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. These are some of the most common ways that sterilization validation is performed.

1. Sterilization Validation
for Medical Devices

2. 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.

3.  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.

4. 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

5. 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.

6. 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.

7. 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.

8. 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.

9. For more information on
sterilization validation for medical
devices at a laboratory, contact
Nelson Laboratories here.