By: 1 March 2022
Disposable spinal instruments to initiate a new era of surgical innovation

Many people suffer from different types of illnesses that are directly or indirectly related to the body’s spinal cord. Spinal injury can be caused by aging, improper body mechanics, trauma, and structural abnormalities. This can cause back pain, numbness and weakness in lower extremities. A spinal cord injury (SCI) affects a person’s sensory abilities, their motor abilities, or both, making daily life activities difficult.

Although this type of traumatic injury is somewhat rare, there are still hundreds of thousands of people who live with spinal cord injuries and thousands more who are diagnosed and affected every year. As per World Health Organisation (WHO), between 250,000 and 500,000 new spinal cord injuries occur each year globally. More than 90% of all SCIs are the outcome of a physical accident such as fall, motorcycle crash or an act of violence.

Most of the times, the apt way to get the spine in working condition again is to undergo a spine fusion treatment. In order to achieve a successful spinal cord fusion, it is best to use disposable spinal instruments. With the advent of disposable spinal instruments in recent years, spine surgeries have become more accessible, efficient, and minimally invasive.

Single-use instruments are used for these procedures as they do not require any sterilisation procedure, which reduces the cost associated with autoclaving. Future Market Insights reported that the overall demand for disposable spinal instruments will grow at a CAGR of 8.3% between 2022 and 2032, totalling a valuation of US$ 98.5 Mn by 2032. As there is a lower risk of infection and cross-infection with disposable spinal instruments, they are considered to be a better alternative over reusable ones.

 

Spinal surgeries to spur with growing geriatric population

In terms of age, the world’s population is getting old. According to United Nations, by 2050, globally over 2 billion people will be aged 65 and above, which is equivalent to one in six people. There were about 970 million people in this age group in 2017. They are at high risk of spinal cord injury and require spinal instruments for it.

With the aging population, degenerative spinal conditions like degenerative spinal stenosis and degenerative disc disorders will also become more prevalent. Some of these patients suffer from debilitating persistent pain and functional disability despite medication, physical therapy, and epidural steroid injections being used to treat them. The appropriate surgical treatment should be considered for these patients, with a great deal of caution. Thus, to avoid any kind of viral or bacterial infection in these patients during spinal surgery, doctors strictly adhere to using disposable spinal instruments.

It is common for orthopaedic oncologists to encounter patients with minor bone lesions difficult to access surgically. These patients require large exposures that are out of proportion to the severity of the disease and have a significant negative impact on the patient.

For such cases, minimally invasive surgical techniques provide the advantage of smaller incisions, shorter operative times, less tissue damage, and lower costs. In the field of spine surgery, minimally invasive technologies have emerged for a variety of surgical procedures. And for these surgeries, the doctors opt for disposable instruments as they are sterile and safe, with zero chances of infection.

One such minimally invasive disposable surgical device is the Minimal Exposure Tubular Retractor (METRxTM) System, which uses a series of dilators to allow access to a surgical site of interest. This system was developed for use in the treatment of disc herniation, spinal stenosis, posterior lumbar interbody fusion, transforaminal lumbar interbody fusion and spinal cord stimulation implantation.

 

Preventing surgical site infections (SSI) with disposable spinal instruments

Surgical site infections (SSIs) result from invasive surgical procedures and are the most frequently reported hospital acquired infections (HAIs). A surgical site infection, or SSI, occurs within 30 days or one year after the operation, depending on whether an implant was left in place.

Increased morbidity and mortality may occur as a result of SSI, as well as prolonged hospital stays, re-admissions to the hospital, and even increased healthcare costs. For example, in the United States, surgical site infections account for approximately 2 to 5% of surgeries and complicate 300,000 to 500,000 surgeries per year, costing the health-care system upwards of $1.6 billion.

An increased rate of deep surgical site infections has been linked to post-sterilisation contamination of surgical instrument sets. The reusable surgical instruments are, at times, not sterilised properly before or after the surgery. As a result, the microbial clumps on those instruments enter the surgical site directly. This can result in severe complications following surgery.

Therefore, to avoid these risks, it is better to use disposable spinal instruments as they can be disposed off easily and are meant for one-time use.

