devices in disrepair or with compromised surfaces – such as oxidation , pitting , cracking , or damage from instrument marking – may not be able to be effectively sterilized . Additionally , instruments that have sustained structural damage may not function as intended . For example , scissor blades , forceps tips or teeth may be misaligned , or ratchet performance may be affected . In addition , discoloration or staining of devices may be indicative of a problem with the process such as presence of detergent residues , poor water or steam quality , and lack of sterilizer or washer maintenance .”
A close review of the manufacturer ’ s instructions for use ( IFUs ) may reveal the maximum number of reprocessing cycles validated for a device , provide a description of when an instrument is no longer appropriate for reprocessing , or may make a statement that organizations must inspect for wear and tear and determine when the item ’ s so-called ‘ useful life ’ is over . As advisory observes , “ With the large number of instruments that some organizations are required to reprocess every day , ensuring careful inspection and application of the manufacturer ’ s instructions about useful life can be a challenge . Especially if the organization does not have replacement instruments and access to maintenance or refurbishing resources .”
The medical literature points to how reprocessing quality can vary among healthcare institutions , thus demonstrating the challenges of reusable instruments and devices , let alone SUDs . One study that analyzed patterns of wear and tear sustained among sets of surgical instruments from two surgical units found patterns of damage to surgical instruments that were still in use . The most common damage was staining , followed by loosening of instrument joints , rust , pitting and malalignment . The most common type of breaks in instruments were broken tips but involvement of the shaft or handle of instruments were also seen . These types of damage to instruments are routinely seen in instruments undergoing reprocessing and should result in the instrument being pulled from service until it is repaired , refurbished , or replaced – but often reuse continues .
The Joint Commission recognizes the fiscal value that reprocessing poses when managing resources but emphasizes that safeguards must be place to protect patients and ensure that instruments and devices are clean , sterile and functional .
The Joint Commission advisory presents the following interventions to prevent reprocessing of instruments or devices that are not appropriate for use :
• Standardized instrument and device visualization occurring during each step of the decontamination , cleaning , and sterilization processes with final inspection prior to use and removal of any instrument inappropriate for use .
• Integration of Infection Preventionist review of critical instruments and devices during the purchasing process .
• Readily available manufacturer ’ s instructions for use and intermittent review of the manufacturer ’ s instructions for use for all critical instruments and devices .
• Education , training , and competency of staff responsible for
These third parties have been approved by the FDA to reprocess specific medical devices labeled for single use and must abide by strict rules that may be even more strict than those applicable to the original manufacturers of the SUD .” reprocessing , oversight and / or supervision of reprocessing sterile products on their role in the reprocessing of reusable instruments and related job duties . Staff responsible for reprocessing must understand the important patient safety role that they play and be empowered to prevent reprocessing of an instrument or device that is not appropriate for use .
• Effective maintenance and refurbishment processes to keep instruments in optimal condition and determine when useful life has been met for each instrument undergoing reprocessing .
• Effective replacement plan for items that are no longer suitable for use or cannot be refurbished .
• Use of rinse water that meets the device manufacturer ’ s instructions for use .
• Compliance with maintenance instructions for all devices and equipment used for reprocessing , including but not limited to :
• Automated dilution and flushing devices . o Ultrasonic cleaners and washer decontaminators
• Sterilizers
• Water treatment systems
• Education , training , and competency of staff handling instruments at the point of use to ensure that they understand which instruments should or should not be reused , even if they appear to have undergone sterilization , and what to do if an item that should not have been reprocessed is identified .
• Education , training , and competency of staff to ensure they understand key issues that can lead to damage of instruments and devices and do not contribute to instrument damage , including :
• Using fragile instruments meant for delicate procedures ( e . g ., ophthalmology instruments ) for other procedures .
• Exposing instruments for prolonged periods of time to blood and other body fluids or allowing these substances to dry on instruments .
• Using saline or corrosives such as bleach or inappropriate cleaning chemicals . o Using abrasives .
• Transporting instruments in a way that places them at risk of damage .
Additional considerations related to SUDs include the following :
• Staff handling SUDs in all areas know that SUDs only may be reprocessed as part of a contract service if the organization has chosen to pursue third party reprocessing .
• Disposal of SUDs at point of use ( e . g ., waste receptacles large enough to accept the SUDs ) or a clear process to segregate them from reusable devices and prevent inadvertent reprocessing of SUDs .
• Staff responsible for reprocessing , oversight or supervision and use of sterile products are educated and trained on their role in identifying single use items that should not be reprocessed at the organization and are competent to perform their related job duties .
Reference :
Joint Commission . Quick Safety Advisory . Ensuring Critical Instruments and Devices are Appropriate for Reuse . Issue 64 . February 2022 .
www . healthcarehygienemagazine . com • april 2022
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