Instruction on the Inspection of Reusable Medical Devices

1. INTRODUCTION The purpose of this document is to describe the inspections the user needs to perform to guarantee the proper functioning of reusable medical devices from NOVASTEP. Refer to the label and package leaflet to establish whether the instrument is reusable. In general, these dysfunctions may be related to poor maintenance or inappropriate use of the device, which may continue until the end of its useful life. Because a high number of factors which are dependent on the user may impair the devices, NOVASTEP does not recommend a maximum number of uses. Rigorous inspection, associated with functional tests if applicable, will make it possible to check the performance of the reusable device and its proper operation throughout its entire useful life.

2. INSPECTION Take precautions when handling blunt and sharp instruments. If necessary, disassemble the device to perform the inspection and reassemble it according to the information provided in the Surgical Technique.

IIDM-Ed1-08-22-EN

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Criteria Condition of sterilization trays

Instructions for visual and functional inspection of the whole device.

Example of defect requiring replacement of the device

Example of the non-defective device

Appearance of the boxes and marking Operation of fasteners and handles

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Disassembled handles

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Damaged fastener Condition of identifiers and markings

IIDM-Ed1-08-22-EN

Readability of markings No corrosion

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Criteria

Condition of cutting tools (drill, countersink, etc.)

Instructions for visual and functional inspection of the whole device.

Example of defect requiring replacement of the device

The teeth and/or tips have not been knocked or deformed No blunt tip The cylindrical part is not deformed (concentricity)

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Example of the non-defective device

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Criteria

Instructions for visual and functional inspection of the whole device.

Example of defect requiring replacement of the device

Example of the non-defective device

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 Condition of the forceps

IIDM-Ed1-08-22-EN

Closing and opening of the forceps Functioning of the springs Appearance of the active zones of the forceps (no burrs, deterioration or deformation) The screws are present and retain their holding ability Functioning of the racks

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Criteria

Instructions for visual and functional inspection of the whole device.

Example of defect requiring replacement of the device

Example of the non-defective device

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The screwdrivers have not been knocked, deformed or broken

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IIDM-Ed1-08-22-EN

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Criteria

Instructions for visual and functional inspection of the whole device.

Example of defect requiring replacement of the device

Example of the non-defective device

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Condition of the gauge

IIDM-Ed1-08-22-EN

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Holding ability of the slide The screws are present Gauge reading Screwing of the gauge shank 7/11

Criteria

Instructions for visual and functional inspection of the whole device.

Example of defect requiring replacement of the device

Example of the non-defective device

Holding ability of the gauge bracket on the body

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Condition of the cannulated or pierced instruments

IIDM-Ed1-08-22-EN

Use the appropriate pin to check that the cannula is not blocked Check that the teeth have not been knocked or damaged

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Criteria

IIDM-Ed1-08-22-EN

Instructions for visual and functional inspection of the whole device.

Example of defect requiring replacement of the device

Example of the non-defective device

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Criteria Condition of the threaded instruments

IIDM-Ed1-08-22-EN

Instructions for visual and functional inspection of the whole device. Check the condition and functioning of the thread

Example of defect requiring replacement of the device

Example of the non-defective device

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Condition of the wires

The tip has not been knocked No deformation, bending or deterioration on the cylindrical part (darkening, grooves, high roughness, etc.)

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 Condition of the handles and AO connections

IIDM-Ed1-08-22-EN

Function of the click and lock mechanism using a connector

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