Facilitate and innovate: Ensuring speedy but safe product reviews

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  • Jul 26, 2019

From OR Manager, August 2019 Issue
by Elizabeth Wood

Surgeons are the biggest factor in any effort to streamline and standardize the purchase of new surgical devices—and thereby lower costs. But surgeons often balk at getting involved in product review and selection because of the additional demands on their time.

Two leading healthcare organizations have moved past this stumbling block by tying surgeon participation in product reviews to faster innovation, lower costs, and greater patient safety. Facilities struggling with standardization and cost reduction may want to consider how they might adopt some of these product review processes.

MD Anderson experience
As a leading US cancer treatment center, the University of Texas MD Anderson Cancer Center in Houston has a value analysis team (VAT) that evaluates and approves the purchase of new products—as do many healthcare organizations. But MD Anderson also has a strong research component, and emphasis on innovation goes hand in hand with that work.

“We’re a high-tech institution; we have five da Vinci robots and several hybrid ORs. In 2017, we invested $844 million in research, and we rank number one in the amount of research grants awarded by the National Cancer Institute,” says Abigail Caudle, MD, MS, executive medical director, perioperative services.

MD Anderson has 44 ORs where more than 20,000 procedures are performed annually by 165 surgeons and about 75 anesthesiologists. “When you have an institution like this that’s committed to being on the edge of technology with a strong part in research, there are a lot of innovative procedures people try to push in the OR,” Dr Caudle notes. However, new technology isn’t always the answer, she says.

Product evaluation algorithm helps surgeons avoid safety risks.
“Almost every time the field of surgery has brought in a new innovation, it has harmed patients,” says Thomas Aloia, MD, head, Institute for Cancer Center Innovation at MD Anderson. “It’s almost a universal principle. The learning curve represents the time it takes to build experience with the new way to do something,” he says.

However, leaders at MD Anderson realized that the push for innovation was driving fairly rapid adoption of new technology without a lot of regulation. “Our patients were at risk, and we were at risk,” Dr Aloia says.

Better vetting needed to ensure product safety
The VAT consists of multidisciplinary professionals responsible for reviewing the business case for new devices—but not safety. This created potential confusion for patients and providers, Dr Aloia says.

“Every case I change slightly to make it better—those are incremental innovations. It happens every day. That’s clear. On the other hand, if something has never been done in a human being or it’s risky, it absolutely needs human subject protection, consent, disclosure, oversight, etc. That’s clear. But the grey area in the middle—whether something is a tweak or needs an IRB [Institutional Review Board] approval—is harder to define,” he explains.

“We proposed a committee to help vet the grey area,” he says. “We already had a standing surgical quality improvement team consisting of infection control, a quality officer, OR nursing and administration, and performance improvement. We were already doing a number of quality improvement projects, including addressing surgical site infections and urinary tract infections, so we added the vetting of instruments going through the
VAT into this committee—the Continuous Quality Improvement Team [CQIT].”

The CQIT review, it was decided, would precede the VAT review of a new device.

The committee spent about a year and a half developing an algorithm (top sidebar, p 21). The algorithm is centered around the following questions that surgeons must answer when requesting purchase of a new device.

What is the rationale for the request? To answer this, they must consider:
• Feasibility—does it perform the advertised function?
• Reliability—how often does it malfunction?
• Safety—What is the frequency and severity of harm?
• Efficacy—What outcome is improved?

Has it been used/done in humans outside of our institution?
• If yes, what are the short- and long term safety outcomes?

Has it been used/done at MD Anderson in another context?
• If yes, what are the internal safety outcomes?
• If no, is there a place to observe/ train on the device/procedure?

Are there references in the literature documenting outcomes?

Are there personnel training requirements?
• Prep, training, cleaning, ancillary equipment, patient follow-up?

Does the submitting group have any financial or other conflict of interest disclosures with the vendor?

Surgeons often believe a new item will work better and/or be safer, but by following this algorithm, they can avoid safety risks and unanticipated problems, Dr Aloia says. For items that could incur risk, the committee can guide the process toward institutional review, he notes.

Likewise, he says, when it comes to training requirements, simulation creates much greater awareness of the risks involved in lack of familiarity with a new device. “In many of our demos, the team was unaware of the new device and its functions,” he says. “The surgeon hadn’t considered that they would be scrubbed and someone else would have to work the machine who might need training.”

