used . A method should be in place to ensure the cleanliness and integrity of every instrument and medical device . Upon inspection , medical devices with retained soil or residue should be subjected to repeated cleaning and decontamination processes until the device is completely clean . Damaged instruments should be removed from service ( damaged instruments should be addressed according to the healthcare organization ’ s policies and procedures ). Methods used to change instruments from their original state — such as using an engraver that can cause fractures or surface damage — should not be performed . To ensure the correct type of inspection equipment is available , it is recommended to review the equipment instructions for use ( IFU ); this should also be done when purchasing new devices .
Section 8.2.1 addresses the inspection of instruments intended to be used with electric current ( otherwise known as electrosurgical instrumentation ). Electrosurgical instruments are insulated and , typically , used in minimally invasive surgery . They are susceptible to physical and mechanical damage and degradation related to repeated use . Using insulated instrumentation with holes in the insulation or other defects places the patient at risk for significant harm . The holes may not be clearly visible ; if they are not detected during instrument processing and the damaged instruments are used during a procedure , the insulation breach can result in an electrical current escape that can burn the patient .
Insulated instruments should be carefully inspected , including their cords , which can become damaged during normal use , processing , contact with sharp instruments , and use of high voltage electricity . It is recommended to organize instruments ( such as in instrument sets ) to protect them from damage .
To prevent patient harm , insulation testing for insulation integrity is recommended each time the instruments are processed , in accordance with the instrument manufacturer ’ s written IFU for inspection . There are different types of insulation testing methods and they vary with insulation tester type . There are also a variety of accessories to test specific instrumentation and cables / cords , based on their design . For that reason , it is vital to refer to the instrument and insulation tester manufacturers ’ written IFU for their recommended procedures . Insulation testers are designed to detect small current leaks that can jeopardize patient safety . Any time instrument insulation does not pass inspection , the device should be immediately removed from service , and damage should be addressed according to the healthcare organization ’ s policies and procedures that address instrument evaluation , repair or replacement .
A table was added that addresses the inspection points and possible damage for various instruments / devices . This table lists the name of the instrument / device , followed by its inspection points , as well as the possible damage to the medical device , and methods to assist with inspection / testing . This quick reference inspection guide will be helpful as these instruments are processed .
Images of instrument and cord failures are also provided to help present the reader with a clearer understanding of what to look for in electrosurgical instrumentation and cord failure .
Education is the cornerstone of good practices . That fundamental understanding is reflected in this amendment , which recommends that personnel responsible for processing these instruments should receive education to ensure they understand how to use testing equipment safely and effectively . In addition , competency should be verified and documented before employees ’ first assignment to use the equipment .
Amendment 3 : Modification of Content Pertaining to Frequency of Cleaning for Routine Care of Sterilizers for Sterile Processing Areas in Health Care Facilities
This amendment changes the recommendations in section 12.4 Routine care of the sterilizers . The previous version recommended daily inspection and cleaning . The revised recommendation directs the user to follow the sterilizer ’ s IFU , which may require that weekly or other prescribed inspection and cleaning be performed ( and it should be documented , per internal procedures ).
Amendment 4 : Content Addressing Recording Biological Indicator Lot Numbers in Sterilizer Records for Sterile Processing in Health Care Facilities
This amendment revises the wording in sections 13.8.2.3 BI PCD test procedure , 13.8.3.3 Test procedure and 13.8.4.3 Test procedure . The previous wording of these sections did not specifically state to record the lot number , only the “ number of both test biological indicators ( BIs ) and control BIs .” To better clarify the specific “ number ” to document , the revised wording specifically states to document the lot number of both test BIs and control BIs .
The amended standard is available at www . aami . org / ST79 . ANSI / AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities will be automatically updated for users with an AAMI eSubscription . Those who previously purchased the printed version or have a PDF version will receive a PDF of the amendments via email at no cost .
Multi-society Guideline for Flexible Endoscope Reprocessing Updated
The American Society for Gastrointestinal Endoscopy ( ASGE ), along with members of the American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy and Standards of Practice committees have updated the Multisociety guideline on reprocessing flexible GI endoscopes and accessories . This guideline was revised using evidence-based recommendations , based on rigorous review and synthesis of the present-day literature — using the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) framework . The GRADE framework is an all-inclusive and transparent system for the quality rating for the evidence and strength of the recommendations . What follows are highlights of this revised guideline .
This guideline states that staff training and competency of endoscope reprocessing skills are important aspects of infection prevention . It is recommended that reprocessing staff be trained on all the endoscope models they are expected to process and shown to have documented competency before being assigned to process them . The healthcare organization should then perform competency evaluations of endoscope processing personnel on a scheduled basis , as defined by the organization ( typically , this occurs when one first assumes endoscope processing