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"Capture the joy of your unborn baby on videotape."
Through the use of modern ultrasound, a Georgia company offered expectant parents this special service to add to their video library.
But FDA says these "keepsake videos," taken for purely entertainment purposes without a doctor's prescription and for no medical reason, are an unapproved use of ultrasound equipment and therefore illegal. As a result, in the first such action of its kind, Fetal Fotos of Gainesville, Ga., agreed in a consent decree signed Sept. 12 to stop producing ultrasound images of unborn babies without a written prescription from a licensed doctor.
According to Tom Jakub, chief of the diagnostic devices compliance branch in FDA's Center for Devices and Radiological Health, obstetricians use ultrasound imaging to check the size, location, number, or age of fetuses; the presence of some types of birth defects; and fetal movement, breathing and heartbeat. "Ultrasound is generally considered safe when properly used for medical reasons, and often the doctor will give parents a still photo from these tests," he says.
But Fetal Fotos did not provide a medical service, as Fulton Varner and Andrew Paeng, investigators with FDA's Atlanta district office, learned when they first inspected Fetal Fotos on May 24, 1995. The inspection was part of FDA's nationwide effort to identify companies using ultrasound for unapproved uses. They questioned Donna Jans, owner of Fetal Fotos and a registered diagnostic medical sonographer, who admitted using an ultrasound scanner system to produce keepsake videos for $75.
The investigators also learned from Jans that she gave customers a consent form that stated "this service is provided only for the purpose of creating the said videotape ... Fetal Fotos does not provide any diagnostic service or any service which could in any manner be construed to be a medical service."
According to Varner, Jans would ask a prospective customer if she had discussed the procedure with a doctor, but if the customer hadn't, she still performed the sonography. In addition, the only record she kept of ultrasound procedures was a customer appointment log.
FDA's Atlanta office sent a warning letter to Fetal Fotos on June 8, 1995, advising the company that this unapproved use of a medical device caused the device to be adulterated and misbranded. FDA warned the company to stop the unauthorized use of the device or face possible regulatory action such as seizure or injunction.
In response to the warning, Jans, through her attorney, told the agency that Fetal Fotos would not produce any more keepsake videos and would provide diagnostic imaging only with a "prescription or other order of a licensed physician."
However, when Paeng returned to Fetal Fotos on March 29, 1996, he found that Jans was still producing keepsake videos. The investigator contacted two of the doctors listed in Jans' records as having given verbal consent for her to perform the procedure on their patients. But the doctors told Paeng that Jans had never contacted them and that they had not issued written prescriptions or verbally authorized the procedure for their patients.
When confronted with this information, Jans admitted that she had never contacted the doctors and, despite FDA's warning letter and three inspections, she indicated that she did not intend to change her business practices.
On April 30, FDA asked the U.S. attorney for the Northern District of Georgia to file a complaint for seizure. The complaint was filed on June 17, and a U.S. marshal seized the equipment and promotional brochures on July 8.
In the consent decree signed and entered in the U.S. District Court for the Northern District of Georgia, Jans agreed to stop producing ultrasound images of babies still in the womb without a doctor's written prescription and to keep detailed records of all ultrasound exams performed, including:
Isadora Stehlin is a member of FDA's public affairs staff.
The patient examination gloves were imported by a California company and labeled "Made in China." Fire inspectors attributed three warehouse fires in 1995 to the gloves.
FDA issued the import alert in 1995, and, following an investigation, issued a public health advisory last summer to hospitals, manufacturers and distributors to inform them that powder-free latex examination gloves have the potential to ignite when stored in large quantities in extreme heat.
FDA continues to study the combustibility of imported powder-free latex examination gloves from China and other countries. According to John Farnham, a consumer safety officer in FDA's Center for Devices and Radiological Health, the United States imports 17 million shipments of latex medical gloves each year.
Powder-free latex gloves are believed to have caused fires in Memphis, Tenn., Middlesex, N.J., and New York City, in spring and summer 1995. In the latter, 67 firefighters were injured battling an eight-alarm fire at Brooklyn Navy Yard. The suspect gloves were imported from China by SJS Supreme Inc. of Yorba Linda, Calif.
FDA issued the import alert Aug. 7, 1995, calling for all shipments of powder-free latex examination gloves imported by SJS to be detained at their ports of entry. On Aug. 18, FDA sent SJS a letter, notifying the importer that, because of the fires, it would have to "eliminate the unreasonable risk of substantial harm ... to persons who may be directly or indirectly exposed to these devices."
SJS recalled the gloves. In a Sept. 18 letter, SJS asked the five distributors that had received shipments of the gloves to destroy their SJS powder-free latex examination glove inventory according to local laws on proper disposal of combustible materials.
