IMDA eNews 041123
The latest news affecting you and your customers…
from the Independent Medical Specialty Dealers Association
Ventilated COVID patients show scant lung damage
The majority of patients who required mechanical ventilation for COVID-19 at a busy European hospital survived at least two years post-discharge, according to Radiology Business. In addition, follow-up CT scans at that interval suggested only a few patients who had been ventilated invasively via endotracheal or tracheostomy tube had fibrotic-like changes, such as scarring and thickening of the lung tissue. However, they were no worse off in measures of overall recovery and quality of life than patients whose ventilation had been administered noninvasively. The researchers analyzed records of 143 individuals who were admitted with COVID-19 pneumonia up to May 28, 2020. All patients’ stays included diagnostic workup with CT, as well as mechanical ventilation with either invasive (61 patients) or noninvasive (82 patients) respiratory therapy equipment.
RSV cases returning to pre-pandemic levels
The Centers for Disease Control and Prevention (CDC) reported that after two years of irregular onsets, respiratory syncytial virus (RSV) circulation appears to be returning to pre-pandemic levels in the United States, according to Reuters. Typically, cases of RSV virus leading to severe illness or death in the very young and old rise in October and wane in April. During the two years of the COVID-19 pandemic, however, the circulation pattern changed. RSV cases in the most recent season began in June 2022 and peaked in November, while cases in the previous year began spreading in May and lasted through January 2022, says the CDC. And in the fall of 2020, cases were far lower than any usual season. Each year, RSV infections typically result in about 58,000 to 80,000 hospitalizations among children aged below 5 years, and 60,000-160,000 hospitalizations among 65-year-olds and above in the United States, the study said.
EPA proposes reducing EtO emissions from commercial sterilization facilities
Today the U.S. Environmental Protection Agency (EPA) proposed regulations to reduce exposure to ethylene oxide (EtO) in commercial sterilization facilities. The proposals include more stringent air emissions standards and additional protections for workers who are exposed to the gas used to sterilize medical devices and certain spices. EPA estimates the proposals would cut EtO emissions to the air from commercial sterilization facilities by 80% per year and apply more protective standards to control those emissions under the law. Long-term exposure to EtO over the course of a 35-year career or 70-year lifetime in or near a commercial sterilizer can increase the risk of certain types of cancer, according to the agency. Actual risks vary based upon a facility’s control measures for workers and community members and the distance and amount of time people live, work, or go to school near a facility.
Late-stage RSV vaccine trial shows promise
A Pfizer vaccine to protect older adults and infants from respiratory syncytial virus (RSV) infection is proving to be promising in late-stage trials, reports CNN. The New England Journal of Medicine recently published results of one company-funded trial in adults 60 and older in which the vaccine prevented both RSV-associated lower respiratory tract illness – which includes acute bronchitis and pneumonia – and RSV-associated acute respiratory illness with no apparent safety concerns. In another company trial, results published in the journal noted the RSV vaccine was given during late-stage pregnancy and was found to be effective against severe RSV-associated lower respiratory tract illness, such as pneumonia and bronchiolitis, or inflammation of the small airway passages entering the lungs in infants. There were no safety concerns identified. Pfizer is seeking FDA approval for its RSV vaccine for both older adults and, separately, pregnant people.
FDA ending emergency use authorizations
With the COVID-19 public health emergency set to expire on May 11, the FDA stated that medical technology companies that brought devices to market under special pandemic rules will soon need to prepare transition plans, according to HealthCare Dive. Device EUAs will not immediately expire when the public health emergency ends. Instead, the Health and Human Services Secretary will publish an advance notice of when the agency’s EUA declaration will end. Companies looking to continue selling their device will need to prepare a marketing submission to the FDA before the EUA termination date. The FDA says it will not object to the continued distribution of devices still under review after their EUA ends, so long as their marketing submission has been accepted by the agency.