Certification Board for Sterile Processing and Distribution (CBSPD) Sterile Processing Technician Practice Exam 2026 - Free Sterile Processing Technician Practice Questions and Study Guide

Question: 1 / 400

If healthcare facilities reprocess single-use devices, which organization must clear these devices?

OSHA

FDA

The correct choice is the FDA, primarily because the U.S. Food and Drug Administration oversees the regulation of medical devices, including single-use devices that are being reprocessed. When healthcare facilities intend to reprocess these devices, they must comply with specific FDA regulations to ensure the safety and effectiveness of the devices when reused. The FDA requires that any reprocessing of single-use devices must be validated and that the reprocessed device meets the same safety standards as a new device. The FDA's guidance helps to mitigate risks associated with reprocessing, ensuring that patients receive safe and effective medical treatment.

Other organizations mentioned in the question, like OSHA, primarily focus on workplace safety and health regulations; the CDC provides guidelines for infection control but does not regulate medical device reprocessing; the WHO is involved in global public health but does not specifically regulate medical devices in the context of reprocessing within healthcare facilities. Thus, in the context of reprocessing single-use devices, the FDA is the essential regulatory body that must clear these devices for reuse.

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CDC

WHO

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