That same month, FDA investigators inspected several Chinese latex examination glove manufacturing facilities and found "numerous GMP [good manufacturing practice] violations," according to Dan Rowland, a compliance officer with FDA's Los Angeles district office. FDA officials also contacted the State Pharmaceutical Administration of China, the Chinese agency that regulates medical devices in that country.
In early 1996, the Office of Science and Technology in FDA's Center for Devices and Radiological Health tested the thermal stability of imported powder-free latex examination gloves by exposing them to heat. The tests revealed that the SJS-imported gloves produced more heat than that to which they were exposed, suggesting that the gloves were capable of spontaneous combustion.
Scientists with FDA's Forensic Chemistry Center in Cincinnati then compared the heat-producing gloves to non-heating ones and found chemical differences between the two. The center is now working on a test to detect gloves that could spontaneously ignite.
FDA's public health advisory, issued June 27, 1996, urged hospitals, distributors, and other facilities that store large quantities of powder-free patient examination gloves to take certain precautions to reduce the risk of the gloves igniting. FDA advised these businesses to avoid large inventories of powder-free latex examination gloves and to break apart stacked cartons to allow air to circulate more freely.
FDA's research indicated that higher temperatures short of ignition could cause latex gloves to deteriorate and lose their effectiveness as an adequate barrier. So, the agency's health advisory also cautioned hospitals and distributors to check powder-free latex examination gloves regularly for brittleness, tackiness, and an acrid chemical odor--all signs of latex glove deterioration.
According to FDA's Rowland, the agency is working with the U.S. Customs Service to determine how best to handle one last shipment of the suspect powder-free gloves detained in Los Angeles.
--Paula Kurtzweil
The government learned of the goods on Sept. 28, 1995, when an anonymous source called FDA's Buffalo, N.Y., district import operations branch to report that the distributor was selling canned ackees, a fruit widely eaten in Jamaica but banned in the United States.
Under an FDA import alert, ackees are supposed to be detained at U.S. borders because the fruit contains natural toxins that can cause illness, even death. The toxins are in the fruit's flesh when the fruit is either green or overripe and in the seeds of the fruit at all times. The ackee is conclusively linked to "vomiting sickness" in Jamaica, causing convulsions, coma and death in most cases.
Mark Prusak, the FDA compliance officer who took the complainant's call, tried repeatedly to meet with the person to get more information, but without success. About a month later, he met to discuss the illegal products with a customs special agent and James Sevchik, chief inspector with the New York State Department of Agriculture and Markets.
On May 29, 1996, Prusak, the customs agent, and Robert Weinberg, another state inspector, visited the wholesale food distributor unannounced and talked to the firm's president.
"We told him why we were there," Prusak says, "and asked him where the ackees were. He showed us one case." Labels identified the fruit as packed for Palm Rose Ltd., Kingston, Jamaica.
The president admitted he bought five to 10 cases a month at $105 to $110 per case, ordering the fruit by telephone from an individual at New York's Bronx Terminal Market. He had no records of the purchases, he said, because he always paid in cash, putting it in an envelope and handing it to a truck driver, who took the payment to the contact at the market and picked up the ackees and brought them back to the store.
Weinberg embargoed the ackees and ordered the firm to store them until further action.
As the investigators continued their inspection, Weinberg noted 24 bottles of Woodward's Gripe Water on the store's shelves. He called the bottles to Prusak's attention. When questioned, the president said he bought this product from another source in the Bronx.
Woodward's Gripe Water contains dill oil or dill water, sodium bicarbonate, alcohol, and other substances. Labeled for such medical uses as relieving baby's hiccups and minor stomach upsets, the product has been used in a number of other countries for years. In the United States, however, FDA considers it an unapproved drug. FDA also requires it to be detained at U.S. borders.
After Prusak informed the distributor that the product was illegal, "he agreed to destroy the gripe water," Prusak says, "and signed an affidavit attesting to this." As Prusak and the others watched, the man opened each bottle and poured the contents down a sink drain.
After being warned by the customs agent against dealing in smuggled goods, the distributor promised he would no longer handle either the ackees or the gripe water. In addition, he provided the names and addresses of his buyers--three grocery stores and three restaurants in Rochester and two restaurants in Syracuse.
State inspectors made sure the ackees were removed from the grocery stores. FDA's Buffalo district office notified the agency's New York district office of the alleged sources of the ackees and gripe water for follow-up.
On June 7, 1996, under Weinberg's supervision, the distributor destroyed the embargoed ackees by opening the cans and pouring a denaturing chemical over the product.
--Dixie Farley