COVID-19: FDA Issues Emergency Use Authorization for Hemolung RAS
ALung is committed to the safety and support of health care professionals, patients, and employees in the treatment of COVID-19. The following represents ALung’s commitment to supporting FDA’s response to the COVID-19 pandemic in the United States.
Hemolung RAS and COVID-19 FAQ’s
Q: How do I request Emergency or Compassionate Use of the device?
A: You must request use of the Hemolung RAS by contacting Tracey Dill at Hemolung_EUA@alung.com. Per FDA regulations hospitals are requested to provide the following patient protection procedures; IRB/Institution acknowledgment, consent, independent physician review and manufacturer approval. https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/investigationaldeviceexemptionide/ucm051345.htm
Q: How does Emergency Use Authorization (EUA) requests differ from Emergency or Compassionate Use requests?
A: For Emergency Use or Compassionate Use, you must follow the FDA regulations noted in the question above.
For EUA usage, if you are a hospital with current Hemolung RAS devices and consumables and have a COVID-19 patient you would like to use the Hemolung RAS, you do not need prior approval from ALung. You will need to follow internal hospital policies and utilize the Hemolung RAS Data Collection Form to satisfy FDA requirements for data collection. ALung does request that you notify us when therapy is initiated to provide needed support and assist with any data collection, including device accountability.
If you currently do not have Hemolung RAS devices, you must contact Tracey Dill at Hemolung_EUA@alung.com to make a formal request. Devices are available on a first-come-first serve basis and requests are not guaranteed to be approved.
Q: Does ALung provide training for Hemolung RAS for emergency use?
A: Yes, if your hospital is not a current VENT-AVOID Trial site, training is required before you can treat any patient with the Hemolung RAS. Training sessions will be performed by a certified Hemolung RAS clinical specialist. ALung provides an extensive portfolio of training materials plus offers a 24/7 Support Hotline.
Q: Is perfusion or ECMO Specialist required to run the Hemolung RAS?
A: No, our certified Hemolung RAS Clinical Specialists will train selected staff as directed by the requesting physician and hospital requirements. The Hemolung RAS was designed with simplicity in mind that nurses, respiratory therapists, and other related medical staff can perform the set-up and daily maintenance and monitoring of the device.
Q: Does the Hemolung RAS require 1:1 care?
A: This is dependent on hospital policies, but the device simplicity does not require 1:1 patient ratio. After the set-up and initiation of the device, there is minimal interaction needed. The device functions at dialysis like blood flow rates (350-550ml/min) and requires continuous device performance monitoring just as you would with mechanical ventilation or dialysis monitoring. Standard of care lab monitoring for blood gases, anticoagulation and related testing is recommended. ALung will provide you with data collection forms to assist with proper monitoring and reporting.