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Document 25 of 101.

May 3, 2000, Wednesday

SECTION: BUSINESS;Pg. C-1

LENGTH: 1445 words

HEADLINE: Sticking to safety; Doctor's device designed to prevent needle injuries

BYLINE: Brian E. Clark; STAFF WRITER

BODY:
Growing up, Dr. Steve Bierman hated shots as much as the next kid.

"Couldn't stand 'em," Bierman said, grimacing. "I remember how much they hurt."

As a physician, avoiding needles -- especially those contaminated with blood-borne pathogens such as HIV -- became a matter of life and death for Bierman. And he is not alone. Each year, he said, thousands of health care workers are injured from inadvertent needle sticks. "You don't want to get stuck if you can avoid it," said Bierman, the 50-year-old CEO of a medical device company called Venetec International.

He has accidentally pricked himself with needles at least a dozen times in his 18-year career as an emergency room doctor. He became ill several times.

These days, the Del Mar resident teaches part time at the University of California San Diego medical school. But he spends most of his waking hours -- workweeks run more than 70 hours -- thinking of better ways to make intravenous catheters stay in place.

Each time a catheter -- flexible plastic tube -- is dislodged, the chances of patient infections and complications rise. And with each restart requiring a needle, health-care workers risk being infected, he said.

Bierman, who is also the firm's medical director, said the most common ways of securing catheters -- using tape or sutures -- are often ineffective, resulting in 100 million unscheduled restarts in the U.S. annually.

Bierman said restarts can be expensive, costing a minimum of $5.50 each for a catheter with a retractable needle. Often, the expense is much greater. But the most compelling reason to avoid restarts is to reduce the chance of mishaps for patients and health-care workers, he said.

Within the past 18 months, the U.S. Occupational Safety and Health Administration, the Centers for Disease Control and a half-dozen states, including California, have passed laws or issued directives requiring greater efforts by health-care organizations to protect against accidental needle injuries.

Nancy Moreau, editor of Practical Access, said catheter securement devices such as Bierman's StatLock can save hundreds of dollars in unnecessary expenses associated with restarts. Moreau's newsletter is published by the National Association of Vascular Access Networks.

Marilyn Hanchett, director of quality improvement at Express Scripts Infusion Services in St. Louis, said the medical community long has accepted dislodgement complications as part of working with catheters.

"And every time a line comes out, the clinician is exposed to blood, contaminated needles and the chance of being accidentally stuck," said Hanchett, a registered nurse.

Bierman's company, with offices in Del Mar Heights, has a staff of 40. Last year, it posted sales of $2 million. He said he is on track to more than double that figure in 2000.

Venetec rivals that produce catheter securement devices include the ConMed and Maersk companies, but Bierman said the biggest obstacle to greater sales is the tradition of using tape.

"Old habits die hard," he said. "But StatLock devices distinguish themselves by their design sophistication and engineering excellence to specific securement needs. The results speak for themselves."

Bierman said published clinical studies on adults have shown that Venetec's products reduce unscheduled catheter restarts by more than 70 percent, and overall patient complications by a similar amount.

Dr. Gregory Schears, a critical care specialist at Children's Hospital of Philadelphia, said he has been impressed with Venetec's devices because they are easy to use, hold catheters securely and avoid the need for tape and sutures.

"They are incredibly practical," said Schears, who also has been accidentally stuck by needles several times in his career. "As an intensive-care physician, I put in many different kinds of lines in critically ill patients. It's frustrating for the patient and the health-care provider when a difficult-to-place catheter comes out."

Schears said clinical trials he is conducting with StatLock devices show reductions in catheter dislodgements and patient complications.

Bierman said he began working on his first idea -- which would become the original StatLock device -- in 1987, four years after he nearly died from an accidental needle prick. The incident occurred at Scripps Memorial Hospital-Encinitas while restarting a patient's catheter. The man had hepatitis B, a potentially fatal malady.

