From Health Care

California Lawmakers Seek Reparations For People Sterilized By The State

Rosie Zaballos liked to host playtime tea parties and was sweet to everyone she met. But her older brother worried that the 16-year-old, whom her family described as “a little slow,” might someday become pregnant.

In his 30s and married, he had three kids of his own. And their mom was sick and needed help. So he took Rosie to be sterilized at a state-run hospital so she couldn’t have babies who might place an extra burden on the family.

Rosie never came home. She died during the operation.

This painful history, recounted by Rosie’s niece, Barbara Swarr, was rarely discussed in Barbara’s family when she was growing up in a Spanish immigrant neighborhood in Hayward, Calif., just southeast of San Francisco.

But in the past few years, Swarr, now 70, has pieced together the details of her aunt’s short life and the prevailing attitudes toward immigrants, poor people and those with disabilities that allowed more than 20,000 Californians to be sterilized under the state’s eugenics law — often without their consent — over a 70-year period in the 1900s.

“This was something nobody thought twice about. ‘If they are not all there, if they are Hispanic … make sure they don’t breed these inferiors,’” Swarr recounted with a mix of sadness and bitterness.

Across the country last century, more than 60,000 people deemed unfit to reproduce were sterilized, many against their will or without their knowledge. It was a public health strategy embraced by 32 states under eugenics laws that advocated “better breeding.” It began at state prisons in Indiana and spread to two-thirds of the country, targeting people with mental illness, disabilities and anyone who exhibited “abnormal” behavior.

California abolished its eugenics law in 1979 during Democratic Gov. Jerry Brown’s first term and apologized in 2003 under Gov. Gray Davis, also a Democrat. Legislation under consideration in the state Senate would go a step further to pay reparations, following in the footsteps of North Carolina and Virginia.

The bill, by state Sen. Nancy Skinner (D-Berkeley), would establish the Eugenics Sterilization Compensation Program for the living survivors of state-sponsored sterilization from 1909 to 1979. As currently written, the measure doesn’t specify the amount of state money survivors would receive — a detail that is still being hashed out by lawmakers.

North Carolina lawmakers in 2013 set aside $10 million, and two years later Virginia authorized $25,000 for each victim.

Researchers and advocacy groups estimate that roughly 800 survivors may still be alive today in California, although none have publicly come forward, whether because they’re ashamed of what happened to them or they just don’t realize they were victims.

Skinner said she hopes that publicity surrounding her bill will encourage survivors to come out and speak out.

“We are trying to ensure this is not forgotten,” she said. “It was a completely unjustified wrong that the state authorized and that the state implemented.”

In California, state records described the women who were sterilized as “weak-willed,” “dependent on others” and “feeble-minded.” The reason for their sterilization: Their mental condition was “likely to become transmitted to descendants.”

State law authorized medical superintendents at 12 state homes and hospitals to perform “asexualization” on patients — vasectomies for men and fallopian tube removals for women.

Sonoma State Hospital carried out about 5,000 sterilizations, more than any other place in the country, according to records compiled by Alexandra Minna Stern, a professor at the University of Michigan and an expert on eugenics laws.

Those records also show that Latinas in California were 59 percent more likely to be sterilized than non-Latinas. They were young girls and women who probably didn’t speak English well and ranked low on IQ tests, said Stern, who uncovered the state’s sterilization records in a file cabinet at the Department of Mental Health in Sacramento. In Southern states, African-Americans were targeted for sterilization. In Iowa, it was the poor.

Being Hispanic, black or poor was characterized as a disability in those days, Stern said.

“The way these laws played out, they impacted racial minorities, but it was through the disability lens, which makes it more insidious,” she said.

California historian William Deverell, a professor at the University of Southern California, traces the eugenics laws to a time when social reformers believed they could perfect the human race for the betterment of society — much like agriculturists at the time were trying to perfect avocados or citrus fruits.

“It’s such a fascinating moment because a lot of do-good human types were eugenicists,” Deverell said. “They had this notion they could bring perfection to bear even in the gene pool.”

