Medical Device Reprocessing Association of Ontario (MDRAO) Practice Exam

What does Spaulding's classification categorize as a critical device?

1. Devices that touch intact skin

2. Devices that touch mucous membranes

3. Devices that enter a sterile space

4. Devices that only contact environmental surfaces

The correct answer is: Devices that enter a sterile space

Spaulding's classification system is essential for understanding how to process medical devices based on their risk of infection. A critical device is classified by this system as one that enters a sterile space, such as the body. This includes instruments like surgical tools and catheters that penetrate skin or mucous membranes, which can introduce pathogens into sterile tissues or bloodstream. The rationale behind classifying such devices as critical lies in their high potential for infection transmission if not properly sterilized. These devices must undergo stringent sterilization processes to eliminate all microorganisms, ensuring patient safety and preventing healthcare-associated infections. In contrast, devices that only contact intact skin or mucous membranes, or those that come in contact with environmental surfaces, have different classifications (non-critical and semi-critical) that involve less stringent reprocessing requirements. Non-critical devices are often cleaned with low-level disinfection, while semi-critical devices must be high-level disinfected due to their potential contact with mucous membranes but not direct access to sterile areas.