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In an operating room, precision and protection are paramount. That’s why every product within the Cardinal Health™ Surgical Drapes and Gowns portfolio is designed to serve as a shield of armor for clinicians, helping to keep them and their patients safe during critical times of care.

The Surgical Drapes and Gowns team is a specialized group within Cardinal Health’s Global Medical Products and Distribution business. It includes research and development, regulatory, medical affairs, clinicians, manufacturing, marketing and other functions. The group is dedicated to providing clinically differentiated solutions that meet surgeons’ needs in the operating room (OR), including gowns that are designed to fulfill the highest standards set by the Association for the Advancements of Medical Instrumentation (AAMI). Through their work, they prioritize surgeons’ safety and level of comfort because they understand just how closely these factors tie to performance on the front lines of care. Their focus goes beyond just meeting the mark though. For them, it’s about providing the right drape or gown for every procedure.

So how does Cardinal Health determine what products to develop? It takes an integrated approach both internally and externally. An approach that is thoughtful, strategic and collaborative with the medical professionals who look to the organization for innovation and OR solutions.

Clinician-inspired innovation
With new product concepts, the Surgical Drapes and Gowns team collaborates with medical professionals to help ensure solutions are both as relevant and effective as possible.

“We’ve developed a broad network of clinical key opinion leaders,” Joel Colyer, vice president, global product marketing at Cardinal Health, explained, "It gives us a distinct advantage because we’re gaining an insider’s point of view from a diverse group of members in the field. Their insights give us a better understanding of their needs and challenges, which helps us provide the most appropriate products.”

Cardinal Health’s product developers share concept ideas with clinicians and gather their feedback to determine best next steps. Digging deep to understand the clinicians’ challenges and evolving needs allows Cardinal Health to unlock even more innovation.

“We’re always thinking three to five years into the future,” Colyer said. “We need to make sure that throughout every step of the process, we’re validating that it’s actually an effective solution that delivers value for clinicians.” 

Cardinal Health organizes panels with key stakeholders and opinion leaders who run operating rooms for large healthcare systems, including the Cleveland Clinic in Ohio and Lehigh Valley Health Network in Pennsylvania. Together with others, these healthcare leaders make up the Cardinal Health Perioperative Advisory Board, a multidisciplinary group that provides clinical feedback to help determine if Cardinal Health is moving in the right direction when creating a new product and where adjustments should be made to improve user experience or performance. The process brings in unique perspectives, and as Colyer attested, having the feedback is beneficial when delivering solutions that matter most to clinicians.

"Being part of the Cardinal Health Perioperative Advisory Board gives me a unique opportunity to provide inputs into new clinical solutions and help shape the future of healthcare,” said Dena Salamon, MSN, RN, Cardinal Health Perioperative Advisory Board member. “During our bi-annual meetings, we provide collective insights to the Cardinal Health team as they work through their product development process. It’s exciting to see something new and innovative come to fruition that enhances the clinician experience and overall patient care, while continuing to deliver quality and safety.”

Fusing student perspectives into product excellence
For further collaboration in product refinement and functionality, Cardinal Health has even looked to the classroom for unique insights.

Upon discovering a need to make surgical gowns more comfortable, Cardinal Health turned to graduate students at the Columbus College of Art and Design (CCAD), a prestigious fashion and arts institute in Ohio, to help infuse a fashion design perspective that would help elevate the functionality and wearability of surgical gowns.

By combining Cardinal Health’s expertise in protective wear and regulatory requirements with CCAD’s perspective on fashion and the user experience, the team recommended material and design changes for future gown options that surgeons may find more modern and comfortable.

“To continue providing the high-quality surgical products our customers expect, we’re always seeking opportunities for improvement,” said Colyer. “And when we think outside the box, and work with partners like CCAD, we often explore the most innovative ideas that push us to adapt and modernize our offerings.” 

Transforming the OR with a mechanic’s toolbelt
The OR is a busy and dynamic environment, buzzing with a steady hum of activity that comes from the complex nature of performing surgery. Bright overhead lights and machines fill the room as a multidisciplinary team gathers around a patient. Scrub nurses and assistants are constantly passing instruments back and forth to the surgeon, and with so much movement, instrument drops, delays and breaches of the sterile field can become a problem.

But what if there was a way to minimize the movement and improve efficiency and convenience during a procedure?