Since implementation of the algorithm, he says, more questions are being asked. For example: Does everyone have laser training? Goggles? “These seem like basic questions, but surgeons have to include these when they fill out their request forms. This has led to much better teamwork and training,” Dr Aloia says.

After surgeons complete the questions in the algorithm, the CQIT makes one of the following recommendations:
• The device is unsafe.
• The device is approved with IRB protection.
• The device is deemed safe, but it goes through an optional quality improvement protocol performed by a separate committee.
• The device is deemed safe, the literature supports it, and it can be implemented.

“The only caveat is, for the first 5 or 10 uses of anything—especially if it plugs into an outlet—the previously standard device must be in the room because you haven’t yet proven reliability of the new device in your own environment,” Dr Aloia adds.

Benefits of buy-in
Resistance to change is always an obstacle, especially when change is perceived as something that will take more time. “We branded this as facilitation of innovation—our people needed to know we were not going to slow things down, and we might even make things faster,” Dr Aloia says.

Surgeons requesting new devices were asked to fill out a form with six questions, which could be done within 10 minutes using a link on the perioperative services homepage. Now, external software vendors are partnering with MD Anderson to provide a web-based product introduction management system that includes safety data.

“This is a nice system,” Dr Caudle says. “You pull up a product you’re considering, and you see information like whether there have been recalls and whether it is approved by the Food and Drug Administration.” The system also provides literature on the device for easy review of similar devices and evidence-based research.

“The VAT is tasked with fiscal stewardship,” Dr Caudle says. “We’re part of the University of Texas [UT] system, which involves several large hospitals, and we had all been working separately. The chancellor of the UT system has leveraged this to make us one university system and think about vendor contracts.”

By putting the CQIT committee review ahead of the VAT committee review, time to trial and time to purchase have been reduced, Dr Aloia says.

“In the 34 items we trialed right before instituting this process, we had about a 10% complication rate. This is typical for new innovations in complex surgery. In the 46 things we brought in after CQIT review, however, we couldn’t find one complication,” he says.

In addition, MD Anderson began using this system to vet new procedures. As nurses became aware of the CQIT’s process, they could reinforce safety by asking if a new device or procedure had undergone an innovation review before being used.

Furthermore, Dr Aloia notes, each surgeon has to be trained on the new device. Only after complete training of attending surgeons are trainees permitted to interact with the device, even if they happen to have prior experience in using it elsewhere, he says.

In a large healthcare system that used to accommodate a lot of individuality and surgeon preference, changing the product review process has increased both efficiency and patient safety. “Integrated review of new products and procedures is the right thing to do for our patients, and establishing systems to facilitate review allows for requests to get into the OR faster,” Dr Caudle says.

Geisinger experience
Like MD Anderson, Geisinger Medical Center in Danville, Pennsylvania, is a leader in healthcare innovation. Geisinger, an integrated health system with 13 hospitals in Pennsylvania and New Jersey, has its own school of medicine—Geisinger Commonwealth School of Medicine and Diverse School of Nursing and more than 1,000 active research projects, says Jun Amora, vice president of enterprise supply chain services for Geisinger Health.

Changing the governance structure
“In 2016 we began looking at areas of variation within our supply chain spend,” says Michael Suk, MD, JD, MBA, MPH, FACS, chair of the musculoskeletal institute in the department of orthopedic surgery and chief physician officer for Geisinger System Services. Finances weren’t the primary driver, he says, but it was clear that reducing variation in the product review process would be beneficial.

“What worked for one major teaching hospital was turning into something cumbersome and challenging as we brought new hospitals into the system. Our process innovation made us see there might be a better way to address variation across physicians and systems,” Dr Suk says.

Geisinger’s chief executive officer at that time, David Feinberg, MD, reached out to Dr Suk for help. “We discussed redesigning clinical programs along institutes rather than just service lines, and we merged 29 different service lines into seven or eight institutes,” Dr Suk recalls. “We created a position called chief physician officer in which I partner with the operations side to bring a clinician’s voice and insight into process improvement.”

Creating the institutes was seen as a way to ensure physician engagement, ownership, transparency of process and price, and a culture of innovation, Dr Suk says.