The hope, historians and advocates say, is that Skinner’s legislation will raise awareness about the sterilizations and the fact that they were little more than a vehicle for state-sanctioned discrimination. They note that these procedures occurred at state facilities as recently as this decade, when doctors sterilized 148 women in California prisons from 2006 to 2010, according to a report by The Center for Investigative Reporting.

The bill requires markers to be placed at the institutions where sterilizations took place, and it calls for the creation of a traveling historical exhibit about eugenics laws.

It’s critical to educate people about this aspect of California’s “dark history,” said Myra Dúran, policy manager for California Latinas for Reproductive Justice, a statewide advocacy group. “It’s important to find the women who were sterilized because it’s important to get their voices heard.”

That’s what Swarr wants for her aunt.

“I honor her by trying to find out about her,” said Swarr, who owns the house where Rosie Zaballos grew up. “I don’t want her to be forgotten. I don’t want her to be just a statistic.”

Peak Health Plan Premiums Give Rise To Activism — And Unconventional Solutions

CHARLOTTESVILLE, Va. — When Garnett and Dave Mellen sent their 19-year-old daughter, Gita, off to college an hour away at Virginia Commonwealth University last fall, they didn’t expect to follow her.

But in November, the family received notice that its monthly health insurance premium in Charlottesville would triple for 2018, from $1,200 to an unaffordable $3,600.

So, the Mellens, both longtime local business owners, packed their bags and spent time with Gita in her off-campus apartment in Richmond.

“My whole life has been rearranged around trying to get health insurance,” Garnett Mellen, 56, said, as she explained that claiming residency with her daughter in the new ZIP code had cut their premiums by more than half.

Charlottesville now claims the dubious distinction of having the highest individual-market health insurance costs in the country — prompting families like the Mellens to look for extreme solutions.

An exodus of carriers, which was blamed on losses caused by the instability of the Obamacare marketplace, created a coverage vacuum, leaving locals and insurance regulators scrambling.

Only one carrier — Virginia Beach-based Optima Health — decided to continue to participate in the individual market, but it did so with monthly premium increases that were, on average, in the high double-digits and for some consumers as much as 300 percent, according to people interviewed for this story.

It’s a problem that’s likely to be replicated elsewhere, said Timothy Jost, an emeritus professor of law at Washington and Lee University in Virginia and expert on the health law.

“In many states, it’s going to be hard to maintain a functional individual market,” he said. “Charlottesville is sort of ahead of everybody else in this … but this is the direction things are heading.”

Insurers nationwide that intend to participate in the individual market face spring deadlines to file forms for 2019 plans and rate proposals. In Virginia, these dates are April 20 and May 4, respectively.

The situation in Charlottesville has left many residents at their wits’ end about how to pay for their health insurance, prompting the evolution of an angry and rebellious civic movement and thrusting the costs of coverage into the center of local politics.

Charlottesville for Reasonable Health Insurance, a grass-roots organization and Facebook group of more than 700 people, has already claimed small victories in the state legislature, such as propelling the passage of a bill that will alleviate the cost burden for some of its members.

But its highest priority has been pressing state regulators to explain and possibly reconsider the decision that allowed for the stunning premium increase.

In the midst of various bureaucratic fits and starts, the state Bureau of Insurance (BOI) responded to the group April 11 by reiterating that Optima’s rates were “actuarially justified.” Ian Dixon, one of the group’s organizers, said it plans to appeal this finding to the State Corporation Commission.

“We’re not going away, that’s for sure,” said Dixon. “They’re hoping they can wait us out. … They would drag this out for a year if they could.”

At the same time, the group has expanded its focus to other issues on health care costs, such as price transparency and regulatory reform.

When the Mellens found out their monthly health insurance premium in Charlottesville would triple for 2018, from $1,200 to an unaffordable $3,600, they packed their bags and spent time with Gita in her off-campus apartment in Richmond. (Julia Rendleman for KHN)

“My whole life has been rearranged around trying to get health insurance,” Garnett Mellen said. (Julia Rendleman for KHN)

How It Came To This

The trouble started in summer 2017, when the state’s major insurance carriers announced they would be leaving the individual market in Virginia, saying the market was “shrinking and deteriorating” — pointing to the instability of Obamacare under the Trump administration.

