BBI Contributing Writer

Syringes, IV catheters and blood collection devices with safety needle features such as protective sheaths and blunt tips are now being marketed. These designs are used to provide protection to health care workers from accidental needle-stick injuries that can result in the transmission of infection from blood-borne pathogens from AIDS, HIV-positive and hepatitis patients. Needleless injection devices have had only modest acceptance in the marketplace (The BBI Newsletter, September 1999). The safest design that employs a needle is one in which the needle automatically retracts into the body of the device in a single-handed operation after use. Several companies are developing retractable needle designs, although these products are more costly. The average price for a conventional syringe is 11 cents; for a safety needle syringe, 30 cents.

OSHA, states adopt safety regulations

Last November, the Occupational Safety and Health Administration (OSHA) issued the Blood-borne Pathogens Compliance Directive that mandates the use of improved and safer needles and requires that health care facilities perform annual reviews of safety and compliance programs. Also, employers need to establish an Exposure Control Plan that documents the evaluation and implementation of effective engineering controls designed to eliminate or minimize exposure to blood-borne organisms. The directive does not mandate the use of particular needle technologies or devices, only that commercially available safer needles be used. The National Institute for Occupational Safety and Health recently issued an alert urging health care providers to avoid unnecessary use of needles where safe and effective alternatives are available. Safety features decrease the frequency of needle-stick injuries but do not completely eliminate the risk. Some safety features cannot be activated until after the needle is removed from the patient and a needle may be inadvertently dislodged during a procedure.

California, Texas, New Jersey, Tennessee, Maryland and New Jersey have enacted legislation requiring the use of safety needle devices, and an additional 20 states have similar legislation pending. This has further stimulated demand for safer products.

More than 5 million needles are used in the U.S. every day. The annual cost for testing and treating the estimated 800,000 health care workers that are stuck by contaminated needles each year is estimated at between $2.2 million and $3.8 million. The OSHA decree addresses a market that is estimated to be $4 billion and could double to $8 billion due to the costly safety needles. BD (formerly Becton Dickinson; Franklin Lakes, New Jersey) dominates the U.S. market for hypodermic syringes with an estimated 80% market share, followed by Tyco's Sherwood Medical (St. Louis, Missouri) and Terumo (Somerset, New Jersey). However, a few small and development-stage companies are making significant contributions in the design and development of innovative safety needle designs.

Med-Design (Ventura, California) has developed 25 safety needle products, including a retractable needle syringe. BD has a worldwide license on five safety needle products and an option to acquire licenses to manufacture and sell 15 additional devices from Med-Design. These products include a safety hypodermic syringe, introducer needle, anesthesiology needle, AV fistula needle, pre-filled syringe, injector, venous and arterial needles. Med-Design had no product sales in 1999.

Specialized Health Products International (SPHI; Bountiful, Utah) has 13 different technologies for improving needle safety and owns 20 patents covering these products. SPHI has several strategic relationships, including a product development and licensing agreement with Tyco's Kendall Healthcare Products (Mansfield, Massachusetts) unit for 11 syringes and devices, a safety needle device licensed to BD, and six safety needle products to Johnson & Johnson Medical (Arlington, Texas). None of these products are on the market yet, but the company expects five of its safety needle products to be launched by J&J Medical in 2000.

L.O.M. Medical International (Kelowna, British Columbia, Canada) is developing its patented, one-handed L.O.M. retractable syringe. It is designed for automated assembly and uses a non-toxic gas-powered system to retract the needle into a sealed chamber after an injection but before withdrawal.

Retractable Technologies (Little Elm, Texas), a private company, manufactures and markets its VanishPoint one-handed, automated, retractable needle syringes and blood collection tubes that feature pre-removal activation after injection. These products are made by automated assembly. The company is ramping up to meet the increased demand for its products which currently exceeds its manufacturing capacity. The products are sold through distributors and hospital group purchasing organizations.

MedTech Group (South Plainfield, New Jersey), an injection molder of medical devices, had developed and previously marketed its eNTrap retractable needle syringe, but discontinued the product due to lack of demand. The product was seemingly ahead of its time.

New Medical Technology Group plc (NMT; Livingston, United Kingdom), a public company, markets the New Medical Technology safety syringe (ZeroStik brand in the U.K.), a spring-based retractable syringe. NMT is having manufacturing difficulties which has delayed by six months the introduction of additional retractable needle devices.

BD recently acquired the patented spring-based retractable needle technology of Saf-T-Med (Barrington, Illinois). The FDA-approved safety-engineered syringe has an interchangeable needle and is designed to be manufactured on high speed manufacturing equipment. It is not yet on the market.

Medi-Hut (Lakewood, New Jersey), a public company that does contract labeling of medical products, has patented a spring-based safety syringe with a transparent sleeve into which the needle automatically retracts after use. The product is patented and has FDA approval but has not yet been marketed.

Medisys Technologies (Baton Rouge, Louisiana) is a small public company that has developed and patented the CoverTip hypodermic syringe and the SofDraw blood collection device. These products employ a micro-thin sheath that covers the tip of the needle after skin penetration. The CoverTip syringe has FDA approval and its market launch is planned for the end of March 2000. It will be manufactured via a joint venture relationship with Dispomedic (Dimona, Israel).

Medisys (Woodbridge, United Kingdom), a public company on the London Stock Exchange unrelated to the above company, has developed the Futura safety syringe. This patented, low-cost, automatically retractable needle syringe will be marketed by its subsidiary, Futura Medical (Solana Beach, California). The company plans to file a 510(k) for this product in early 2000. The syringe will be manufactured by Acumen Enterprise in Kuala Lumpur, Malaysia.

Painless drug delivery through the outer skin

The use an array of "microneedles" having diameters thinner than a human hair is being developed by Redeon (Boston, Massachusetts) for the painless administration of drugs. Dr. Mark Prausnitz, its principal investigator at the Georgia Institute of Technology (Atlanta, Georgia), uses fabrication techniques that were originally developed for the microelectronics industry to produce tiny hollow metal needles. The microneedle array only penetrates the outermost layer of skin that contains no nerve endings.

Elan (Athlone, Ireland) has developed the Medipad disposable drug delivery device that adheres to the skin. It contains a microinfusor that penetrates only the outer skin layer and is claimed to be painless. The Medipad uses controlled gas generation as the mechanism for delivery. Elan has established joint ventures with Endorex (Lake Bluff, Illinois), Celtrix Pharmaceuticals (San Jose, California), MiniMed (Sylmar, California), Ribozyme Pharmaceuticals (Boulder, Colorado) and Isis Pharmaceuticals (Carlsbad, California) for use of Medipad to deliver their drugs. Elan plans to file for its first product using the Medipad device during the first half of 2001.