The Requirements of the EU Sharps Directive and What it Means for Manufacturers
On May 10, 2010, EU Directive 2010/32/EU was introduced to prevent injuries and blood-borne infections to hospital and healthcare workers from sharp instruments such as needles and lancets. Member states will have until May 11, 2013, to ensure that the provisions of the directive have been implemented into national legislation. The obligation is on the employer to ensure the safety and health of workers in every aspect related to their work with devices containing medical sharps. Sharps are defined as any device or object which is used to puncture or lacerate the skin.
The directive aims to ensure the safest possible working environment, to prevent sharps injuries and to protect healthcare workers and patients at risk. It recommends conducting risk assessments in all situations where there is potential for injury, or exposure to blood and other infectious material. Where such risks are identified, the directive recommends that either processes or devices must be put in place to reduce or eliminate the risk. It also requires the implementation of policies for risk assessment and prevention, training, information awareness and follow-up and response procedures.
What this means for manufacturers
Pharmaceutical and medical device manufacturers are not legally obligated to reduce the risk of needlestick injuries or to provide passive or active needle devices.
Nevertheless, it will be important for them to react to the directive to fulfill the market requirements and keep up their sales opportunities.
One company which is able to help companies looking to respond is German pharmaceutical label manufacturer Schreiner MediPharm. The company describes itself as a certified tier one supplier and development partner for the pharmaceutical industry.
Medical Plastics News asked Schreiner MediPharm to provide details of how its products can help manufacturers of medical sharps. The company responded with details of its Needle-Trap, a label-integrated needle protection system for prefilled syringes. The system works by having a safety mechanism built in as an integral component of the label, securing the blood-contaminated hypodermic needle after an injection.
According to the company, Needle-Trap is easy to handle for healthcare professionals. The activation of Needle-Trap’s safety mechanism can be conducted with one hand only, allowing the other hand to be kept free for clinical procedures.
The capability of adding Needle-Trap to a prefilled syringe manufacturing line is apparently relatively painless (please excuse the pun). Conventional labeling equipment can be used with just minor modifications. According to Schreiner MediPharm, this is a quick and easy integration into existing processes which gives manufactures the possibility to react rapidly to the directive and the resulting market requirements.
The company adds that additional costs of investments necessary are minimal. Thanks to the compact design there are no changes of secondary packaging required. Needle-Trap is adaptable to all standard syringe dimensions.
The unique system design complies with occupational safety and health regulations (FDA 510(k) certification). The authorisation for medicinal products can be submitted as an adaption of the prefilled syringe label.
In terms of the outlook for this sector, Schreiner MediPharm has been able to reach double-digital growth rates and is expecting this to continue. In the prefilled syringe market, experts are predicting an average growth rate of more than 9% over the next five years.
Needle-Trap is said to be particularly useful for clinical trials because compared with passive devices it can be easily combined with a booklet label which provides essential information.
Schreiner MediPharm says it fully supports manufacturers from the initial idea to production, creating customised solutions which optimise processes, reduce costs, and add value.
Medical Plastics News would like to thank Susanne Zinckgraf at Austrian injection moulding machine maker Engel for putting us in touch with Schreiner MediPharm.