Page 175 - Assurance of Sterility for Sensitive Combination Products and Materials

Preventing health care associated infections 157

gown could have with Level 1 being the lowest level of protection and
Level 4 being the highest level of protection. The level of protection should
be chosen according to the volume of fluid expected for the surgical proce-
dure being performed. For nonsurgical and isolation procedures the level of
protection chosen should also consider the volume of body fluids expected
to be encountered. In all cases, the severity of the contagion also helps to
determine the level of PPE required. Highly contagious diseases, e.g., Ebola,
require AAMI Level 3 or Level 4 protection. Level 3 is acceptable for visi-
tors who will not have direct contact with the patient. Level 4 protection is
needed if there will be direct contact with the patient or their body fluids.
Drapes are used in surgery to protect the patient from contamination
from the surgical team and from the patient’s own body flora. Only sterile
drapes can be used in the sterile field.

Cleaning
Cleaning is an important component of preventing HAIs. This includes
both environmental cleaning as well as cleaning the reusable medical de-
vices. There have been cases of patients being infected from a previous pa-
tient that occupied the same room [25–28]. Improved surface cleaning and
disinfection can reduce the transmission of an HAI. There have also been
incidents of patients being infected by improperly cleaned reusable medical
devices [29–32].

Cleaning validation Cleaning markers are used to validate a cleaning
process. The cleaning marker consists of a medical device inoculated with
a clinically relevant test soil that contains various markers, e.g., protein, he-
moglobin, carbohydrate, endotoxin, or bioburden. After cleaning, the mark-
ers are extracted to measure if the soil has been removed from the device.
The manufacturer must determine the acceptance level or concentration
of marker that can remain on a device after cleaning. Although there is no
current standard for acceptable residual levels that can remain on the medi-
cal device after cleaning, AAMI TIR30:2011 [33] provides guidance on the
topic. FDA requires the use of a minimum of two markers for validating a
cleaning process.

Disinfection Disinfectants are classified as low level, intermediate level
(medium level) or high level. The level of disinfection required depends
on how the device will be used. Nonmedical devices and environmen-
tal surfaces that will contact intact skin only can be low-level disinfected.
Noncritical devices that contact intact skin only should be subjected to