This question came to mind for Joseph Dearani, M.D., Director of Pediatric and Adult Congenital Heart Surgery at Mayo Clinic, who has practiced medicine for more than 25 years. Before he exchanged his uniform for scrubs, Dr. Dearani worked as a mechanic repairing and maintaining cars. Each day in the garage he wore overalls with pockets that provided easy access to the tools he needed. Why not try to incorporate this convenient  efficiency into the OR? Adding pockets to a surgical gown seemed like a natural and practical idea, yet it was an unconventional notion in the medical field at the time.

“I think that it’s a practical solution to a frustrating, common problem,” Dr. Dearani said. “When I’m performing surgery, it’s nice for me to have the suture scissors and the forceps, which are the two most common things, with me at all times.”

To develop the first-ever disposable gown with pockets — now called the SmartGown EDGE^™ Breathable Surgical Gown with ASSIST^™ Instrument Pockets — Dr. Dearani first turned to Mayo Clinic Ventures, Mayo Clinic’s commercialization arm, to file patents. It wasn’t long before the Mayo team decided to bring in Cardinal Health, through an exclusive license agreement to provide expert counsel and eventually develop, manufacture and commercialize the gown. 

Dr. Dearani explained that he and the Surgical Drapes and Gowns team went through a scientific process to determine the design and ensure regulatory approval, which took almost two years to complete. They knew the gown’s pockets needed to be placed between the shoulder and waist to keep instruments within the designated sterile field. They considered factors that made the pocket placement suitable for clinicians in any specialty — no matter if surgeons sit or stand or work in a small or larger operative field. Human height variations also came into play because of the impact on the area of sterility.

The group also conducted a series of experimental designs and collected feedback from actual product users. Evaluating all factors was critical for ensuring protection from sharp objects, easy instrument accessibility and patient safety.

The final result is a gown the team is confident enables clinicians to conveniently access the tools they need and make smooth transitions during procedures. It features two slanted pockets — one on each side of the chest — and a third, deeper pocket strategically placed in the middle to hold commonly used tools such as forceps and scissors.

SmartGown™ is the leading brand of AAMI level 4 surgical gowns in the U.S.,¹ providing the highest barrier of protection against liquid and viral penetration. As the newest addition to the SmartGown™ portfolio, SmartGown™ EDGE resists high fluid exposure and blood-borne pathogens and is designed with unique breathable technology to keep surgical staff cool and comfortable.

Reflecting back on the product development process, Dr. Dearani said, “There’s a lot of opportunity for more process innovation. We have to take the time to examine and think about the operating room, patient and clinician, then consider what we can do to optimize efficiency and standardization of surgical supplies.”

An ongoing focus on protection and efficiency
Solving challenges and driving product innovation are cornerstones for Cardinal Health’s commitment to delivering safe, quality medical products to healthcare professionals. And incorporating the valuable insights and feedback from clinicians – and sometimes, students – ensures the team is providing offerings that are practical, effective and aligned to the realities of today’s healthcare settings.

In addition to SmartGown EDGE™, here are some of the latest solutions the team has added to its advanced product portfolio with operating room conditions and performance in mind:

Stray Away™ Hair Management Drape: When preparing for a craniofacial procedure, clinicians often spend time braiding, tying, shaving or even stapling hair away from blocking the surgical site. The process is tedious and can even be invasive for the patient.

The Cardinal Health Stray Away™ Hair Management Drape is specifically designed to help prevent hair from obstructing the sterile surgical site. It features three unique anchoring points — linear edge tape, Hair Velcro^® and stabilizing clips — to maintain a firm grip and make it easy to remove. The solution is designed to help the surgical team save valuable time while providing a less intrusive experience for the patient.

CoolSource™ Cooling System: Overheating while performing a procedure can cause a surgeon to become stressed or distracted, impacting overall performance. That’s why an OR nurse worked in tandem with Cardinal Health to invent the CoolSource™ Cooling System (including pocket vest and cooling packs), a solution that is designed to help keep surgeons cool during long and labor-intensive procedures. It’s designed with six cooling pack placement options targeted at heat zones in the lower body. Plus, it’s lightweight and custom fit for surgeons to move comfortably.

The design of the cooling system is based on direct feedback from surgeons who determined factors that are impacted by overly warm OR conditions, including lower concentration, fatigue and discomfort.

Colyer said, “The next great idea can come from anyone. We don’t need to change what’s already working, but we all keep an open mind, actively listen and dare ourselves to explore new perspectives. It’s this passion that will help us to advance the industry.”

¹Clarivate 2022 data analysis

Disclaimer
Mayo Clinic does not endorse the following products: Cardinal Health Stray Away™ Hair Management Drape and Cardinal Health CoolSource™ Cooling System.