Levels of Disinfection

The CDC (Centers for Disease Control and Prevention) in the USA and the RKI (Robert Koch Institute) in Germany classify medical devices according to their use. For each classification, they specify the level of disinfection/sterilization processing that is required.

Device Classification Use Level of Processing Required
Noncritical Device contacts skin Cleaning and disinfecting
(in the USA, low-level disinfectiona))
Semi-critical Device contacts mucous membranes
(for example, endocavity applications) 		Immediate cleaning and disinfection
(in the USA, high-level disinfectionb))
Critical(transducers) Devices enters otherwise sterile tissue (for example, intraoperative applications) Immediate cleaning followed by sterilizationc)
Critical(all puncture attachments) Device contacts otherwise sterile tissue (for example to take a biopsy) Disinfection (preferably mechanical) plus steam sterilization
a In the USA, the EPA maintains a list of approved detergents and hospital disinfectants.
b In the USA, the FDA maintains a register of commercial solutions that have been cleared for use as sterilants and high level disinfectants [1]. Please contact yourBK Medical representative if you are in any doubt about what you can use.
c When sterilization is not possible, the FDA and RKI recognize that disinfection (in the USA, high-level disinfection) and the use of a sterile gel and sterile transducer cover, is an accepted method of infection control for ultrasound transducers [2,3].
[1] FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices (More).
[2] Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. FDA Center for Devices and Radiological Health (More).
[3] Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten, Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 2001. 44:1115-1126 Springer-Verlag 200. Available from the RKI website.


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