“We aren’t trained on supply chain as medical residents. We’re not exposed to price and process. So we had to go through a process with our institute leads to get them engaged and understand why they needed to play a role in managing these requests within their institutes and taking ownership of them,” he explains.

The institute leaders are directly responsible for the clinical use evaluation (CUE) process, Dr Suk says. For example, as the chair of the musculoskeletal institute, he is accountable for all aspects of clinical use and evaluation for orthopedics, such as physical medicine, rehabilitation, physical therapy, and wound care.

Revamping product requests
Amora says when he joined the organization in 2018, he and Dr Suk discussed the need for a process based on transparency. “We lacked a way to give requestors the evidence they needed,” Amora says. Many times product requests went through the CUE process without any literature search or review of competitive items in the market, he notes.

“We also needed to ensure we had a simple enough tool to drive the workflow that we wanted,” Amora says. “We reoriented our CUE process to flow through supply chain review, financial review, and an institute review. We needed a technology to drive that process.”

In spring 2018, Geisinger deployed a web-based product introduction management system developed by Lumere, a Chicago-based company. The tool allowed evidence-based comparisons of clinically and functionally similar products.

“We require the clinician (usually the physician but sometimes other providers) to put the product request order in because it makes them go through the process of learning about the evidence,” Amora says. The tool searches a product catalog for evidence related to that product.

“We set out to build a supply chain pipeline composed of clinical and nonclinical projects, in particular one for surgical specialties. We looked at contracts, price opportunities, expiration, high benefit/low effort projects, and prioritized projects that we knew we’d get clinical buy-in for,” Amora explains.

They began with shoulder arthroplasty, a fairly new procedure where a lot of innovation is occurring. “We’ve seen a tremendous growth in the number of shoulder procedures being done in our system,” Dr Suk says. “We had six surgeons doing these procedures, using six to 10 different vendors, so there was great variation in price. To address that, we wanted to review evidence and hear the claims about which implants were best.”

Through a request for proposals, Geisinger considered products available from 12 different vendors. Of those 12, he says, eight met Geisinger’s price caps, and four—including one long-time vendor—were eliminated from their contracts. One of the surgeons affected by the loss of that vendor received training from a new vendor, Dr Suk says. “We partner with our vendors not just from a price standpoint but to ensure that our physicians are the best trained, and invite them to provide that training largely at their expense.”

Other early product request projects included neurostimulation, orthobiologics, and coronary revascularization— all of which, Amora says, are not easy and can take a lot of time. “I knew we’d have success primarily through physician partnerships, putting them in the driver’s seat, and giving them the evidence,” he says. His supply chain team learned how to collect evidence and present it clearly, and the categories of products were refined a couple of times to enable physicians to compare similar items.

“We were nervous about the level of physician engagement,” Dr Suk says. There were concerns about doing more work without compensation, but once the process began, physicians got on board. And the net result is a decrease in the number of new requests, largely because surgeons learned that sometimes what they want to do is not that new, or the products are already on the shelf, he adds.

Asking physicians to review the evidence increases their engagement, Dr Suk says. And when the supply chain team has questions, they know who the clinical champion is. Furthermore, he notes, the institute leader knows which of the institute members have requested a product, and they can have an open discussion about it. “We have accountable leadership throughout the process,” Dr Suk says. “The physicians feel that they’re not just doing extra work but they actually own the process.”

Dr Suk believes this process can be adopted at other organizations. “When you have the ability to be transparent, let physicians have a high degree of autonomy and decision making, and encourage them to own a positive clinical outcome, those things are universal,” he says. Conversations may differ according to whether surgeons are employed versus not employed by the organization, but he says the process can work regardless of employment model.

Ingredients for success
At MD Anderson, separating the safety review from the business review and implementing a rapid way for surgeons to provide input helped dramatically reduce the time to review new devices. Geisinger achieved much greater product standardization through its process revisions, along with more effective communication among physician leaders. Both organizations approached their product review processes in different ways, but engaging physicians was the common key to success—and something other facilities may wish to emulate.
—Elizabeth Wood

Aloia T, Caudle, A. Create innovation ramps, not roadblocks, to speed review of new devices and procedures. 2019 OR Business Management Conference, San Diego, California.
Suk M, Amora J. Leveraging physician partnerships in reducing variation. Webinar. March 7, 2019.