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CARLSBAD, Calif., Aug. 16, 2021 /PRNewswire/ — Thermo Fisher Scientific, the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0, both highly accurate assays designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.

Both PCR-based kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that causes COVID-19. This built-in redundancy helps ensure accuracy of results in situations where gene expression in the virus vary as new mutations emerge.

“The Delta variant is just the latest example of how SARS-CoV-2 mutations can have a major impact on the efficacy of global pandemic management,” said Manoj Gandhi, senior medical director for genetic testing solutions, Thermo Fisher Scientific. “We are working to keep laboratories, public health officials and communities one step ahead of the virus, and these tests play a key role, alongside our full menu of diagnostic solutions, in supporting that effort.”

The TaqPath COVID-19 Fast PCR Combo Kit 2.0 assesses raw saliva and uses a simple workflow from sample collection direct to PCR to help preserve supplies. Results are returned in about two hours to enable broad, high-frequency testing.

The TaqPath COVID-19 RNase P Combo Kit 2.0 is designed with an approximate three-hour turnaround time and can detect SARS-CoV-2 from individuals suspected of COVID-19 by their health care provider, as well as from patients who are asymptomatic.*

The first generation TaqPath COVID-19 Combo Kit received EUA from the FDA in March 2020. For more information on the TaqPath platform, please visit: www.thermofisher.com/covid19evolved

For In Vitro Diagnostic Use. For Emergency Use Authorization Only | Rx Only

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

* when tested twice over 2 or 3 days with at least 24 hours (and no more than 36 hours) between tests. 

Mauricio Minotta
Director, Public Relations
Phone: +1 760-929-2456
E-mail: mauricio.minotta@thermofisher.com

Ariane Lovell
FINN Partners
Phone: +1 646-307-6317
E-mail: ariane.lovell@finnpartners.com

SOURCE Thermo Fisher Scientific

If you have any questions regarding this Press Release, please email us at media.relations@thermofisher.com.

August 16, 2021 at 4:04 PM EDT

RICHMOND, Va.–(BUSINESS WIRE)–Aug. 16, 2021– Owens & Minor today announced a new online emergency tracker as part of its comprehensive emergency preparedness and response offerings. Owens & Minor piloted the new feature in early July to support customers in their advance preparations as Tropical Storm Elsa gained strength in Florida and up the east coast. Now, with Tropical Storm Fred causing rain and flooding in the Florida panhandle, and Tropical Depression Grace threatening the Atlantic, the tracker is once again live to serve customers who may be impacted. The emergency preparedness tracker features a scrolling alert that includes up-to-date storm information and impacts as well as additional content detailing Owens & Minor’s preparedness and response plans enacted to support healthcare customers.

The Richmond-based company has consistently made emergency readiness and response a point of pride, with the safety of frontline teammates a top priority that enables its ongoing ability to serve the healthcare community. Beyond its emergency response activities during hurricanes, floods, wildfires, and other natural disasters, Owens & Minor has protocols to navigate other uncertain or evolving situations. For example, in instances when customers experience cybersecurity threats at their location, Owens & Minor has protocols that facilitate medical supply orders outside the system so that product flow is not interrupted.

“What’s extraordinary about Owens & Minor is the level of preparation and resourcefulness we use for any contingency, no matter how uncertain or unpredictable,” said Jeff Jochims, EVP, Chief Operating Officer and President, Medical Distribution at Owens & Minor. “Many years ago, during Hurricane Katrina, our distribution team rented amphibious duck boats to navigate flooded roads and deliver products to our hospital customers. Throughout COVID-19, O&M teammates worked around the clock to manufacture and distribute critical supplies through multiple hurricanes that severely impacted large portions of the United States.”

The emergency tracker adds to Owens & Minor’s suite of proactive, customized, and actionable preparedness offerings that enhance customer response capabilities and help minimize disruptions. The tracker appears on Owens & Minor’s website on an as-needed basis to keep customers informed throughout rapidly changing situations.

“As a healthcare company, our emergency response and preparedness plans are foundational to our ability to deliver on our Mission of Empowering Our Customers to Advance Healthcare™,” said Jochims. “We believe that our thorough and advanced preparation empowers our ability to maintain business continuity and to serve our customers. This latest tool in our emergency protocol will bring valuable, timely updates to customers and members of the healthcare industry as we collectively focus on supporting patient care in every situation.”

To plan for healthcare supply contingencies and access breaking updates during potential emergency situations, visit https://www.owens-minor.com/distribution/emergency-response/.

About Owens & Minor

Owens & Minor, Inc. (NYSE: OMI) is a global healthcare solutions company that incorporates product manufacturing, distribution support and innovative technology services to deliver significant and sustained value across the breadth of the industry – from acute care to patients in their home. Aligned to its Mission of Empowering Our Customers to Advance Healthcare™, more than 15,000 global teammates serve over 4,000 healthcare industry customers. A vertically-integrated, predominantly Americas-based footprint enables Owens & Minor to reliably supply its self-manufactured surgical and PPE products. This seamless value chain integrates with a portfolio of products representing 1,200 branded suppliers. Operating continuously since 1882 from its headquarters in Richmond, Virginia, Owens & Minor has grown into a FORTUNE 500 company with operations located across North America, Asia, Europe, and Latin America. For more information about Owens & Minor, visit owens-minor.com, follow @Owens_Minor on Twitter and connect on LinkedIn at www.linkedin.com/company/owens-&-minor.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210816005665/en/

Heather Sabharwal, Sr. Manager, Media Relations, media@owens-minor.com

Source: Owens & Minor, Inc.

