After years of research, debate, and Food and Drug Administration review, the federal agency will allow nonanesthesia professionals to use a device that administers sedation during colonoscopy and esophagogastroduodenoscopy procedures, provided that certain requirements are met.
This article first appeared in the March 2015 issue of HealthLeaders magazine.
Increasingly, a colonoscopy team includes not just a gastroenterologist, but also an anesthesiologist. Not content with conscious sedation achieved through a combination of intravenous drugs, more patients and gastroenterologists are opting for deep sedation that only an anesthesia professional can deliver.
That scenario is about to change. After years of research, debate, and Food and Drug Administration review, the SEDASYS system is now available. The device, the federal agency states, will allow nonanesthesia professionals to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures "provided they have training that meets the requirements and in settings having immediate availability of an anesthesia professional as defined in the labeling."
The emergence of the SEDASYS system and other devices may herald the age of automation in anesthesia. Systems that aid humans in monitoring and responding to vital signs are already routinely used by anesthesiology professionals in Europe. Recent studies suggest the benefits of automated intubation and IV fluid systems. And researchers at McGill University in Canada are also working on the McSleepy, an automated monitoring and drug delivery device.
John Pawlowski, MD, PhD, is director of thoracic anesthesia at Beth Israel Deaconess Medical Center in Boston, a 649-licensed-bed facility with more than 800 full-time staff physicians. While his organization does not currently use SEDASYS, he says the approach is the "wave of the future" because not only are the automated systems more efficient, they are safer. "We never react as well in the third hour of a procedure as we do in the first hour of a procedure."
Not everyone in the anesthesiology community is sold on the SEDASYS system. . Concerns about safety led the FDA to reject the device the first time it came up for approval in 2010. A requirement for an intensive training program and postapproval clinical trials led to an FDA nod in 2013.
Sonya Pease, MD
The American Society of Anesthesiologists issued guidelines for the use of the device in 2014, but did not endorse the system.
Under consideration
The question for healthcare leaders will be: Should we get one? Anesthesiologist Sonya Pease, MD, is the chief medical officer for TeamHealth Anesthesia, a national provider of hospital-based clinical outsourcing. She says the use of automated systems, such as SEDASYS, is a topic of much discussion in the C-suites she visits. One driver: patient satisfaction.
"There has been a huge trend of patients wanting to have anesthesia and sedation for procedures and a lot of these procedures are being done outside the operating room," she says.
Expanding sedation services through automation will require the support of anesthesiology programs, Pease says. The key to those using a system like this is to choose patients properly and have an emergency response team ready to react if things go wrong, she says. "We will work with the hospital to implement a patient safety response team if complications arise from use of the device," she says.
Karen S. Sibert, MD, an associate professor of anesthesiology at Cedars-Sinai Medical Center in Los Angeles, has written about SEDASYS on the KevinMD blog. She says the device will work fine for routine procedures. But she cautions about situations if there is no one in the room to handle complications. And those complications can come on very quickly. Propofol, Sibert says, can be a "very treacherous medicine" and anesthesiologists have nightmares about being called in to handle a complex breathing problem.
"Sedation can be scary," Sibert says. "There's a fine line between breathing and not breathing." Cedars-Sinai Medical Center has no plans to use the device, she says.
Still, GI patients often want propofol and doctors are accommodating them. In addition to offering deeper sedation, the drug wears off much more quickly than the drugs used for conscious sedation. The percentage of colonoscopy procedures making use of an anesthesiologist is expected to rise from 23.9% 2007 to 53.4% in 2015, according to a 2010 study in the journal Gastrointestinal Endoscopy.
Karen S. Sibert, MD
Another study found slightly lower numbers, but a similar trend. Between 2003 and 2009, the use of anesthesia in gastroenterology procedures increased "substantially," according to a 2012 report in the Journal of theAmerican Medical Association. Conducted by researchers at the Rand Corporation, the study found a 50% increase in the number of gastroenterology procedures performed on commercially insured patients in that period.
