Pre-Sterilized Extremity Implants & Instruments:
Flexible, Efficient, Manageable and Traceable

• Increasing financial constraints facing hospitals and insurers;
• Reducing risk of Surgical Site Infections (SSI); and,
• Greater operating room efficiencies.

• Pre-sterilized trays streamline processing on the front and back end.
• They take less time to check in.
• Drop-off can happen anytime, even the night before a procedure.
• They can head directly to the core and the case cart, bypassing sterilization with zero worries about possible contamination and OR delays due to a hole in the drape, moisture in the tray, or an overlooked contaminated instrument.
• Eliminates the mislabeling of a wrapped tray in regards to its contents.
• The surgical staff knows everything for the procedure is there, ready to go via see-through packaging and precision content labeling. They don’t have to open a tray to know exactly what they have.
• Interaction time between hospital sterile processing staff and product rep is also simplified and reduced which saves time and maintains efficient work flows.
• Relieves the financial impact to hospital for lost instruments.

Improved Inventory Access and Management

No organization wants equipment that is oversupplied and underutilized. Hospitals, particularly trauma hospitals, will always have general ortho plates and screws on hand.

The idea of keeping a small emergency inventory of pre-sterilized plates and screws for the unannounced and unplanned situation can benefit any hospital, particularly in light of recent natural and man-made disasters. Several trays can be kept off to the side for quick access or for transport, as pre-sterilized trays are easily moved without fear of contamination.

One area where pre-sterilized trays are gaining popularity is with ambulatory surgery centers (ASC). ASCs find greater efficiencies with pre-sterilized instruments. They allow more procedures to be performed with shorter turnover time, take less room to store, are easily received into inventory by staff, and can be supplied at similar cost to traditional implants and instruments that require processing and sterilization.

Device Tracking with UDI and EHR

Ongoing federal requirements for making implantable devices adequately identifiable through the FDA’s Unique Device Identification (UDI) system, and then entered into a patient’s Electronic Health Record (EHR) and insurance claims, is made easier via pre-sterilized implants and instrument kits.

With an abundance of screw and plates of various sizes (including some that are quite small), managing what specific implants go into a patient can make tracking and compliance difficult. Having all implants in sterile packaging with detailed labeling – including the required UDI’s marked by the manufacturer – simplifies compliances as well as eases the data entry burden on hospital staff.

Nursing Staff Efficiencies

One of the common concerns among health professionals is how greater data entry encroaches on their workload as healthcare clinicians. The regulatory environment around UDI compliance is complicated and a point of anxiety for some hospitals and some device makers alike. It is becoming clear that recordkeeping compliance will continue to deflect more staff time away from caring for patients.

Consider that every tiny plate and screw must have its own UDI, and each device used in a case may be required to be entered into the EHR and insurance claims in the not so distant future. Now imagine eliminating that added administrative headache of looking through a device maker’s “cross reference UDI catalog” (with pages numbering upward of a thousand) to find the device and enter the number into the EHR. Pre-packaged, single use implants have the promise to introduce a bit more simplicity into a complex environment.

Gaining Traction

Of course, shifting entirely over to pre-sterilized implants and instruments would require changes in procurement, process management, stock control, storage, and contract maintenance.

Some countries have already taken these steps and are moving to a new model of pre-sterilized small extremity implants and single use instruments. Considering a hospital’s need to reduce their financial burdens, minimize their infection risk and create more operational efficiencies, the switch to “one and done” makes for smart business, quality patient care and offers benefits worth the effort.

What are your experiences using pre-sterilized devices?