August 2, 2021 – COVID infections in the United States spiked at an unprecedented rate during July. At one point mid-month, new cases surged 70% from one week to the next. The South suffered greater than the rest of the country, with Florida and Texas accounting for nearly one-third of all new infections reported during July. Nonetheless, underlying trends point to slowing infection spread and perhaps declining new daily cases within a few weeks.

The following charts illustrate the rapid growth in new infections. Since reaching a pandemic low on June 21, new daily infections increased more than five-fold in 40 days. The current rate exceeds last summer’s peak yet, remains only a third of its early January peak.

Infections have surged across the country. Comparing infection rates from just two weeks ago to now demonstrates how quickly the virus has spread.

Fortunately, surging infections have not resulted in comparable spikes in hospitalizations or deaths with COVID.  The daily average death total rose by one-third in the past three weeks – a pace 70% slower than the preceding infection growth. Similarly, despite infections more than five times higher than a month ago, COVID hospital census “only” doubled.

Still, the virus is stressing hospitals and staff in several parts of the country.

Eight states are devoting at least one of every five inpatient beds to treating COVID patients. Nevada (49% of inpatient beds occupied by COVID patients) and Florida (46%) are under the most significant stress.

In Alabama, Arkansas, Georgia, Louisiana, Missouri, and Texas, rates vary between 20-24%.

Nationwide, 14% of inpatient beds are in use by COVID patients.

How long will this surge last?

Over the weekend, Dr. Anthony Fauci posited that infections would continue to spike in the United States. Conversely, Dr. Scott Gottlieb, former head of the FDA, hypothesized those daily infections would recede within two to three weeks.

They both may be right.

Each COVID infection surge has followed a similar pattern: infections accelerate for several weeks before falling back to pre-surge levels. The most prolonged surge in the United States occurred from September 2020 through early January. Notably, there were no vaccines available to moderate this surge. Most waves here and in other countries have lasted one to two months.

The Delta variant produced intense surges in both India and the United Kingdom. In both countries, the waves lasted about two months. Further, both countries experienced rapid ascending infections, followed by similarly quick descending infections.

The following chart illustrates infection rates in Israel, the United Kingdom, and the United States. The infection surge in the United Kingdom commenced about one month earlier than in Israel and the United States. Lasting about two months, the United Kingdom’s wave peaked on July 21. New infections then plunged by half in just eleven days.

Will the United States (and Israel) follow a similar pattern as the United Kingdom? Doing so would mean that infections would surge for another three weeks or so, with daily infections significantly higher than today (supporting Dr. Fauci’s projection). Nonetheless, these countries could gain relief in the form of declining new infections by the third week of August (supporting Dr. Gottlieb’s expectation).

We found evidence corroborating Drs. Fauci’s and Gottlieb’s views. When analyzing past surges, we discovered that a coming peak in new cases is “telegraphed” weeks in advance. The key comes in watching the rate at which new cases increase each day. Early in each surge, new cases grow at an increasing rate every day (no doubt reflecting the high transmission rate of the virus). However, this rate starts decelerating during the middle of the surge. The deceleration point is the signal that declining new cases are on the horizon. (Of course, new cases still increase for several weeks, just at a slower rate. Ultimately, this slowdown translates to declining new cases.)

The chart below illustrates how this pattern is underway in the United States. The rate of increase in new cases began dropping on July 15. This followed four weeks of accelerating new cases. Should this pattern continue, we can reasonably assume that new cases could peak in the next few weeks.

We also depict the experiences in Florida and Texas, as these states accounted for one-third of all new cases in the United States in July. Like the United States as a whole, Florida saw its rate of infection increase peak on July 15. Texas’s peak occurred a few days later.

Of note, the Institute for Health Metrics and Evaluation’s (IHME’s) latest projection has Florida’s new cases peaking this Wednesday and Texas’ by August 13. Stress on the healthcare system continues for another few weeks: IHME predicts that the COVID census in each state will not peak until at least two weeks after new infections begin to fall.

In sum, the Delta variant will continue to drive new infections in the United States for at least a few more weeks. However, by mid-to-late August, we could begin to see some relief.

Contributing writer:

Mark A. Van Sumeren, strategic advisor, Medical Devices & Integrated Delivery Networks

Health Industry Advisor LLC, provides a regular report on COVID-19 numbers for the health care industry.

For more information, or to sign up for the report, contact Mark at Mark.VanSumeren@HealthIndustryAdvisor.com; or visit www.HealthIndustryAdvisor.com.

Filed Under: Repertoire’s Dail-eNews

Kelly Gooch and Hannah Mitchell – Updated Friday, July 30th, 2021 Becker’s Hospital Review

The number of hospitals and health systems requiring COVID-19 vaccination for employees is growing.

Here are the healthcare organizations that have announced mandates:

Editor’s Note: This webpage was updated July 30 and will continue to be updated. The list is in chronological order based on when the mandate was announced or reported on.

