Medical and surgical devices and supplies need to have a level of cleaning that will prevent transmission of infectious during their use. Spaulding developed a classification of devices based on their use which can help determine the type of processing required.
Spaulding device classification:
(1) critical
(2) semicritical
(2a) instrumentation
(2b) contact only
(3) noncritical
Spaulding also had a category for housekeeping.
Critical devices enter sterile tissue and/or the vasculature:
(1) implants
(2) surgical instruments
(3) needles and sutures
(4) dental instruments that penetrate oral soft tissue or bone
Semicritical (instrumentation) that touch mucous membranes with significant insertions:
(1) endoscopes
(2) laryngoscopes
(3) endotracheal tubes
(4) dental instruments no penetrating oral soft tissue or bone
Semicritical devices (contact only) that touch the mucous membranes with no or minor insertions:
(1) thermometers
(2) hydrotherapy tanks
Noncritical devices touch intact skin:
(1) stethoscopes
(2) table or countertops
(3) bedpans
|
Device Classification |
Spaulding Process Classification |
EPA Product Classification |
|
critical |
sterilization |
sterilant, disinfectant |
|
semicritical, instrumentation |
high-level disinfection |
sterilant, disinfectant |
|
semicritical, contact only |
intermediate level disinfection |
hospital disinfectant with tuberculocidal activity |
|
noncritical |
low level disinfection |
hospital disinfectant without tuberculocidal activity |
|
Spaulding Process Classification |
Kills |
Does Not Kill |
|
sterilization |
everything, including bacterial spores |
NA |
|
high-level disinfection |
all nonspore micro-organisms |
not all spores if large numbers present |
|
intermediate level disinfection |
M tuberculosis, most vegetative bacteria, most fungi |
bacterial spores |
|
low level disinfection |
most bacteria, some viruses, some fungi |
M tuberculosis, bacterial spores or resistant organisms |
Specialty: Infectious Diseases
