Another discovery in the diving word eh? Or perhaps an incentive for risk taking divers to go to the extremes – who knows. It is fascinating to see that someone has created a “gummy bear for the deep”.
From SporkDiver.UK: Nitrogen narcosis, or the ‘Raptures of the Deep’, as Jacques-Yves Cousteau called it, is the disorientating effect and altered state of mind caused by breathing nitrogen at a high partial pressure. The deeper a diver descends, the higher the partial pressure of nitrogen and other gases in his air will be. For this reason, nitrogen narcosis is usually thought of as a function of depth. The deeper a diver goes, the greater the narcosis.
The FDA is at it again. If you have been advertising (even on your website) that you treat anything other than the “approved indications” and you haven’t seen a “WARNING LETTER” from the FDA yet – IT WONT BE LONG before you do. The age of regulation is upon us and the government needs to have a “return on investment” (ROI) for the hiring the largest number of regulators in US history. Good, bad, or indifferent, everyone in the industry will be affected by this crackdown- even if you are doing everything correctly. It will only take one bad news article about HBOT and down goes the reputation of the therapy. I am sure you are asking yourself “What does the FDA have to do with my advertising of my facility or my chambers?” This is from the FDA’s website:
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law.
In addition, FDA advances and encourages better communication of labeling and promotional information to health professionals and to consumers.
Please do remember that hyperbaric chambers are “cleared” by the FDA and that the FDA also monitors and can regulate the advertising of “off-label” indications to the consumers. I am sure one can argue that the FDA has no right to tell a physician what they can and cannot treat in their chambers but they do seem to have the right to monitor unsubstantiated claims about what HBO can and cannot treat.
In case no one has seen Title 21 (good reference). I hope you enjoyed this update.
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES
Subpart F–Therapeutic Devices
Sec. 868.5470 Hyperbaric chamber.
(a)Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient’s tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (878.5650).(b)Classification. Class II (performance standards).
FDA Notice/Warnings/Consumer Updates
Three years later and we have finally developed a Hyperbaric Safety Instructions Card for Monoplace chambers. This patient education piece is geared more towards patients rather than the clinical professionals in hyperbaric medicine. The inspiration for this came from the airline industry (flight safety card located on seat backs of airline seats). The FAA requires airlines to have an educational piece that is easy to understand with universal signage that almost anyone – no matter where they are from or what language they speak could understand. We have tried to make this as universal as possible – this is why it took three years. The language is in English and a Spanish one is being developed as we speak.
Illustrated Step-by-step Guide for all your patients
This patient educational piece provides your patients a step-by-step guide as to what to expect prior to, during, and after each treatment (THIS IS NOT A REPLACEMENT FOR APPROPRIATE PATIENT EDUCATION BUT MAY BE USED AS AN ADJUNCT TO THE CURRENT EDUCATION YOU PROVIDE YOUR PATIENTS). This guide could be used to assist in educating each patient about what to expect during the hyperbaric treatments.
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Clostridium difficile or C-Diff for short is one tough bug and is one that is difficult to eliminate with current approved acrylic disinfectants. Using a disinfectant that the chamber manufacturer does not recommend could cause you to void the chambers warranty but not addressing C-Diff in the chamber is a patient safety issue. I have several links that discuss c-diff and hyperbaric chambers below. Hopefully these links are helpful.
Mexico closes hyperbaric clinic article.
MEXICO CITY — Mexican authorities have temporarily closed a private clinic after a patient was found dead inside a hyperbaric chamber.
The federal oversight agency in charge of medicines and health care says service at the Hyperbaric Medicine of Toluca clinic will be suspended while authorities investigate whether it followed appropriate procedures.
The agency said late Wednesday that 70-year-old Filemon Consuelo Loria died in the chamber in Toluca, a city just west of the capital in Mexico state. State prosecutor Miguel Contreras earlier gave his age as 60.
Prosecutors detained a doctor and three workers at the clinic after Consuelo Loria was left inside the chamber overnight. He suffered from diabetes.
Investigators haven’t determined if he was left inside the oxygen-enriched chamber by mistake or on purpose.
Paradigm Medical Management (www.pmmhealthcare.com) is hiring for a Hyperbaric Safety Director to work at a successful Wound & Hyperbaric Center in Los Angeles, CA (near Beverly Hills). Please send your resume to Denise Chouinard at email@example.com immediately.