For both Medicare and commercially insured patients, the proportion of procedures using anesthesia increased from approximately 14% to 30%, according to the study, which was financially supported by Ethicon Endo-Surgery Inc. Ethicon, the maker of SEDASYS, is a subsidiary of Johnson & Johnson.
Soeren Mattke, MD, DSc, MPH, a Rand Corporation researcher and one of the authors of the study, says that the standard of care limits anesthesia services to high-risk patients during routine endoscopies. His team's research found that more than two-thirds of anesthesia services were delivered to low-risk patients. The fees paid to anesthesiologists for those procedures added up to $1 billion a year in charges for services "that are not consistent with current, evidence-based standards," he says.
The GI community has attempted to get FDA permission to use propofol, but a large clinical trial would be required to convince the FDA the drug can be used safely by a non-anesthesiology professional, he says. The SEDASYS is what Mattke calls "a patch" around that labeling restriction in that it allows nonanesthesiologists to use propofol without an FDA-approved change of the drug's label. Or as the device's website notes, the system can "help address the challenges in the current healthcare environment."
The SEDASYS system is an example of type of automated sedation delivery knows as CAPS for Computer Assisted Personalized Sedation. A bed-side monitor gauges a patient's oxygen saturation, blood pressure, respiration, and heart rate. That connects to a drug delivery unit and full-screen monitor that displays a provider interface.
Soeren Mattke, MD
According to the FDA, the system was associated with "deeper-than-intended sedation in approximately 2.5% of patients." However, a simulation-based moderate sedation training program developed by the International Society for Anesthetic Pharmacology was designed to prevent and mitigate problems by training users in "airway management and the pharmacology of propofol."
In addition, the FDA notes that "post-approval studies will be conducted to evaluate the need for immediate availability of a trained anesthesia professional for safe use of the SEDASYS system in clinical practice."
Early adopter
Virginia Mason, a 336-licensed-bed hospital in Seattle that performed a total of 9,468 colonoscopies and 4,876 EGDs in 2013, began using the system in September 2014. Otto S. Lin, MD, director of quality for the hospital's Digestive Disease Institute, had been monitoring development of the SEDASYS and contacted the manufacturer once it was approved by the FDA. He says the system addresses two major issues: cost and access. The GI program was having trouble scheduling anesthesia professionals to meet demand. And, he says, gastroenterologists can deliver the same sedation care at a much lower cost using the SEDASYS system for low-risk patients.
Lin says some providers and freestanding practices use anesthesiologists for every colonoscopy, a practice he describes as "an inefficient use of healthcare resources."
"It's expensive for the healthcare system, it's expensive for the health insurance companies, and sometimes it's expensive for the patients if they have a deductible or copay," he says.
The hospital did not have to buy the three SEDASYS systems now in its endoscopy unit. Ethicon owns the units and receives a fee for each case. So, Lin says, there were no upfront capital costs for Virginia Mason, but the hospital needs to pay the company about $50 per case.
"Not only are patients not billed for anesthesia services, they also are not billed for the use of the SEDASYS system, the cost of which is absorbed by Virginia Mason hospital," he says.
Before the system was in place, the hospital did not have enough anesthesiologists available to meet the demand for services in the GI suite, Lin says. The demand for GI sedation services fluctuates and the hospital's anesthesiology department was unable to add more providers at short notice. The director of the Digestive Disease Institute and the director of GI/endoscopy brought representatives from anesthesiology, information technology, purchasing, and billing into the discussion about whether to adopt the technology.
Lin says that because the hospital's anesthesiologists recognized the access problem, they were not opposed to the SEDASYS system. And the anesthesiologists still have an important role in the GI suite because the hospital continues to use anesthesia professionals for high-risk cases.
"They don't feel threatened by the technology," Lin says. "They've been very supportive. I don't think we could have gotten the technology into our hospital if anesthesiologists were opposed."
One of the results of Virginia Mason's using the system is improved patient satisfaction, Lin says. "The SEDASYS system has improved patient satisfaction because they recover from sedation more quickly and are able to remember discharge instructions better and leave the unit sooner."
