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Sterilization

Sterilization describes the process that destroys or eliminates all forms of microbial life.

Sterilization can be achieved through various means, both physical and chemical. Physical methods include steam under pressure (autoclave), dry heat, gamma irradiation, while common chemical methods include sterilization by Ethylene Oxide.

Sterilization in Medical Devices

Sterilization and disinfection are indispensable steps for ensuring that medical devices will not bear potentially hazardous microorganisms that can be transmitted to a patient. Failures in the adequate sterilization of medical devices may result in significant harm to patients. Risk-based approach is employed to determine whether cleaning, disinfection, or sterilization is indicated for a medical device on the basis of its intended use.

Medical devices are categorized as critical, semi-critical, and noncritical according to the degree of risk for infection involved in the use of the items. Medical devices that enter sterile tissues or vascular system present a high risk and classified as critical; these devices must be sterilized.

Sterilization Methods

  • Steam Sterilization - The preferred method for heat-resistant medical devices is steam sterilization since it simple, cost-effective and non-toxic. However, many devices cannot withstand heat sterilization, since they are made of heat-sensitive materials.
  • Gamma-sterilization process is suitable for many types of materials, however, certain polymers and semiconductors might deteriorate following exposure to gamma-irradiation.
  • Ethylene oxide - Ethylene oxide is an excellent and widely used sterilization method. The main disadvantage of EO as a sterilant is its toxicity. Medical equipment/devices sterilized with ethylene oxide shall be thoroughly aerated prior to handling or use in order to eliminate EO residuals and to ensure specified limits outlined in ISO 10993-7 are met.

Sterilization by EO is:

  • the method of choice for medical devices that cannot withstand high temperatures and moisture;
  • particularly suitable for devices with long lumens (such as catheters and endoscopes);
  • can be used for medical devices made of materials that prone to deterioration by gamma irradiation;
  • excellent sterilization method for medical devices with incorporated electronic components.

 

Since 2007 Li-Med has been working with both domestic and international customers to formulate and execute successful regulatory activities and quality assurance, exclusively serving the medical device industry.

We will be happy to supply additional vital information in the field of sterilization and assist your efforts towards achieving a better product.