Their departures left Albemarle County, home to Charlottesville, bare — meaning residents had no insurance options.

When Optima opted to continue to offer plans in and around Charlottesville, state insurance regulators breathed a collective sigh of relief.

But Optima’s decision came with updated rate increase proposals, which gained the OK of the under-the-gun BOI, led by Commissioner Scott White.

“I think the [regulators] decided they were willing to accept almost anything to get someone to cover Albemarle County and Charlottesville,” Jost said.

About 15 miles north of Charlottesville on U.S. 29, there’s a billboard that some residents now view with bitter irony. It features a smiling man with the message: “I chose Optima.”

On one hand, Optima did fill a void and offer health plans where no other insurer would. Still, many residents found their only choice came with a 300 percent boost in premium costs. They felt that state regulators had fallen short of their consumer-protection responsibilities.

“Any assumption that I had … that I thought [the Bureau of Insurance would be] protecting the people … was completely naive,” said Sarah Stovall, 40, who works for a small software company, lives in Charlottesville with her husband and two sons and has struggled to find affordable coverage.

But Ken Schrad, the director of the Division of Information Resources for the State Corporation Commission, said the bureau is still questioning Optima, checking its math and evaluating its actuarial decisions.

He couldn’t answer specific questions about a matter he said is pending.

Schrad said the bureau reached out to carriers and worked with them last summer when it was clear that much of the commonwealth wouldn’t be covered.

“It wasn’t a question of what the premiums would be,” Schrad said. “It was whether there would be any coverage.

“[Filings] must be based on actuarially sound decisions, and that’s all the bureau can review. The market is the market.”

A Movement Is Born

Stovall, 40, teamed up with Dixon, 38, a web app developer, to manage the emerging Facebook group, which was originally set up as a support system for people in search of new insurance options in a short window of time. Soon, Karl Quist, 46, who had been actively calling the BOI to lodge complaints, joined the effort.

“The three of us did not know each other before November,” Dixon said. “We feel like we’re relatives now.”

Others quickly piled on, including the Mellens and Gail Williamson, 64, a part-time secretary at a private school who needed insurance for herself and her husband, who owns a business restoring antiques.

Like many of the people in the group, the Williamsons made too much money to qualify for federal subsidies, but too little to be able to afford the $3,725 monthly premium that Optima would have charged them.

Sharing their knowledge, many Charlottesville for Reasonable Health Insurance members have resorted to imperfect jury-rigged policies that do not come with many of the coverage guarantees that protect patients from unexpected costs under the Affordable Care Act.

Instead of paying $2,920 a month for Optima’s least generous family health plan, Quist is saving $2,300 a month by purchasing two non-ACA-compliant plans, one for sickness and one for accidents.

Williamson has settled on a “silly little” three-month policy for $1,400 per month, plus an extra $35 a month in supplemental accident insurance for her husband.

“If I won the lottery, the first thing I’d do before giving my kids any money would be to buy health insurance for everyone in that group,” Williamson said.

Washington and Lee’s Jost said he worries about the impact of such cobbled-together coverage.

He said having these plans could damage the ACA market further by skimming the healthier people away from the more comprehensive coverage, leaving behind those who are ill or have chronic conditions.

“It makes the situation worse because the only people who are going to pay premiums that high are people who are desperate,” Jost said.

For Charlottesville resident Garnett Mellen (right), finding a way to cut her steep health insurance premiums involved spending more time at daughter Gita’s off-campus college apartment in Richmond. (Julia Rendleman for KHN)

Forward Motion

Over the past months, the community-based effort has evolved beyond being an ad hoc information clearinghouse into a powerful organizing tool.

For instance, it has raised almost $20,000 to hire lawyer Jay Angoff, a former federal and state insurance official, to appeal to Optima and state regulators about the Charlottesville-area rates.

Dixon, Stovall and Quist also regularly pile into Stovall’s minivan, drive to Richmond and become lobbyists for their cause.

“The insurance companies pay people very good money to lobby for them on a regular basis,” Stovall said. “Meanwhile, I have to take off work, Ian [Dixon] has to leave his business for a day.”

