The day before his vice president would lose to George W. Bush in the most controversial election in U.S. history, President Bill Clinton signed the Needlestick Prevention Act, one of the many bills he signed on the way out of office.
The bipartisan measure outlined several steps to help nurses, doctors and health care workers avoid the 600,000 to 800,000 annual needlestick injuries which pass bloodborne pathogens like the HIV virus and hepatitis B and C to its victims.
One way to avoid these injuries, the bill says, is to enforce the use of safety syringes, which have retractable or covered needles. The largest maker of these, and all other types of syringes, is $3.7 billion medical supply company Becton, Dickinson & Co. Becton, Dickinson was thrilled by the passage of the legislation and lauds it on its Web site, but there’s a line in this bill that it refuses to talk about.
That line reads, “(Needlestick prevention plans should) document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure.”
Such a device is commercially available and is undergoing the final phases of FDA clinical testing. Such a device exists that destroys and seals a syringe needle, rendering it virtually harmless, and it would save hospitals $500 million annually, according to the U.S. General Accounting Office.
The Occupational Health and Safety Administration (OSHA), the watchdog of worker safety, however, won’t openly endorse these devices. Why? Perhaps it’s because of the sketchy track record of previous needle destruction devices. Several calls made to OSHA over the course of a month were not returned.
That brings us to Joe Adkins, president of Broadview Heights-based Safeguard Medical Devices Inc. and creator of the Disintegrator, a new syringe needle destruction device. Adkins, who has a three-employee operation, is fighting a multibillion-dollar company and one of the largest divisions of the U.S. government to get his product in America’s 5,000 hospitals and 100,000 health clinics and medical offices.
And he’s starting to win.
Joe Adkins, a tall, lean man with swept-back red hair and a deep smoker’s voice, jams his unprotected hand into a two-foot-deep box full of syringes.
“I’d say there are maybe 2,000 syringes in here,” says Adkins, vigorously working his hand through the pile. “They’re all destroyed, so they’re not going to stick you.”
Adkins clearly has confidence in his product. The Disintegrator, which he spent two years developing, destroys any size syringe needle using electrical current. The device is about the size of a box of kitchen matches and burns the needle down to the nub, sealing it, so no fluid can escape. The process takes less than three seconds, and all it requires is the press of a button.
The idea came from Adkins’ mother-in-law and sister-in-law, both nurses. In 1998, when the Needlestick Prevention Act was introduced into Congress, there was a lot of publicity because hundreds of thousands of health care workers are stuck each year, resulting in more than 1,000 serious infections.
Adkins’ mother-in-law told him, “You’re an engineer; you would think you would be able to come up with something to solve this problem.”
So Adkins did.
He looked at what had been done in the past. He saw that previous needle destruction devices burned the needle by short-circuiting the battery, which required the user to feed the needle into the device incrementally. The devices also required an immense amount of power, so batteries didn’t last long.
The Disintegrator uses an air arc, similar to a welder’s arc, or a metal cutting arc. That arc jumps a 3/16th inch gap to an electrode that comes over and strikes the needle, creating a momentary controlled short circuit.
The electrode is set at an angle so that the closest point is at the bottom of the needle. As the needle melts, that closest point of the electrode rises, and the arc follows that tip of that needle all the way up to the nub.
Although Adkins’ device works much more efficiently than previous products on the market, it is being written off as just another clumsy needle destruction device. One of those groups dismissing the product is OSHA.
“I do understand OSHA’s position,” Adkins admits. “The needle destruction units that they have seen to date are really not adequate. They were very large, they are very heavy, and they really can’t be used.”
To help overcome this prejudice, Adkins called on Rep. Steven LaTourette (R-OH), to alter the Needlestick Prevention Act to include language about using devices other than safety syringes. Since the law was passed, there has been little progress in getting other devices approved by OSHA.
“Some of the field operatives for OSHA feel differently, and they’re trying to get some sort of across-the-board clarification for these people that this is an acceptable device,” says Terry McNaughton, a legislative aide for LaTourette. “We’re trying to get a trickle-down effect going.”
While OSHA stalls on its ruling on needle destruction devices, the tax dollars spent on safety syringes continue to add up. The most common type of safety syringe in hospitals costs 20 cents more than a standard syringe. It will cost an average 100-bed hospital an extra $12,500 a year for the safety needles, Adkins says.
To put a needle destruction device at each bed would cost the same amount, but it would only be a one-time cost. The only additional cost is a battery replacement after three or four years.
On top of the added base cost, safety syringes need to be overfilled because they waste more medication due to the complex mechanism inside. These syringes also require extra training for nurses and health care workers. And add to that the cost of a higher medical waste bill due to the heavier weight and size of the safety syringes.
“In reality, they could be looking at $1.5 billion a year, easily,” Adkins says. “If it’s costing the medical profession that, guess who’s paying for it? You and me.”
Helping Adkins endure the battle with OSHA is his investors, South Coast Holdings, which is affiliated with Akron-based law firm Roetzel & Andress.
“The fact that he had been working at this for two years, and he was nearly through the FDA process, was remarkable,” says Terry Smith, executive vice president of South Coast. “A lot of products don’t get as far as he did. We’re not typically start-up investors, but we just felt this idea was phenomenal.”
The professional model of the Disintegrator is where Adkins hopes to make his fortune, but in the meantime, he has to pay for the two years of research and development.
In March of this year, he received FDA approval of the Disintegrator consumer model for the diabetic market. But it looked like it would take him another two years to get it on the shelves of pharmacy and retail chains.
Enter Perfecta Products, makers of Zim’s Crack Crème. The company discovered the Disintegrator and offered to co-market it along with its foot cream designed for diabetics. Zim’s Crack Crème is in 41,000 retail stores including CVS, Walgreen’s and Wal-Mart.
“They feel they can put some serious numbers behind this thing,” Adkins says. “By having the way in to that many retailers is a benefit that they can offer that would take me two or three years to try to duplicate.”
The Disintegrator is retailing for $99.95, about the same price as the blood glucose meters diabetics use to test their blood sugar. The glucose meters are covered by Medicare and diabetics are allowed to purchase one a year, even though the meters last five to 10 years. Once again, Adkins is faced with an uphill battle to convince a government agency that his device is just as valuable to diabetics as a glucose meter, and therefore should be covered.
“The trouble we’re running into right now in Washington is the climate,” Adkins says. “It’s a deficit climate, which means that any new programs must be offset by cuts in existing programs, which gets to be a little difficult to do.”
On a grassroots level, Adkins is lobbying the 100 chapter presidents of American Association of Diabetes Educators. They each received a free unit and literature in hopes that they will recommend the devices to their 8,500 educators on a regional level.
“A newly diagnosed diabetic, he’s got enough problems,” Adkins says. “His whole life just changed. The last thing he needs to worry about is what to do with these things (needles). Here’s an answer. Spend the $99, and he doesn’t have to worry about that now.”
With headlines dominated by war and terrorism, the drive to prevent health care workers from accidental needlesticks doesn’t get much ink in the papers or attention by lawmakers, and whatever happens on Election Day is unlikely to change that. But despite all this, the Safeguard team is committed to keep fighting.
“We’re definitely optimistic,” Smith says. “That’s the fun part of it. It’s a challenge. And the feedback from people who have used them, from the trials, is phenomenally positive.”
Adkins takes a decidedly more adversarial approach.
“When I get this thing ready to go, there is no way OSHA’s going to prevent me from marketing it, not when Congress said I could,” Adkins says. “I know it seems like an open-and-shut case — you would think.”
How to reach: Safeguard Medical Devices Inc., (440) 717-9860 or www.safeguardmd.com
