News From the Cause
Little oversight of oxygen chambers (THE INTELLIGENCER, DOYLESTOWN, PA)
October 03, 2011
After federal agents removed records and equipment related to what was his soon-to-reopen hyperbaric oxygen therapy program, Dr. William J. O’Brien III said that he suspected the investigation was motivated by safety concerns.
Among the items FBI agents confiscated Sept. 14 was a 10-person hyperbaric oxygen chamber at his Middletown office. The chamber was the same one that O’Brien’s company, Hyper Ox, previously used at Lower Bucks Hospital in Bristol Township.
In recent years, hyperbaric oxygen therapy has gained the mainstream medical community’s acceptance particularly for chronic wounds. Most local hospitals use it as part of their wound care programs.
But while the therapy’s popularity has grown, third-party oversight of the medical device and its operators has not, creating an environment ripe for misrepresentation and fraud.
“It’s less regulated than what I think most of us would like,” said Tom Workman, director of quality assurance and regulatory affairs for the Undersea & Hyperbaric Medical Society, the leading information and accrediting source on the medical sub-specialty.
Accreditation of hyperbaric oxygen programs is voluntary; training and certification programs exist, but they aren’t mandatory, either. Medicare requires only that doctors complete 40 hours of introductory hyperbaric medicine training, though other employees may perform the treatments.
In Pennsylvania, like most states, no government agency is responsible for monitoring hyperbaric medicine programs. Neither the Pennsylvania Department of Health nor the Department of State tracks the number or location of programs in the state.
The state health department conducts an occupancy review only for chambers located in a building under a hospital’s license, said Christine Cronkright, a health department spokeswoman.
The sale of hyperbaric oxygen chambers or services by anyone other than a doctor violates federal law, and, in Pennsylvania, it could trigger charges of practicing medicine without a license, said Ron Ruman, a Department of State spokesman.
The Undersea & Hyperbaric Medical Society said one of its databases shows Pennsylvania has 58 hyperbaric oxygen programs; the society has accredited only four, none of them located in Bucks or Montgomery counties.
Hyperbaric oxygen therapy involves breathing pure oxygen while inside a sealed chamber, in which the pressure has been raised up to three times higher than normal atmospheric air pressure. Under these conditions, the lungs can collect up to three times more oxygen than would be possible by breathing pure oxygen at normal air pressure.
The increased oxygen dissolves in the blood and circulates throughout the body. The oxygen-rich blood stimulates the release of growth factors and stem cells that promote faster healing in the body.
The Food and Drug Administration considers medical oxygen a controlled drug that must be prescribed by a doctor. Hyperbaric oxygen chambers are treated as medical devices and their manufacture, marketing and sales also falls under FDA authority.
The FDA approved O’Brien’s application to use and market his Hyper Ox 101 chamber in March 2006, according to agency records. O’Brien, who holds a Pennsylvania medical license, is president of WJO Inc. a network of family medical practices in Bucks, Philadelphia and Northampton counties.
In November, WJO Inc. filed for Chapter 11 protection with U.S. Bankruptcy Court in Philadelphia, according to court records. WJO’s holdings include Hyper Ox and another company that O’Brien owns, East Coast TMR Inc., a pain-management practice. Click here to view more