Arkansas Heart Hospital in Little Rock said July 30 its directors, executives, managers, advanced practice nurses, physicians and physician assistants will be required to be fully vaccinated for COVID-19 by Sept. 30. On Aug. 1, new employees will be required to receive their first dose within 30 days of employment.
Phoenix Children’s is mandating vaccines for all staff, effective Oct. 1. The hospital told Becker’s July 30 that most of its staff is already fully vaccinated, but it will support the remaining employees as they work toward getting inoculated.

Texas Health Resources in Arlington said July 30 that it will require vaccination as a condition of employment. Employees will need to have received either both shots of the Pfizer or Moderna vaccine or one Johnson and Johnson shot, effective Sept. 10. The policy also applies to physicians and advanced practice providers on the medical staffs, students, vendors and contractors.

The policy is a crucial step to fighting the surging delta variant and will protect both patients and caregivers. Similar to the flu vaccine, being fully vaccinated against COVID-19 will be a condition of employment for all Texas Health employees. To be considered fully vaccinated, either both shots of the Pfizer or Moderna vaccine or the single Johnson and Johnson must be administered. The policy goes into effect on Sept. 10.

Conway (Ark.) Regional Health System said July 29 that it will require new hires and leaders, including executive leadership, directors and managers, to get vaccinated. The requirement is effective Aug. 8. Leaders receiving two vaccine doses will be required to receive the second dose by the end of August, the health system said. New hires receiving two vaccine doses will be required to get the second dose within 30 days of employment.   

Millinocket (Maine) Regional Hospital will require employees to receive the Pfizer or Moderna shots when they receive final FDA approval, the Press Herald reported July 29. Staff will be able to request exemptions.

Methodist Health System in Dallas said July 29 that it will require its workforce to be vaccinated by Oct. 1. The health system said once it achieves its workforce vaccination goal, full-time employees will receive a $500 bonus, and part-time employees will receive $250.

Self Regional Healthcare in Greenwood, S.C., is requiring team members to get vaccinated, Fox Carolina reported July 29. The organization said it aims to have unvaccinated employees inoculated by Sept. 30, according to the report.

ChristianaCare said July 29 that it will require employees, medical-dental staff, residents, students, contracted employees, temporary labor, volunteers and vendors to be vaccinated. Caregivers at the Newark, Del.-based health system must receive their first vaccine dose of a two-dose vaccine or their single Johnson & Johnson shot by Sept. 21. 

Children’s Hospital of Philadelphia will require workforce members at any location to get inoculated, the hospital said July 29. A deadline has not been announced.

Mary Washington Healthcare in Fredericksburg, Va., will require its workforce to get vaccinated by Oct. 31, the health system said July 29. The requirement will apply to employees, medical staff and volunteers.

UCHealth, an Aurora, Colo.-based health system with 26,000 employees, said July 28 that it will require employees, providers, volunteers and partners to be vaccinated by Oct. 1. UCHealth’s employees may receive the vaccine of their choice or obtain an exemption for medical or religious reasons. Those who obtain an exemption must wear a mask at all times in UCHealth facilities and be tested weekly, the health system said. 

Pullman (Wash.) Regional Hospital will require employees to be fully vaccinated or complete the exemption process, by Oct. 27, the hospital said July 28. Employees can request a medical exemption, religious belief exemption or personal belief exemption. The personal belief exemption will expire on June 1, 2022, or within two months of full FDA approval of a vaccine. 

Baylor Scott & White Health, a 52-hospital health system based in Dallas, is requiring employees, providers, volunteers, vendors, students and contract staff to receive both doses of the Moderna or Pfizer COVID-19 vaccine, or the single-dose Johnson & Johnson shot, unless granted an exemption, the health system said in a statement shared with Becker’s July 28. The deadline for the requirement is Oct. 1. 

Spectrum Health in Grand Rapids, Mich., said July 28 that it will require the COVID-19 vaccine for team members, medical staff, students, volunteers and contractors. The 14-hospital health system plans to require vaccination within eight weeks of the FDA approving the first vaccine, or sooner depending on pandemic circumstances. Spectrum will consider exemptions.

Ascension, a 149-hospital health system based in St. Louis, will require COVID-19 vaccination for its 160,000 employees. Ascension’s requirement will apply to workers who provide direct patient care, as well as those who work in health system sites of care or remotely, the health system said July 27. This includes workers employed by subsidiaries and partners; physicians and advanced practice providers (employed and independent); and volunteers and vendors entering health system locations. Ascension said employees have until Nov. 12 to complete the vaccine series and meet the vaccination requirement.

Care New England is moving forward with mandatory vaccination for all staff, the Providence, R.I.-based health system said July 27. Vaccination has been required for students, volunteers and new hires since July 1, and the next step is to require managers to begin the vaccination series before Labor Day, said Care New England. 

Baystate Health said July 26 that employed team members, including those working remotely, clinical staff, contractors, volunteers, students, and those conducting business within the Springfield, Mass.-based health system, will be required to be fully vaccinated by Oct. 1. Employees will be able to request an exemption for religious or medical reasons, and pregnant employees may request a deferral.

Truman Medical Centers/University Health in Kansas City, Mo., said July 26 that vaccination will be a requirement for staff members, according to KMBC. The deadline to be vaccinated is Sept. 20.

Mayo Clinic in Rochester, Minn., said all health system staff must be fully vaccinated by Sept. 17. Those who do not meet the deadline will be able to keep their jobs. However, they will be required to complete a formal refusal process, which includes watching education modules, wearing face masks and maintaining social distancing while on campus.

