Pre-Sterilized Extremity Implants & Instruments:
Flexible, Efficient, Manageable and Traceable
It’s a subject more hospitals and surgeons now ponder: do pre-sterilized, single-use instruments and implant-related devices have distinct advantages over those that are repeatedly sterilized?
While single-use equipment is nothing new in healthcare, what is changing are the kinds of instruments and related devices going the route of “one and done.”
Advancements in pre-sterilized, tailored surgical kits that supply only the implants (such as screws and plates) and accompanying instruments necessary for specific procedures are gaining traction.
The typical drivers behind single-use, pre-sterilized implants are also at work here:
But, there are newer administrative, regulatory and logistical considerations that make the kits attractive to surgeons, hospitals and, even to the companies that produce them.
Seldom does a surgeon enter a procedure without a clear plan on how to treat his or her patient. But, they do prefer to have the flexibility to choose the right device in those cases where, once the surgery is underway, they can fully assess the situation and change the direction of treatment if necessary.
In terms of using instrument trays that have been sterilized on-site at the hospital, doctors and nurses may be presented with multiple large trays with an array of plates, screws and various other “tools”. Too much choice crowds case carts, back tables and can be overwhelming; plus, the potential for contamination is a concern with “wrapped trays.”
By contrast, pre-sterilized instrument kits are a quarter of the size of regular trays, and the surgical team uses only what is needed, cutting down on waste, minimizing contamination risk, while making the most of limited space in the O.R.
Think about a hospital’s instrument in-take procedure and its multiple steps, check-in procedures and coordination. The 48 to 72 hours many hospitals require to receive instrument trays before a scheduled procedure may distract employees from other tasks and result in possible missteps. Not to mention the back-end cleaning, restocking and storage required caring for this inventory.
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.
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.
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.
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?
About the Author
John Wells is a medical device executive with 20+ years of experience in the orthopedic device field encompassing roles including hospital servicing, product distribution, sales leadership and executive management.
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