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FDA chief leads redefinition of digital-health-product regulation


— Graphic by Paul Sonnier

The Food and Drug Administration is redefining how it regulates digital health products.

The agency’s new commissioner, Scott Gottlieb, M.D., says its new Digital Health Innovation Plan will “include a novel, post-market approach” to digital devices and that the FDA will present new guidance for digital health product design to provide more clarity for manufacturers.

Dr. Gottlieb asserts that that program will help eliminate regulatory ambiguity while promoting innovation and free  regulators to focus  on more pressing  healthcare matters.

Digital health industry leaders were happy about Dr. Gottlieb’s remarks.

“All in all, I feel like I’ve died and gone to heaven,” Bradley Merrill Thompson, a medical-device lawyer with Epstein Becker Green and the Clinical Decision Support Coalition’s general counsel, told FierceHealthcare.

Health IT Now Executive Director Joel White said he is “deeply encouraged” by the  Dr. Gottlieb’s approach, adding that regulations need to keep pace the “rapid development cycles of health IT.”

“This is all about a modern FDA that better serves the needs of patients,” he said.

Dr. Gottlieb likes a “third party certification program” in which lower-risk devices could be marketed without FDA approval, while  approval of higher- risk devices could be streamlined and speeded based on a company’s history.

To read more, please hit this link.

Possible FDA leader called ill-informed and swimming in conflicts


Dr. Roy M. Poses, M.D., in his Health Care Renewal Web site, writes:

{Jim O’Neill} a candidate to be the new head of the Food and Drug Administration floated by the incoming administration has no experience in medicine, biomedical science, healthcare research, etc. He would thus be a prototypical ill-informed leader. He currently runs a venture capital firm which has major existing investments in biotechnology firms (hence his appointment would be a striking example of the revolving door, a form of conflict of interest, if not corruption).  Finally, he has proposed that the FDA abandon its mission to prospectively assure the efficacy of new drugs and sometimes devices, which actually would apparently violate the law.  So here is one example writ large of the “yuuuuge” problems we started writing about in 2003.  True healthcare reform would put people who understand about healthcare, care about its values, and would be willing to be accountable to uphold them in charge of health care organizations, among other things.”

To read Dr. Poses’s site, please hit this link.

Cures Act: Good for Big Pharma, bad for patients


“Avarice,” by Jesus Solana.

Jonathan H. Burroughs, M.D., MBA, FACHE, FAAPL,  a certified physician executive and a fellow of the American College of Healthcare Executives and the American Association for Physician Leadership, deconstructs the 21st Century Cures Act and it isn’t pretty. To read the whole piece from FierceHealthcare, please hit this link.

He lists its winners as:

  • Drug companies.
  • The NIH and other healthcare research agencies and individuals.
  • Medical-device manufacturers.

He lists its losers as:

  • Patients.
  • Evidence-based medicine.
  • The FDA.
  • Regenerative medicine.
  • Consumer advocacy groups.

FDA raps hospitals over medical-device mistakes


For Kaiser Health News

Federal regulators said 12 U.S. hospitals, including well-known medical centers in Los Angeles, Boston, and New York, failed to promptly report patient deaths or injuries linked to medical devices.

The Food and Drug Administration publicly disclosed the violations in inspection reports this week amid growing scrutiny of its ability to identify device-related dangers and protect patients from harm.

Some of the reporting lapses were found at Massachusetts General Hospital, in Boston, NewYork-Presbyterian Hospital and two hospitals in Los Angeles — the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center.

Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the violations pointed to a larger problem among hospitals nationwide in reporting patient harm tied to medical devices.

“We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” Shuren wrote in an agency blog post this week. “Hospital staff often were not aware of, nor trained to comply with, all of the FDA’s medical device reporting requirements.”

Under federal rules, hospitals must within 10 days report serious injuries potentially caused by devices to the manufacturer and notify both the manufacturer and the FDA about any deaths that may have resulted. Manufacturers are required to file reports to the FDA within 30 days of learning about an injury or death that may have been caused by a device.

Among the 17 hospitals reviewed, the FDA said six didn’t properly report both patient deaths and injuries linked to devices within 10 days as required. Five other hospitals didn’t report serious injuries in a timely manner, according to the FDA. The inspection at one hospital, NewYork-Presbyterian, focused only on a death.

NewYork-Presbyterian said it filed medical device reports “in accordance with FDA regulations” and none of the agency’s findings related to the quality or safety of patient care.

It’s hard to discern what devices were involved or other details in many of these cases because the inspection reports are brief and partly redacted by the FDA. The inspection reports indicate that in some cases hospitals reported events late and in others not at all.