“On some level, I have faith that if we keep pushing, I don’t know what the eventual outcome will be, but we’ll find some type of justice,” Dixon added.

Their greatest victory came with the passage of SB 672. This law redefined what a “small employer” is so that self-employed people can buy insurance in the small-group market.

The group sought this change because many people, including Dixon, found that the cost of adding an employee to a company of one allowed them to save money by obtaining insurance as a small group, though it still added significant overhead costs to these businesses.

Many in the group see this success as only a band-aid fix. Though it allows some people to obtain cheaper insurance, it doesn’t address the root of the problem: Optima’s rate increases.

For Garnett Mellen, though, the issue seems resolved, at least for now. She found a job with health benefits in Charlottesville, which enabled her and her husband to move back there.

It’s a big relief — both for her and for Gita, her college-aged daughter.

“She [was] not entirely happy with us being there,” Mellen said.

Can Failed Weight Loss Drugs Be Repurposed To Fight Opioid Addiction?

Scientists see a common thread between fighting obesity and the opioid crisis: addiction. In other news on the epidemic: it’s unclear whether a new proposal to empower the DEA will achieve its goal; a look at how a patient advocacy group is being used to promote a drugmaker’s painkiller; despite methadone’s proven effectiveness Medicare doesn’t cover it; and more.

4 New Ways You Can Avoid Fines For Not Having Health Insurance

There are already more than a dozen reasons people can use to avoid paying the penalty for not having health insurance. Now the federal government has added four more “hardship exemptions” that let people off the hook if they can’t find a marketplace plan that meets not only their coverage needs but also reflects their view if they are opposed to abortion.

It’s unclear how significant the impact will be, policy analysts said. That’s because the penalty for not having health insurance will be eliminated starting with tax year 2019, so the new exemptions will mostly apply to penalty payments this year and in the previous two years.

“I think the exemptions … may very marginally increase the number of healthy people who don’t buy health insurance on the individual market,” Timothy Jost, emeritus professor of law at Washington and Lee University in Virginia who is an expert on health law.

Under the new rules, people can apply for a hardship exemption that excuses them from having to have health insurance if they:

  • Live in an area where there are no marketplace plans.
  • Live in an area where there is just one insurer selling marketplace plans.
  • Can’t find an affordable marketplace plan that doesn’t cover abortion.
  • Experience “personal circumstances” that make it difficult for them to buy a marketplace plan, including not being able to find a plan in their area that gives them access to specialty care they need.

The first new exemption isn’t relevant for consumers this year. Since the Affordable Care Act’s marketplaces opened, there have been no “bare” counties that lack insurers.

However, in about half of the U.S. counties — in which 26 percent of enrollees live — there is only one marketplace insurer this year, according to the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

As for the abortion exemption, in many places it won’t be an issue either. Women in 31 states didn’t have access to a marketplace plan that covered abortion in 2016, according to a Kaiser Family Foundation analysis. Still, a few states — California, New York and Oregon — generally require abortion coverage in their marketplace plans, and women who live there might have trouble finding a plan that excludes that coverage, experts said.

The ACA established several different types of exemptions from the penalty for not having coverage. Among them are exemptions for not being able to find coverage that is considered affordable or being without insurance for less than three consecutive months in a year. People claim these more common exemptions when they file their tax returns.

Hardship exemptions that had already been on the books protected people who faced eviction, filed for bankruptcy or racked up medical debt, among other difficulties. Consumers apply for these exemptions by submitting an application to the ACA insurance marketplace.

The new hardship exemptions apply to people in all 50 states, according to an official at the federal Centers for Medicare & Medicaid Services, which oversees the health law’s insurance marketplaces. To apply, people generally need to provide a brief explanation of the circumstances that made it a hardship for them to buy a marketplace plan, along with any available documentation, when they submit their application to marketplace officials. They can apply for the current calendar year or going back two years, to 2016.

It’s difficult to gauge how many people will try to take advantage of the changes, said Tara Straw, a senior policy analyst at the Center on Budget and Policy Priorities.

“People aren’t sure how to apply or if they’re eligible, and that discourages them from applying,” Straw said.

