Frequently Asked Questions (FAQs)

Why are single procedure torque instruments and procedural kits becoming so popular?

The advantages are many including implant OEMs can sell more implant products as the instruments are sterile-packed and always surgery ready. This is especially critical in trauma implant cases where instruments and implants must be ready for surgery at a moment’s notice to support an osteosynthesis procedure.  Disposable sets are also lower cost, eliminate instrument cleaning and reprocessing, reduce life cycle management, reduce surgical site infection (SSI) and offer efficiency gains in hospital and surgical center operations including operating room productivity. Early healthcare adoption was limited to IV and blood bags, disposable swabs, needles and the like. Today, with global initiatives to drive out unneeded costs and increase healthcare efficiency the focus is on broader use of single-use and disposable products including precision torque instruments and procedural kits where it makes sense. New technologies have given rise to high quality, superior performance instruments now available at a fraction of the cost of traditional reusable devices.

 

What materials are ECA Medical Instruments disposable torque limiting instruments composed of?

Single-procedure or disposable torque instruments are made of surgical stainless steel shafts and tips specially inserted and secured into polymer handles of various material types, handle sizes, shapes and grips. ECA Medical Instruments uses the finest biocompatible polymers in the industry and has over 30 years expertise in injection molding of plastics, tooling and over molding. Materials are also bioburden, endotoxin, cytotoxicity tested and validated.  Polymer strength is outstanding and tested well beyond operating specifications using both FEA and physical testing processes.

 

Can ECA Medical Instruments make special or custom ergonomic designs and handles?

Yes. ECA Medical Instruments provides turnkey design, prototype and pilot to production solutions under one roof. We are a turnkey one stop shop product company. We design and development products to customer specifications. Provide us your drawings and specifications and we will collaborate with you to develop the best quality, most cost effective and highest performance products and kits available. ECA Medical Instruments uses a quality by design (QbD) process coupled with rapid prototyping engineering to provide quick product designs and accelerate time to market for new products.  ECA Medical Instruments is typically the manufacturer of record and the OEM implant firm, which holds the 510k, is the distributor of record. ECA Medical Instruments takes care of all product testing, validations and regulatory compliance needs. In addition to torque-limiters ECA Medical Instruments also designs and builds: fixed drivers, awls, trocars, trial plates, drill guides, depth gauges, K-wires, drill bits and many other instruments required in a procedural kit. They are all fully validated and meet exacting customer specifications.

 

Do you have over-molding capabilities?

Yes. ECA Medical Instruments has a wide range of engineered polymer handles and over mold options and ergonomic designs tailored to our customers’ specifications.

 

What torque ranges does ECA Medical Instruments offer to its customers?

We offer standard and custom precision torque-limiting instruments with torque ranges from as low as 2 oz. /in. for highly precise low torque CRM and Neuro applications to as much as 106 lb./in. (12Nm) for securing screw implants, connectors and fasteners in demanding orthopaedic and spine procedures.

 

What are the primary medical applications of single procedure torque limiting devices and for procedural instrument kits?

Disposable or single-use torque limiting instruments and kits are used in a wide range of medical procedures and applications including securing leads and fasteners for medical implants. These include cardiac rhythm management, neuromodulation, cardiovascular, orthopaedic, spine, spinal fusion, small bone and trauma reconstruction and many more procedures.

 

Are they as accurate as reusable torque instruments?

Yes. And most likely more accurate. Reusable devices may easily fall out of calibration after several uses and most are said to be used for up to six months or a year before they are returned to the medical device OEM or vendor for calibration. In fact, reusable torque limiting devices today may be out of calibration long before the six month or one year rotation cycle and there is no record of how many actuations or cleaning cycles that may have occurred on any individual instrument, which raises high risk for being out of tolerance and hospital acquired infection. ECA Medical Instruments’ single procedure torque instruments are factory set to within +/- 10% of torque set point (or tighter if required by customer specifications) and are guaranteed to perform as per spec. Every disposable torque instrument is brand new in the operating theater and is sterile packed and ready for use. ECA Medical Instruments has shipped over 32 million torque limiting instruments for use in over 500 million surgical actuations. For over 30 years leading medical device and implant OEMs have relied on ECA Medical Instruments for their torque-limiting solutions.

 

What are the primary reasons OEMs, surgeons and hospitals are switching or have switched to disposable/single-procedure torque limiting instrument and procedural kits?

Safety and cost. Disposable instruments and fixation kits are pristine, sterile, fully calibrated and offer precise torque for every procedure and patient. Reusable torque limiters, in contrast, can easily fall out of calibration and pose a safety risk if an implant is improperly secured in a patient. They are also hard to manage and clean and new cleaning guidelines oftentimes require complete disassembly, cleaning, reassembly and recalibration after every surgery making them very expensive to service and support.

