The increasing availability of Single-Use, Sterile, Pre-Packaged (SSP) surgical instruments and implants provides an unprecedented opportunity for cost savings due to increased surgery throughput, sterilization cost savings, and reducing Surgical Site Infections (SSIs) and their related costs.

1. Increased Surgery Throughput

With shrinking orthopedic surgery reimbursements and increasing implant and staff costs, the need to generate savings through improved OR utilization is more pressing than ever. Delays and scheduling inefficiencies in the OR can cause facilities to hemorrhage money, and the overall cost of a single OR including its full complement of staff can cost up to $62 per minute. (1)

One study of orthopedic surgeries showed that of 1071 procedures, over 5% are delayed more than 30 minutes or cancelled because of Sterile Processing Department (SPD) delays or a shortage of sterile instruments. (2)

In another example, use of SSP instruments in Total Knee Arthroplasty (TKA) substantially reduces OR turnover time, with an average reduction of between 12-15 minutes per procedure. (3) Another found that use of SSPs reduced turnover time by an average of 20.9 minutes. (4) As a result of this reduced turnover time, an additional TKA procedure was made possible in 51% of 12-hour OR days. (3) Critically, because the majority of OR costs are fixed, this additional procedure provides a much higher gross profit margin. Other studies have shown that SSP instruments reduce set-up time by an average of 30% (2) across the spectrum of orthopedic procedures.

Likewise, SSP instruments have been shown to save significant OR time in a variety of instrumented spinal surgeries. An SSP pedicle screw instrument kit used in lumbar arthrodesis, for example, was shown to reduce OR time by an average of 14 minutes per procedure (5) as well as reduce post-procedure time by 10 minutes. (6) The ability to have SSP instruments and potentially also SSP implants available facilitates adding an additional surgery or performing back-to-back surgeries because the required, sterilized instruments are immediately always ready for use.

2. Saved Sterilization Time & Cost

Equally significant, switching to SSP instruments saves staff time associated with required sterilization volume and associated cost. The fully loaded cost of sterilization personnel averages $1.3/minute (3) (including administration, management, taxes, health insurance, etc.). In one orthopedic surgery cost analysis, the median sterilization time for conventional instruments was 1565 minutes, compared to an average time of 936 minutes when SSP instruments were used. (7) When the cost of reduced SSI was included (see further SSI analysis below), the total savings averaged $994 per case—roughly 10% of the total case cost. (5)

In another study specific to TKA procedures, the total consumable and staffing cost of instrument reprocessing was found to be $140 to $220 per tray. (2) Through the use of SSPs, the total sterilization volume per procedure was significantly reduced, and the resulting sterilization and reprocessing cost was reduced by $480 to $600 per case. (5)

In Open Reduction Internal Fixation procedures, use of distal radius volar plate sets, utilization of complete sets of SSP distal radius volar plate sets and instruments saved an average of $1,313 per case in an ASC environment. (8) The aggregate cost of using SSP instruments is also significantly lower in the well-studied scenario of single-use sterile pre-packaged flexible bronchoscopes vs. reusable flexible bronchoscopes. Meta-analysis shows that SSP use reduced overall instrument, staff, and processing cost by 43%. (9)

3. Cost Savings by Reducing Occurrence of SSIs

Perhaps most importantly, use of SSP instruments substantially lowers the incidence of SSIs, providing the opportunity to increase profitability while simultaneously improving patient outcomes.

SSIs occur in 2% to 13% of orthopedic procedures (10), with the incidence rate varying primarily based on the applicable procedure type. Multiple studies have shown that use of SSP instruments in short instrumented spinal fusion surgeries led to a reduction of SSI occurrence from 6% to 2%. (10)(11) Another study showed that instrumented spinal fusion with conventional instruments result in SSIs 8.7% of the time, suggesting that SSP use could reduce the overall rate of SSIs by as much as 6.7%. (12) There are numerous causes of the increased incidence of SSIs when using conventional, reusable instruments, including that nearly 50% of sterilization units fail to meet ISO 2000 standards (13), and over 2% of sterilized instrument packaging is defective. (14)

Use of SSPs produces similar reductions in SSI rates across many procedure categories. One critical example is single-use flexible bronchoscopes, which have been shown to reduce SSIs from 2.8% to 0.0%. (2) Likewise, use of SSP total knee arthroplasty (TKA) instruments have shown a reduction in SSIs from 3% to 0.2% (3) – especially significant because the average cost of treatment for as SSI following a TKA is $51,000 (15), a savings of $1,428 per procedure. Even more significant, when a periprosthetic infection procedure is required, the treatment cost averages $116,000. (2)

