Page 174 - Assurance of Sterility for Sensitive Combination Products and Materials

156 Assurance of sterility for sensitive combination products and materials

Traffic patterns
Traffic to operating rooms, other procedure rooms, all sterile processing
rooms and isolation rooms should be minimized. These areas should have
restricted access with all personnel requiring special attire. PPE might also
be required in these areas depending on the role of the person working in
the area, e.g., sterile surgical team members are required to wear a sterile
surgical gown, hat, facial mask, sterile gloves, and shoe covers.

Protection and barriers
Various steps can be taken to protect HCWs and visitors from getting an in-
fection. These include facial masks, eye protection, hoods, caps, shoe covers,
gloves, and, for sterile procedures, gowns and drapes.

Facial protection Surgical facial masks serve a dual purpose: they pro-
tect the patient from droplet transmission from the surgical team and they
protect the surgical team from splash from the patient. When performing
procedures where splashing to the face can occur it is also necessary to wear
eye protection. Either goggles or face shields can be used for eye protection.

Hoods, caps, and shoe covers Hoods and caps need to completely
cover the hair. Their purpose is to prevent hair from falling into a surgical
wound during surgery, or on to the dressing during dressing changes or into
an instrument set during instrument preparation.
Gloves Sterile gloves must be worn for all surgical and invasive pro-
cedures including any vascular access procedure. For surgical and invasive
procedures, the glove must cover the gown cuff. In these procedures the
sterile glove is intended to prevent the normal flora present on the HCWs
hands from contacting the incision or wound. Gloves also serve the dual
purpose of protecting the HCW from any infectious organisms that might
be present in or on the patient. Double gloving is recommended for most
surgical procedures. Non-sterile gloves can be used in isolation procedures.

Gowns and drapes Sterile gowns and drapes must be used in surgery
and other invasive procedures. These items have a dual purpose: (1) provide
a barrier between the HCW and the patient to reduce microbial and body
fluid contamination of the surgical wound and (2) protect the HCW from
contact with the patient’s blood and body fluids. The entire area of a surgical
gown is not considered sterile.
Gowns used as protection should be resistant to blood and body fluid
penetration. ANSI/AAMI PB70 describes four levels of protection that a