Beyond the GI suite—and the U.S. border—some anesthesiologists are embracing automation for their own practices. An approach used in Europe is the closed-loop system, which adjusts sedation, or fluid administration, based on monitoring of measures like brain waves and arterial blood pressure.
Advocates often compare closed-loop system to a cruise control or air conditioning. BIDMC's Pawlowski says such systems are used in about 70% of all sedation procedures in Europe. He's observed them in France and Romania and believes they work as well—or better—than an anesthesiologist.
Kirk Shelley, MD
"You get distracted," he says. "I don't think the devices are going to totally replace us. But when you set them up and start running them in somebody who is fairly stable and has pretty predictable response to medication, they make your job easy."
Concerns
In a written response to questions for this article, FDA spokeswoman Jennifer Haliski says the agency is concerned about the over- and under-delivery of anesthetics. "If a trained healthcare provider is not available to attend to the patient, the patient may experience hypoxemia, hypoventilation, and deeper than intended anesthesia or may experience emergence. All conditions require the presence of a trained clinician."
Pease of TeamHealth says hospitals already have emergency response teams for patients who code—or go into cardiac arrest or suffer a stroke. Hospitals using the system might have to have to put together an additional response specifically for anesthesia emergencies, she says.
Kirk Shelley, MD, PhD, is the chief of the ambulatory division of the Yale University School of Medicine in New Haven, Connecticut. He says one of the concerns about automation in anesthesia is that there is too much going on that the machine cannot manage. But he says it seems clear that the anesthesiologist does not need to be in the room all the time—just nearby.
"They are always going to need a smart guy in the hallway if something goes wrong," he says. "Someone needs to be able step back in and put the wheels back on. Every unit needs a professor. You do need someone who can think way outside the box as the situation is evolving."
Shelley says the SEDASYS system is a positive step toward automation. Despite concerns, providers recognize that the approach is worth studying, he says. Over the next 10 years, he expects to see "an explosion" of automated systems in Europe and in the developing world, where machines will help address provider shortages. However, Yale is not planning to use the system at this time.
"It's still very early," Shelley says. "The pioneers get the arrows. If I were a hospital administrator, I would let the others innovate around me and then step into the game."
Healthcare leaders are weighing evidence and making decisions on the value of adopting new cancer services, including low-dose CT scans, high-priced drugs, and efforts to address comorbidities.
This article first appeared in the March 2015 issue of HealthLeaders magazine.
Data began to emerge in the late 1990s that computed tomography scans could detect early-stage lung cancer, and patients started lobbying hospitals to offer the service. Lung cancer is difficult to catch early and is usually lethal.
But many hospitals are just now offering the service. Low-dose CT lung cancer screening looked promising 20 years ago, yet there were enough outstanding questions to keep most payers from covering it.
What has changed? In 2011, a long-term randomized clinical trial produced evidence of a 20% reduction in mortality for high-risk patients. In November 2014, the Centers for Medicare & Medicaid Services announced that it would begin paying for the scans. Once Medicare moves, private insurers usually follow.
Despite a continuing shortage of saline solution among hospitals, safety concerns make it prohibitive for hospitals to compound their own solutions, says a quality executive with the American Society of Health-System Pharmacists.
Hospitals are learning how to stretch their limited supplies of IV fluids and are unlikely to resort to compounding saline for routine use, pharmacists say.
Three times in the past year, the Food and Drug Administration responded to the ongoing shortage by allowing three top US suppliers—BBraun, Fresenius Kabi USA andBaxter—to distribute supplies from European plants. While there is some hope that the shortage may clear up in 2015, the once plentiful and much-in-demand product remains in short supply.
Bona E. Benjamin, director of medication use quality improvement with the American Society of Health-System Pharmacists (ASHP), says she is unaware of any hospitals that are routinely compounding their own solutions. Logistics and safety concerns would make it prohibitive, says Benjamin, who spent roughly 30 years working in hospital compounding services.
