FDA’s OK of Surgical Safety Device Sought

Alco International Group is seeking federal Food and Drug Administration approval for a device that would alert doctors and nurses to the presence of potentially infectious blood and body fluids that sometimes seep into surgical gloves during operations.

The company, which moved its headquarters to San Diego last summer from Florida, intends to market the device to surgical teams that operate on patients with AIDS, hepatitis and other potentially contagious diseases. Alco expects to receive FDA approval by mid-year.

Although the mere presence of contaminated blood and fluids inside surgical gloves doesn’t necessarily lead to infections, the risk can increase noticeably if surgeons or nurses have open wounds on their hands, according to Alco International president and chief executive Robert L. Donnell.

Federal Centers for Disease Control guidelines require the use of surgical gloves during certain procedures, but many doctors now question whether gloves alone are adequate protection, Donnell said.

“People have always assumed that gloves were good barriers, but we’ve found that many will leak with time,” said Max Willscher, a urologist who tested the device for a year at a New Hampshire hospital. “It’s common to rip or tear gloves and not even be aware of it until you see blood under the glove.”

“If you’re working (with surgical gloves) that are wet with fluid and blood for a half hour or so before you realize it, you’ve increased the potential for infection if there’s an open sore or a cut,” Willscher said.

While Alco will market its Barrier Integrity Monitor as a protective mechanism for operating room personnel, the company also believes the device will help to prevent the accidental infection of patients by doctors and nurses whose gloves are ripped or torn while performing surgery.

The monitor, which is powered by a 5.6-volt battery, is relatively simple to use, Donnell said. The decidedly low-tech device works by creating an electrical circuit that links the patient and operating room personnel. However, the circuit is activated only if a glove is penetrated by blood or fluid, Donnell said.

The electrical circuit is created by linking the patient to the device with an inconspicuous wire. Operating room personnel, who wear disposable foot covers with a conductive strip, stand on a disposable floor mat that is also linked to the monitor.

When gloves are intact, the electrical circuit remains incomplete. But, if a glove is ripped and fluid or blood seeps in, a complete electrical circuit is formed, and the device beeps. “The trickle of electric current sets off the alarm,” Willscher said. “All the surgeon has to do is stand on the (disposable) floor mat. . . . It works very well.”

Alco will concentrate at first on the operating room market, Donnell said. But the company sees additional markets, including dentists’ offices, emergency rooms and paramedic units, where health-care workers are in danger of coming into contact with--or spreading--infectious diseases, Donnell said.

Alco, which was founded in 1981, trades over-the-counter on NASDAQ. Its stock, which is trading at about $4, is up from $1 early in 1991, Donnell said.

Only six of the company’s 87 employees are in San Diego. The rest are employed by the company’s containerized shipping subsidiary in Dania, Fla.

Alco moved its corporate headquarters to San Diego in 1991 as part of a planned shift from shipping to medical products. “We’ve decided to change our emphasis to medical products,” and Southern California “is where the medical growth is,” Donnell said.

During the last half of 1991, Alco acquired marketing rights to the Barrier Integrity Monitor and the “Rabbit Ovulation Computer,” a hand-held, battery-operated device that women can use to chart basal body temperatures and determine when they are ovulating.

Gordon Ramseier, formerly president of Immunetech Pharmaceuticals, is serving as chairman of InCoMed, an Alco subsidiary that is developing medical products for the parent company.

Alco reported a $14,157 loss on $2.2 million in revenue for the nine-month period ended Sept. 30, 1991. It reported a slight profit on $2.6 million in revenue during the corresponding period a year earlier.