Bioburden and Its Effect On Sterilization of Elastomers In Medical Devices and How Antimicrobials Fit Into the Picture

The wonderful benefit of today’s disposable medical devices is the high quality of these devices which offer life-saving products for patient treatment and care while also assuring cleanliness, sterility, ease of use and effectiveness of each product. 

Medical devices must be clean and sterile in order to be safely used in patient care.  When components or subassemblies of these devices are contaminated during the manufacturing or assembly, the ability to clean and sterilize the finished medical device is adversely affected.  Elastomers are often a special challenge because of their unique manufacturing requirements, material properties and the critical environments in which they are often used. 

This paper will review some of the most popular elastomers used in the medical device industry, discuss why bioburden needs to be carefully controlled and how product sterility is affected by any bioburden.  Each common method of sterilization (steam autoclaving, ethylene oxide gas and radiation by gamma or beta) will be explained and shown why one is selected over the others.  A brief discussion will also show how anti-microbial material properties, (antimicrobials) while promising in concept, do not necessarily offer advantages to the majority of products used in healthcare and in some instances lead to unwanted complications.