is one of seven AdvaMed member respiratory manufacturers. “These limited
numbers of invasive ventilators can be reserved for the most severe cases by using non-invasive
devices to care for those with less acute respiratory symptoms and findings,” continued Dr.
Nunez.
“With the extraordinary demand for ventilators, both for immediate needs and for future
pandemic planning, our industry’s increased production and delivery of non-invasive ventilators
is already helping to match available supply with the clinical needs of patients,” said Hillrom
President and CEO John Groetelaars, another AdvaMed member company. “This form of
respiratory therapy is ideal for treating patients with mild to moderate respiratory distress
across various acute care settings, including the emergency department, med-surg and post-
ventilator weaning support.”
Wherever hospitals’ capacity and available equipment is insufficient to meet demand, it’s
important to support as many patients as are clinically appropriate on NIV devices. The U.S
National Academy of Medicine indicated that the use of NIV therapy could be a way to forestall
the need for intubation and reduce days on a ventilator. As it is with all clinical decisions,
providers considering NIV therapy for COVID-19 patients must ensure that the appropriate
design mitigations are in place to minimize spread of the disease. Recommendations from the
WHO and the CDC include using negative-pressure isolation rooms for patients, and gloves,
gowns and masks for caregivers.
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A survey of AdvaMed ventilator manufacturers recently found the member companies combined
could produce, on average, 60,000 NIV devices per week by the middle of the second quarter.
This estimate represents an increase from approximately 14,000 per week manufactured
presently, due in large part to the less complex design of the non-invasive construct.
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Original press release available at AdvaMed.org