The Department of Veterans Affairs is mandating COVID-19 vaccinations for 115,000 of its front-line healthcare workers, the first federal agency to do so. Starting July 28, those workers have eight weeks to get fully vaccinated or face penalties, including possible removal.

Rush University Medical Center in Chicago is requiring its workers, contractors and volunteers to get the shot. They must be fully vaccinated by Oct. 1. 

HonorHealth in Scottsdale, Ariz., said July 23 that it will require vaccination as a condition of employment. Employees must submit proof of vaccination by Nov. 1. 

Sanford Health in Sioux Falls, S.D., said July 22 that all employees across its 46 hospitals and hundreds of other medical facilities will be required to be vaccinated by Nov. 1. More than 90 percent of clinicians and 70 percent of nurses are already vaccinated, the health system said. Those who do not get vaccinated will not be working, but a final decision on a furlough has not been decided.

Duke University Health System, a three-hospital health system based in Durham, N.C., is requiring vaccination for employees. The deadline for employees is Sept. 21, news station ABC11 reported July 22. 

Cone Health in Greensboro, N.C., said July 22 that it will require vaccination for workers, effective July 30. The mandate will apply to employees, medical and dental staff, professional students and volunteers. The deadline for compliance is Oct. 1. 

UNC Health said July 22 that it will require teammates at UNC Medical Center, UNC Rex Healthcare, Chatham Hospital, Johnston Health, UNC Health Southeastern, UNC Rockingham Health Care, UNC Physicians Network Practices and UNC Health Shared Services locations to get vaccinated. The deadline for employees at the Chapel Hill, N.C.-based health system is Sept. 21.

Wake Forest Baptist Health said July 22 that the Winston-Salem, N.C.-based organization is requiring teammates to be fully vaccinated or obtain an approved medical or religious exemption. The mandate applies to remote workers, physicians, medical residents, faculty, fellows, trainees, contractors, students/visiting students, members of the medical staff, temporary workers and volunteer staff.

Novant Health is requiring team members to be fully vaccinated, the Winston-Salem, N.C.-based health system said July 22. Workers must be vaccinated by Sept. 15.   

Atrium Health is making vaccination mandatory for all teammates, the Charlotte, N.C.-based health system said July 22. Teammates, including remote workers, physicians, medical residents, faculty, fellows, trainees, contractors, students/visiting students, members of the medical staff, temporary workers and volunteer staff, must be fully vaccinated or obtain an approved medical or religious exemption by Oct. 31. 

Arkansas Children’s in Little Rock is requiring that its leaders (managers, directors, vice presidents, senior vice presidents and executive vice presidents) receive a first vaccine dose as a condition of employment, according to a message sent July 22 from Marcy Doderer, president and CEO. Leaders must receive their first dose by Aug. 20 and be fully vaccinated by Sept. 30. Beginning Aug. 16, all new Arkansas Children’s new hires will also be required to receive a first shot by their start date and a second one within 30 days of employment, said Ms. Doderer.       

OSF HealthCare, a multistate health system based in Peoria, Ill., said July 21 that it will require all employees to be vaccinated against COVID-19 by the end of September. The requirement does not apply to Michigan Nursing Association bargaining unit members. OSF HealthCare has 150 locations in Michigan and Illinois.

Banner Health will require COVID-19 vaccination as a condition of employment for its roughly 52,000 team members, the Phoenix-based health system said July 20. The deadline for employees to be fully vaccinated is Nov. 1, with limited exceptions. 

Southcoast Health, a three-hospital health system offering services in southeastern Massachusetts and Rhode Island, said vaccines will be mandated for all employees, staff and providers once at least one of the vaccines receives full FDA approval, The Standard-Times reported July 20. Employees will be able to request exemptions if they have documented medical and religious reasons, or if they are pregnant or intend to become pregnant.

Valley Health, a Winchester, Va.-based health system with 6,300 employees and affiliated physicians, said July 19 that it will add COVID-19 vaccination to its list of required vaccinations for all employees, medical staff members and contractors. Health system officials said the standard is effective immediately for new employees, who must provide evidence of vaccination or complete the vaccination series two weeks before beginning work. Employees who are managers or above and medical staff members must provide evidence of prior completion of the vaccination series or receive their first dose by Aug. 16. Remaining staff have until Nov. 1 to either obtain an exemption or be fully vaccinated.

Tidelands Health in Georgetown, S.C., said July 16 that it will mandate vaccination for employees, employed providers, volunteers, learners and contractors. Employees have until Sept. 7 to comply, and the health system is providing an attestation and declination process for those who cannot get vaccinated for medical or religious reasons. Tidelands Health said employees who have previously tested positive for COVID-19 may also choose to decline the shot.

Hackensack Meridian Health, a 17-hospital system based in Edison, N.J., will require its staff to be fully vaccinated against COVID-19, NorthJersey.com reported July 15. A memo to employees cited by NorthJersey.com gave Nov. 15 as the deadline for the mandate. Workers, including physicians and nurses, must receive at least one dose of the Pfizer, Moderna or Johnson & Johnson shots by Oct. 1 and a second dose of Pfizer or Moderna by Nov. 15. The deadline to request an exemption is Aug. 16. 

Beacon Health System in South Bend, Ind., said July 15 that it will require employees and others who work regularly at a Beacon facility to be fully vaccinated by Oct. 1. Employees may request an exemption.

