Firm May Have Shipped Unsterilized Medical Tools, FDA Warns

WASHINGTON â€”  The Food and Drug Administration warned Thursday that a Georgia medical supply company may have been shipping unsterilized obstetrics and gynecology equipment since 1999, creating the “potential of causing death and serious injury such as infection, infertility and miscarriage.â€�

The company, A & A Medical Inc./Rocket USA, is under investigation for allegedly manufacturing devices labeled “sterile� that may not have undergone any sterilization, FDA officials said.

The FDA told health-care professionals and consumers to “immediately� stop distributing and using products from the Alpharetta, Ga.-based company, which also uses the name LifeQuest.

The FDA, however, was unable to say Thursday how many unsterile devices may have been shipped or where they had been sent. A & A Medical Inc. has less than $10 million in annual sales, according to the online InfoUSA directory.

Jihad Mansour, who is listed as the quality assurance officer for A & A Medical Inc., refused to comment when reached at his Georgia home Thursday night.

“I have nothing to tell you,� Mansour said.

FDA officials said they were not aware of any injuries caused by use of the company’s medical devices, which include curets used to take tissue samples, uterine dilators and harvesting pumps used in in-vitro fertilization.

FDA officials said they were tipped off by former employees that the company was shipping unsterilized equipment internationally.

Kathleen Kolar, an FDA spokeswoman, said that some of the products manufactured and shipped by the company had been sterilized while others had not.

“The bottom line is this product will be removed from the market as soon as possible whether the company follows our urging to voluntarily recall it or if we have to take further steps,� Kolar said.

FDA investigators went to the company’s plant after a whistle-blower came forward in recent days, and they found reason to warn the public and the medical community immediately, Kolar said.

Thursday’s warning was in the form of an “alert� rather than an official recall, which requires more formal steps.

The FDA has been under fire recently for not acting aggressively enough to protect consumers from faulty medical devices. The FDA had to step up the investigation into a defective bronchoscope made by Olympus America of Melville, N.Y., after it became clear that doctors were continuing to use the $12,000 device more than three months after it had been recalled by its manufacturer.

The additional effort came after officials at Johns Hopkins University revealed that two patients who had undergone bronchoscopies, which allow the doctor to examine the lung, had died after the recall notice was misdirected.

The manufacturer, in that instance, issued a recall in November, two months after being warned by an epidemiologist that the device might resist disinfection between uses. After Johns Hopkins went public with its problem, hospital officials in a number of states complained that the recall information had been unevenly distributed and an unknown number of doctors may never have been alerted to stop using Olympus devices.

Health-care experts said news that a medical device manufacturer may have knowingly mislabeled equipment as sterile was disturbing.

“These supplies come in very clearly labeled sterile, and a hospital would have no reason to question that,� said Jan Emerson, a spokeswoman for the California Healthcare Assn., which represents nearly 500 hospitals. “This is alarming not just to hospitals but to patients and the public. You put your faith and your trust in the people you contract with for your supplies.