Bioburden testing helps keep medical equipment safe for use by finding harmful microbes to eradicate during the sterilization process.

1. Bioburden
Testing
Keeping Patients and Doctors Safe

2. What is Bioburden Testing?
• It is microbial testing performed
on medical equipment and
products.
• It measures the number of living
organisms on a surface prior to
final sterilization and use.
• Certain microbial levels are
allowed during handling of a
product, and Bioburden testing
makes sure those limits are in
force.

3. • Bioburden testing shows how
many living organisms are
present and how to best sterilize
the product in question.
• It is usually performed before
large numbers of a product are
manufactured so that the
sterilization procedure can be
implemented into the assembly
process.
• Random testing must be
performed regularly to ensure
levels have not changed.

4. How is Bioburden Testing
Regulated?
• All Bioburden tests must conform
to the procedure outlines in ISO
(International Organization for
Standardization) 11737.
• Tests must fit the basic FDA
criteria which include testing for
the following:
– Yeast Candida albicans
– Bacteria Escherichia coli
– Bacteria Pseudomonas aeruginosa
– Bacteria Staphylococcus aureus
– Fungus Aspergillus niger

5. How is Bioburden Testing
Performed?
• Swabs of the outside of a
product are collected and grown
in petri dishes.
• Once the samples have grown,
they are tested for various
bacteria, fungi, and other
contaminants.
• Bioburden is measured in colony
forming units (CFU) per gram of
product.
• A sterilization procedure is
determined.

6. • For a visual representation of the
Bioburden testing process, watch
this Youtube video.
http://www.youtube.com/watch?v=1rCuoEAMVT8

7. What Would Happen Without
Bioburden Testing?
• Without a proper way to test
what still needs to be sterilized
on a product, bacteria or strains
of diseases could come in
contact with someone’s body.
• Imagine an unsterilized metal
plate being inserted into a
person’s leg. The risk of infection
to the patient and the surgeons
who inserted it rises
exponentially.

8. Sterilization after Bioburden
Testing
• Sterilization can be performed
two ways.
• 1. Radiation
• 2. Ethylene Oxide

9. 1. Radiation
• Radiation sterilization can utilize
different forms of radiation
including
– X-rays
– Electron beams
– Gamma rays
– Ultraviolet light
• Radiation kills microbes without
affecting the integrity of the
product.

10. 2. Ethylene Oxide
• Ethylene oxide is a toxic gas
used to sterilize temperature-
sensitive materials
• It penetrates most plastic, paper,
and cloth products to kill
microbes.
• It can be used repeatedly on the
same product without harm.

11. Bioburden testing helps keep medical
equipment safe for use by finding harmful
microbes to eradicate during the sterilization
process.
What do you think about Bioburden testing?