The penalty for not having health insurance in 2018 is the greater of $695 or 2.5 percent of household income.

During the 2017 filing season, there were more than 106 million tax returns reporting that all family members had health insurance, and nearly 11 million tax returns that claimed an exemption from the requirement to have it, according to a report from the Treasury Department’s inspector general for tax administration. In addition, more than 4 million returns reported paying penalties totaling nearly $3 billion for not having health insurance.

People often don’t realize they may owe a penalty until it’s time to do their taxes, said Alison Flores, a principal tax research analyst at H&R Block’s Tax Institute. H&R tax preparers first work to see if clients can qualify for an exemption that can be claimed on their tax returns. If that doesn’t work, they move on to the hardship exemptions. The preparers help people get the hardship exemption application, but it’s up to consumers to send it to the marketplace and get the exemption certificate.

The federal guidance about the new exemptions was released April 9, shortly before the end of the income tax filing season. People who’ve already filed their taxes and qualify for the new exemptions for 2016 or 2017 and get marketplace approval can file an amended tax return to receive a refund of any penalty they paid, said Katie Keith, a health policy consultant who writes regularly about health reform.

“You have to really be motivated,” Keith said.

Choice Of Bay Area For AIDS Conference Exposes Tension Among Activists

After George Ayala learned last month that San Francisco and Oakland had been chosen to co-host the International AIDS Conference in 2020, he quickly published a statement of disapproval.

Ayala, an Oakland-based AIDS advocate, does not want the conference in his own city — or anywhere else in the United States, for that matter.

His statement of opposition and a second one drafted by colleagues at other AIDS organizations have been co-signed by hundreds of organizations and individuals in the United States and around the world.

Their biggest concern: long-standing U.S. visa policies will prevent many of the people most affected by AIDS and HIV, including drug users and sex workers who live in other countries, from attending the conference. They also worry about new restrictions affecting travel from Muslim countries.

George Ayala (Credit: Nadia Rafif)

“In this day and age, I have to wonder why we support big international AIDS conferences happening in places that bar anyone,” said Ayala, executive director of the Global Forum on MSM [Men who have Sex with Men] & HIV.

HIV/AIDS is far more prevalent in many countries, especially in Sub-Saharan Africa, than in the United States. Almost 19 percent of people ages 15 to 49 in South Africa are infected with HIV, as are more than 20 percent in some neighboring countries.

In the U.S., prevalence among the same demographic group hovers around a half of 1 percent — although that masks some stark disparities. Last year, the Centers for Disease Control and Prevention projected that 1 in 2 black men in the U.S. who have sex with men were at risk of contracting HIV. Globally, nearly 37 million people are living with HIV.

Ayala and other critics of the Bay Area location raise broader questions about the cost and frequency of a biennial event they say is enormously expensive and often excludes the very people it purports to represent.

The organizers of the conference and others who support the decision to bring it to the Bay Area say they understand these worries.

“Travel restrictions to the U.S. remain a significant concern for us,” said Mandy Sugrue, spokeswoman for the International AIDS Society, which organizes the conference.

However, Sugrue and other proponents of a San Francisco-Oakland conference venue argue that the politically liberal Bay Area offers a perfect platform for rebuking the Trump administration’s exclusionary immigration policies and its perceived retreat from leadership on AIDS policy.

In December, the administration fired all remaining members of the Presidential Advisory Council on HIV/AIDS, six months after a half-dozen others had resigned in protest. Trump officials have also proposed cutting national HIV/AIDS spending by more than $100 million and reducing the U.S. contribution to global funding by more than $1 billion.

“If there is any place in the U.S. where people can come and protest and rise up and have their voices heard … Oakland is it,” said Cynthia Carey-Grant, executive director of the Oakland-based group Women Organized to Respond to Life-Threatening Disease. She penned a statement in support of the conference location that has been signed by nearly a dozen individuals and groups.

Carey-Grant believes the contrast between upscale, predominantly white San Francisco and its decidedly poorer neighbor across the Bay offers a window on the disparities that pervade AIDS treatment and funding around the world – to the detriment of low-income communities of color.

