The FDA says it is aware of recent reports of fires that occurred with HBOT devices that resulted in serious injuries and deaths, but the root cause of these events is not known.
The US FDA issued a letter to healthcare systems reminding providers and facilities about the safe use of hyperbaric oxygen therapy (HBOT) devices and the importance of following the manufacturer’s instructions for use.
The FDA said it is aware of recent reports of fires that occurred with HBOT devices that resulted in serious injuries and deaths. Currently, the root cause of these events is not known, the agency said in its alert.
“Reviewing and following the manufacturer’s instructions for use for each HBOT device being used and ensuring proper fire prevention and safety measures are followed can help reduce potential risks associated with the use of these devices,” the FDA said in an alert.
According to the FDA alert, hyperbaric oxygen therapy is a type of treatment that involves breathing 100% oxygen in a special chamber. The air pressure inside is raised to a level that is higher than normal air pressure. The increased air pressure in the chamber helps the lungs collect more oxygen, the FDA says.
The agency noted that HBOT devices are Class II medical devices and are cleared by the FDA through the 510(k) process, and FDA-cleared devices can be identified by searching for Product Code CBF in the 510(k) database.
“While the FDA believes that serious adverse events associated with HBOT devices are rare, healthcare providers and users should be aware that these events can and do occur and should follow the manufacturer’s instructions to help reduce potential risks,” the FDA said.
FDA Recommendations for Healthcare Providers and Facilities
- Review and follow the manufacturer’s instructions for use for each hyperbaric oxygen therapy (HBOT) device being used.
- Ensure fire prevention and safety measures are followed for HBOT devices.
- Be aware that there is a heightened risk of fire with use of oxygen at a high concentration.
- Ensure proper grounding equipment is used.
- Ensure proper training is provided and maintained for staff with use of HBOT devices.
- Ensure the patient is properly monitored and supervised for the duration of the treatment with use of HBOT devices.
- Ensure that manufacturer recommended cleaning procedures, maintenance intervals, and safety checks are followed for each HBOT device being used.
- Follow the manufacturer’s instructions to avoid potentially prohibited items during use of the HBOT device, including electrical or static devices. Be aware that some items may require additional grounding measures.
- Ensure patients wear clothing that is made of hyperbaric compatible materials according to the manufacturer’s instructions, such as cotton.
- Be aware that some patient clothing and some fabrics may produce more static electricity than others (such as wool and synthetic materials).
