Compliance focuses on contamination control
Mark A. DeSorbo
ALPHARETTA, GA-Executives of a medical-device manufacturer here have reportedly left the country amid a U.S. Food and Drug Administration (FDA) investigation and recall of obstetric and gynecological surgical devices that were labeled “sterile,” but may have never undergone any sanitization process.
“We believe the owners have left the country, but we are investigating,” says FDA spokesperson Sharon Snider.
Several types of OB/GYN surgical de vices manufactured by A&A Medical/
Rocket USA are believed to have never undergone sterilization and therefore have the potential to cause death or such serious injury as infection, infertility and miscarriage, Snider says.
At the time of this report, the FDA continued to recall all products labeled by A&A as sterile or ethylene oxide processed that were shipped nationwide and internationally to Canada, Egypt, Italy and Lebanon.
“The recall includes all products labeled as sterile and shipped since 1999,” Dr. David W. Feigal, Jr., director of the Center for Devices and Radiological Health, wrote in a March letter to doctors, surgeons, hospital administrators and risk managers.
The OB/GYN devices made by A&A are used only in surgical and gynecological procedures, according to the FDA. The products include, but are not limited to flexible and rigid curettes, uterine dilators, endometrial sampling tests, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, harvesting pumps used in in-vitro fertilization and aspirations sets.
FDA spokespersons say the compliance issue is centered on contamination control. The devices were labeled as “sterile” or “ethylene oxide processed,” which is widely used by the healthcare and medical industries to process sensitive instruments. Ethylene oxide is a potent, antimicrobial agent, that kills all known viruses, bacteria and fungi, annihilating even the most sterilization-resistant types of microorganisms, bacterial spores.
FDA spokesperson Kathleen Kolar says the agency conducts inspections of medical- device manufacturing facilities with the same contamination-control criteria it uses when it inspects a pharmaceutical manufacturing environment.
Kolar says the agency was informed of the sterilization issue with A&A products, but would not provide specifics. When asked if there were any deaths or injuries associated with the use of A&A's medical devices, Kolar replied, “not to my knowledge.”
“The agency is conducting an investigation, and we are restricted under legal requirements on what we can say,” she adds, declining further comment.
Under the Safe Medical Devices Act of 1990, hospitals and other user facilities must report deaths and serious injuries associated with medical devices, including recalled devices.
A call placed by CleanRooms to a number provided by the FDA press office for A&A was forwarded to a Select Surgical Inc., another medical-device manufacturer in Alpharetta.
A woman who answered the telephone at Select indicated that Select once rented space next to A&A, but was in the process of moving to another location in Alpharetta. “[A&A] hasn't been in that office in weeks, and as far as we know, their phone numbers are no longer in service.”