Vanderbilt University Medical Center in Nashville, Tenn., will require its entire staff to get the vaccine, according to an employee newsletter distributed July 15. All hospital leaders must get the first dose or achieve a medical exemption by Aug. 15 They must fully be vaccinated by Sept. 15. The deadline for all employees is under consideration.

The University of Mississippi Medical Center in Jackson said July 15 that it will implement a new vaccination policy requiring those who work or learn in a medical center-controlled space to be fully vaccinated against COVID-19, with limited exceptions, or wear an N95 mask while at any medical center facility. Medical center officials said those who are fully vaccinated will only be required to wear a mask of their choosing or as determined according to the clinical situation in patient care areas. The policy will be phased in over three months, with all who work in a medical center-controlled space required to be fully vaccinated or wearing an N95 mask at all times on or by Nov. 1.

Hartford (Conn.) HealthCare said July 14 that it will require COVID-19 vaccination for its employees. Health system officials said employees may apply for an exemption, but those without an approved exemption must show proof of vaccination by the end of September.

St. Jude Children’s Research Hospital said July 14 that the Memphis, Tenn.-based hospital and its foundation partner, ALSAC, are requiring that St. Jude and Memphis-area ALSAC employees be vaccinated against COVID-19 by Sept. 9. In a memo, St. Jude President and CEO James Downing, MD, told employees they must have their final dose scheduled and administered by the deadline, or, if vaccinated outside of St. Jude, have the documentation to the hospital by the deadline date.

University of Chicago Medicine will require its workers to be vaccinated against COVID-19, according to a July 13 memo to students, faculty and staff. The mandate will apply to employees of University of Chicago Medical Center and to medical center volunteers and contractors at both the Hyde Park campus and other medical center sites, health system leaders wrote. They added that the mandate may be subject to discussion with unions representing workers.

Piedmont Healthcare in Atlanta said June 12 it is requiring leaders, physicians, providers and new employees to be fully vaccinated against COVID-19, with plans to eventually extend the mandate to all its more than 23,000 workers. As of Sept. 1, the mandate will apply to that initial group and to the rest of Piedmont’s employees in “the near future,” following Sept. 1.

Virtua Health in Marlton, N.J., will require its more than 14,000 workforce members to be fully vaccinated against COVID-19. Virtua employees must be fully vaccinated by Sept. 15. Virtua said July 12 that all employees, regardless of vaccination status, will continue to maintain COVID-19 safety protocols per CDC guidelines, and it will consider employee requests for exemptions based on religious beliefs or disability/medical condition. 

Uvalde (Texas) Memorial Hospital is requiring its 493 employees to be fully vaccinated against COVID-19. Employees were notified of the mandate July 7 and have until Aug. 6 to obtain an initial or final dose of the shot of their choice. Uvalde Memorial said July 12 that staff may apply for medical exemptions or religious objections.

Inova Health System in Falls Church, Va. informed its 18,000 employees that they will have to be vaccinated by Sept. 1.

Trinity Health in Livonia, Mich., will require its 117,000 employees across 22 states to get the COVID-19 vaccine after the number of employees who received at least one shot stagnated at 75 percent.

St. Luke’s Health System in Boise, Idaho, will require its employees to be vaccinated against COVID-19, according to a memo sent to employees July 8 from Chris Roth, president and CEO of the health system. St. Luke’s will require all employees, providers, volunteers and contractors to receive their first vaccine dose by Sept. 1. 

Mercy in St. Louis will require its 40,000 employees across 44 hospitals and healthcare facilities to receive the COVID-19 vaccine, health system officials said on July 7. All employees will be required to be vaccinated by Sept. 30.

University Hospital in Newark, N.J. will require all of its employees to be vaccinated, according to a June 30 report.

Yale New Haven (Conn.) Health officials said in a June 30 press conference that all health system employees will be mandated to get the vaccine, however, the deadline is still being determined.

Connecticut Children’s Medical Center in Hartford will require all employees to be fully vaccinated against COVID-19. The hospitals’ CEO and president, Jim Shmerling, PhD, said hospital employees will have until Sept. 30 to get vaccinated, according to a June 29 letter to employees.

Henry Ford Health System in Detroit, which employs more than 33,000 people, said June 29 it will require its workforce to be vaccinated, effective Sept. 10. The requirement applies to team members, students, volunteers and contractors. 

SSM Health in St. Louis said June 28 it will require its nearly 40,000 employees, providers and volunteers to be fully vaccinated by late September. Team members can request a medical or religious exemption.

Medical University of South Carolina Health employees were provided a final deadline of June 30 to be vaccinated, or to obtain a medical or religious exemption, as part of the Charleston-based health system’s mandate. The health system fired five out of about 17,000 employees for noncompliance.

Mass General Brigham will require employees to be vaccinated, the Boston-based health system said June 24. The requirement will apply to Mass General Brigham’s 80,000 employees once one of the three vaccines being distributed in the U.S. is fully approved by the FDA. The health system said employees will be able to request exemption if they are pregnant or intend to become pregnant. Employees may also request an exemption for medical and religious reasons. A deadline for the mandate will be determined after FDA approval. 

Beth Israel Lahey Healthin Cambridge, Mass., said June 24 it plans to require all physicians and staff to be vaccinated against COVID-19 and the flu as a condition of employment. Flu vaccination will be required later this year, and COVID-19 vaccination for employees will be required after one of the vaccines is fully approved by the FDA.

