FDA Report of a 1.3ATA Bag Explosion; They call a “Common Occurrence”

This is a story I found on: a site dedicated to protecting consumers against faulty bags.

The FDA published a report not long ago regarding a 1.3ATA bag explosion – I love the part where it states “Seller claims that this is a common occurrence with that particular model and compares it with (b)(6), a work in progress.” An explosion of a bag chamber is a “common occurrence” really?

To see the FDA report click here: FDA Report

Thanks to my new Twitter friend @RobertMDenver for exposing these bags and their weaknesses.

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UHMS Knocks out negative HBO article written by Margolis on DFU’s

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Great response! Please share this response with your HBO docs and referring physicians who have read the negative article.

The below letter is sent in response to the Margolis Paper (referenced below) on behalf of UHMS President, Dr. John Feldmeier as we have received many inquiries on this:

Dear Members,

The recent article by Margolis et al that reports the failure of hyperbaric oxygen in the treatment of diabetic foot ulcers has created major concerns by the hyperbaric community. This article is one of many published on this topic and other articles including several randomized controlled trials have previously shown a benefit for hyperbaric oxygen in achieving healing and preventing amputation.

I have read the Margolis article several times and believe that there are several serious criticisms that can be leveled at the article. First of all, it was not a randomized controlled study. Statistical techniques were applied to the results to compensate for the design not being randomized and controlled, but certainly still fall short of this standard. The study failed to use transcutaneous O2 measurements in the selection process of patients. Many have previously shown the importance of baselineTCPO2 measurements and response to an oxygen challenge for selecting patients appropriate for HBO2 intervention. The authors state that patients were determined to not be ischemic by their treating physicians. No methodology is described and certainly no consistent studies were applied. Certainly, ankle-brachial indices would be appropriate in most patients and even angiographic studies in some. A careful read also shows that one half of the patients received fewer than 29 treatments. Finally, the groups were mismatched in terms of their Wagners scores with the hyperbaric group including 45.7% and the non-HBO group containing only 18.4% of wounds with Wagners grade of 3 or more,

It is important that readers of the hyperbaric literature are equally critical in reading both negative and positive reports. It is also important that clinicians in hyperbaric oxygen carefully select patients likely to respond to treatment by applying selection criteria that have been shown to predict for a successful course of treatment.

A positive study for HBO2 in diabetic foot ulcers consisting of a systematic review was just published in the Mayo Clinic Proceedings. The authors conclude that “quality of life could be improved in selected patients with HBO.” This study consisted of a meta-analysis of 624 patients.

Our Authorization, Utilization, Quality and Reimbursement Committee is preparing a comprehensive review to be posted on the website readily available to our members. Dr. Enoch Huang will be presenting a review of this topic for the UHMS annual scientific meeting in June in Orlando.

Finally, I urge all our member experts to forward letters to the editor of Diabetes Care pointing out these deficiencies and any others detected after a careful and critical review of the paper.

John J. Feldmeier, D.O. FACRO, FUHM

President

Undersea and Hyperbaric Medical Society

References:

1. Margolis D, Gupta J, Hoffstad O, Papdopoulus M, Glick H, Thom S, and Mitra N. Lack of effectiveness of hyperbaric oxygen for the treatment of diabetic foot ulcer and the prevention of amputation. Diabetes Care published online February 19,2013.

2. Liu R, Li L, Yang M, Boden, Yang G. Systematic review of the effectiveness of hyperbaric oxygen in the management of chronic diabetic foot ulcers. Mayo Clin Proc.2013;88(2):167-175

Bill funding hyperbaric chamber for veterans advances to Senate floor

OKLAHOMA CITY – A Senate panel passed a bill Wednesday to set up a pilot program to treat veterans and service members with brain injuries and post-traumatic stress disorder in hyperbaric chambers.

The Senate passed House Bill 1942 by a vote of 17-3. The measure moves to the Senate floor.

Sen. Frank Simpson, R-Ardmore, the measure’s Senate sponsor, said the FDA is studying hyperbaric chambers as a treatment option.

Sen. Rob Standridge, R-Norman, said that because there is no conclusive evidence that the treatment works, promoting it may give false hope to those who have a brain injury or PTSD.

Simpson replied that some studies have shown that the conditions of some patients have improved as a result. Hyperbaric chambers have been used successfully to treat diabetic wounds, he said.

Simpson said he hopes to secure $3 million to $5 million in state funds for the pilot program. The location for the proposed program has not been determined.

Sen. Dan Newberry, R-Tulsa, said he has serious concerns that state funds are being sought when the research results are not in.

Simpson said the issue can be emotional, adding that some service members returning from duty have a high rate of suicide, deal with disintegrating families, and self-medicate with alcohol or drugs.

If the treatment worked, he said, it would return some veterans to being productive members of society and pay for itself.

For the original article click here