Night-vision equipment detained

FDA Consumer, April, 1995 by Marian Segal

Certain night-vision devices imported from the former Soviet Union are being automatically detained by the U.S. Customs Service at FDA's request because of possible laser radiation hazards. The devices, which resemble binoculars, telescopes or gunsights, are advertised in magazines and catalogs for hunting, boating, birdwatching, and surveillance.

"Some of the devices are newly produced instruments intended for export, and some are military surplus of equipment used for night combat," says FDA compliance officer Frank Mackison.

Finding a large American market for the devices, importers are bringing them in through international airports all over the country for sale, primarily in gun shops and through catalogs. Since problems with the instruments were discovered in 1993, 13 companies have recalled 1,813 devices for repair or have replaced devices not in compliance with compliant units. In some cases, the noncompliant units were reexported.

The devices consist of an infrared image intensifier used to view objects in subdued light. Some include an infrared illuminator, which brightens the object being viewed. The illuminator may be a light-emitting diode or a laser diode. (A diode is a solid-state light-emitting electronic device similar to a transistor.)

Ken Miles, radiological health representative in FDA's Pacific Region office, says the binocular-type device, which may be hand-held or worn on the head, has an image intensifier similar to a tiny television screen in front of the eyes. The viewer doesn't see the actual object, but the light-intensified image on the screen. "It's like the green image seen through the device worn by the killer in the movie Silence of the Lambs," he says.

There are two health concerns with these devices--laser radiation and excess x-radiation. Excess x-ray emissions from the image intensifier can cause or contribute to the development of cataracts and skin cancer on the hands or face. Laser radiation emitted from the illuminators can damage the eye.

"In addition, the laser illuminators are subject to the federal laser performance standard and must be certified by the manufacturer as meeting that standard," says Mackison. "To date, none of these imported laser products made in Russia are in compliance, and cannot be legally imported into this country."

FDA first became aware of possible problems with the instruments in early 1993 from an importer who brought three models of the devices to the agency's Center for Devices and Radiological Health, asking what would be needed to bring them into compliance.

The agency tested one device and in April asked the district offices across the country to collect additional devices for testing. In August, all Russian-made night-vision equipment with laser illuminators were placed under automatic detention. Devices with light-emitting diodes are not being detained because they are not subject to the federal performance standard for laser products.

"We tested between 75 and 100 devices," says Mackison, "and found that, generally, only one particular model out of all those imported was emitting excess x-rays. The manufacturer, as far as we can tell, is now installing shielding around the imaging tube in new production to reduce x-ray emissions to acceptable levels."

Mackison says that because the instruments with laser diodes are being detained the Russians are now trying to ship mostly devices with light-emitting diodes.

In addition, importers have submitted plans to correct the problem in devices already distributed by replacing the laser diodes with light-emitting diodes. FDA continues to detain products suspected of containing laser illuminators until they are shown to be in compliance. Importers often reexport the shipment rather than try to bring the device into compliance.

FDA has not received any reports of injuries from use of the night-vision equipment.