7
A big-data miracle of surgical
inventories: feeding of the 5,000
Automation may be easier to see, but the bigger shifts will be
happening behind the scenes, where surgical instrument data is gath-
ered, analyzed and reapplied to "do more with less" in the SPD depart-
ment of the future. Instrument-level utilization data will let periopera-
tive leaders, administrators and surgeons see the massive amounts of
surgical waste in their trays, resulting in a reduction in setup, turnover
and assembly times — as well as saving replacement costs, storage
space and unnecessary repair expenses. Surgical inventories will be
able to serve more surgeons, for more procedures, without adding
more instrument waste to the process. Even though many SPD/OR
personnel already know overstocked trays are a challenge, the
absence of actionable data has held many teams back from making
needed improvements.
8
Transparent traceability:
patient-level instrument management
With the FDA direct marking requirements for Class 1 medical
devices scheduled to begin enforcement in 2022, unique device identi-
fication (or "the UDI rule" as it is being called) will take sterile pro-
cessing departments and ORs by storm in the coming years. While
this will inevitably bring with it much confusion and complexity, it
will also take us one step closer to the ultimate goal for the reprocess-
ing industry: true instrument-to-patient traceability. With few excep-
tions, the closest that many facilities can come today to instrument
traceability is identifying a particular tray that may have been used in
a surgical procedure, but transparency beyond that is still out of
reach. As direct marking for Class 1 devices takes hold, reprocessing
departments will be able to see the entire history of particular devices
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