Publish Date: September 25, 2019
Surgery centers thrive on efficiency. This is true for the completion of procedures and subsequent turnover of operating and procedure rooms. When procedures and room turnover are completed in an efficient manner, an ASC can better maximize case volume and reduce costs per case. However, any efforts to boost performance that jeopardize patient safety will negate the benefits associated with improved efficiency.
This is also true for sterile processing of medical devices. Efficient turnover of instruments can help ensure a surgical team has the equipment it needs to perform procedures while reducing the amount of equipment a surgery center must purchase and keep in inventory. But if ASCs make sterile processing mistakes or cut corners, patients can be harmed, says Terri Link, MPH, BSN, CNOR, CIC, CAIP, FAPIC, AORN's product manager for guideline implementation tools.
"Shortcuts have resulted in inadequate cleaning and resultant sterilization and high-level disinfection (HLD) failures," she says. "When inadequately cleaned devices are used during procedures, patients are at a higher risk for developing surgical-site infections. If clinical staff discover that instrumentation was not properly cleaned, they will need to find replacement equipment, possibly delaying or even cancelling cases."
Link shares the following six dos and don'ts for sterile processing in ASCs.
DO process reusable medical devices based on the intended use of the item. Items that enter a sterile cavity are considered critical items and should be sterilized. Items that are classified as semi-critical, such as endoscopes, should be sterilized whenever possible and undergo HLD at a minimum if sterilization is not possible."
For example, biopsy forceps, which are sterile, are introduced through an endoscope and breach an intact mucous membrane and should undergo sterilization. An endoscope may be high-level disinfected because it does not come in contact with a sterile cavity or non-intact skin or mucosa, but the sterile biopsy forceps is introduced through a lumen that is high-level disinfected, so it should be sterilized if it can be.
"Select the sterilization method based on how the device is designed, the material it is made of, packaging, compatibility with the sterilant, load limitations, environmental concerns and safety requirements," Link says. "ASCs should only select those medical devices it has the capability to process correctly as part of the purchasing decision. If a facility does not have the resources or equipment to sterilize an item, that should be a factor in selection.
She advises ASCs to perform a risk assessment to determine the method for reprocessing items, such as biopsy forceps, which have the capability of entering sterile tissue.
DON'T use loaner instruments without sterile processing them. When industry representatives bring in instruments on loan, ASCs will not typically know what these instruments have been exposed to since they were last used, Link says. Furthermore, when a loaned instrument is used, it is not possible to know how the instrument has been handled, whether the manufacturer's instructions for use (IFU) for processing were followed or if packaging could have been compromised in transport.
"These instruments may have been in a back seat of a car, a storage facility or an office or exposed to contaminated air, sunlight or moisture," she says. "Expectations should be clear to industry representatives that loaned instruments must arrive in time for the receiving facility to properly perform all of its processing steps."
DO protect sterile items from contamination and damage during transport. Successful sterile processing can quickly be undone by poor instrument transportation.
"With frequent transfer of items, such as when transporting items to and from a centralized sterile processing department, more opportunities occur for contamination of surgical instruments," Link says. "Develop processes that limit exposure of instruments to moisture, dust, direct sunlight, temperature and humidity extremes as these increase the potential for contamination and degradation of sterilized items. Also, make sure processes reduce the risk of potential packaging tears that can expose instruments to harmful elements."
If you use a centralized sterile processing facility, which Link says is becoming more commonplace for ASCs, implement processes that best ensure instruments are properly transported.
"Procedures for transporting instruments offsite for processing should include point-of-use treatment and immediate transport," she says. "Point-of-use treatment and thorough cleaning are the most important steps in processing instruments before sterilization because biofilm and other debris can prevent surfaces from being exposed to the sterilant. Also, have processes in place for cleaning of transport vehicles and containers. Policies and procedures should be clear as to the expectations for offsite processing, and designated personnel should oversee all these processes."
- DON'T rely on immediate-use steam sterilization (IUSS). It may be tempting to use IUSS to reduce cleaning time and bypass steps in instrument preparation. This is not advisable, Link says. "IUSS should only be performed when specific conditions can be met (i.e., all the same processes that occur prior to any sterilization method). Don't use IUSS in place of having adequate instrument inventory and never use IUSS for vendor instruments when instruments have not been brought in ahead of time. Finally, do not use IUSS for implantable devices except in cases of a defined emergency, such as when no other option is available."
Another recommendation from Link: "Items processed by IUSS or in liquid chemical sterilant should not be stored for future use or held from one procedure to another."
DO provide education and competency verification activities related to sterilization processes. Personnel who perform sterilization activities must receive adequate training and have their skills verified, Link says.
"Medical device-related infections are often attributed to inadequate cleaning and processing of instruments," she says. "The design of these items is often complex. Cleaning and processing may take up to a hundred steps. Personnel should receive initial and ongoing education and show competency in their sterile processing performance. Keeping current with IFU is crucial, and this includes obtaining IFU for loaner instruments."
DON'T take liberties with manufacturer’s IFU. Sterile processing staff should always follow IFU for medical device sterilization and packaging.
"Follow standardized processes to ensure the sterility of instruments and include initial cleaning at the point of use, thorough cleaning of the item, inspection for cleanliness, correct packaging and finally sterilization of the item to eradicate any microbial contamination," Link says. "Perform sterilization in an area intended, designed and equipped for sterilization processes. Best practice is performing instrument processing in a decontamination room, with a clean room or area for packaging and sterilization."
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