Wellforce in Burlington, Mass., which includes Boston-based Tufts Medical Center, will require vaccination for employees, the system said June 24. The requirement takes effect after full FDA approval of one of the vaccines, which is expected later this year.

Dana-Farber Cancer Institute in Boston said it will require employees to be vaccinated, The Boston Globe reported June 24. Dana-Farber will wait until after the FDA fully approves a vaccine.

The Connecticut Hospital Association said June 24 it has adopted a consensus, statewide policy reflecting a commitment by the state’s hospitals and health systems to implement mandatory vaccination for employees and clinical staff. The association will develop best practices for implementation.

BJC HealthCare in St. Louis will require employees to be fully vaccinated beginning in the fall, according to a June 15 statement from the health system. Employees and those who work in BJC facilities must comply with the mandate by Sept. 15 or receive a medical or religious exception.

San Francisco will require personnel in high-risk settings such as skilled nursing facilities, acute care hospitals, homeless shelters and jails to be vaccinated, the city said June 14. The requirement takes effect once one of the vaccines being distributed in the U.S. receives full FDA approval. 

University of California Health will require COVID-19 vaccines for faculty, staff, academic appointees and students accessing University of California campuses this fall, the system said June 14.

NewYork-Presbyterian in New York City said all employees, physicians, students, clinical rotators, volunteers and vendors must have received their first dose no later than Sept. 1. For two-dose vaccines, workers must complete the vaccination process on the prescribed timeline. Newly hired employees also must follow a vaccination or exemption process. 

Community Health Network in Indianapolis is requiring employees to be fully vaccinated by Sept. 15 unless they receive exemptions for religious or medical reasons, according to a June 10 news release. The requirement applies to vendors, contractors and volunteers who work at Community’s hospitals and care sites.

The District of Columbia Hospital Association, said June 9 that hospitals in Washington, D.C., signed a consensus statement to mandate vaccination for their workers. Each of the 14 hospitals will set their own vaccination deadline.   

University of Maryland Medical System in Baltimore announced June 9 that it will require vaccination for current and new employees. The 13-hospital health system said teammembers and partners who remain unvaccinated will be required to get tested weekly, and health system leaders at the manager level and above will have until Aug. 1 to be vaccinated or comply with weekly testing. Beginning Sept. 1, all teammembers will be required to get inoculated or participate in weekly testing.

The Maryland Hospital Association said June 7 that hospitals and health systems in the state signed a consensus statement to mandate vaccination for their workers. Each organization will set their own vaccination deadline.

Indiana University Healthin Indianapolis is requiring employees to be fully vaccinated, The Indianapolis Star reported June 1.  Employees must be vaccinated by Sept. 1 or obtain an exemption.

University of Louisville (Ky.) Health is requiring team members and providers, including residents, fellows and rotating students, to be fully vaccinated by Sept. 1, according to a May 26 news release.

RWJBarnabas Health in West Orange, N.J., is requiring supervisors and employees ranked above them to be vaccinated no later than June 30 and said May 20 that it plans to extend the mandate to all employees.

University of Pennsylvania Health System in Philadelphia said May 19 that it is making the vaccine mandatory for all employees and clinical staff by no later than Sept. 1. New hires must provide proof of at least one dose two weeks before beginning work.  

Benefis Health System in Great Falls, Mont., said May 19 it made the vaccine mandatory for about 250 employees working in senior services. Employees who are not exempt are required to get their second doses by July 1.

Houston Methodist rolled out its mandatory vaccination policy March 31, with April 15 as the deadline for managers to receive at least one dose or get an exemption. All employees had a deadline of midnight June 7 to get the COVID-19 vaccine as part of the health system’s mandate. The count as of June 8: Nearly 100 percent compliance with 24,947 workers being fully vaccinated. 

Izzul Ikram theedgemarkets.com

July 04, 2021

KUALA LUMPUR (July 4): Malaysian Rubber Glove Manufacturers Association (MARGMA) today urged the government to allow glove factories in Selangor to operate under the Enhanced Movement Control Order (EMCO), which came into effect yesterday (July 3).

In a statement today, MARGMA president Dr Supramaniam Shanmugam said the association is seeking an urgent meeting with the Ministry of International Trade and Industry on the issue, as 58% of all gloves produced in Malaysia are sourced from glove manufacturers in Selangor.

He said there was a big fear going around the global healthcare sectors when the possibility of the glove industry shutdown was announced, as medical gloves are sorely needed to protect frontliners and hospital staff.

“Medical examination gloves, like face masks, are essential personal protective equipment (PPE) items that are highly required by countries around the world especially in this pandemic season to fight against the spread of Covid-19 and other diseases.

“Since the government’s announcement on the imposed EMCO on the state of Selangor, global customers of our manufacturers have been calling with great concern on shortage of production and delivery of gloves to them.

“Our members are under tremendous pressure from global hospitals and healthcare workers as the pandemic has now evolved into another variant,” he said.

He said MARGMA members collectively produce and export gloves to 195 countries around the world, supplying 67% of global consumption.

“Our members have been supportive of the government’s effort to fight the spread of Covid-19 pandemic and have been coping with the 60% ordinance in MCO 3.0 to ensure no severe shortage of this important PPE supply to the world. Though lead times on delivery have been stretched slightly longer, it was still manageable.