At Massachusetts General, an FDA investigator found reporting delays of 10 months and 18 months in two separate patient deaths related to devices.

In a statement, hospital spokeswoman Terri Ogan said the FDA’s findings all have been addressed. “Massachusetts General Hospital takes its reporting obligations very seriously and strives to comply with all requirements in a comprehensive and timely manner,” she said.

At Huntington Memorial Hospital, in Pasadena, Calif., an FDA investigator found that a patient died from complications related to a multi-drug resistant infection and cardiac arrest following a procedure involving a duodenoscope, a long and flexible instrument put down a patient’s throat.

According to FDA records, the hospital learned through test results that the patient’s infection was likely related to 14 other confirmed infections caused by contaminated duodenoscopes. “However, this death was not reported to the FDA and the manufacturer by your facility,” the FDA inspector wrote in a December 2015 report.

A spokeswoman for Huntington Memorial, Eileen Neuwirth, said “we have taken steps to ensure rigorous compliance going forward.”

The FDA findings underscore concerns raised by a U.S. Senate report in January, which exposed reporting failures by hospitals as well as mistakes by device makers that contributed to multiple superbug outbreaks across the U.S. from contaminated duodenoscopes. The FDA’s oversight of medical devices was also faulted in the report.

As many as 350 patients at 41 medical centers worldwide have been infected or exposed to contaminated duodenoscopes from 2010 to 2015, according to the FDA.

The agency initiated its investigation of hospitals’ reporting in December 2015, a month before the Senate report was released. But the agency was already under fire by then for spotty oversight of duodenoscope manufacturers and other devices.

Shuren said in his blog post that the agency focused on hospitals where safety issues had occurred involving either duodenoscopes or power morcellators, a surgical tool used in hysterectomies. Morcellators are used to cut up benign growths called fibroids, but the FDA has warned about the device spreading cancerous tissue in the abdomen and pelvis. The investigators examined incidents involving other devices as well.

Other than publicly announcing the violations, Shuren said the agency didn’t plan on taking further action against the hospitals. Instead, he said he wants to work with the hospital industry to improve monitoring of devices.

“We feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path,” Shuren wrote.

Lawmakers, health policy experts and the FDA have proposed various reforms aimed at strengthening device surveillance, including tracking insurance claims data to supplement the injury reports and automating “adverse event” reports through electronic health records.

The issue may take on more urgency after federal authorities this month highlighted the infection risk from yet another commonly used device — heater-cooler units used in open-heart surgeries. The FDA is holding a public meeting Dec. 5 on improving hospital-based surveillance of devices.

According to the FDA, the hospitals that didn’t report deaths as required were Advocate Lutheran General, in Park Ridge, Ill.; Huntington Memorial Hospital; Reading Hospital and Medical Center, in West Reading, Pa.; Allegheny General Hospital, in Pittsburgh; NewYork-Presbyterian; and two in Boston — Brigham and Women’s Hospital and Massachusetts General.

The agency said those that failed to report serious injuries in time were UCLA; Cedars-Sinai; Virginia Mason Medical Center. in Seattle; UMass Memorial Medical Center. in Worcester, Mass.; and Dartmouth-Hitchcock Medical Center, in Lebanon, N.H.

The FDA inspection for Advocate Lutheran General Hospital refers to 10 deaths related to a scope-related outbreak of carbapenem-resistant enterobacteriaceae, a superbug known as CRE. But a spokeswoman for the hospital said a “review of medical records in all 10 cases confirmed the cause of death was not linked to CRE.”

Dr. Leo Kelly, vice president of medical management at Advocate Lutheran, said \the hospital will continue to work with the FDA and manufacturers “to ensure the safety and well-being of our patients.”

Many of the hospitals involved said they welcomed the agency’s feedback and supported efforts to improve device oversight.

Cedars-Sinai said the FDA’s findings related to its use of a surgical stapler in June 2015.

UCLA said it promptly reported scope-related cases to the FDA but the agency asked for duplicate reports through a separate system.

Suzanne Anderson, president of Virginia Mason Medical Center, said the FDA’s recommendations on device reporting “will ultimately enhance patient safety across the country.”


Caveats on physicians’ DIY medical devices



Scottish physician James Young Simpson on the floor after using chloroform as an anesthetic on himself in the 1840s.