Because hospitals use saline for both rehydration and drug delivery, any in-house compounding effort would "approach the scope of manufacturing," she says. And the volume of saline solution needed by a hospital would overwhelm a hospital- based compounding service.
"As an IV person , I would not want to be tasked with doing that," she said. "You would need a lot of space, a lot of people, and a lot of equipment, and you would have to run it 24/7"
State Regulation
A survey by the AHSP earlier this year found that 6% of the responding hospitals reported a shortage of IV saline. "While conservation strategies are working for 53% of respondents experiencing this shortage, 29% of respondents reporting a shortage have a supply inadequate to meet all patient needs," the group reported.
Compounding of saline would fall under the same regulatory rules as other compounding activities. While the FDA regulates commercial compounding companies, state pharmacy boards oversee hospital pharmacy operations. In-house compounding efforts must comply with the rules set by the United States Pharmacopeia (USP), a federally recognized standards-setting organization. Compliance is also reviewed as part of Joint Commission accreditation process.
David Jaspan, director of pharmacy and materials management at Union Hospital of Cecil Countyin Elkton, MD says he's beginning to see "some loosening up " of the supply, but noted that it's still a problem. Hospitals are getting limited allocations based on their past routine use.
"If we routinely use 100 bags a week, and I'm given 60, after a period of time it is gong to be a problem," he says.
He sees compounding as a last report that his staff members use on occasion to produce half-normal saline, which Jaspan says is also currently unavailable. Both Jaspan and Benjamin cited another downside of using concentrated sodium chloride for compounding – it too is in short supply too and there is no substitute.
Hospital Compounding Discouraged
The non-profit Association for Safe Medication Practices also defines compounding as a last resort. A January "safety alert" issued by the group's website notes that: "We can't stress enough the importance of exhausting all other alternatives before compounding IV sodium chloride solutions."
One major safety concern is labeling, Benjamin says. Bags of saline come from the manufacturers with labels. If the hospitals were to reuse bags, they would have to be re-labled, which raises the risk of medication errors.
So, hospitals are finding ways to conserve. But, the shortage can have an impact on patient services and budgets. With scarcity, comes price increases.
At Union Hospital, that means a greater awareness of a product that many once took for granted.
"For every patient who comes into the emergency department, they used to hang a liter of normal [saline] and now maybe they hang a 500cc bag because if they don't use it all, they throw it away after the patient is evaluated," Jaspan said.
Benjamin says that efforts like these have kept the shortage from having a visible impact on care. She encourages hospital administrators to be sure they are monitoring the shortages and giving staff the resources they need to cope.
"It's only by of a lot of dancing behind the scenes and just-in-time management that patients are not feeling this worse than they already are," she says.
Healthcare leaders are stepping up efforts to diagnose and treat AKI.
This article first appeared in the July/August 2014 issue of HealthLeaders magazine.
Acute kidney injury—the sudden decline of renal function—has been underdiagnosed and, in recent years, redefined and renamed. So it's no surprise the condition often goes undetected in hospital patients, with one study estimating that AKI is diagnosed in only 13% of those affected.
The often asymptomatic condition is treatable, but linked to long-term risk for chronic kidney disease and cardiovascular problems. The push is on now to prevent it and, when that fails, catch it and treat it early. The Centers for Medicare & Medicaid Services is moving toward adding a form of AKI linked to contrast agents to its list of complications it no longer covers. Hospitals are setting up programs to screen patients identified as being at risk for the condition.
Sometimes, awareness alone can bring change. When doctors at Cincinnati Children's Hospital Medical Center—which reported patient services revenue of $1.3 billion last year—flagged signs of AKI in a select group of patients from July 2011 to June 2012, the number of days it took those patients to recover dropped by 42%.