 

Disposable instruments to become more economical

It is much harder to quantify and predict the true cost of reusable medical devices. Purchasing single-use medical devices in bulk, storing them and constantly replacing them are far more expensive than purchasing a multi-use instrument. However, this comes with additional costs. As surgeons need more than one instrument of each type, the initial expenditure on new instruments increases dramatically.

The costs of sterilisation after every single surgery include both the actual cost of sterilisation and staffing and transportation costs related to collecting, packing, and transporting the instruments to a sterilisation facility. It is also important not to overlook the costs associated with replacing tools damaged or lost in the cleaning process.

Thus, considering all these aspects, it can be well deduced that disposable instruments are more preferred than the reusable ones. The National Center for Health Statistics reports that over 650 000 spinal fusion surgeries are performed each year. Thus, estimation can be made on the overall expenditure and savings done with the help of the disposable instruments for such a huge number of surgeries every year. This will also help to strengthen the overall medical system too.

 

The cervical and lumbar kits to gain more attention

Since disposable instruments have proven to have multiple advantages, there is a growing demand for disposable spinal surgery kits among both surgeons and patients. The benefits of disposable spinal instrument kits are the reduction of preoperative and postoperative sterilisation costs and the elimination of contamination. The cost-effectiveness of these kits over reusable ones is a major reason why patients prefer disposable kits over reusable ones.

NuVasive, Inc. recently launched its new C360TM cervical spine portfolio, including the thinnest cervical plate on the market at 1.6 mm. NuVasive, Inc. is a leader in spinal technology innovation, focused on innovating minimally disruptive, procedurally integrated solutions for the spine. C360 demonstrates NuVasive’s commitment to developing innovative treatments for the anterior and posterior cervical spines. The quality of care will be improved even in the most established spine area.

US Food and Drug Administration (FDA) has also approved Paradigm Spine’s disposable instrument set for its Class III spinal device under a pre-market supplemental approval (PMA). One of the first spinal instruments to be approved by the FDA is the co-flex Inter-laminar Stabilization device. It reduces the financial and operational burdens of facilities by utilising simple, disposable, sterile kits.

 

Future scope of disposable spinal instruments

The healthcare professionals are slowly moving towards the disposable instruments for spinal surgeries because of wide array of reasons. In comparison with small-gauge instruments, these larger instruments were less expensive to repair and maintain. These instruments have a one-time cost, cutting off the other hidden costs for maintenance and sterilisation. There are no associated costs linked up with these instruments, which eventually decreases the overall expense of the treatment or that of the surgery.

A number of major companies dealing with these instruments are expanding globally through acquisitions and product developments. Recently, Spine Surgical Innovation launched a range of disposable spinal instruments, such as disposable drills, disposable forceps, and disposable surgical blades. New product launches of this nature are expected to increase consumer interest in disposable spinal instruments.

At the same time, with laparoscopic surgeries being more adopted by medical science, the doctors are moving towards enhancement of instruments. This makes them more inclined towards disposable spinal instruments as they are meant for one-time use, cost-friendly and easy to dispose of. Medical practitioners believe that these instruments will open up a new era in the field of medical science by offering lower infection rates.

 

Author Bio: Saurabh Sharma, General Manager Healthcare Research at Future Market Research at Future Market Insights

Saurabh is the General Manager for Healthcare Research domain at ESOMAR-certified market research and consulting firm Future Market Insights (FMI). The award-winning firm is headquartered in Dubai, with offices in the US, UK, and India. MarketNgage is the Market Research Subscription Platform from FMI that assists stakeholders in obtaining in-depth research across industries, markets and niche segments. You can connect with Saurabh on LinkedIn.

Future Market Insights (FMI), is an ESOMAR-certified market research and consulting market research company. FMI is a leading provider of market intelligence and consulting services, serving clients in over 150 countries; its market research reports and industry analysis help businesses navigate challenges and make critical decisions with confidence and clarity amidst breakneck competition. Now avail flexible Research Subscriptions, and access Research multi-format through downloadable databooks, infographics, charts, and interactive playbook for data visualisation and full reports through MarketNgage, the unified market intelligence engine powered by Future Market Insights.