Particularly troubling, sterilization department failures can result in significant clusters and incidence of SSIs as sterilization department failures, staff training requirements, and other persistent causes are at the root of most SSIs. While SSIs may be reported, SSIs are not diagnosed for an average of 4 weeks after a procedure, and hospitals currently have no system to retroactively identify patients exposed to the same potentially contaminated instruments, meaning they are unable to engage in enhanced medical monitoring practices. While not currently a regulatory requirement, litigation related to these medical monitoring failures is beginning to gain traction in malpractice cases. For example, following the first occurrence of an SSI caused by a contaminated bronchoscope, Johns Hopkins Hospital implemented an SSI monitoring procedure. Over the next 414 bronchoscopy procedures, SSIs skyrocketed to an incidence of 9.4% (from a standard occurrence of 2.8%) and were determined to be the cause of three patient deaths. (16) No retroactive patient identification and enhanced monitoring occurred.

Overall, use of SSP instruments has been shown to dramatically reduce the incidence of SSIs, resulting in an average avoided SSI treatment cost per-case of several hundred to over one thousand dollars.

Conclusion

Use of SSP instruments has the potential to significantly reduce cost and improve profitability in the full spectrum of orthopedic surgical procedures while simultaneously improving patient outcomes. The savings averages between 10% to 20% of the total procedure cost (3), and these savings add directly to a hospital’s or ASC’s bottom line profits. This is achieved by SSP instruments’ ability to increase surgical throughput for better OR utilization, reduce sterilization and associated staffing costs, and avoid significant per case cost of treatment of surgical site infections.

About Sure Retractors, Inc.: Sure provides the world’s first and only single-use, sterile, pre-packaged (SSP) surgical retractor for use in the full spectrum of spinal surgeries and many orthopedic procedures. As outlined below, Sure’s revolutionary retractor will play a significant role in the cost savings and increased profits driven by use of SSP instruments. Learn more about the Sure Retractor at www.suresystem.com. Spartan Medical (www.SpartanMedical.com) is a distributor of Sure Retractors.

References

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• Can the number of surgery delays and postponements due to unavailable instrumentation be reduced? Evaluating the benefits of enhanced collaboration between the sterilization and orthopedic surgery units, Huynh, E., et al., Orthopaedics & Traumatology: Surgery & Research, Volume 105, Issue 3 (2019).
• Single use instruments for total knee arthroplasty Michele Romeo1, Giuseppe Rovere, Leonardo Stramazzo, Francesco Liuzza, Luigi Meccariello, Giulio Maccauro, Lawrence Camarda. Available online at: https://ljkzedo.ba/mgpdf/mg34/47_Romeo_1321_A.pdf
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• A comparative analysis of a disposable and reusable pedicle screw instrument kit for lumbar arthrodesis: integrating HTA and MCDA – C Ottardi, A Damonti et Al Eur J Orthopaedic Surg Tramatology 01/09/15.
• The benefits of single-use instrumentation in spine surgery, L Durand, J Nguyen et al : 26th Journees Europharmat, Bordeaux 11-13th October 2016.
• Teissier V, Biau D, Hamadouche M, Talon D, Anract P. Time is Money! Influence on Operating Theater and Sterilization Times of Patient-specific Cutting Guides and Single-use Instrumentation for Total Knee Arthroplasty: A Full Factorial Design of 136 Patients. Arthroplast Today. 2022 Oct 22;18:95-102. doi: 10.1016/j.artd.2022.09.004. PMID: 36312884; PMCID: PMC9596960. Available online at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9596960/
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• Schömig F, Perka C, Pumberger M, Ascherl R. Implant contamination as a cause of surgical site infection in spinal surgery: are single-use implants a reasonable solution? – a systematic review. BMC Musculoskelet Disord. 2020 Sep 25;21(1):634. doi: 10.1186/s12891-020-03653-z. PMID: 32977778; PMCID: PMC7519515. Available online at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519515/
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• Peter Cram, et al., Bundled Payments for Elective Primary Total Knee Arthroplasty: An Analysis of Medicare Administrative Data. Geriatric Orthopedic Surgery & Rehabilitation, Vol. 6(I) 3-10. https://journals.sagepub.com/doi/pdf/10.1177/2151458514559832
• Srinivasan, A., et al., An Outbreak of Pseudomonas aeruginosa Infections Associated with Flexible Bronchoscopes, N Engl J Med 2003; 348:221-227. Available online at: https://www.nejm.org/doi/full/10.1056/nejmoa021808