WEBCAST: Mayo Clinic & Vanderbilt Health—The New Social Media Playbook Date:September 16 1:00-2:30pm ET—presentations and live Q&A Expert speakers from Mayo Clinic and Vanderbilt University Medical Center reveal what key platforms are still making an impact, how to leverage social technologies to improve patient experience and drive engagement, and how to optimize your resources to ensure consistent brand messaging. >>>Register
"We didn't tell anyone to do anything else but monitor kidney function," says Stuart L. Goldstein, MD, director of the hospital's Center for Acute Care Nephrology. "We didn't tell them to change doses of antibiotics. We didn't tell them to change the prescriptions that were being used. All we did was raise awareness and identify kids at risk. The pharmacists rounding with the healthcare teams were instrumental in identifying at-risk patients and recommending daily kidney function monitoring for them." The doctors took it on themselves to take action, he says.
Once considered the unavoidable consequence of useful drugs and diagnostics, AKI is being recast as preventable and treatable. Nephrologists say risk stratification and awareness programs, like the one at Cincinnati Children's, are key. By flagging and monitoring patients most likely to lose kidney function, researchers are finding new ways to get at the underdiagnosed condition.
It's a bad one. The National Kidney Foundation reports that AKI affects 20% of all hospitalized patients and more than 45% of patients in a critical care setting. AKI, by some counts, has a 50% mortality rate, according to a study published last year in Critical Care Research and Practice.
It's not surprising the hospitalized patients are at risk of kidney injury. They often are admitted with conditions characterized by unstable cardiac status and electrolyte shifts, and are exposed to powerful contrast agents and medications, says nephrologist Alan S. Kliger, MD, vice president and chief quality officer of the Yale New Haven Health System, a three-hospital system with 2,130 licensed beds in Connecticut.
So, doctors often viewed AKI the same way they once saw catheter-associated urinary tract infections and central line–associated bloodstream infections: as inevitable complications. But over time, "culture change has led from an acceptance of the infections' perceived inevitability to real reductions in dangerous complications," Kliger says.
Clinicians, researchers, and payers are counting on bringing about the same culture change with AKI. CMS has delayed putting contrast-induced kidney injury on the list of preventable complications pending the upcoming update to the International Classification of Diseases. But organizations such as Cincinnati Children's, the Mayo Clinic, and the Hospital of the University of Pennsylvania are taking advantage of electronic medical records, risk stratification, and monitoring programs to reduce AKI.
Nephrologists don't hesitate to describe healthcare-acquired AKI as a "silent killer" or an epidemic. But for many years, they didn't quite agree on how to define the condition—or what to call it. Now what was known as acute renal failure is called acute kidney injury in an attempt to remove the suggestion that the damage is irreversible.
Over the past decade, two different groups have come up with diagnostic criteria. The most recent set of guidelines was unveiled in 2006 by a panel of kidney specialists knows as the Acute Kidney Injury Network. The approach is built around routine lab tests that measure kidney function by looking at blood levels of a chemical known as creatinine. Because the kidney filters creatinine and other waste products from the blood, high creatinine levels are a sign of reduced kidney function.
Ravindra L. Mehta, MD, associate chair for clinical research in the department of medicine and director of the acute dialysis program for the University of California San Diego Health System, was a member of that panel. Standardizing the definition and diagnostic criteria, he says, has allowed researchers to collect data on the incidence of the condition in a range of patient populations, including inpatients, outpatients, patients in and out of critical care, and those in cardiac surgery and trauma units.
In 2013, Mehta was the lead author of a study that looked at how these biomarkers were being used in clinical practice. While calling for more research, the group concluded that "the combined use of biomarkers of kidney dysfunction and damage may facilitate an earlier diagnosis of AKI, along with more accurate differential diagnosis and prognostic assessment, particularly when such markers are monitored serially over time and are combined with clinical parameters."
The consequences of ignoring signs of AKI are significant for hospitals, Mehta says, noting that changes in creatinine are associated with increased resource utilization, including length of stay, long-term and short-term mortality, and rehospitalization rates.
In adults, contrast agents used in routine imaging studies are one of the most common causes of healthcare-acquired AKI. For children, certain IV antibiotics and drug combinations can put them at risk. Dehydration and low blood pressure are risk factors, as are some chronic conditions, including heart disease, lung disease, diabetes, and preexisting chronic kidney disease.
