(Nomination for 2012 AUREA Award): Boci Co - Device for destroying medical needles

In late October 2011 the company Boci Co opened a plant in Knic to produce a unique device for destroying medical needles – Sharps Terminator.

The owner of this plant, which is one of the kind in the world, is Belgrade-based Boci Co, but the device is a U.S. patent owned by the company Medical Safety Solutions, Ohio, USA (they have never managed to start the mass production in USA), whereas the exclusive distributor for Europe is Belgrade-based Niki.

A team of engineers of Boci Co has completely re-engineered the U.S. patent, added numerous improvements, designed a factory model and all tools and established standards for the production and use of the product.

The investment is treated as Serbian-American, paid in advance, and as soon as the value of devices delivered to USA has covered the investment, the plant will be 100% owned by the Serbian company. The total amount of the investment, including the development of the patent, prototypes, factory versions, investments in the plant and a distribution system, is about USD 12 million, and the plant in Knic currently employs 60 workers.

Sharps Terminator is a safe and cost-effective solution for preventing accidental needlestick injuries at the point-of-procedure. It is intended for all those using syringes and needles at work because it eliminates the risk of bloodborne pathogen transfer due to percutaneous needle punctures.

Until now, there has been no adequate and completely safe solution anywhere in the world for preventing needlestick injuries after the use. Needles have mainly been covered by a plastic cap and disposed of in sharps container. It takes Sharps Terminator three seconds to destroy and disinfect a needle upon use. The needle is burned inside the device, and what remains in the user’s hand is only a plastic syringe, so that the risk from an injury is reduced to a minimum. Since the device destroys the entire needle, there is no need for sharps container.

The device runs on batteries, it is small, light and extremely portable, and it works on 90% of needles in use, including intravenous and butterfly types.

Most of the parts required for the production of this device are made in Serbia (about 85%). At the moment, the only components that need to be imported are batteries, chargers and motors, but the company already works intensively on finding manufacturers of these parts in Serbia.

The expected annual turnover is USD 120 million, and a batch of these devices has already been delivered to the markets of USA and Saudi Arabia.

INNOVATION

Sharps Terminator is a device that reduces sharps and treats used needles in a unique way. After administering an injection, the user can destroy the needle in three seconds at the point of procedure by means of an efficient, one-handed operation. The device will destroy the needle from the tip to the hub as the needle body completes a circuit between two angled copper electrodes. Resistance from the needle creates heat sufficient to destroy the metal portion of the needle. The device then cuts the plastic “hub” above the metal needle so that no metal is left on the syringe. Finally, the debris from the needle falls into a clean-out tube at the bottom where it is exposed to UV light to eliminate contaminants. The remaining plastic syringe is no longer a sharp and can be disposed in the regular medical waste bag.

After 30 needles are burned, the container will signal that it needs to be emptied. Waste is disposed of in classical sharps containers, but the needlesticks treated in this way take much less space (it takes 12 containers to dispose of 4,200 used needlesticks, whereas the same number of needlesticks burned with Sharps Terminator fit into 1 container), and there is no danger from any further injury.

The device burns needles between 0.45 and 1.2 mm thick and up to 5 cm long, meaning that over 90% of needles in use can be treated.

This device is also unique because it runs on batteries. It uses Nickel Metal Hydride (NiMH) batteries and can burn between 100 and 300 needles before a battery empties. The battery is charged via a charger off the mains, and the device can operate after half an hour of charging, while still connected to the charger. It takes four hours to recharge a battery, and between 150 and 250 needles can be burned per charge. Sharps Terminator is always in standby mode, meaning that it consumes a very small amount of energy, and it is activated when a needle is inserted.

It is made of ABS plastic and polymers resistant to high temperatures. This device, 18 cm tall, is extremely portable and weighs 1.8kg.

Sharps Terminator is not categorized as a medical device, and its price for end-users in all markets is EUR 800.

The product guarantee promises 20,000 destroyed needles. The device comes with CE-certified battery and charger, it has got an FDA approval in USA, which is usually pending for up to five years, and the Slovenian consulting company SIQ is hired to provide European certificates as well.

The projected monthly production capacity of the plant is 10,000 devices with one shift.

SOCIAL UTILITY

Sharps Terminator is intended for all those using syringes and needles at work. Doctors, medical staff, vets, dentists, laboratory technicians, people working at houses of correction and tattoo studios, policemen, customs officials, cosmeticians, social workers and others are exposed to a risk of needlestick injuries on a daily basis.

Although used needles have to be disposed of in an appropriate way, there is no law regulating the method of their disposal, but European directives stipulate that the disposal of medical waste will be mandatory as of 2013.

Until now, there has been no adequate and completely safe solution anywhere in the world for preventing needlestick injuries after the use. Over 1,200,000 medical and other workers in Europe are the victims of accidental needlestick injuries every year, 30% of which turn out to be fatal. Used needles have mainly been covered by a plastic cap and disposed of in sharps container, thus increasing the risk of injuries.

It takes Sharps Terminator only 3 seconds to save a life, that is, to destroy and disinfect a needle. The device destroys all known bacteria, HIV, Hepatitis B and C and other viruses and dangerous proteins.

The plastic syringe remaining after the needle is destroyed is not treated as medical waste, but it is recommended to be disposed of in sharps container. It takes 12 containers to dispose of 4,200 used needles, whereas the same number of needles burned with Sharps Terminator fit into 1 container.

The plant in Knic is the only facility in the world to produce Sharps Terminator, and it employs 60 people.

Over USD 3 million were invested in technologies and adaptation of the plant in Knic, and the total amount of the investment, including the development of the patent, prototypes, factory versions, investments in the plant and a distribution system, is close to USD 12 million.

FINANCIAL POTENTIAL

Batches of this product, which costs USD 800 a piece, have already been shipped to USA and Saudi Arabia, and orders have also been placed by clients in Great Britain, Italy, Germany and Spain. There are also interested potential buyers in Serbia, Kazakhstan, Turkmenistan, and the company is already negotiating with South African Republic.

Most of the parts required for the production of this device, about 85%, are made in Serbia. At the moment, the only components that need to be imported are batteries, chargers and motors, but the company already works intensively on finding manufacturers of these parts in Serbia. The projected monthly production capacity of the plant in Knic is between 10,000 and 20,000 devices, that is, about 150,000 devices a year, and the expected annual turnover is about USD 120 million.

If Sharps Terminator is your favorite for the innovative investment of the year, you can cast your vote on the official website of the 2012 Aurea Award.