Disposables in the O.R.
While the use of disposables in healthcare is certainly nothing new, their implementation as instrumentation in orthopedic procedures is. Offering an array of benefits for OEMs and hospitals alike, such as cost savings, improved efficiencies, and enhanced safety, without sacrificing the durability and strength of more traditional instruments, it’s no wonder this trend is occurring.
Advancements in developing robust and ergonomic disposable surgical instruments and the advent of turnkey single-use procedural kits are promoting broader adoption across medical product and implant makers and hospitals worldwide. Pent-up demand for single-use instruments is on the rise as medical device designers, manufacturers, and surgeons now have viable alternatives to traditional reusable instruments.
For decades modern medicine has relied on costly and difficult to clean and maintain reusable tools in the operating theaters of both the acute and ambulatory surgery settings. The future will offer a hybrid model of both reusable and disposable instruments and/or kits as surgeons and healthcare leaders alike embrace the cost benefits, assured sterility, reduced inventory management, and convenience offered by single-use devices. This includes newly minted, single procedure, torque-limiting instruments and kits for the demanding orthopedic market. In the long run, market dynamics point to single-use solutions overtaking reusable instruments with few exceptions, given the sustained cost savings and ease-of-use benefits. They are the “way of the future.”
Disposable instruments and products are not new to the medical field. For decades, a wide range of products using reliable and high strength medical grade engineered polymers or plastics have been used for blood bags, intravenous drips, tubing and connectors, catheters, scissors, scalpels, retractors, biotech cell culture development, and other applications.
The ease-of-use, lower upfront and lifecycle cost, sterile-pack off-the-shelf convenience, and procedure specific designs are driving demand and increased use in outpatient and hospital procedures. Estimates are that global demand for disposable medical supplies, including commodity items like medical gloves, and diagnostic and laboratory disposables, will grow at 6.4% per year thru 2016 to nearly $200 billion. Broken down, this equates to $7.5 billion in hospital room supplies and $32.2 billion for surgical instruments, procedural kits, and related supplies.1 The U.S. market for disposable medical supplies is expected to top $46.7 billion by 2016 or 23% of global demand.2
In the O.R., the current standard is general purpose and specialty reusable instruments and surgical trays. That is changing—fast. Competition, healthcare reform, margin erosion, inefficient hospital inventory management, and concerns over instrument accuracy and sterility are changing that mindset. The pursuit of higher quality product with a significant reduction in risk is a message being delivered by the caregiver and being received clearly by the manufacturing community.
This is especially true in the orthopedic implant market. While single-use instrument and kits have been commonplace for decades in many implant procedures, including cardiac rhythm management, neuromodulation, and cardiovascular implant procedures, they are new to the orthopedic market. In orthopedic surgeries, a wide range of specialized and highly robust tools, including torque-limiting instruments to secure screws, fasteners, and connectors, are needed to treat trauma cases and complex spine surgeries. The robustness of single-use instruments has been the prime concern as ortho torque instruments must withstand multiple actuations and torque set points up to 11 Nm (more than 100 lb./in.), enough to secure the implant into the strong and heavily demanding stability structure of the lumbar vertebrae.
Precision torque-limiting technology using surgical stainless steel mated to engineered polymers are now showing up on bills of material for both legacy and next generation implants at top ortho OEMs. They are using the same technology that has been deployed in over 25 million single-use torque-limiting instrument cases with over 500 million flawless actuations to secure CRM, CV, and Neuro implants over the past two decades.
In medical implants, precision torque is mission critical. Too tight and the surgeon damages the implant. Too loose and the implant can degrade functionally or fail. New robust and ergonomically designed disposable instruments are now available with torque-limiting ranges from 0.112 Nm to over 11 Nm, covering the full range of ortho implant requirements. The versatility and variability of such instruments cover every aspect of fixation, including general reconstruction; small bone, extremities, and trauma applications; cervical fusion, vertebroplasty, and related spine implant; and treatment cases including cranio-maxillofacial implants.3
Major OEMs in the $45 billion orthopedic market are now adopting both single-procedure torque-limiting and fixed-driver instruments to replace reusable tools. U.S.- and E.U.-based instrument and procedural kit firms are preferred by top implant OEMs. Proven design and development processes, established brands, and medical device histories and quality management systems mitigate risk and provide traceability. ISO 13485, FDA registration, and CE mark certifications are mandatory.
