The Next Generation of Low Dead Space Disposable Syringes
MARKET WATCH ~ A HISTORY LESSON
A ruling in Scotland may spur uptake of safe syringes.
Safety devices for prefilled syringes from Rexam Pharma feature a passive design, in which the needle automatically retracts inside a protective cover following injection.
Safety at any price? Not when it comes to syringes, apparently. Although it is estimated that 1 million needlesticks occur in Europe each year, only 2.5% of syringes on the market are fitted with a safety device, according to international consultancy Frost & Sullivan (London). About half of the 12 billion syringes produced annually for the global market could be replaced with safety products, but the expense involved in doing so has been a formidable barrier.
Syringes are considered to be a commodity product, and anything that drives up production costs faces almost insurmountable odds in gaining acceptance. Cost-benefit analyses, thus far, have failed to persuade regulators and purchasers. But what has been called a landmark decision in Scotland may change the terms of the debate, according to William Dierick, corporate planning manager at Terumo Europe N.V. (Leuven, Belgium) and a member of the EUCOMED task force on sharps injuries prevention.
Cost Is Not a Valid Defense
The ruling involves the case of a paramedic in Edinburgh who accidentally jabbed himself with a needle while giving a shot of adrenalin to a patient who had overdosed on drugs. The paramedic was due to be married in a few months, and the possibility that the needlestick might have infected him with HIV or hepatitis caused him and his fiancée considerable anguish. Scotland’s public service employee trade union Unison took the case to court on his behalf.
“Scotland’s National Health Service (NHS) had been studying the introduction of safety devices, but ruled out recommending them because of the costs involved,” says Dierick. “The judges in the Unison case determined that NHS’s refusal to introduce safety syringes on cost grounds alone was a breach of employment and safety laws. Basically, this ruling says that liability cannot be swept away simply because of the cost of [implementing] a safe workplace,” says Dierick. “At EUCOMED, we consider this to be a landmark case.”
Speaking to a reporter from the British Broadcasting Corp., Unison solicitor Patrick Maguire said that NHS is in breach of national and European law if it does not introduce safer needles. Cost is not a defense, he stresses. “There is no excuse any longer. NHS has to do something about it.” Adds Unison official Jim Devine, the precedent set by the test case affects all healthcare workers. “Every health board in Scotland will have to take on board the implications of this decision,” says Devine. “They have to discard the old-style needles and introduce safety needles throughout the Scottish health service.”
The US Model
Sharps injury prevention has been mandated in the United States since the Needlestick Safety and Prevention Act was signed into law in 2000. It required the Occupational Safety and Health Administration to revise existing regulations governing bloodborne pathogens standards to facilitate the use of “safer medical devices,” including sharp objects with built-in safety mechanisms and needleless systems. The updated standard also requires employers to maintain a log of injuries from contaminated sharps. What little analogous legislation exists in Europe has been ineffective, thus far.
“There is workplace regulation in force at the European level, but nothing specific to needlesticks,” notes Patrice Lewko, marketing director at Rexam Pharma (Suresnes, France). Lewko notes that directives 89/391/EEC, 89/655/EEC, 2000/54/EC, and even the Medical Devices Directive (93/42/EEC) oblige healthcare providers to eliminate or reduce risk in the workplace.
“Germany’s TRBA 250 are the only national guidelines in Europe that specify safety requirements for healthcare employees. In particular, they state that sharps should be replaced by safety products whenever possible,” says Lewko. But the guidelines have not had much of an impact thus far, according to Dierick. “The technical rules, or guidelines, are about one year old, and implementation is about 1%. That is why EUCOMED is urging greater action on the legislative front,” he adds.
In the United States, healthcare personnel were instrumental in pushing legislation forward, notes Frost & Sullivan analyst Kavitha Ravikumar, who authored the report, “Strategic Analysis of the European Safety Syringes Market.” Public pressure has the potential to be a driver in Europe as well, she believes. Safety-syringe manufacturers must consider supporting movements lobbying for laws and simultaneously work at raising awareness of safety issues, she stresses. The minute that a law is passed, adds Ravikumar, the market will surge. In this regard, Scotland may be a bellwether for the rest of Europe. According to Lewko, it’s quite possible that the makers of prefilled syringes will be the avant garde of the movement.
Rexam’s Safe’n Sound safety device for prefilled syringes has sparked considerable interest among customers, says Lewko. “The syringe snaps into the system,” explains Lewko. “Following injection, the needle retracts inside a protective cover.” Since it is a passive device, retraction is automatic, preventing needlesticks and reuse.
While the company has been showing the product for about two years, it has not yet been made on an industrial scale. “Because of the different syringe formats, we can’t begin mass production of the Safe’n Sound system until we have a commitment from a customer,” explains Lewko. He is, however, cautiously optimistic. “We feel that there will be forward momentum in the prefilled-syringe market. The pressure to contain costs is not as pronounced in this sector as it might be in the medical device market, because the drug and the syringe are bundled together,” says Lewko.
Clearly the technology is available to dramatically reduce sharps injuries in the workplace. Rexam’s Safe’n Sound, and UltraSafe products from US-based SafetySyringes Inc., are but two well-known examples. “It’s hard to predict where the market is going in terms of technologies and costs, because it hasn’t even begun [to take shape] in Europe,” says Terumo’s Dierick. “But I can say this: We need to look beyond the cost of safety devices and consider the hidden costs of doing nothing.”
Machines Automate Assembly of Safety Syringes
Available in two versions, an automated packaging system has been designed to insert syringes into a safety device. The APS200 and APS300 systems, named according to the number of items that can be processed per minute, were developed by Corima (Sienna, TU, Italy), part of the Marchesini Group, to process products such as the UltraSafe Passive Delivery System from US-based Safety Syringes Inc.
