The FDA says it’s conscious of latest studies of fires that occurred with HBOT gadgets that resulted in critical accidents and deaths, however the root trigger of those occasions is just not identified.
The US FDA issued a letter to healthcare methods reminding suppliers and services concerning the protected use of hyperbaric oxygen remedy (HBOT) gadgets and the significance of following the producer’s directions to be used.
The FDA mentioned it’s conscious of latest studies of fires that occurred with HBOT gadgets that resulted in critical accidents and deaths. Presently, the basis trigger of those occasions is just not identified, the company mentioned in its alert.
“Reviewing and following the producer’s directions to be used for every HBOT gadget getting used and guaranteeing correct hearth prevention and security measures are adopted may help scale back potential dangers related to the usage of these gadgets,” the FDA mentioned in an alert.
In accordance with the FDA alert, hyperbaric oxygen remedy is a kind of therapy that entails respiratory 100% oxygen in a particular chamber. The air strain inside is raised to a stage that’s increased than regular air strain. The elevated air strain within the chamber helps the lungs acquire extra oxygen, the FDA says.
The company famous that HBOT gadgets are Class II medical gadgets and are cleared by the FDA by way of the 510(okay) course of, and FDA-cleared gadgets will be recognized by looking for Product Code CBF within the 510(okay) database.
“Whereas the FDA believes that critical opposed occasions related to HBOT gadgets are uncommon, healthcare suppliers and customers ought to be conscious that these occasions can and do happen and may observe the producer’s directions to assist scale back potential dangers,” the FDA mentioned.
FDA Suggestions for Healthcare Suppliers and Services
- Evaluation and observe the producer’s directions to be used for every hyperbaric oxygen remedy (HBOT) gadget getting used.
- Guarantee hearth prevention and security measures are adopted for HBOT gadgets.
- Remember that there’s a heightened threat of fireside with use of oxygen at a excessive focus.
- Guarantee correct grounding gear is used.
- Guarantee correct coaching is offered and maintained for workers with use of HBOT gadgets.
- Make sure the affected person is correctly monitored and supervised at some point of the therapy with use of HBOT gadgets.
- Make sure that producer really useful cleansing procedures, upkeep intervals, and security checks are adopted for every HBOT gadget getting used.
- Observe the producer’s directions to keep away from probably prohibited gadgets throughout use of the HBOT gadget, together with electrical or static gadgets. Remember that some gadgets might require extra grounding measures.
- Guarantee sufferers put on clothes that’s product of hyperbaric appropriate supplies in keeping with the producer’s directions, similar to cotton.
- Remember that some affected person clothes and a few materials might produce extra static electrical energy than others (similar to wool and artificial supplies).
Extra info is accessible on the FDA web site.