Sofia Tobar (Courtesy of Sofia Tobar)

Sofia Tobar, a 50-year-old transgender woman from Oakland who was diagnosed with HIV in 1998, said the conference is an opportunity “for Oakland’s diverse humans to embrace people from other countries … and to also highlight what we’re lacking.” She is especially interested in speaking out against federal cuts to AIDS services and violence targeting the transgender community, she said.

Others say they are eager to honor San Francisco’s long history of battling AIDS.

Joe Hollendoner, CEO of San Francisco AIDS Foundation, noted that the conference organizers have secured use of the Moscone Center, the central conference venue, free of charge. They will use the money they save to help more people attend, he said. His foundation, along with the San Francisco Travel Association, led the committee that submitted the successful conference bid.

The planners of the International AIDS Conference usually try to alternate venues between affluent and lower-income countries. The conference was last held in the United States in 2012 in Washington, D.C. In 2014, it was in Melbourne, Australia, and in 2016, in Durban, South Africa. This year, the conference will be in Amsterdam.

Conference organizers said they reached out to a number of lower-income countries to host the 2020 conference, but none submitted a bid. As many as 20,000 people, perhaps more, are expected to attend the conference — and many cities cannot accommodate such a large gathering, they said. Sugrue, the International AIDS Society spokeswoman, said they are not considering changing the venue.

She said the location of major conference donors was not a factor in the 2020 venue decision.

In this day and age, I have to wonder why we support big international AIDS conferences happening in places that bar anyone.

George Ayala, Global Forum on MSM & HIV

Gilead Sciences Inc., which is based 20 miles from San Francisco and makes the HIV prevention drug Truvada, is one of the top sponsors of this year’s conference, as it was in 2016. Other big industry donors are not located in the Bay Area, including Johnson & Johnson, Merck and ViiV Healthcare, which specializes in HIV drugs. Funding for the 2020 conference has not yet been confirmed, Sugrue said.

Naina Khanna, the executive director of the Oakland-based Positive Women’s Network, said the fact that no developing countries submitted a bid isn’t enough to assuage her concern for the people who will likely be excluded. Khanna helped draft a separate statement demanding that the conference be relocated outside the U.S. More than 100 organizations and nearly as many individuals have signed the statement.

“Where is our commitment to actually holding the conference where the most people are impacted?” asked Ruth Morgan Thomas, global coordinator of the Global Network of Sex Work Projects, which includes 305 organizations representing sex workers in 85 countries.

Prior to the Washington, D.C., conference, the U.S. had lifted a ban on people with HIV entering the country, and many were hopeful that similar prohibitions against sex workers and drug users would also end. But they didn’t, and sex workers scrambled to organize a parallel conference in Kolkata, India, Morgan Thomas said. Drug users convened one in Kiev.

Khanna, of the Positive Women’s Network, said that the high cost of accommodations in the Bay Area will also make the conference inaccessible to many people within the United States — especially low-income African-Americans in the South, who are disproportionately burdened with the virus.

Marsha Martin, coordinating director of the Global Network of Black People Working in HIV, said she would have been happy had Bangkok or South America or even Atlanta been chosen to host the conference. “But if venues don’t submit bids, there’s nothing to do about it,” she said. So she’s treating the Bay Area conference as an opportunity to grapple with the big disparities in AIDS funding and to reinvigorate efforts in the U.S. to combat the disease.

“If we do bring it [to the Bay Area] and make it the best conference we can make it, then we win,” Martin said. “We show the world we are not giving up.”

Study: Nearly Three-Quarters Of Commonly Used Medical Scopes Tainted By Bacteria

In an ominous sign for patient safety, 71 percent of reusable medical scopes deemed ready for use on patients tested positive for bacteria at three major U.S. hospitals, according to a new study.

The paper, published last month in the American Journal of Infection Control, underscores the infection risk posed by a wide range of endoscopes commonly used to peer deep into the body. It signals a lack of progress by manufacturers, hospitals and regulators in reducing contamination despite numerous reports of superbug outbreaks and patient deaths, experts say.

“These results are pretty scary,” said Janet Haas, president of the Association for Professionals in Infection Control and Epidemiology. “These are very complicated pieces of equipment, and even when hospitals do everything right we still have a risk associated with these devices. None of us have the answer right now.”

