Sterilization Validation for Medical

Devices

What is sterilization validation?

Every medical device produced must be sterilized before being shipped to hospitals, doctors’ offices, and other medical locations.

Random samples of these devices must then be tested to be sure the sterilization kills disease causing microbes including bacteria, fungus, and spores in every device.

According to the FDA regulations for Current Good Manufacturing Practices Regulations for Finished Pharmaceuticals and Good Manufacturing Practice Regulations for Medical Devices, sterilization processes should achieve a sterility assurance level (SAL) of 1x10-6.

That means medical devices need to be completely clean and incapable of spreading disease or infection when used.

The correct sterilization technique procedures are given to medical facilities so they can sterilize their devices between uses.

Methods of Sterilization

Wet/Steam* Dry Heat Ethylene Oxide* Sporicidal Chemicals Glass Plasma Irradiation (Gamma Rays) *

Methods marked with a “*” are the most commonly used

Wet/Steam

Also known as “moist heat” sterilization. Gravity displacement cycles - 121ºC, 20-30 minutes

Prevacuum cycles – 132-134 ºC, 3-5 minutes

Uses extremely hot water to eradicate microbes. This is an easily accessible method for healthcare

providers to use and potentially can be completed hundreds of times on a reusable device.

Validation approves the sterility level and number of times a device can be sterilized before it is unsafe to reuse.

Ethylene Oxide

The most often used sterilization method because it has such high success rate.

Technicians seal devices in a chamber and treat them with ethylene oxide for a determined number of hours.

Ethylene oxide is a dangerous chemical, so only trained and well-equipped professionals can administer it. It is usually performed at professional labs.

Irradiation (Gamma Rays)

A fast sterilization process that can allow medical devices to be used the same day they are sterilized.

Irradiation is strong enough to penetrate hard surfaces, such as metal, and is ideal for devices that have complicated patterns or hard-to-reach places.

Irradiation can cause discoloration and other changes in product quality over time.

Where is sterilization validation performed?

Most sterilization validation procedures are performed by a third party laboratory.

These labs follow specific guidelines in their testing and can help determine what needs to be done to sterilize medical devices if they do not pass the right tests.

For more information on sterilization validation for

medical devices at a laboratory, contact Nelson Laboratories

here.