CRM and Neuro implant device manufacturers have been employing disposable precision torque limiting instruments for pacemaker; defibrillator and pulse generator lead connections for over 30 years. More recently the orthopaedic market led by the sports medicine OEMs have embraced the technology as result of cost reduction demands by hospitals, outpatient surgical centers and healthcare reimbursement agencies and insurance companies. OEMs are also concerned about the increased cost and risk of traditional reusable instruments in general. Hospitals are especially concerned about what is termed uncontrolled reprocessing of reusable instruments.

Huge upfront cost, spiraling life cycle cost, lack of consistent torque accuracy, greater risk of infection due to poor cleaning and multiple autoclave cycles, the growing carbon footprint and hospital inefficiencies make reusable torque devices and instruments antiquated and unsustainable in the reimbursement model. The primary and sustaining value of single-procedure instruments and kits are simple: they are lower cost, clinically robust, assure proper fixation and outcomes, reduce inventory hassles and costs and increase operating room efficiency and productivity.

 

What are the estimated cost savings realized by using single procedure vs. reusable instruments and kits?

Estimates suggest a savings of more than $1,000 with every implant procedure by switching to disposable surgical torque limiting instruments and procedural kits. In the US that means a potential savings of over $1.0 billion per year. If you consider the reduction in life cycle cost, greater inventory turns and also the increase in operating room and hospital personnel productivity the gains could be 2X to 3X that amount annually.  Disposable instruments and kits may also be sold to customers providing OEMs a new annuity revenue stream.

 

How does ECA Medical Instruments work with its customers?

ECA Medical Instruments serves as a one stop shop design and development partner with its OEM customers. Every product we manufacture is the result of close collaboration and the meeting of customer specifications. We work hand in hand to find the best product functionality at the best value and for a wide range of applications including trauma, CMF, extremity, spine and general recon procedures.

 

Can customers modify or customize products and kits for specific applications?

Yes. ECA Medical Instruments offers standard configurations of torque and fixed instrument products as well as surgical procedural kits. They may be modified as semi-custom units or completely customized to meet customer requirements. ECA Medical Instruments offers turnkey engineering to production capabilities following ECA Medical Instruments’ ISO stage book product development process, design for manufacturability and rapid prototyping steps. The company assigns a dedicated team to every customer to insure collaborative development and reduce cycle time to get products to market quickly.

 

Can these disposable kits be sterilized? What types of sterilization?

ECA Medical Instruments and procedural kits are EtO or Gamma compatible at 25-40 kGy and sterility assurance level (SAL) of 10-6.

 

What is the sterilized shelf-life of a single-procedure instrument?

ECA Medical Instruments’ standard shelf life is 2 years but we can conduct aging studies for multiple years.

 

Are major OEM firms using single procedure torque limiting instruments and disposable procedure kits?

All the major medical devices OEM firms use disposable products including single-use torque limiting instruments and sterile-packed surgery ready kits with wide range of instruments. ECA Medical Instruments is the industry leader in designing and manufacturing precision single-use torque limiting instruments and procedural kits for the global medical device market.

 

Is the US FDA a supporter of single-procedure or disposable technologies?

Yes. While the FDA has not and is not expected to provide formal industry guidance it is a backer of disposable technologies. The agency’s support of disposable technologies for healthcare and biopharma applications has been stated by numerous FDA officials in Washington DC. Single procedure products, primarily made of plastic materials, reduce risk of cross contamination, reduce hospital acquired infections (HAI), and reduce the need for cleaning and sterilization systems and validation. In addition, disposable products can be recycled and cut the carbon footprint created by the transportation and logistics costs associated with life cycle management of reusable devices.

 

What kinds of packaging options are available?

We offer a complete range of packaging configurations for our customers. We will take and create a specification using your packaging requirements or help you design a winning solution including double barrier bags and pouches, tray in a tray, PETG and Styrene trays and pouches, Tyvek and Polymer films, sterilization, labeling, drop test and high shelf life and ruggedized configurations and more. ECA Medical Instruments takes care of all the validations and documentation.

 

Can you use disposable instruments or kits more than once?

No. This insures the surgeon has a brand new precisely calibrated and sterile torque instrument or procedural kit for each patient and procedure. They are designed for a single-procedure and then disposed of as medical waste or for recycle. Multiple uses of the instruments or kits are not the intended purpose and violate the product warranty.

 

What is the fastest way to get a sample of a custom torque limiting instrument?

Contact ECA Medical Instruments sales and product development team who will work with you to create a solution for your medical implant product or application. We work with all companies to create surgical instrument solutions for the complete range of screw sets, locking mechanisms, connectors and fasteners used in the medical device industry.

Call ECA Medical Instruments at:  +1 805-376-2509 or email ECA Medical Instruments at: sales@ecamedical.com