The study found problems in scopes used for colonoscopies, lung procedures, kidney stone removal and other routine operations. Researchers said the findings confirm earlier work showing that these issues aren’t simply confined to duodenoscopes, gastrointestinal devices tied to at least 35 deaths in the U.S. since 2013, including three at UCLA’s Ronald Reagan Medical Center. Scope-related infections also were reported in 2015 at Cedars-Sinai Medical Center in Los Angeles and Pasadena’s Huntington Hospital.

The bacteria this latest study found weren’t superbugs, but researchers said there were potential pathogens that would put patients at high risk of infection. The study didn’t track whether the patients became sick from possible exposure.

The study’s authors said the intricate design of many endoscopes continues to hinder effective cleaning and those problems are compounded when health care workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient. The study identified issues with colonoscopes, bronchoscopes, ureteroscopes and gastroscopes, among others.

“Sadly, in the 10 years since we’ve been looking into the quality of endoscope reprocessing, we haven’t seen improvement in the field,” said Cori Ofstead, the study’s lead author and an epidemiologist in St. Paul, Minn., referring to how the devices are prepared for reuse.

“If anything, the situation is worse because more people are having these minimally invasive procedures and physicians are doing more complicated procedures with endoscopes that, frankly, are not even clean,” Ofstead said.

The rise of antibiotic-resistant superbugs such as CRE (carbapenem-resistant Enterobacteriaceae), which can be fatal in up to half of patients, has made addressing these problems more urgent. About 2 million Americans are sickened by drug-resistant bacteria each year and 23,000 die, according to the federal Centers for Disease Control and Prevention.

“We’re not moving fast enough to a safer world of reusable medical devices,” Michael Drues, an industry consultant in Grafton, Mass., who advises device companies and regulators. “There is plenty of fault to go around on device companies, hospitals, clinicians, on basically everybody.”

Fluid droplets found inside a gastroscope, which tested positive for bacterial growth. (Courtesy of Ofstead & Associates Inc., American Journal of Infection Control)

Despite the potential risks, medical experts caution patients not to cancel or postpone lifesaving procedures involving endoscopes. These snake-like devices often spare patients from the complications of more invasive surgeries.

“Patients should speak to their provider and think about the risks versus the benefits,” said Haas, who is also director of epidemiology at Lenox Hill Hospital in New York City.

The Food and Drug Administration and Olympus Corp., a leading endoscope manufacturer in the U.S. and worldwide, both said they are reviewing the study.

Last month, the FDA issued warning letters to Olympus and two other scope makers for failing to conduct real-world studies on whether health care facilities can effectively clean and disinfect their duodenoscopes. The FDA ordered the manufacturers to conduct those reviews in 2015 after several scope-related outbreaks in Los Angeles, Seattle and Chicago made national headlines.

Olympus spokesman Mark Miller said the Tokyo-based company intends to “meet the milestones set forth by the FDA. … Patient safety has always been and remains our highest priority.”

The latest study examined 45 endoscopes, with all but two manufactured by Olympus. The other two were Karl Storz models.

Last year, researchers visited three hospitals, which weren’t named, and performed visual examinations and tests to detect fluid and contamination on reusable endoscopes marked ready for use on patients. One hospital met the current guidelines for cleaning and disinfecting scopes, while the other two committed numerous breaches in protocol.

Nevertheless, 62 percent of the disinfected scopes at the top-performing hospital tested positive for bacteria, including potential pathogens. It was even worse at the other two — 85 and 92 percent.

Researchers observed damage inside scopes that could hinder high-level disinfection. Above, the lining of a gastroscope had come loose. (Courtesy of Ofstead & Associates Inc., American Journal of Infection Control)

The study painted a troubling picture at the two lower-performing hospitals, which were well aware researchers were watching.

Among the safety issues: Hospital technicians wore the same gloves for handling soiled scopes fresh after a procedure and later, when they were disinfected and employees wiped down scopes with reused towels. Storage cabinets for scopes were visibly dirty and dripping wet scopes were hung up to dry, which is a known risk because bacteria thrive on the moisture left inside. The two hospitals also turned off a cleaning cycle on a commonly used “washing machine,” known as an automated endoscope reprocessor, to save time.

