• The study conducted by a team from the Kremlin-Bicêtre University Hospital involving 40 patients over one year compared reusable and single-use instruments in lumbar spinal surgery
  • Single-use instruments saved the hospital almost 2.5 hours per operation, which represents an estimated financial saving of 181 euros

Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company specialising in the design and marketing of implants and single-use instruments for spinal surgery, announces the publication in the European Journal of Orthopaedic Surgery & Traumatology of an article written by a team from the Kremlin-Bicêtre University Hospital presenting a one-year randomised study on 40 patients who underwent spinal surgery. The objective was to compare the cost of reusable and single-use instruments.

Kremlin Bicêtre teams analysed all the steps necessary for a spinal operation, from the preparation of the equipment beforehand to the cleaning and sterilization of the reusable equipment and the disposal of single-use instruments afterwards. They estimated the cost of each step by taking into account the work time required in both cases and the cost of the equipment used.

Financial advantage of single-use instruments resulting from pre- and post-operative duration

The study shows that the average length of the operations was the same for both groups. On the other hand, the time required for preparation beforehand (ordering, restocking) and post-operation procedures (cleaning, reconditioning, and sterilisation of instruments) was almost 3 hours (exactly 176 minutes) in the case of reusable instruments and only half an hour (precisely 33 minutes) with single-use instruments.

With reusable instruments, the post-operation disinfection phase took 27.5 minutes, the assembly of instruments took 73.7 minutes, and sterilization took 52.4 minutes, accounting for 87% of the three hours required. With single-use instruments, the longest step was the preparation of the kits, which took an average of 17 minutes. In total, the reduction in the overall process time with single-use instruments was 143 minutes, representing a savings of 181 euros per operation for the hospital. This is in addition to the potential increases in productivity that hospitals could achieve by reallocating staff dedicated to equipment sterilization operations.

Knowing that social security sets the purchase price of the equipment for the manufacturers for each operation, the use of single-use devices represented a saving of 26% for the hospital.

Advantages of weight and availability of instruments

The study also identified two other interesting findings. The first is the influence of work conditions on hospital staff. The weight of the reusable instruments, which are transported to the operating room in three boxes, totals 42 kg. They are therefore difficult for staff to handle and can lead to musculoskeletal problems over time. The weight of single-use instruments is limited to 1.2 kg, because the instruments are more versatile and non-metallic.

The second point highlighted by the Kremlin-Bicêtre study concerns the availability of instruments. Given the time required to sterilize and prepare the equipment, hospitals may have to delay procedures due to the lack of availability of reusable instruments. Single-use instruments are, by definition, always ready to use because they are delivered sterile, with traceability for each device.

“Our study shows that single-use instruments have a place in spinal surgery, not only because of the cost savings they provide for hospitals, but also because of their ease of use for surgeons and the comfort they provide for hospital staff. Once this innovative technology has been apprehended, the instruments are reliable and versatile. Without modifying surgical technique, they make it possible to optimize the operating durations as measured in the study,” explained Professor Charles Court, surgeon at the Kremlin-Bicêtre University Hospital.

“We thank and congratulate the Kremlin Bicêtre University Hospital team for publishing its study on our technologies in the European Journal of Orthopaedic Surgery & Traumatology, the leading scientific journal in our sector. This randomized study shows an 80% reduction in pre- and post-operative duration using our technologies and offers the benefit to surgeons of having a sterile, ready-to-use technology. Helping the surgeon reduce surgical risks for the patient and enabling hospitals to reduce their costs are important issues for Safe Orthopaedics,” declared Pierre Dumouchel, CEO of Safe Orthopaedics.

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics, is a French medical technology company that offers the safest technologies to treat spinal fractures. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, anywhere. These technologies enable minimally invasive approaches, redcucing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, SteriSpineTM kits are CE marked and FDA cleared. The company is based in Eragny-sur-Oise (95) and has 40 employees.

For more information: www.SafeOrthopaedics.com

Safe Orthopaedics François-Henri Reynaud Chief Financial and Administrative Officer Phone: +33 (0)1 34 21 50 00 investors@safeorthopaedics.com Investor Relations NewCap Mathilde Bohin Phone: +33 (0)1 44 71 94 94 / SafeOrtho@newcap.eu Media Relations Ulysse Communication Bruno Arabian / 06 87 88 47 26 / barabian@ulysse-communication.com Nicolas Daniels / 06 63 66 59 22 / ndaniels@ulysse-communication.com