DePuy Synthes

Drill Bit 3.2mm Tibial

Processing Synthes Reusable Medical Devices – Instruments, Instrument Trays and Cases

6 Pages

Processing Synthes Reusable Medical Devices – Instruments, Instrument Trays and Cases These recommendations are for processing Synthes reusable medical devices sold in North America. Synthes reusable medical devices include certain surgical instruments, instrument trays and cases. The information provided does not apply to Synthes implants. These recommendations are to be followed unless otherwise noted on specific product inserts. • • • • • • • • • Warning and Cautions  • • • •  •  • Limits on reprocessing  •  Do not use steel wool or abrasive cleaners. Avoid solutions containing iodine or high chlorine content. Soiled or used Synthes devices should not be loaded in a case and cleaned in a mechanical washer. Synthes devices must be cleaned separately from Synthes instrument trays and Synthes cases. Soiled devices are devices that have blood, tissue and/or bodily fluid/matter in or on the surface of the devices. Long, narrow cannulations, blind holes and intricate parts require particular attention during cleaning. All devices must be thoroughly cleaned. Synthes instruments are critical devices and must be terminally sterilized prior to use. The sterilization parameters are only valid for devices that are adequately cleaned. Do not stack trays of instruments in a mechanical washer. Immediate-Use Steam Sterilization is only intended for individual instruments and should only be considered under emergency situations. The following parameters are only valid for properly installed, maintained, calibrated and compliant reprocessing equipment. Cleaning agents with a pH within 7 – 9 are recommended. The recommended cleaning method for Power tools is manual. Do not place Power tools in an ultrasonic cleaner. Do not submerge Power tools in aqueous solutions. Refer to product specific literature for care of Power tools. The sterilization parameters cannot be used for the Synthes Power Drive Unit, PN: 530.100, Power Drive Set, PN: 105.957, Synthes Piezoelectric Handpiece, PN: 05.001.401 and the Synthes Piezoelectric System, PN: 68.001.400. For the Synthes Power Drive Unit and Power Drive Unit Set, the Synthes Piezoelectric Handpiece and Piezoelectric System, please refer to the User Manuals for Sterilization guidelines. Surgical patients identified as at-risk for Creutzfeldt-Jakob disease (CJD) and related infections should be treated with single-use instruments. Dispose of instruments used or suspected of use on a patient with CJD after surgery and/or follow current national recommendations.  Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on Synthes surgical instrumentation. End of life of a device is normally determined by wear and damage due to use. Evidence of damage and wear on a device may include but is not limited to corrosion (i.e. rust, pitting), discoloration, excessive scratches, flaking, wear and cracks. Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.  Clinical Processing Instructions  Form (Non-PPE) | 103509580 | Rev. 2 | Ref: W-D-S072  Page 1 of 6
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File Name: Johnson & Johnson Medical - DePuy Synthes - 103509580 - Processing Synthes Reusable Medical Devices – Instruments, Instrument Trays and Cases - Rev 2.pdf

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