Spaulding classification
Dr. Earle H. Spaulding
Dr. Earle Spaulding of Temple University (Philadelphia, Pa) in a 1939 paper on disinfection of surgical instruments in a chemical solution[1] proposed "a strategy for sterilization or disinfection of inanimate objects and surfaces based on the degree of risk involved in their use."[2] for the medical community.
"Due to his extensive study of disinfection and sterilization of medical instruments, Spaulding further refined his classification of appropriate treatment of medical devices based upon how a device is used. Chemical disinfection was classified as low level, high level, and sterilization based upon whether a device contacted intact skin, mucous membranes, or was introduced into the sterile cavity of the body."[1]
Spaulding classification:
- The three categories are critical, semicritical, or noncritical.
- The system also established three levels of germicidal activity for disinfection (high, intermediate, and low).
- Used for the basis of FDA and EPA guidelines.
Spaulding Classifications
| Body Contact | Disinfection Requirements | FDA Device Class |
|---|---|---|
| intact skin | low level | non-critical |
| mucous membranes | high level | semi-critical |
| sterile body cavity | sterilization | critical |