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(a) Identification. A sharps needle destruction device is a prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Performance testing must demonstrate the following during operation of the device:
(i) The device safely contains or ventilates aerosols or fumes from device operation.
(ii) Excessive heat or sparks are not generated that may injure users or patients.
(iii) Simulated use testing must demonstrate sharps and/or needles are completely destroyed using a range of types and sizes of sharps sufficient to represent actual use.
(iv) Simulated use testing must demonstrate that the device is physically stable on the surface for which it is intended to be mounted to ensure the risk of harm to the patient/user as a result of the device falling is minimized.
(2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in the instructions for use.
(3) Analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device, under conditions which are consistent with the intended environment of device use.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include:
(i) A clear description of the device and its technological features;
(ii) How the device is to be used, including validated cleaning and disinfection instructions;
(iii) Relevant precautions and warnings based on performance and in-use testing to ensure proper use of the device; and
(iv) Instructions to install device in adequately ventilated area and stable area.
[83 FR 19628, May 4, 2018]
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