Medical Devices Check In
Loaner Tray Check in SPD with Information about the names and quantity of trays
surgeron/case.
Healthcare facility requires receipt of loaner trays/items at least two (2) business days prior to
the scheduled case. All first-time vendor-loaned sets require three (3) business days for in
servicing, inspecting and processing. In the designated staging area of the healthcare facility’s
SPD, loaner trays received will be logged on an inventory loaner sheet. Trays will be weighed
upon delivery. The weight of the tray is not to exceed the maximum weight allowance
determined by current ANSI/AAMI ST79 (25 pounds). If the vendor and/or SPD representative
need to reconfigure the tray contents for any reason, proper validation and documentation
must be supplied to make this change by the device manufacturer. All tray(s) will be tagged
with date, surgeon name(s) and procedure, and placed and/or stored in the designated area. If a
healthcare facility has an instrument tracking system with bar coding capabilities, this can be
used in place of a tag system (write on the outside tape the name of surgeon, room number,
number of trays, and date and time of surgery). After being logged in and tagged, trays may be
placed in a specific area waiting for processing. Vendor must provide in-service to SPD staff for
any tray(s) that are brought in as a loaner. This includes, but is not limited to, decontamination,
inspection, assembling, packaging, sterilization, handling, and any other information that is
needed for proper processing of the instrumentation. In advance of the surgical case, the
vendor and SPD Program Manager must ensure that all information is on file for loaner
instrumentation as it pertains to decontamination, inspection, assembly, packaging, sterilization,
and storage.
Sign the inventory sheet confirming all contents are present when the sales representative or other
company representative picks up the tray(s). Remove all loaner instrumentation from the facility (SPD)
within two (2) business days after use.
Sales Representative’s Duties before Surgery: Supply the OR and SPD with information about the
names and quantity of tray(s) surgeon/case, and method of shipment before the instruments are
received and delivered by vendors. Provide written inventory of all items on the tray(s) and verify the
inventory of any missing stock [to be noted with a SPD technician upon receipt of tray(s)]. Discuss
responsibility and cost for missing and damaged items before the procedure. Ensure all loaner
trays/items are delivered no less than 48 hours before a scheduled case in order for SPD to: •
Decontaminate • Inspect • Assemble • Package • Perform routine biological testing if implants are
involved and allow adequate time for final results and quarantine • Sterilize • Dry, and cool the tray(s)
using the manufacturer’s FDA-cleared written instructions • Perform product testing when required
Healthcare facility requires receipt of loaner trays/items at least two (2) business days prior to the
scheduled case. All first-time vendor-loaned sets require three (3) business days for in servicing,
inspecting and processing. In the designated staging area of the healthcare facility’s SPD, loaner trays
received will be logged on an inventory loaner sheet. Trays will be weighed upon delivery. The weight
of the tray is not to exceed the maximum weight allowance determined by current ANSI/AAMI ST79 (25
pounds). If the vendor and/or SPD representative need to reconfigure the tray contents for any
reason, proper validation and documentation must be supplied to make this change by the device
manufacturer. All tray(s) will be tagged with date, surgeon name(s) and procedure, and placed and/or
stored in the designated area. If a healthcare facility has an instrument tracking system with bar coding
capabilities, this can be used in place of a tag system (write on the outside tape the name of surgeon,
room number, number of trays, and date and time of surgery). After being logged in and tagged, trays
may be placed in a specific area waiting for processing. Vendor must provide in-service to SPD staff for
any tray(s) that are brought in as a loaner. This includes, but is not limited to, decontamination,
inspection, assembling, packaging, sterilization, handling, and any other information that is needed for
proper processing of the instrumentation. In advance of the surgical case, the vendor and SPD
Program Manager must ensure that all information is on file for loaner instrumentation as it pertains to
decontamination, inspection, assembly, packaging, sterilization, and storage
SPD notified of loaners prior to receiving them
Received in facility (decontam) at least 1 working days (24 hours) for existing loaner sets and
2 working day (48 hours) for new sets before scheduled case
Inventory list available
Written recommendations for cleaning, packing and sterilization available
Inventory and quality check completed
Multiple trays numbered and labeled (patient name, surgeon)
Tray do not exceed 25 pounds
All instruments in good condition, no rusting, tape, residue, etc