Medical Device Link.

MARKET PLACE

Regulation meets commercial reality

Improved safety is one of the important focusses of the medical industry. Safety may be defined as the development and use of devices that are robust and protect health-care providers and patients. As a result, the demand for safety syringes is rapidly increasing. The role of copolyester materials in helping manufacturers achieve safer products is examined here.

Regulations such as the Needle and Syringe Safety Prevention Act (2001) in the United States and the European motion for Protection of European Healthcare Workers from Blood Borne Infections Due to Needle Stick Injuries (2006/2015 INI), are driving the replacement of traditional syringes with safety syringes.

In Europe alone, there are approximately 1 million needle stick-injuries each year;¹ of these, approximately 20% are related to the use of disposable syringes. As well as eliminating the risk of needle-stick injuries, these safety devices also prevent the reuse of syringes. The reuse of disposables is still an area of concern in certain applications and countries in Europe. Despite the fact there are technical solutions and a real understanding of the need for safety syringes, the growth of this market is in large part driven by anticipation of legislation/regulations.

Manufacturers are constantly weighing cost pressures and the need to reduce budgets against the desire for more advanced, lower-cost devices that combine ease of use, resistance to different sterilisation techniques, safety and environment-related considerations. This is a complex balancing act.

Protecting doctors, nurses and nursing practitioners from needle-stick injuries and related blood borne pathogens requires sound design as well as robust materials. However, health-care professionals prefer little or no change in operating technique, clear drug visibility, and the use of nonbreakable components to protect the needle.

Material choice

Syringe manufacturers employ numerous designs to protect syringe users from needle sticks. Depending on the type of technology, certain material properties are important. Safety syringes require clarity, toughness, modulus and appropriate coefficient of friction. Copolyesters possess the following characteristics:

• clarity of approximately 90% transmittance measured by ASTM D1003
• toughness characterised by the notched Izod impact test, measured according to ASTM D256, and ranging from 40-370 J/m
• tensile strength at break measured according to ASTM D638 test showing elongation until 6 330 %
• flexural modulus (important for the function of the safety feature) from 6 1800–2500 MPa according to ASTM D790 test.

Copolyesters are free of orthophthalate plasticisers, bisphenol-A and halogens. They also have several beneficial processing properties, including, low processing temperature and good flow properties, which enable efficient and high quality part manufacturing. They are versatile in that they can be processed by most traditional methods: injection, injection blow moulding and injection stretch blow moulding, calendaring, extrusion and extrusion blow moulding, and vacuum forming.

Broader potential

The combination of benefits of copolyesters helps manufacturers design safety syringes that meet the robust needs of the medical industry. This unique benefits package is not restricted to the manufacture of safety syringes. Copolyesters enable robust designs in a range of applications such as minimally invasive surgical devices, diagnostics, laboratory ware, blood therapy and fluid administration. The performance and processing benefits of copolyesters will ensure that these versatile materials continue to play an important role in the medical industry. 

For more information, contact Bart van de Krol, Market Development Manager, Medical, Eastman Chemical Company, Capelle aan den Ijssel, The Netherlands, tel. +31 651 120 539 e-mail: bvandekrol@eastman.com www.eastman.com