“EMCO on the other hand, will now further hamper the supply situation,” he said, adding its MARGMA members have agreed to vaccinate all their employees at their own costs.

All glove makers’ employees, besides being registered for the National Immunisation Programme on MySejahtera, are registered with Public-Private Partnership Industrial Covid-19 Immunisation Programme (PIKAS), Selangor Vaccination Programme (SELVAX) and the latest Vaccination Programme for the Agri-commodity Sector (VACOMS).

“However, up until today, we are still waiting for the delivery of vaccines,” he added.

He also said that MARGMA has appealed to the government to make saliva-based Covid-19 test kits available as soon as possible, and that MARGMA members have agreed to bear all costs, as it will greatly enhance the frequency for screening workers.

Justin Lim/theedgemarkets.com
July 07, 2021

KUALA LUMPUR (July 7): Glove manufacturers have suspended their operations in Klang due to the Enhanced Movement Control Order (EMCO) in several districts in Selangor.

Top Glove Corp Bhd, the world’s largest glove manufacturer, said it is temporarily halting the operations of its medical glove factories in Klang, in compliance with EMCO directives.

It added that it is awaiting clarification from the National Security Council on the matter, but did not give further details.

“The company looks forward to safely resuming operations at the appropriate time and continuing to produce its much needed medical gloves for frontliners and healthcare workers in Malaysia and globally.

“The company continues to maintain strict adherence to the relevant rules and regulations, as well as Covid preventive standard operating procedures, and is committed to safeguarding the health and safety of its workforce and the communities in which it operates,” said Top Glove.

Its peer Hartalega Holdings Bhd also said it has initiated a full shutdown of all its manufacturing facilities in Bestari Jaya and Sepang.

“Regrettably, this will have a significant impact on both the local and international healthcare value chain in terms of disruption to availability of supply, as Hartalega is a key manufacturer of nitrile gloves for hospitals globally,” Hartalega said in a written reply to The Edge.

Likewise, Kossan Rubber Industries Bhd also stated it has implemented temporary stoppage of its glove manufacturing facilities in Klang for the same reason.

Among other glove manufacturers that have operations in Klang include Supermax Corp Bhd and Mah Sing Group Bhd.

The EMCO for 34 districts in Selangor and 14 localities in Kuala Lumpur is in force from July 3 to July 16.

The shutdown came as a surprise to some analysts as rubber gloves are deemed as essential personal protective equipment.

On Sunday (July 4), the Malaysian Rubber Glove Manufacturers Association (MARGMA) urged the government to allow glove factories in Selangor to operate under the EMCO.

“Since the government’s announcement on the imposed EMCO on the state of Selangor, global customers of our manufacturers have been calling with great concern on shortage of production and delivery of gloves to them.

“Our members are under tremendous pressure from global hospitals and healthcare workers as the pandemic has now evolved into another variant,” said MARGMA president Dr Supramaniam Shanmugam in a statement.

June 14, 2021

• Philips is initiating a voluntary recall notification* to ensure patient safety in consultation with regulatory agencies
• Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices
• Philips aims to address all affected devices within the scope of this correction as expeditiously as possible

Amsterdam, the Netherlands – Following the company update on April 26, 2021, Royal Philips(NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.

To date, Philips has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation.

Therefore, Philips has decided to voluntarily issue a recall notification* to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO of Royal Philips. “In consultation with the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices. Patient safety is at the heart of everything we do at Philips.” 

Recall notification* advise for patients and customers

Based on the latest analysis of potential health risks and out of an abundance of caution, the recall notification* advises patients and customers to take the following actions:

• For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.*
• For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.*

Possible health risks

The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. To date, there have been no reports of death as a result of these issues. Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions. 

Repair and replacement program

Philips is providing the relevant regulatory agencies with required information related to the launch and implementation of the projected correction. The company will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances. Philips aims to address all affected devices in scope of this correction as expeditiously as possible.

As part of the program, the first-generation DreamStation product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances. Philips’ recently launched next-generation CPAP platform, DreamStation 2, is not affected by the issue. To support the program, Philips is increasing the production of its DreamStation 2 CPAP devices, that are available in the US and selected countries in Europe. 

Financials

In terms of the financial impact, Philips anticipates that the expected revenue headwinds in the Sleep & Respiratory Care business in 2021 will be compensated by the strength of the company’s other businesses. Therefore, the full year comparable sales growth and Adjusted EBITA margin guidance provided on April 26, 2021 remains unchanged.

The updated instructions for use of the affected devices have resulted in adjustments to and acceleration of the repair and replacement program, as well as intensified communication with customers and patients. This had led to an increase of EUR 250 million in the expected costs of the corrective actions on the installed base, in addition to the provision that the company recorded in the first quarter of 2021.

Additional information

For more information on the recall notification,* as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. 

*    This is a recall notification for the US only, and a field safety notice for the rest of the world
**    Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication.

Kate Gibson, CBS News

Philips is recalling breathing devices and ventilators due to foam that might degrade and become toxic, possibly causing cancer, the Dutch medical equipment maker said on Monday.

The recall involves specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) and mechanical ventilator devices to address potential health risks related to polyester-based polyurethane sound abatement foam that is in the machines, Philips said in a news release.

Foam used to soften the sound made by the machines can deteriorate and project tiny particles and gases that can irritate airways, cause headaches and possibly be toxic or carry cancer risks, according to the company.

