U.S. Marshals Seize Unapproved Ozone Generators

U.S. Marshals Seize Unapproved Ozone Generators
By Cole Petrochko, Staff Writer, MedPage Today
Published: January 31, 2010


WASHINGTON -- U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.

The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.

The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.

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The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.

The FDA recommended that healthcare professionals and consumers cease use of the devices.

The agency said it obtained an inspection warrant for the company's manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA's good manufacturing practice requirements for medical devices, which had never been approved in the first place.

Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.

Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.

Friday's seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.

A statement on the company's Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.


http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/18228
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