Draeger—Anesthesia Devices: Manufacturer Addresses Off-Label Use for Long-Term Ventilation
March 25, 2020 | Risk Management News
ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Device Alerts. For more information contact us at email@example.com.
Draeger states that if an anesthesia device is used off label, the user recognizes that it is not the intended use of the device and does so on their own responsibility and at their own (liability) risk; however, in a situation in which a patient requires long-term mechanical ventilation but cannot be ventilated because of a lack of intensive care ventilators, the benefit of being able to ventilate such a patient with a Draeger anesthesia device must be weighed against the risk of the off-label usage of a Draeger anesthesia device. This risk-benefit assessment and the resulting decision must be made by the responsible healthcare professional based on the circumstances of the particular case. Draeger recommends contacting your legal counsel...