No deaths have been reported in connection with the recalled devices.

“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” CEO Frans van Houten stated.

Philips has produced millions of devices using the foam, with a low complaint rate of 0.03% last year, the company reported.

Those using the ventilators to sustain life should not alter their prescribed therapy until they’ve talked to their physician, with others using bi-level PAP and CPAC devices should discontinue their use and talk to their doctor, the company said. Consumers can learn more here.

The company, one of the largest manufacturers of sleep apnea machines and ventilators, reported in quarterly earnings in late April that it had identified a quality issue with some sleep apnea and respiratory products, stating it was looking into the matter.

Jesus Jiménez and Niraj Chokshi New York Times

Dozens of staff members at a Houston-area hospital protested on Monday night against a policy that requires employees to be vaccinated against Covid-19.

The hospital, Houston Methodist, had told employees that they had to be vaccinated by Monday. Last month, 117 employees filed a lawsuit against the hospital over the vaccine policy.

While the U.S. Centers for Disease Control and Prevention recommends health care workers get a flu shot, and some hospital systems require it, few American companies have required Covid-19 shots, despite federal government guidance that says employers can mandate vaccines for onsite workers.

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Executives, lawyers and consultants say that many companies remain hesitant because of a long list of legal considerations the Equal Employment Opportunity Commission says must be followed before mandating vaccinations. Some companies say they are wary of setting mandates until the vaccines have received full approval by the Food and Drug Administration, which has so far granted emergency use authorization.

Jennifer Bridges, a nurse who led the Houston Methodist protest, has cited the lack of full F.D.A. approval for the shots as a reason she won’t get vaccinated.

Vaccine hesitancy has been high among frontline health care workers in the United States: Surveys showed that nearly half remained unvaccinated as of mid-March, despite being among the first to become eligible for the shots in December. A March 2021 survey by the Kaiser Family Foundation found that health care workers had concerns about the vaccines’ newness and their possible side effects, both of which are common reasons for waiting to be vaccinated.

By Monday evening, dozens of Houston Methodist employees had gathered outside the hospital system’s location in Baytown, Texas, holding signs that read “Vaxx is Venom” and “Don’t Lose Sight Of Our Rights.”

“If we don’t stop this now and do some kind of change, everybody’s just going to topple,” Ms. Bridges told local news media covering the protest. “It’s going to create a domino effect. Everybody across the nation is going to be forced to get things into their body that they don’t want and that’s not right.”

Those who did not meet the hospital’s vaccination deadline on Monday will be placed on a two-week unpaid suspension. If they do not meet the requirements by June 21, Houston Methodist said it would “initiate the employee termination process.”

The workers’ lawsuit accuses the hospital of “forcing its employees to be human ‘guinea pigs’ as a condition for continued employment.”

In a statement, Houston Methodist said that by Monday, nearly 100 percent of its 26,000 employees had complied with the vaccine policy. The hospital said it was aware that some employees who had not met the vaccine requirements planned to protest, and had invited other employees to join them.

“We fully support the right of our employees to peacefully gather on their own time, but it is unacceptable to even suggest they abandon their patients to participate in this activity,” the hospital said. “We have faith that our employees will continue putting our patients first.”

On Monday, Gov. Greg Abbott of Texas signed a law prohibiting businesses or government entities in the state from requiring vaccine passports, or digital proof of vaccination, joining states such as Florida and Arkansas. It’s unclear how or if the new law will affect employer mandates like Houston Methodist’s.

In some industries, including aviation, employers are taking a middle-ground approach. Delta Air Lines, which is distributing vaccines out of its flight museum in Atlanta, said in May that it would strongly encourage employees to get vaccinated and require it for new hires.

United Airlines, after considering a blanket mandate, said last week that it would require anyone hired in the United States after June 15 to provide proof of vaccination no later than a week after starting. Exceptions may be made for those who have medical or religious reasons for not getting vaccinated, the company added.

June 7, 2021 – Medline Industries, Inc. (Northfield, IL), has entered into a definitive agreement through which it will receive a majority investment from a partnership comprised of funds managed by Blackstone, Carlyle, and Hellman & Friedman.

Following the close of the transaction, Medline will remain a privately held, family-led company. Medline will continue to be led by the Mills family, who will remain the largest single shareholder. The entire senior management team will stay in place, Medline says.

The company plans to use the new resources from the partnership to expand its product offerings, accelerate international expansion and continue to make new infrastructure investments to strengthen its global supply chain.

Including debt, the transaction would be valued at about $34 billion, and north of $30 billion excluding borrowings, people familiar with the matter said. That could potentially make it the largest healthcare leveraged buyout ever, according to the Wall Street Journal.

Family-owned Medline is a major player in the field of medical equipment. Brothers James and Jon Mills founded the company in 1966, taking it public in 1972. The brothers bought back the shares five years later. James’s son Charlie has been Medline’s CEO since 1997.

It manufactures and distributes equipment and supplies used in hospitals, surgery centers, acute care and other medical facilities in more than 125 countries. Medline’s vast array of products include surgical gowns, examination gloves and diagnostic equipment, as well as consumer-facing brands such as Curad bandages.

The investment is expected to be completed in late 2021 and is subject to regulatory approvals and customary closing conditions.

Following the transaction, the family would remain the single largest shareholder in the company after the buyout, and the management team would remain in place, the company said Saturday.