Page 173 - Assurance of Sterility for Sensitive Combination Products and Materials

Preventing health care associated infections 155

to be pulled above the gown cuff. The gown cuff itself is not sterile because
it can easily be penetrated and contaminated by body fluids. The contents
of the packages must not be contaminated when opened. The exterior of all
packages is not sterile; only the contents are sterile following terminal steril-
ization. Using aseptic techniques when handing supplies and instruments to
the surgeon; keeping count of instruments, sponges, and sharps; and moni-
toring aseptic practice are all important activities. Non-sterile members of
the surgical team, including the circulating nurse and the anesthesiologist,
must work outside the sterile field and do not wear sterile attire.

6.5.5 Engineering solutions—HCFs

Engineering solutions are effective because they remove the behavioral el-
ement which can lapse especially when experiencing time pressures. There
are many engineering solutions that can be implemented as part of the de-
sign of an HCF that will help to prevent HAIs from occurring. These solu-
tions can include construction design for patient rooms, operating rooms,
and procedure rooms; controlling airflow and ventilation; controlling ambi-
ent air; controlling traffic patterns and use of protection and barriers.

6.5.5.1 Suite/room design
Surface materials for walls, ceilings, counters, doors, etc., should be chosen
for the following characteristics: ease of maintenance, cleanability, seamless
construction, and nonporous materials. Ceilings should be at least 10 ft above
the floor. Particular attention should be paid to airflow and ventilation.

Airflow and ventilation
Surgical suites, other procedure rooms, and sterile processing areas (prepara-
tion and packaging, sterilization, and sterile storage areas) must remain at a
positive pressure relative to adjacent areas. This will tend to create an airflow
away from these sensitive areas. Special negative pressure rooms used for air-
borne isolation must remain at a lower pressure relative to adjacent areas and
should not have their air changes adjusted when the room is unoccupied.
Decontamination rooms should also always be lower pressure compared to
adjacent areas.
Certain types of rooms require all air changes per hour to be fresh air, e.g.,
negative pressure airborne isolation rooms and decontamination rooms. Doors,
windows, and doors to pass through machines should be kept closed except
when in use. If doors or windows are left open it will be difficult to maintain
the appropriate pressure relationships needed for specific types of rooms.