Medical Device Sterilization Methods

Medical devices are sterilized in a variety of ways including using moist heat steam dry heat radiation ethylene oxide gas vaporized hydrogen peroxide and other sterilization methods for.

Medical device sterilization methods.

However compliance to. E beam s medical sterilization methods are the most efficient and proven solutions in the industry offering many advantages over other processes such as ethylene oxide. A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site. With a wealth of experience providing sterilization for medical devices steris ast has been providing a first.

While eto is a very effective sterilant cd has many benefits over eto for a variety of applications. Ethylene oxide treatment is the most common chemical sterilization method used for approximately 70 of total sterilizations and for over 50 of all disposable medical devices. Sterilization by ionizing radiation primarily by cobalt 60 gamma rays or electron accelerators is a low temperature sterilization method that has been used for a number of medical products e g tissue for transplantation pharmaceuticals medical devices. 27 28 ethylene oxide treatment is generally carried out between 30 and 60 c 86 and 140 f with relative humidity above 30 and a gas concentration between 200.

At best using an insufficient or inappropriate sterilization method can prevent your medical device from getting marketing clearance from regulatory bodies like the fda. Steris applied sterilization technologies ast offers the medical device industry s most comprehensive array of contract sterilization options using gamma irradiation electron beam irradiation x ray irradiation and ethylene oxide sterilization. Medical devices are complex so the choice of sterilization technology must take into consideration the device s design material product packaging and final packaging. At worst poor sterilization can lead to transmission of infectious diseases causing patient illness and even death.

Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization. Firms may elect to comply with these standards. Choosing a sterilization method is one of the most important steps in developing a medical device. Medical device as a manufacturer we understand your need to deliver trusted sterile medical devices to your customers and end users around the globe.