sterile processing
sterile processing
By David Taylor III , MSN , RN , CNOR
Loaned Device Management is Crucial for Patient Safety
Loaned or borrowed instruments are medical devices owned by a manufacturer and temporarily loaned to an organization . In most instances , the loaned instruments come with little or no cost , particularly if the healthcare organization is paying for implantable devices ( e . g ., screws , plates , joints ). The organization may agree to use the medical devices for a fixed number of interventions . If the items are loaned for several interventions or a longer period , a separate agreement — usually a consignment agreement — between the two parties is established .
Borrowing instrumentation is a common practice that can offer many advantages , including reduced costs and the ability to expand services . More specifically , borrowed specialty surgical instrumentation and subsequent implantable items can provide the much-needed inventory for healthcare organizations , without the need to purchase large quantities of expensive instrumentation to support robust surgical programs .
Despite the positives , loaned instrumentation can pose numerous challenges , chief among them being hidden costs for the facility , and risks to patient safety . The costs associated with handling and processing loaned instrumentation appropriately can be substantial . Some costs can include increased staffing costs , particularly in sterile processing departments ( SPDs ). For example , when a manufacturer delivers numerous loaned trays late or unannounced , sterile processing ( SP ) leaders often need to put other work on
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hold or use unscheduled overtime hours to process them .
Over the past several decades technological advancements have changed the face of surgery , and healthcare organizations have been forced to keep pace with those changes . One way for them to do so without adding significant costs to their bottom line is through a focused , comprehensive and effectively implemented loaned instrument program .
Follow organizational policies and guidelines
A formal and effective loaned instrumentation program hinges on having specific policies and established controls in place that allow SP professionals to effectively manage borrowed instruments and implants . Facilities should emphasize the importance of developing a standardized system that all parties ( e . g ., surgeons , nurses and SP staff ) agree upon .
Providing effective management of loaned instrumentation processes and ensuring that those processes are standardized is critical . SP professionals must help establish and adhere to policies for all reusable surgical instruments that are not owned or consigned in their healthcare facility . One aspect of an effective policy is the time loaned instruments arrive in the SPD . To process loaned instrumentation thoroughly , loaned devices will ideally arrive at the user facility at least 24 hours ahead of the procedure ( ideally , 48 hours in advance ). This allows the SPD adequate time to properly receive , inspect , document , process and otherwise manage
LOANED INSTRUMENTATION FACTORS
The growing prevalence of loaned instrumentation in hospitals today can stem from :
● Insufficient inventory and / or lack of financial ability to purchase instrumentation
● Growing demand for surgical specialties ( orthopedic , spine , etc .)
● Lack of storage space in healthcare organizations
● Clinical trials
● Patient-specific needs
● Scheduling conflicts and multiple procedures scheduled per day
● Owned instrument sets with missing or damaged items that are out for repair the loaned instruments . Note : For new sets not consigned to an organization , industry standards recommend that loaned instruments arrive 72 hours prior to the surgical encounter . This allows all parties involved with those instrument set ( s ) an opportunity to become familiar with them prior to use . For the SPD , special processing ( disassembly , extended soak times , brushing , etc .) may be required . For the surgical team ( technician , nurse , surgeon ), it creates an opportunity to become familiarized with the instrumentation prior to the procedure .
Policy and procedure recommend that a loaned instrumentation program include ( at minimum ):
● Requesting loaned instrumentation or implant ( s ) when surgical procedure is scheduled
● Time requirements for pre-procedure processing ( 48 to 72 hours ) and inservicing as needed
● Post-procedure processing and pickup ( within 24 to 48 hours )
● Acquisition of loaned items , including a detailed inventory list ( with photographs ) and manufacturers ’ detailed written IFU
● Cleaning , decontaminating , and sterilizing borrowed instrumentation performed by the receiving facility
● Transporting processed loaned instrumentation to the point of use
● Post-procedure decontamination , processing and inventorying
● Returning instrumentation to the representative of the company providing the loaned devices
● Maintaining chain of custody records for all transactions
Trust but Verify
Loaned instruments can be quite specific and complicated . It ’ s not uncommon for a procedure to require up to two dozen multi-layered instrument trays . Complicating matters further is that the SP technicians may be unfamiliar with the items , including what they are used for or how they should be arranged in the trays
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