The equipment inserts the ready-to-use syringes into the safety device. A machine vision system verifies the assembly: if any of the supports are misaligned, the syringe mechanism is tripped to render the device unusable. The vision system can be programmed to verify other customer-specified parameters. Cylindrical safety devices also can be processed by the system, which can be fitted with a labeling device for round products.
The versatile system can be installed downstream from filling and labeling machines or upstream from thermoforming equipment.
The Corima APS200 is currently being used to package safety devices at a German pharmaceuticals facility.
Firm Offers Detachable Labels for Safety Syringe Use
Various labels are designed by a company to facilitate the work of hospital staff and to protect patients. One such product offered by Schreiner Group GmbH & Co. KG (Oberschleissheim, Germany) is suited for use with safety syringes. After administering a drug, the user can peel two detachable labels off the needle protector for documentation purposes simply by rotating the syringe.
Operating in a similar fashion, the company’s Pharma-Comb labels can be easily detached and reapplied to another surface. This feature permits information from the product vial to be transferred directly to a syringe. E-Temp labels are also available. They record temperatures to which a product has been exposed to determine if a drug that has been in transit, for example, has stayed within its predefined temperature limits.
For medical device OEMs, the firm routinely develops self-adhesive products that incorporate added-value and functional elements. RFID solutions, high-end instrument labeling, and membranes for pressure compensation and humidity protection are among its capabilities.
UV Systems Provide Rapid Cure for Safety Syringes
Microwave-powered UV curing systems reportedly provide unrivaled consistency and repeatability in medical bonding applications. That was why Futura Medical Corp. (Solana Beach, CA, USA) specified a UV curing system when it approached sortimat Technology (Winnenden, Germany) to design an automated assembly system for its line of safety syringes. The F300SQ UV curing system supplied by Fusion UV Systems Inc. (Alton, Hants, UK) cures the adhesive that bonds the stainless-steel needles to the plastic cannulae.
During the assembly process, an automatic dispenser places a precise amount of adhesive onto the parts, which then travel underneath the curing lamp. Throughout five station indexes, or a total of 10 seconds, the parts are exposed to the lamp to ensure sufficient curing.
On occasion, a problem may cause the machine to stop operation. When this happens, the F300SQ lamp goes into standby mode, maintaining low power to enable lamp restart at any time. This ensures that the plastic parts under the lamp don’t melt while technicians fix the problem. When the machine starts up again, the UV curing unit is able to restart immediately.
Curing equipment from Fusion UV Systems is available with a remote blower or a built-in modular unit, which is typically used with automated safety syringe assembly systems.
Silicone Improves Performance of Autodisabling Syringes
A manufacturer of autodisabling syringes based in Taiwan replaced a thermoplastic vulcanizate (TPV) material used to make certain syringe parts with a liquid silicone rubber (LSR). Supplied by GE Bayer Silicones (Leverkusen, Germany), the LSR reportedly improved the performance of the devices and boosted manufacturing productivity.
IRI, which manufactures and markets the syringes, recently entered the medical device molding market. It was important to the company to establish a reputation for excellence right out of the gate, says operations manager Andrew Zheng. The syringes, which are produced in 1-, 3-, 5-, 8-, and 10-ml models, contain a proprietary O-ring and plunger tip and stopper that attach to the needle holder. TPV did not fulfill the product’s performance requirements, notes Zheng, and the company switched to the LSR material, which enabled the syringes to function and disable correctly. It also led to manufacturing efficiencies.
Ultimately, the company expects to produce five billion syringes per year, so it was important to source a material for the syringe components that could accommodate accelerated cycle times. According to IRI, GE’s LSR 2670 exhibits some of the best cycle times available. It also features good demolding characteristics and minimal mold fouling to further speed production.
Additional properties of the two-component material include low viscosity and chemical and UV light resistance.
Systems Designed for Syringe - Marking Applications
Drawing on more than 40 years of experience developing printing and laser marking equipment, a company specializes in building systems that meet specific customer needs. Tampoprint AG (Korntal-Münchingen, Germany) has designed numerous systems for the medical sector that comply with GAMP guidelines, including a number of machines for syringe-marking applications.
The company offers printing machines with a throughput of 300 to 400 syringes per minute that can be easily integrated into assembly lines. Machine vision systems can be added to verify print quality. Innovations introduced by the firm include the use of UV pad-printing inks, instead of solvent-based inks, to accelerate curing cycles and streamline processing; a vertical printing unit that can be used without an ink pump, thus reducing changeover times; the use of ceramic clichés in lieu of steel cylinders; and the development of a silicone ink for transfer printing along with a core ring system that reduces production costs by requiring that only the silicone, and not the entire core, be changed.
Copolyester Is Clear Choice for Safety Syringe
The UltraSafe passively activated safety syringe from Safety Syringes Inc. (Carlsbad, CA, USA) comprises two moulded components: an outer guard that prevents needlesticks, and an inner body. The outer guard is moulded from polycarbonate (PC). For the inner body, the company needed a material that had the strength and clarity of PC while minimizing friction. The firm ultimately settled on Eastar copolyester DN003 from Eastman Chemical (Kingsport, TN, USA).
The UltraSafe system’s outer guard has a grip that is automatically activated after injection. When the plunger bottoms out, the syringe slides back into the body of the device, where the needle is covered up by the guard.
During product design, engineers determined that the inner and outer parts of the device should have the same look and feel. To reduce friction and ensure the timely release of the safety mechanism, however, each component had to be moulded from a different material. The copolyester from Eastman Chemical was selected because it did not cause undue friction yet provided the required mechanical functionality. In addition, the material processes similarly to PC.
Copyright ©2005 European Medical Device Manufacturer