eNews March 25, 2020

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

IMDA eNews readers: COVID-19 news is generated 24/7. Much of that news is outdated minutes after fingers click “Send.” Nevertheless, here are two items specialty dealers might find of interest.

Ford and the medical market

Ford made the following announcements on Tuesday:

 

  • It is working with 3M to manufacture Powered Air-Purifying Respirators (PAPRs). They will collaborate on the new design leveraging parts from both companies to meet demand for first responders and healthcare workers. Ford is exploring production of the new PAPR in a Ford facility in addition to 3M production.

 

  • Ford and GE Healthcare are working together to expand production of a simplified version of GE Healthcare’s existing ventilator design to support patients with respiratory failure or difficulty breathing.
  • And, in cooperation with the UAW, Ford will assemble plastic face shields at a Ford manufacturing site to help medical professionals, factory workers and store clerks. The first 1,000 face shields were to be tested this week at Detroit Mercy, Henry Ford Health Systems and Detroit Medical Center Sinai-Grace Hospitals. Roughly 75,000 of these shields are expected to be finished this week and more than 100,000 face shields per week will be produced at Ford subsidiary Troy Design and Manufacturing’s facilities in Plymouth, Mich. Ford also will leverage its in-house 3D printing capability to produce disposable respirators for healthcare workers

 

Conserve the ventilators!

On March 22, the FDA issued guidance outlining a policy intended to help increase availability of ventilators and their accessories as well as other respiratory devices during the COVID-19 pandemic. Among its recommendations:

 

Manufacturers may make certain modifications to FDA-cleared indications, claims, or functionality of these devices, without prior submission of a premarket notification where the modification will not create an undue risk in light of the public health emergency. In such circumstances, FDA recommends that the manufacturer provide clear instructions delineating FDA-cleared indications and claims from those that are not FDA-cleared, in addition to a general statement about changes that have not been cleared by FDA.

 

For providers, if the number of ventilators in the facility is running low, consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring such ventilatory support. Examples:

  • For any patient needing ventilatory support, continuous ventilators labeled for home use may be used in a medical facility setting depending on the features of the ventilator and provided there is appropriate monitoring (as available) of the patient’s condition.
  • For stable patients, emergency transport ventilators may be used for prolonged ventilation in a medical facility setting.
  • For any patient needing ventilatory support, anesthesia gas machines capable of providing controlled ventilation or assisted ventilation may be used outside of the traditional use for anesthetic indication. Because of significant differences between the anesthesia gas machine and traditional critical care ventilators, use or supervision by an anesthesia provider is recommended. Refer to the manufacturers’ websites for specific instructions on safe use of anesthesia gas machines for this indication.
  • Noninvasive Ventilation (NIV) Patient Interfaces capable of prescribed breath may be used for patients requiring such ventilatory support, including NIV Patient Interfaces labeled for sleep apnea.
  • Continuous Positive Airway Pressure (CPAP), auto-CPAP, and bilevel positive airway pressure (BiPAP or BPAP) machines typically used for treatment of sleep apnea (either in the home or facility setting) may be used to support patients with respiratory insufficiency provided appropriate monitoring (as available) and patient condition.

 

Given the potential for extensive use of ventilators and anesthesia gas machines in response to the COVID-19 pandemic, and to avoid depletion of breathing circuit supplies, FDA says health care facilities may consider extending the shelf life and duration of use of these products for treating individual patients, depending on the availability of resources. Providers may also consider extending the duration of use of passive humidifiers (heat-moisture exchangers) for up to one week depending on patient condition and available resources.