Adoption of sterile pack, single use and surgery ready instruments and procedural kits in the operating room is accelerating across the orthopaedic industry. Primary drivers are to cut costs, reduce infection risk and achieve sustainability targets while providing pristine sets of tools for implant fixation.
The strength and high flow moldability of Ixef® PARA makes it the ideal choice of ECA Medical Instruments, the global leader for the development of cost-effective, high-precision, single-procedure instruments and complete surgery ready kits for trauma, extremities, spine, and joint reconstruction cases.
Growth in Same-Day Surgery Drives Interest in Disposable Instrumentation
The selection of single-use solutions over traditional reusable metal sets continues to evolve in hospitals seeking to improve operating room (OR) efficiencies, reduce costs, and lower hospital-acquired infections (HAIs) to avoid negative impacts on reimbursement. The most rapid shift is occurring in ambulatory surgery centers (ASCs), which will account for over 68% of all surgeries by 2025 with orthopaedic procedures being among the most profitable. Reusable instruments are problematic in the ASC due to reduced sterilization capacity, limited inventory space and the logistics hassles and costs associated with reprocessing. The industry is solving these pains by shifting to optimized and tailored sterile pack instruments and implants that can make the surgery more efficient, allow for faster OR turnover, reduce the carbon footprint by 30% or more and eliminate reprocessing costs. The successful manufacturing of high performance single use instruments to meet the needs of one-way orthopaedic applications that are sterile-pack and surgery-ready, is best achieved through the combination of ECA Medical Instruments product design and Solvay’s material expertise in using high-performing materials.
ECA Medical Instruments: The Go-To Source for transitioning to Single-Use Surgery-Ready™ Solutions
ECA is the worldwide leader in single-use torque limiters and,Surgery-ReadyTM procedural kits. With over 44 years’ experience of serving medical device leaders, ECA’s portfolio of single-use instruments, together with its industry leading sterile procedure kit development and manufacturing, offer unique, differentiated solutions that add measurable value for both implant OEMs, hospitals, and ASCs.
ECA is the single source solution for producing the industry standard in single-use, Surgery-Ready™ procedure kits and instruments.
The Importance of Precise Torque
Precision torque is critical to the success of an orthopaedic implant. An under torqued plate and/or screw can come loose post-surgery. If over torqued it could cold weld, strip or break a screw head, which creates costly and anxious delays in the OR. The use of torque limiters allows precise control of screw torque and reduces subsequent revision surgeries.
ECA Medical’s TruTORQ™ hand operated and TruPWR™ power operated torque limiting instruments offer precision fixation of orthopaedic implants. TruPWR was introduced in 2022 and has become the instrument of choice to not only cut OR time but eliminate surgeon fatigue, especially in complex spine and trauma cases with multiple or lengthy screws to secure. In addition, the reprocessing steps for reusable instrumentation are significant and expensive, requiring repeated recalibration based on hard to measure time and usage to maintain correct precision levels as well as the chronic life cycle costs for product spares and repairs. Cleaning of reusable instruments also creates a large carbon footprint given the need for harsh chemical and cleaning agents used in sterile processing departments and scores of gallons of fresh water used for rinsing and repeated steam sterilisations.
Advantages of Single Use Instrumentation
Single-Use Torque Limiters
The growth of same-day surgery, with an increasing number of procedures carried out in ASC's is driving demand for single use instrumentation. Single Instruments allow a simplified workflow, lowers cross-contamination risk and improves productivity.
- Calibration – pristine from the factory. Always in proper torque set point for every procedure and patient.
- Consistent implant tightening – No concerns about implants being too loose or too tight, screw breakage or cold welding.
- Confidence in outcome – peace of mind for surgeons who can operate knowing the torque limiter is in spec and will meet the implant final tightening requirements.
Orthopaedic Surgery-Ready™, Single-Use Procedure Kits
OEM implant firms are demanding optimized and tailored sterile pack instrument sets
for a wide range of trauma, extremity, joint recon, CMFT, spine and other procedures. The Surgery-Ready™ single-use kits are sterile packed instruments tailored for every procedure and patient. This provides significant cost savings compared to reprocessing and maintaining of traditional reusable instruments:
- Reduced reprocessing logistics
- Optimized by indication
- Pristine & unused
- Always available
- Improved case flow
Surgery-Ready™ represents the new standard for safe and efficient operating rooms
Selecting the Best Material for Single-Use Medical Devices
By definition a single-use medical instruments and devices are used for one procedure and then discarded, recycled or repurposed. Your material choice must then be based on several important factors, such as: robustness for the clinical procedure, economic value, manufacturability and patient contact safety.
Medical devices that are brought into direct contact with a patient’s body fluids or tissues are subject to more stringent regulatory controls. Therefore, a material supplier that performs comprehensive biocompatibility testing can provide their customers with greater confidence that the material will not pose a potential risk due to its contents.
Biocompatibility is of course a required first step but the choice of a material is critical from a physical performance and processing point of view. The use of injection molding requires good material processing characteristics to enable the best flow and maximum material attributes.
“We chose Ixef® PARA for our single use instrumentation because of its strength, its ergonomic weight ratio and the design freedom given by this extremely high-flow resin,” commented Lane Hale, President, and CEO, ECA Medical Instruments. “Design to cost and design for manufacturability (DFM) are critical for single use solutions therefore the ease of use and predictable behavior in the molding process of Ixef® PARA facilitates and accelerates product development.”
Ixef® PARA the Strong, Smooth Surface Alternative to Metal
Ixef® PARA compounds offer metal-like strength, rigidity, and dimensional stability, while providing a high-quality surface. The appearance of Ixef® PARA gamma-stabilised colors make them a cost-effective alternative to metal, particularly for single-use medical instruments and devices in the Healthcare market. Ixef® PARA has ISO 10993 limited contact duration biocompatibility data and is supported by a Food & Drug Administration Master Access File for the polymer, additives and colorants.
ECA Medical Instruments has chosen Ixef® PARA for the development of many of its products.The resin allows ECA Medical to develop instrumentation that is clinically robust and provides measurable economic value. They are used in both hospitals and ambulatory surgery centres worldwide.
With over 30 years of experience as a leading materials supplier to the healthcare industry, Solvay provides the experience and innovation medical device manufacturers need from their partners. Our polymers specialists can help you select the right materials that meet the performance and compatibility requirements for single-use medical devices.