sterile processing
sterile processing
By David Taylor III , MSN , RN , CNOR
Sterile Processing Leaders : Are You Keeping Track of IFU and Manufacturer Updates ?
Today ’ s medical devices are increasingly sophisticated and complex , and with up to thousands of items being processed through the sterile processing department ( SPD ) each day , it is essential that sterile processing ( SP ) professionals have access to — and diligently follow — manufacturers ’ most current instructions for use ( IFU ) and other pertinent updates about their products .
As a consultant who travels the country to assist with SP operations , I often witness departments that are not keeping up with their IFU . As a result , they are either processing devices incorrectly or devices are being used for a purpose other than their intended and approved purpose . When I have questioned these practices , the answers are typically the same : “ We have always done it that way ” or “ We didn ’ t know we were using it incorrectly .”
Here ’ s just one example : Nearly nine years ago , Parks Medical Electronics Inc . issued a letter to their customers outlining the appropriate use of their doppler probes . The items are classified by the U . S . Food and Drug Administration ( FDA ) as Class II medical devices ( noninvasive ), which are deemed moderate to high-risk . Class II devices are not for subcutaneous use ( under the skin ). Despite the manufacturer ’ s notification , nearly every hospital I have visited still uses these devices inappropriately . More specifically , I have witnessed the probes being used for vascular , cardiac and urological procedures — not their intended purposes .
Of course , the probe misuse is just one example of many . Many facilities use needle holders as pliers , for example , to pull pins and twist wire , which can cause cracks and render the instruments nonrepairable . 1 There are other incidents where recalled products are still in use . Whatever the case , misusing devices and equipment poses a significant safety risk to users and patients . It can also void manufacturer warranties , cause premature product replacement , and increase liability for the healthcare facility .
Understand and follow device classes In 1939 , Earle H . Spaulding devised a rational approach to disinfection and sterilization of patient care items and equipment . His deep study of disinfection and sterilization refined the classification of appropriate treatment of medical devices based upon how the devices are to be used . He proposed a strategy for sterilization ( or high-level disinfection ) of inanimate objects and surfaces based on the degree of risk involved for their medical use . Known as the Spaulding Classification , the risk-based system includes three categories for medical devices : critical , semi-critical and non-critical . 2
Critical items are equipment and instruments that penetrate the skin or enter sterile tissue or the vascular system . They can include surgical instruments , cardiac or urinary catheters , implants , and ultrasound probes . These items require sterilization ( i . e ., steam , ethylene oxide , hydrogen peroxide gas plasm ). Semi-critical items contact mucous membranes or nonintact skin . This category can include respiratory therapy and anesthesia equipment , some endoscopes , laryngoscope blades , esophageal manometry probes , cystoscopes , among other devices . At minimum semi-critical items require high-level disinfection ( HLD ) using chemical disinfectants ( i . e ., glutaraldehyde , hydrogen peroxide , ortho-phthaladehyde , or peracetic acid with hydrogen peroxide ). Note : Because of device complexity , sterilization is being recommended for more semi-critical devices . Non-critical items are those that only contact intact skin ( not mucous membranes ) and pose the least risk for infection transmission . This category can include items such as blood pressure cuffs , stethoscopes , bedpans or crutches . In most cases , cleaning followed by disinfection with an Environmental Protection Agency-registered , hospital-approved disinfectant is sufficient for processing .
Understanding device classification helps provide the “ why ” behind the IFU . The IFU , of course , will reflect the device classification and should clearly outline how to handle , disassemble , inspect and process the item . If product-related updates occur , customers should receive updates directly from the manufacturer — and those should then be promptly reviewed and relayed to all SP professionals . Any questions about the revised IFU or other manufacturer notification about their devices , equipment , supplies or services should be shared directly with the company for clarification .
There may be times when a notification or update from the manufacturer is missed or accidentally
Understanding device classification helps provide the “ why ” behind the IFU . The IFU , of course , will reflect the device classification and should clearly outline how to handle , disassemble , inspect and process the item .”
april 2024 • www . healthcarehygienemagazine . com •
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