Page 156 - Assurance of Sterility for Sensitive Combination Products and Materials

138 Assurance of sterility for sensitive combination products and materials

this forum was to work toward developing solutions to prevent device-
associated HAIs. Specifically, the attendees looked at causes and solutions in
terms of three factors: people, places, and things.
There is also an issue with the underreporting of HAIs. Many HAIs are
not diagnosed until after the patients are discharged because hospital stays are
shorter than the incubation time for a pathogenic organism to cause an in-
fection. Any infection that becomes evident within 48 h after hospitalization
is considered an HAI. However, many SSIs do not exhibit symptoms until
around 21 days after surgery and some organisms have much longer incu-
bation times meaning that these infections may not be counted as an HAI.

6.3.1 Identifying HAIs
The CDC defines an HAI as a localized or systemic condition resulting
from an adverse reaction to the presence of an infectious agent(s) or its tox-
in(s). To be classified as an HAI, there must be no evidence that the infection
was present or incubating at the time of admission to the acute care setting,
indicating that if the patient gets an infection while at the HCF then the
infection was acquired in the HCF and is an HAI [4]. HAIs can originate
from endogenous sources (body sites such as skin, nose, mouth, GI tract,
vagina) or from exogenous sources (eternal to the patience such as other
personnel, equipment, medical devices, or the health-care. Infections in in-
fants that result from passage through the birth canal are included in HAIs.
However, many infections that a patient in the hospital has are not con-
sidered an HAI. These include the following:
• infections that were present when the patient was admitted to the HCF,
• infections in infants acquired transplacentally, e.g., herpes simplex, syph-
ilis and that become evident within 48 h of delivery,
• reactivation of a latent infection, e.g., herpes zoster (shingles), syphilis,
and tuberculosis (TB),
• colonization of microorganisms on skin, mucous membranes in open
wounds or in excretions or secretions but not causing adverse clinical
signs or symptoms, and
• inflammation that results from tissue response to injury or stimulation
by noninfectious agents, e.g., chemicals.

6.3.2 Assessing the burden/impact of HAIs
HAIs pose a significant impact to the patient, their family, and on soci-
ety. Patients are subject to additional pain and suffering such as fever and
prolonged hospital stays. An HAI can lead to further issues including