While discreet instrument replacements are gaining market share, the ultimate goal for these OEMs, surgeons, and hospitals is fielding complete, sterile-packed, disposable procedural kits for specific orthopedic implants. Small bone, extremity, and trauma sets for distal radius and shoulder repair, for example, are hitting the market now. Procedural sets for a wide range of spine implants will enter the market in 2014. These sterile-packed, disposable instrument procedural kits provide distinct competitive advantage to the orthopedic implant maker and end-user in several ways:
- Instruments are presented in a ready-to-use sterile-packed tray
- Patient safety increased as surgeons have full confidence in instrument torque calibration accuracy
- Reduction in surgical site infection opportunity
- Minimal inventory footprint with easy to stock, off-the-shelf kits for every implant
- Operating room efficiency and utilization improvements
- General reduction in hospital and ASC operations and maintenance costs
An off-the-shelf and sterile-packed single-use instrument kit offers savings of over $400.00 per ortho implant procedure.3 That equates to over $1 billion in variable costs savings in the U.S. per year. Savings are derived from increased hospital and ASC operating room efficiency, elimination of instrument cleaning and re-sterilization costs, as well as curbing carbon footprint woes derived from cleaning and handling, energy usage, chemicals and waste water, and fuel and transportation costs to rework, fix, and calibrate reusable instruments and devices. Fixed cost savings could easily double that number.
Moreover, single-use instruments and kits eliminate a nagging industry pain. Instrumentation for ortho cases is either hospital owned (about 10-15%) or OEM loaners. Loaned or consigned inventory stock is typically handled by highly paid company sales reps who manage both medical implant and instruments for their hospital and ASC accounts. This is costly, hard to manage, inefficient, and has hidden risks, including product availability, sterility, and calibration concerns.
Today, nearly 10% of the total value of reusable orthopedic instruments in the field are written off as lost, waste, scrap, inoperable, or expired. The result is tens of millions of dollars annually in inventory write-downs and logistic costs that belt-tightening OEMs can no longer afford to absorb.4 Those costs are typically passed off to the patient, hospital, or insurance carrier. It is not sustainable as private insurance and CMS reimbursements become more restrictive and margin dollars are squeezed all around. Instrument stock and logistics is even higher in markets outside the U.S. and E.U. and especially in emerging markets where accounting for reusable instruments and devices is difficult.
The market for single-use or disposable medical supplies and instrumentation is growing at over 6% per year. Disposable instrument kits and O.R. supplies will account for 16% or $32 billion of the $200 billion market by 2016. The use of precision, single-use, torque-limiting and fixed-driver surgical instruments common in CRM, CV, and Neuro implants is being adopted by orthopedic implant OEMs. This change is occurring as technology has evolved to serve the specialized torque, robust design, and ergonomic requirements associated with complicated and high torque ortho implant procedures as well as delicate small bone and CMF surgeries. U.S. and E.U. instrument and kit companies with strong design capabilities, product brands, and industry leading quality management systems will be preferred over off shore firms in order to mitigate operational risks and quality concerns.
Use of turnkey procedural kits provides the ultimate solution by pairing medical device implants with customized disposable instrument kits. They offer convenient, sterile, and robust solutions for surgeons and O.R. personnel while hospitals and ASCs enjoy sustained cost savings, operational efficiencies, smaller carbon footprints, improved inventory, reduced surgical site infections, and lower operating costs. The conversion to single-use, torque-limiting instruments and kits will expand rapidly over the next decade. We can expect to see hybrid applications combining reusable and single-use instruments and products over the next few years with exclusive disposable solutions winning out where they add distinct and sustainable clinical and economic value.
For more information, visit www.ecamedical.com.
1 Global Information Inc. (www.giiresearch.com), November 15, 2012 study and report on World Disposable Medical Supplies.
2 Freedonia Industry Study (www.freedoniagroup.com), Disposable Medical Supplies, March 2012. Study #2853.
3 Schultz, J.; Nino, J. Currie, M. ECA Medical Instruments, Orthopaedic Implant OEMs, Hospitals and ASCs Gain Sustained Benefit with Introduction of Single-Procedure Torque-Limiting Instruments and Kits. White Paper, ECA Medical Instruments, October 2012 (www.ecamedical.com/white-paper.php).
4 Conway, Karen, executive director GHX. Industry’s Achilles Heel: The Supply Chain. BoneZone magazine (Orthoworld, Inc.) August 2013.