Healthcare reform initiatives may reward or penalize facilities based on patient outcomes. Some of these penalties include value-based care and reduced Medicare reimbursements for high rates of healthcare-acquired infections (HAIs) and readmissions. However, healthcare organizations can’t afford to cut corners when it comes to quality. At the same time, medical-surgical supply expenses are second only to labor for most hospitals. Therefore, they must make product purchasing decisions that enable their organizations to deliver high quality care in a cost-effective manner.
In an effort to increase care quality, reduce costs, and minimize waste, a growing number of organizations are supplying their operating rooms (ORs) with reposable laparoscopic instrument systems. These systems feature a re-usable hand piece that may be fitted with a number of interchangeable disposable tips. The most expensive component of the device, the handle, is fully reusable as it is durable enough to withstand cleaning and sterilization by a hospital’s central sterile/sterile processing (CS/SPD) department. The handle is matched with a brand new disposable scissor tip for every case. The only per procedure cost and waste is the tip, which is the highest quality every time.
In the January/February issue of Medical Design Technology, my article entitled “Reposable Instruments Solve the Cost/Quality Equation,” offered an overview of reposable laparoscopic instrumentation, including overall design considerations. In this article, I dive deeper into reposable instrument design, addressing design considerations for two key stakeholders involved in product purchasing decisions – surgeons and materials managers – as well as the needs of the central sterile/sterile processing (CS/SPD) department.
Meeting the Needs of Surgeons: Quality is Critical
A surgeon’s number one priority is having a quality instrument in his/her hand so that he/she can perform safe and effective procedures. Cheaply made, plastic disposable handles do not provide the palpable, physical feedback and tactile feel that a surgeon requires when manipulating tissue and other structures within the body.
When designing reposable instruments, it is critical that the handle be constructed of a durable and resilient polymer. It must also be ergonomically designed so that the surgeon can easily “feel” the patient’s anatomy through the instrument.
Comfort is another key consideration to prevent a surgeon from experiencing hand/finger fatigue during long, complex procedures. Designers should consider the following product features to support these requirements:
- A design that facilitates right or left handed operation
- The ability for a surgeon to rotate the device 360 degrees in a single-handed manner
- Various size removable, reusable ring inserts for custom fit and comfort
- Coaxial threading on both the handle and tip ensure a tight connection and precise alignment
Mario Nutis, M.D., FACOG, professor of Obstetrics and Gynecology and medical director of the Center of Excellence of Minimally Invasive Surgery at Del Sol Medical Center, has been using reposable laparoscopic instruments for minimally invasive gynecological procedures. He comments on the need for quality.
“A reusable handle is more substantial in weight and feels safer and secure compared with a disposable handle,” says Dr. Nutis. “There is a significant difference in both quality and precision. You have an instrument in your hand that you feel more comfortable using.”
Another benefit of a reposable platform is that the central sterile/sterile processing (CS/SPD) department only has to process the handle since the surgeon uses a new tip for each procedure. When designing a reposable handle, designers must consider how the design facilitates effective cleaning. The CS/SPD must be able to easily remove any debris or bioburden. Furthermore, the handle must be constructed of a material that can withstand the rigors of cleaning, decontamination, and sterilization. Designers should consider the following product features to support these requirements:
- A smooth handle surface without crevices or grooves that can harbor debris
- The use of durable handle and shaft materials that can stand up to multiple rounds of processing (e.g. high dielectric strength PEEK)
- For electrosurgical devices, a monopolar cautery pin with flushport that allows high-flow inner lumen flushing for fast, safe, and effective cleaning
“There have been times during surgery when I’ve been handed fully reusable instruments that have gone through the autoclave only to find the scissors don’t cut the way they should or the needle driver doesn’t hold the needles securely. If we don’t have extra instruments in the OR then we have to wait for new ones to arrive,” says Dr. Nutis. “One of the advantages of a reposable platform is that I always have a new tip and I know it’s going to work as the manufacturer intended.”
Balancing Cost and Quality: A Materials Manager’s Perspective
St. Jude Medical Center in Fullerton, Calif. has purchased fully disposable, fully resuable, and single-use reprocessed laparoscopic instrumentation. The hospital’s director of Materials Management, David Saffert, describes the challenges healthcare facilities face when balancing product quality and cost.
