Page 163 - Assurance of Sterility for Sensitive Combination Products and Materials

Preventing health care associated infections 145

Microorganisms can become airborne and become suspended in the air
for long periods of time. Air currents will then move these organisms about.
This will only happen with small-particle size organisms. Invasive devices
provide a portal of entry and facilitate the transfer of microorganisms from
one part of the body to another and from the health-care worker to the
patient.
A final means of transmitting microorganisms is through a common
vehicle. In this transmission method, a common inanimate vehicle of con-
taminated food, water, medication, solution, device, or equipment can result
in a large number of exposures in a short period of time.

6.4.2 Procedural-related characteristics
In addition to the patient-related characteristics there are many procedural
characteristics that create a risk for getting an HAI. Patient care variables for
procedures include antibiotic use, invasive medical device use, prophylaxis,
and patient length of stay (LOS). Administrative variables for procedures
include the ratio of nurses to patients, the level of patient care personnel
education, use of permanent versus temporary staff, variable use of aseptic
techniques used by HCWs, contaminated ventilation and water systems,
and the physical layout of the patient care area.

6.4.2.1 Risks based on the procedure
Intact skin is one of our biggest defenses to infection and when the skin
is breached it is easier for pathogenic microorganisms to start an infection.
The risk of infection increases any time that a surgical or other invasive
procedure is performed where the skin is breached. Procedures that involve
contact with intact mucous membrane, e.g., endoscopic procedures, carry
a lower level of risk compared to procedures that invade sterile areas of
the body. The type of procedure being performed will impact the risk of
a patient getting an HAI. Any procedure where the skin is breached and
normally sterile tissue or the vascular system is invaded carry a higher risk
of an HAI occurring.
Even when the skin is not breached, devices that remain in place in-
crease the likelihood of infection, e.g., urinary catheters, ventilators. The
chronic nature can lead to abrasion in the skin barrier resulting in a path for
microbes to invade the body.

HAI classification
HAIs can be non-device associated or medical device associated. Non-
device-associated HAI are predominantly human sources, e.g., patients,