Six months later, on a surfing trip to Bali, the symptoms hit Bierman like a freight train.

"In the best moments, I felt like a decrepit 80-year-old," he said. "I remember seeing children dancing in the rain under banana leaves during the worst part. I decided that Bali was a good place to die."

But Bierman did not expire. He limped back to the United States and eventually recovered. He also vowed to do something about unnecessary needle sticks.

"Each year in the U.S., there are 800,000 needle injuries and several hundred health-care worker deaths," he said. "That's unacceptable."

Like many an entrepreneur, Bierman began his efforts in a garage, working with design engineer Wayne Mitchell. Simply stated, their creation is a nonirritating adhesive anchor pad that sticks to the skin. On the pad are two plastic cradle-like devices into which a catheter and tube snap and lock.

"I got my first patent in 1989," Bierman said. "In 1990, I formed a research and development firm and worked on other products that came from that original idea."

Over the next few years, he tested and redesigned products and molds using the latest plastics and adhesives. Now, he holds 38 patents and has 42 more pending.

"Basically, we wanted to come up with something that a blind man could use while riding on a galloping horse," Bierman said.

"In other words, I wanted it to work well in poor light and in an ambulance with a slippery floor that was rocking back and forth. You don't want catheters coming out on their own or being pulled out by patients."

In 1995, the first StatLock device received government approval. A year later, Bierman got his first large contract. And in 1996, after seeing 65,000 patients during 17 1/2 years of work as an emergency room doctor, he quit his job to focus on Venetec.

Bierman financed the company with $300,000 from friends and acquaintances in the San Diego area. Since then, venture capital firms from New York and Chicago also have backed the company's growth.

Even though cost-cutting and managed care have been the mantra of the health-care industry since the mid-1990s, Bierman said he was not prepared for the battles he would have to fight with the financial community, insurers or hospital administrators.

"Still, I've never considered giving up," he said.

Bierman said he owes a special debt of gratitude to San Diego businessmen Bill Davidson and George Walker, who built the Integra Biotechnical maquiladora in Tijuana three years ago specifically to handle Venetec's assembly and packaging. Today, Bierman said Integra manufactures between 250,000 and 500,000 StatLock devices each month.

In hindsight, Bierman said his seed money was not enough.

"The average start-up medical device company requires three to five years and $17 (million to) $22 million to reach profitability," he said. "But we docs did not know that when we started out. Eventually we turned to financial institutions to support the effort."

He said his advice to would-be entrepreneurs is to get proper capitalization.

"But I know that's rarely an option the first time through the tunnel," he said. "Also, hire excellence regardless of the cost. And no matter what other field you are coming from, trust your instincts."

Through it all, Bierman has persevered.

He said he believes he has convinced many in the medical establishment, plus some insurers and health maintenance organizations, that his devices can save money and lives.

In addition to Children's Hospital of Philadelphia, Bierman said StatLock products are in use at many hospitals, including the Department of Veterans Affairs Medical Center in La Jolla, Cedars-Sinai Medical Center in Los Angeles and the National Institutes of Health in Maryland.

Bierman said his company also has inked distribution agreements with major catheter manufacturers, including San Diego-based Alaris.

QUICK AUDIT [] Company: Venetic International [] Business: Catheter securement devices [] Chief Executive: Dr. Steve Bierman [] Headquarters: San Diego [] Employees: 40 [] Projected 2000 revenues: $4 million [] Company motto: A patient is not a pin cushion

GRAPHIC: 3 PICS | 1 CHART; 1,2,4. SCOTT LINNETT / Union-Tribune photos; 1. Taking care: This StatLock securement device by Venetec International is designed to stay put and hold a catheter in place even when it is attached to knuckles. 2. Dr. Steve Bierman 3. QUICK AUDIT 4. Making sure: Dr. Steve Bierman, CEO and medical director of Venetec International, holds one of the catheter securement devices his company makes. (C-2)

LOAD-DATE: May 5, 2000

Document 25 of 101.


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