“In the past four or five years our physicians have become more engaged in what we are trying to accomplish in terms of cost and quality,” says Saffert. “Certainly we don’t want products in our facility that aren’t up to a certain quality, but we also want to be as cost effective as we can. Being based in Southern California there are also many concerns about what gets into the waste stream and how can we eliminate some of that.”
In today’s healthcare environment, hospitals and health systems are placing greater scrutiny on medical/surgical supply purchases. Although materials managers cannot sacrifice quality for cost as positive patient outcomes are increasingly tied to reimbursements, they must take in to consideration how their purchases impact the physical health of their patients – and the financial health of their institutions.
Reposable instrumentation can help material managers provide surgeons with high quality devices for every procedure coupled with low per use and long term costs while minimizing waste. Designers should consider the following product features to support these requirements:
- A reusable handle, which is the most costly component of the surgical instrument system, with the durability to be used and processed many times so that the hospital gets the most out of its investment
- An assortment of disposable tips to meet various procedural needs so that the hospital doesn’t have to invest funds in additional instrumentation
- Minimal product packaging to reduce waste and the costs of waste disposal
“If the only portion of an instrument being used on the patient is the tip then why not make the handle reusable?” questions Dr. Nutis. “With this approach, the surgeon has a precise, quality instrument with a new tip, the patient is being safely and effectively cared for and the facility is reducing its costs and environmental footprint.”
Dr. Nutis points out another benefit of a reposable instrument system when it comes to a hospital avoiding cost and waste. He recalls times when he was using fully disposable instruments for procedures and the OR staff would open instruments that would go unused. He points out that either the hospital would have to absorb the cost of that instrument, or pass it along to the patient because the device was out of its packaging, and therefore, no longer sterile and could not be reprocessed.
“Sometimes the tech would open a disposable device and I wouldn’t use it – sometimes I wouldn’t even know it was on the table – and it would be thrown away,” says Dr. Nutis. “A reposable platform reduces costs by giving the hospital and surgeon much more control. If a tip is inadvertently opened or falls on the floor, it’s a fraction of the waste compared with a full instrument.”
Because the operating room (OR) is the revenue center for most healthcare organizations, designers must also take into consideration how instrumentation supports procedural efficiency. The more cases surgeons can perform in a day, the greater the revenue capture. Surgical instrument systems that are easy to set up, use and breakdown for processing streamline these processes, while more complex devices can prolong surgical cases.
According to Dr. Nutis, a reposable platform contributes to greater procedural efficiency in a number of ways. For example, having a reusable handle with a broad range of disposable tips to perform various surgical functions versus multiple instruments means the OR staff can prep a smaller tray. Also, when the surgeon is performing a case and determines that he/she needs different instrumentation than originally planned, it is much faster and easier for the staff to procure what is required.
“There are times when I’m performing surgery and realize that an instrument of a different size or shape would be optimal,” says Dr. Nutis. “If I were using individual instruments for the procedure, the scrub techs might have to open a completely different tray or leave the room to find the instrumentation. With a reposable platform, the scrub techs have accessible in the OR small boxes with different tips that they can quickly access when needed. It’s very easy to remove a tip and lock a new tip into the handle.”
In the past, medical device manufacturers were designing solely with the needs of surgeons in mind. As medical/surgical supply purchases have come under greater scrutiny by healthcare organizations, the needs of materials managers and other stakeholders (e.g. CS/SPD, infection control, value analysis) have become equally important. In the effort to balance cost and quality, many hospitals and health systems have turned to reposable instrument systems.
Reposable instrumentation can help healthcare organizations deliver greater value through high quality coupled with lower costs. Because a reposable system features both reusable (handle) and disposable (tip) components, it presents a variety of unique design considerations related to the various individuals and departments that interact with the device (surgeons, surgical staff, CS/SPD). By considering their needs early on in the design process (e.g. ergonomics, handle/tip connection) and carrying them through to manufacturing (e.g. materials) and product delivery (e.g. packaging), a manufacturer can deliver a solution that meets the needs of all decision makers in today’s value-driven healthcare environment.
About the author: Terry Belluche is a medical device leader with over 20 years of experience in medical device design, development manufacturing and marketing. He is currently the head of marketing for Microline Surgical, a leader in laparoscopic reposable instruments that provide a cost effective, eco-friendly solution for today’s operating room. www.microlinesurgical.com