With shifting definitions, the precise incidence of AKI has been hard to establish. A study out of Oregon Health & Science University, found AKI rates in ICU patients ranging from 20% to 50%, with contrast-induced AKI occurring on 11.5%–19% of all admissions. But the researchers noted that existing clinical studies on the exact incidence of AKI in the ICU "proved sparse" and were often complicated by varying definitions. The past decade has brought some clarity, but the researchers note that clinicians frequently underreport the incidence of AKI.
In England, British newspapers picked up on the issue after a paper published in the journal Nephrology Dialysis Transplantation reported an estimated 40,000 "excess" deaths annually in the United Kingdom, with the cost of care eating up 1% of the National Health Service budget. With these numbers in mind, the NHS has set up a nationwide Keep Kidneys Healthy program designed to "measure, educate, and manage better."
The U.K. study found that AKI prevalence in inpatients may be considerably higher than previously thought, and "up to four-fifths of cases may not be captured in routine hospital data."
Like all underdiagnosed conditions, the reported growth of AKI incidence raises the question: Are more patients developing the condition or are doctors getting better at identifying it? Stanley Goldfarb, MD—a professor of medicine at the Hospital of the University of Pennsylvania in Philadelphia, part of 1,637-licensed-bed Penn Medicine—says he wouldn't be surprised if AKI rates were increasing. But he says he thinks the change is being driven by a shift in the patient population and the sensitivity of the new diagnostic criteria.
"We're dealing with sicker and sicker older patients who are getting surgery that we never had dreamed of before," he says. "That puts them at risk for this."
A renal critical care specialist, Goldfarb has mixed feelings about the pending Medicare rule. Contrast-induced AKI is common and can't always be prevented. But he says it can be reduced if hospitals have protocols in place, and the CMS move may push hospitals in that direction. Still, such programs can take time and effort to establish, says Goldfarb, who has consulted with other hospitals on how to set up a monitoring program. For example, logistical questions emerge, such as, Should radiologists or the clinicians administer fluid that can prevent contrast-induced AKI? And, in some cases, the clinicians don't want the hospitals to tell them what to do, he says.
"Having said that, I think it still can be done if you can identify the really high-risk patients and do something about it," Goldfarb says.
Cincinnati pediatric nephrologist Goldstein is using electronic medical records to do just that. He says he got tired of consults that required him to repeatedly note "AKI secondary to NTMx [nephrotoxic medications], we will follow with you" in patient charts. He started to think that a simple, inexpensive creatinine test could be used to detect warning signs of the condition.
To be cost-effective, such a test would need to be targeted to pediatric patients most likely to develop kidney injury. Goldstein hypothesized that certain groups of patients were most at risk: those receiving the intravenous antibiotic aminoglycoside for more than three days and those who had been exposed to three nephrotoxic medications simultaneously. After a diagnostic database offered evidence supporting the elevated risk, the hospital's IT services programmed the hospital's electronic health records decision-support system to identify those patients so they could be screened.
With little prodding, doctors started to take note of dangerous changes in kidney functions and took steps to stave off AKI, he says.
The first year's 42% drop in AKI intensity—the number of days a patient has AKI before kidney function returns to baseline—translated into 900 patient days of AKI avoided in one year.
"What this program did was change nephrotoxic AKI from a necessary evil that we had to accept in treating complex patients to, in some cases, a potentially modifiable adverse safety event," he says. "Once you frame it that way, it takes on a whole different flavor."
Now, he hopes to share the lessons of this program with other hospitals. But, as with Goldfarb, Goldstein sees the need to get house staff to buy in. Pharmacists also are key to Goldstein's team. And efforts like these need support from the top.
"You absolutely have to have a hospital administration that believes there is a business case for quality," says Goldstein. That way, they will be willing to make the up front investment in information technology and pharmacy services.
The goal is to learn from the barrier he and his team had to overcome in Cincinnati.
"We basically want to make this a playbook so we can spread this to other hospitals."
