By Cheryl Clark, for HealthLeaders Media, February 12, 2014
A device that allows untrained nurses to sedate colonoscopy patients without an anesthesiologist, hospital gowns woven with infection-fighting copper, and oral drugs embedded with sensors are among the emerging technologies senior executives may be pressured to bring into their hospitals and healthcare systems.
But the 2014 edition of the ECRI Institute's annual "Top 10 Hospital C-Suite Watch List" aims to distinguish between must-have technologies and hype.
The Pennsylvania-based non-profit group conducts independent research to verify manufacturers' claims, regulatory compliance, and any emerging safety or efficacy issues associated with emerging technologies, especially those that cost a lot of money.
"These technologies are worthwhile to look at, but hospitals need to think about how they [would have to] make necessary changes to implement them," says Robert Maliff, ECRI's director of applied solutions.
1. Sedasys Computer-Assisted Sedation System
Approved by the U.S. Food and Drug Administration in 2013, the Sedasys system from Ethicon Endo-Surgery, Inc. purports to allow "non-anesthesiologist clinicians" to replace more expensive nurse anesthetists and anesthesiologists in administering sedation, specifically propofol, for millions of endoscopic procedures such as colonoscopy.
This could save the healthcare system $160 million in 2015, the manufacturer says.
Evidence of efficacy, however, is based on a single manufacturer-sponsored trial of 1,000 patients during routine procedures, which showed that many patients were deeply sedated, which "may elevate the risk of cardiopulmonary complications such as interrupted breathing."
"Concerns remain about procedure risks," the ECRI report says.
2. Symplicity Catheter-based Renal Denervation Device for Hypertension
In use only in Europe, but expected in the U.S. next year, Medtronic, Inc.'s device called Symplicity would treat hypertension and sleep apnea, which are associated with high morbidity and mortality.
ECRI recently updated its report to note Medtronic's announcement that an efficacy endpoint was not reached in a "pivotal trial" of the device, a major snag in its approval process.
Some 48% of hypertensive patients whose conditions are inadequately controlled through medication would be a candidates for treatment with Symplicity. It involves the use of a catheter to disrupt a signaling pathway from the kidneys to the central nervous system that contribute to hypertension.
ECRI recently updated its report to note Medtronic's announcement that an efficacy endpoint was not reached in a "pivotal trial" of the device, a major snag in the approval process. The company plans to continue trials of its product for other non-hypertension clinical indications.
3. EDs for the Elderly (GEDIs)
One concept being pitched to hospital executives is special emergency departments tailored for the elderly. These efforts involve a major construction effort that reorganizes floor plans and brings in special equipment such as reclining chairs, padded stretchers, non-skid floors handrails, special lighting and bedside commodes.
"It's easy to say you're going to sequester and equip five ED bays and then call yourself an elder ER, when what you really need to do? is have clinicians that are trained in elder care issues," Maliff says.
"It's not just you putting a marketing sign out that you have a senior ED. You have to have a physician staff, [and] social workers trained around issues of elder care to make it a successful unit," Maliff says.
At Mount Sinai School of Medicine in New York, these structural and systemic changes are called Geriatric Emergency Department Interventions or GEDIs.
ECRI analysts say the use of such systems is growing in U.S. hospitals and that costs vary widely, from $3.2 million at Newark Beth Israel Hospital to $150,000 in Holy Cross Hospital in Silver Spring, MD.
Positive outcomes, such as reduced readmissions are expected, but "published evidence for that has not yet accumulated."
4. Copper Surfaces in Hospital Rooms
Copper's ability to reduce transmission of bacteria, and potentially, viruses in healthcare settings is well understood and approved by the U.S. Environmental Protection Agency. But whether hospitals should retrofit their stainless-steel and plastic inpatient and intensive care units with copper surfaces, copper bed rails, food trays, grab bars, carts, sinks, and faucets, remains unclear. The use of copper could even permeate patient gowns through copper-spun threads.
Reducing hospital-acquired infections could save money by reducing length of stay, readmissions, and "administrators could see a return on investment due to fewer infections within their own staffs."
But the estimated cost to equip every hospital room with copper products ranges between $1.5 billion to $2.5 billion.
The steep expense raises the question about how much to use and in what areas. "Determining the number of copper-fitted items to place in a room is a big question and should be based on evidence-based design?that is, clinical evidence," the ECRI report says.
5. Powered Exoskeletons
As shown in an episode of the TV show, Glee, and in this video, powered exoskeletons, now in use in about 30 rehabilitation hospitals, enable patients with paraplegia from spinal cord injuries to stand upright and even to walk.
They can cost $100,000 or more, "but less expensive options are also on the horizon," the ECRI report says.
ECRI advises hospitals that adopt the technology at this early stage should "plan fundraising initiatives to support acquisition, maintenance, and training," but be on the lookout for newer products because "this technology is quickly evolving.
6. MRI-Guided, Focused Ultrasound for Bone Pain Reduction
Several hundred thousand patients with cancer such as breast and prostate develop extreme pain from metastases to bone, which this technology, the ExAblate at a cost of between $750,000 and $1.5 million, seeks to reduce.
However, "the body of evidence of its effectiveness for bone pain is small and limited by lack of comparative evidence to other options at this time," the ECRI report says.
The reimbursement climate is poor, with major health plans listing the device as investigational.
7. The NanoKnife System
The NanoKnife system purports to reach hard-to-access tumors and avert complications associated with other ablation techniques. But ECRI says this technology is another one "that may be diffusing before its time." It requires a major investment, and has no FDA approved indications for treatment.
Organizations that want to use it should restrict application to "ongoing FDA-approved investigational device exemption trials" or others that compare the NanoKnife to other options, ECRI advises.
8. Simultaneous MRI and Radiation
The ViewRay system is a cancer treatment option that combines a way to visualize a tumor with magnetic resonance imaging while radiating it, allowing "on-the-fly" changes to target size and dose.
The system "theoretically holds promise," and received FDA approval in May of 2012. But, with a price tag of $8 million and $500,000 per year in maintenance costs, "ECRI Institute cautions health systems to curb enthusiasm for now."
9. Intelligent Sensor Pills
Poor medication adherence in patients after discharge is a known cause of readmissions and patient complications that the three-pronged Proteus Digital Health Feedback System is trying to fix.
It combines an ingestible sensor embedded in a pill, a personal monitor, and a mobile phone or web-based platform to communicate data.
A patient swallows the sensor-embedded pill that releases a chip that is activated by stomach fluids. The sensor transmits information about the drug, dose, and time of ingestion.
Detection rates are high, but cost effectiveness remains unclear, and data are lacking in this technology's ability to reduce readmissions and other patient complications.
10. Big Data from EHR Systems
Registries of patient outcomes maintained by payers and product manufacturers can open doors to better healthcare decisions, the report says.
These so called "big data," systems can help facilities "use tools to alert providers and patients of potentially harmful events, such as medication side effects, allergic reactions, and even the development of an infection," and thus can reduce hospital admissions and readmissions.
But using big data to improve care is taking a long time, the report says. That's because gathering and cleaning data to make it useable "is still in its infancy" in part because of the "fragmentation of data in multiple places," from outpatient labs, to hospitals, to nursing homes.
"With data residing in individual silos, data sharing can be a seemingly insurmountable challenge, but survival requires strategic planning for big data aggregation and analysis."
ECRI says only a handful of large healthcare systems have the technology and personnel to harness data analytics. Others "will most likely have to partner with other organizations, such as an accountable care organization, to successfully take advantage of analytics."