Jeremy A. Greene, M.D., writing in The New England Journal of Medicine on  the headline “Do-It-Yourself Medical Devices — Technology and Empowerment in American Health Care,” concludes:

“Whether doing it yourself is ultimately liberating or dangerous depends on our approach to risk and technological literacy. How do we decide who is competent enough to deal with risks of technological auto-experimentation and who is not? But the same questions could also be asked regarding consumers who purchase expensive wearable technologies and smartphone apps whose claims to produce healthier lives remain unvetted by the FDA. As we try to distinguish hope from hype in the promises made about smart medical devices, it’s important to remember that DIY medical technologies are neither wholly new nor wholly liberating. And in offering means for circumventing physicians, they may well expose patients to new costs and new risks.”

How to encourage cost-saving tech inventions


An article in the current JAMA, headlined “Obstacles to Developing Cost-Lowering Health Technology: The Inventor’s Dilemma,” suggests, among other things:

“First, to inspire innovators, federal agencies and philanthropies should commit a larger share of their research budgets to high-risk, high-reward science.

“Second, to entice inventors to address challenging problems, there could be greater use of prizes (e.g., cash for the first inventor who creates a drug or device that meets a specific need).

“Third, to ensure that low-cost, high-value discoveries reach the market, patent buyouts could be offered. This could increase the likelihood that these products are commercialized and offered at prices sufficiently low to encourage widespread adoption.

“Fourth, to give inventors access to the capital required to bring a cost-lowering technology to market, a public-interest investment fund could be established. The public-interest investment fund would seek out promising products that are not attractive to conventional investors, and replenish its coffers with shared savings from successful inventions.

“Fifth, to streamline the regulatory approval process, the FDA could be authorized to use existing mechanisms, such as fast-track or breakthrough therapy authority, to expedite review of cost-lowering technologies. This would require expanding the FDA’s mission beyond safety and efficacy to address costs.

4 steps to reduce unnecessary care


Robert Pearl, M.D., writes in Forbes on how to cut back on unneeded healthcare.

He offers four steps:

1. “Empower patient decision-making. New tools, including interactive videos, can help patients objectively evaluate the pros and cons of procedures and treatments. ”

2. “Shift to value-based pay practices. Paying for the value of care, rather than for the volume of services, would eliminate the perverse incentives in the current fee-for- service reimbursement system. A major step in that direction was the announcement from the U.S. Department of Health and Human Services to shift 50 percent of Medicare reimbursements to reward higher quality and pay based on clinical outcomes by 2018. ”

3. “Determine when new approaches are really better. To help accomplish this, every medical journal should require authors to compare new procedures, devices and drugs to current, often lower-cost alternatives. In a similar vein, the FDA should revise its charter to enable it to require that existing therapies be compared to new drugs and devices prior to approval.”

4. “Reform medical malpractice. Changes to litigation for medical malpractice would lessen the burden of unnecessary care associated with defensive medicine. What motivates many doctors to do too much for patients, including much they would never choose to do for themselves, is fear of missing an extremely unlikely problem and being sued.”


How to fight monster systems



This piece looks at market-based solutions to the market-domination issues raised by the expansion of such powerful systems as Partners HealthCare, in Massachusetts, that have displayed great pricing power, offending many insurance payers in the process.

The writers say:

”We need policies that challenge expansions and preserve competition, not those that assist the dominant player {like Partners}. …encouraging payment reform that rewards quality and cost-effectiveness; liberalizing scope-of-practice regulations, licensing rules, and other prohibitions to allow more efficient use of human resources; ensuring that professional regulations, state boundaries, and FDA rules do not impede telemedicine and digital products that enable mobile health management; and refining anti-kickback rules and reimbursement restrictions to enable providers to pursue creative, integrated ventures that could revolutionize the delivery of care. And there is much that  {state} attorneys general can do to promote such innovation-oriented policies.”


Skepticism swells about new medical products


Many years too late and many billions of dollars wasted,  physicians, insurers, regulators and, most important, patients are starting to think much more about what is being called medicine’s “gray zone.”

As Modern Healthcare notes: “Many drugs, devices and procedures may have been proven effective in the clinical trials …submitted to the FDA.  But after they are widely deployed by physicians and hospitals outside that carefully controlled trial environment, they {often} don’t achieve the same outcomes. Sometimes they perform worse than cheaper alternatives already on the market or do more harm to patients.”

Complaints about the poor performance of pricey, heavily marketed and sometimes perilous new medical stuff had for a long time mostly been limited to consumer advocates. But now they’re getting a long-needed more skeptical look. That’s driven in part by the flood of ailing and aging Baby Boomers into the maw of the healthcare sector. The country simply cannot continue to spend at the rate it has been spending.


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