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, New York-Presbyterian Hospital and two hospitals in Los Angeles — 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 Monday in an agency blog post. “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 have 10 days to 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. For the most serious problems that would require immediate action to prevent major public health harm, companies have five days to report them to FDA.

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

At Massachusetts General, FDA investigators 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 multidrug-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 Hospital, Eileen Neuwirth, said, “We have taken steps to ensure rigorous compliance going forward.”

Many of the hospitals involved — such as Cedars-Sinai — said they welcomed the agency’s feedback and supported efforts to improve device oversight, but some disputed them or offered explanations.

New York-Presbyterian said in a statement that 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. Also in a statement, UCLA said it promptly reported scope-related cases to the FDA but that the agency asked for duplicate reports through a separate system.

The findings underscore concerns raised by a 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 17 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 so-called 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.

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. You can follow Chad Terhune on Twitter: @chadterhune.

Let’s block ads! (Why?)

Aging can take a toll on teeth, and for many older people paying for dental services is a serious concern because they can’t rely on their Medicare coverage.

Low-income seniors in particular are struggling. More than a third with incomes below 200 percent of the federal poverty level (about $23,000 annually) had untreated tooth decay between 2011 and 2014, according to an analysis of federal data by the American Dental Association.

“What ends up happening is that almost everybody, when they get to be 65, is sort of on their own and they have to pay for dental care out of pocket,” says Dr. Michael Helgeson, chief executive officer of Apple Tree Dental. Apple Tree is a Minneapolis-based nonprofit organization that operates eight clinics in Minnesota and California that target underserved seniors. It also has mobile units that provide on-site dental care at nursing homes and other facilities.

Traditional Medicare generally doesn’t cover dental care unless it’s related to services received in a hospital. Medicare Advantage managed care plans generally provide some dental care, but the coverage can vary, and often is minimal, dental care advocates say. The plans often are “a loss leader,” said Dr. Judith Jones, a professor of dentistry at Boston University. “It’s meant to attract people. It gets people in, but the coverage is really limited.”

In a way, older people are victims of dentistry’s success. Regular visits to the dentist, along with daily tooth brushing and water fluoridation, have all contributed to improvements in oral health. In the first half of the 20th century, by the time people reached their 30s or 40s many had already lost all their teeth, Helgeson said. Today, more than 60 percent of people in nursing homes still have at least one tooth.

But teeth need tending. Without regular dental care, tooth problems can cause pain and limit how much and what type of food people are able to eat. Similarly, gum disease can loosen teeth and allow bacteria to enter the body. A growing body of research has linked treating periodontal disease with lower medical costs for diabetes and heart disease, among other conditions.

People’s lives are affected in other ways by their oral health. “You use your mouth to eat and kiss and smile and interact socially,” said Jones. “It’s a source of great embarrassment and suffering for many adults without access to care.”

With limited income and no insurance, seniors may skip visiting the dentist regularly, even though many report that their mouths are dry and painful and they have difficulty biting and chewing, not to mention avoiding smiling and social interaction if they have missing or damaged teeth.

Medicaid, the state and federal insurer for lower income people, covers dental care for children in every state, but coverage for adults is much spottier. Most states cover emergency dental care for people covered by Medicaid, but eight states offer no adult dental benefits at all, according to a study by Oral Health America, an advocacy group.

Even trying to purchase private dental insurance, which typically covers a few thousand dollars’ worth of dental care, may not provide good value, said Marko Vujicic, vice president of the American Dental Association’s Health Policy Institute. “When you add up the premiums and copays, for the vast majority of adults it’s not worthwhile to have dental insurance,” he said.

Seniors with limited means have few options for help affording dental care. Federally qualified health centers may provide geriatric dental services on a sliding-fee scale based on income, and clinics like Apple Tree help a limited number of seniors who live in their service area. But they’re a Band-Aid, said Jones.

She and other advocates want Medicare to add a dental benefit to Medicare Part B. Their proposal would provide a basic bundle of diagnostic and preventive services through a premium increase, and seniors would only be responsible for copayments if they need pricey restorative work like crowns and bridges.

But a dental benefit has faced stiff competition from other priorities, including adding a prescription drug benefit in 2006 and preventive coverage under the health law in 2010.

Kaiser Health News is an editorially independent news service that is part of the nonpartisan Henry J. Kaiser Family Foundation. Michelle Andrews is on Twitter:@mandrews110.

Let’s block ads! (Why?)