Page 164 - Assurance of Sterility for Sensitive Combination Products and Materials

146 Assurance of sterility for sensitive combination products and materials

HCWs, household members, and other visitors. Non-device-associated in-
fection can include: SARS, flu, hepatitis B and C, fungal infections from the
environment, Noro virus, and Ebola. Standard precautions and respiratory
precautions are used to fight transmission of these infections.
Device-associated infections result from the interface of microorganisms
with the device and host factors. Although the most important pathogenic
factor is the microorganism, device factors are more commonly addressed
because of the ability to control them. It is important to understand the dif-
ferent types of HAIs that can occur if we are to effectively treat and prevent
their spread.

6.4.2.2 Non-device-associated infections
Many microorganisms are spread by contact, e.g., MRSA, and C. difficile (C.
diff). These organisms can be spread by touching a person who is colonized
or who has an infection (direct contact) or the organism can be spread by
touching objects that have the bacteria on them. Bloodborne pathogens
such as hepatitis B, hepatitis C, or HIV can be spread in HCFs by contact
with an infected person’s blood or other body fluids. Simple controls such
as environmental cleaning are an important part of the solution. Additional
appropriate controls need to be implemented relative to the risk. In highly
contagious cases, e.g., airborne infections such as tuberculosis, special nega-
tive pressure rooms are needed to prevent the spread of the pathogen.

6.4.2.3 Device-associated infections
It has been estimated that approximately half of all HAIs are device related
[10]. Infections caused by devices include:
1. Central Line-Associated Blood Stream Infections (CLABSI),
2. Catheter-Associated Urinary Tract Infections (CAUTI),
3. Ventilator-Associated Pneumonia (VAP), and
4. Surgical Site Infections (SSI).
CAUTI are the most common device-associated HAI.
Microbial biofilms can form on device surfaces and make it easier for
an infection to occur. Biofilm is formed when bacteria excrete an extra-
cellular polymer glue-like substance that allows them to adhere to surfaces
in moist environments. Biofilms facilitate adhesion and provide a structural
matrix that makes them very difficult to break down and remove. Biofilms
can be up to 1000 times more resistant to antimicrobial agents than are
vegetative microorganisms. Biofilms provide a barrier protecting the com-
plete colony from exposure to cleaning agents as well as antimicrobial