“It was very disturbing to find such improper practices in big health systems, especially since these institutions were accredited and we assumed that meant everything would have been done properly,” said Ofstead, chief executive of the medical research firm Ofstead & Associates.

Ofstead and her co-authors recommended moving faster toward sterilization of all medical scopes using gas or chemicals. That would be a step above the current requirements for high-level disinfection, which involves manual scrubbing and automated washing. A shift to sterilization would likely require significant changes in equipment design and major investments by hospitals and clinics.

In their current form, many endoscopes aren’t built to withstand repeated sterilization. Some also have long, narrow channels where blood, tissue and other debris can get trapped inside.

In some cases, disposable, single-use scopes are an option, and new products are starting to gain acceptance. In other instances, certain parts of a scope might be disposable or removable to aid cleaning.

The Joint Commission, which accredits many U.S. hospitals and surgery centers, issued a safety alert last year about disinfection and sterilization of medical devices in response to a growing rate of noncompliance. In 2016, the Joint Commission cited 60 percent of accredited hospitals for noncompliance and 74 percent of all “immediate threat to life” citations from surveyors related to improperly sterilized or disinfected equipment.

Michelle Alfa, a professor in the department of medical microbiology at the University of Manitoba, said accreditors may need to conduct more frequent inspections and endoscopy labs should be shut down “if they don’t get their act together. These results are totally unacceptable.”

Study: Nearly Three-Quarters Of Commonly Used Medical Scopes Tainted By Bacteria

In an ominous sign for patient safety, 71 percent of reusable medical scopes deemed ready for use on patients tested positive for bacteria at three major U.S. hospitals, according to a new study.

The paper, published last month in the American Journal of Infection Control, underscores the infection risk posed by a wide range of endoscopes commonly used to peer deep into the body. It signals a lack of progress by manufacturers, hospitals and regulators in reducing contamination despite numerous reports of superbug outbreaks and patient deaths, experts say.

“These results are pretty scary,” said Janet Haas, president of the Association for Professionals in Infection Control and Epidemiology. “These are very complicated pieces of equipment, and even when hospitals do everything right we still have a risk associated with these devices. None of us have the answer right now.”

The study found problems in scopes used for colonoscopies, lung procedures, kidney stone removal and other routine operations. Researchers said the findings confirm earlier work showing that these issues aren’t simply confined to duodenoscopes, gastrointestinal devices tied to at least 35 deaths in the U.S. since 2013, including three at UCLA’s Ronald Reagan Medical Center. Scope-related infections also were reported in 2015 at Cedars-Sinai Medical Center in Los Angeles and Pasadena’s Huntington Hospital.

The bacteria this latest study found weren’t superbugs, but researchers said there were potential pathogens that would put patients at high risk of infection. The study didn’t track whether the patients became sick from possible exposure.

The study’s authors said the intricate design of many endoscopes continues to hinder effective cleaning and those problems are compounded when health care workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient. The study identified issues with colonoscopes, bronchoscopes, ureteroscopes and gastroscopes, among others.

“Sadly, in the 10 years since we’ve been looking into the quality of endoscope reprocessing, we haven’t seen improvement in the field,” said Cori Ofstead, the study’s lead author and an epidemiologist in St. Paul, Minn., referring to how the devices are prepared for reuse.

“If anything, the situation is worse because more people are having these minimally invasive procedures and physicians are doing more complicated procedures with endoscopes that, frankly, are not even clean,” Ofstead said.

The rise of antibiotic-resistant superbugs such as CRE (carbapenem-resistant Enterobacteriaceae), which can be fatal in up to half of patients, has made addressing these problems more urgent. About 2 million Americans are sickened by drug-resistant bacteria each year and 23,000 die, according to the federal Centers for Disease Control and Prevention.

“We’re not moving fast enough to a safer world of reusable medical devices,” Michael Drues, an industry consultant in Grafton, Mass., who advises device companies and regulators. “There is plenty of fault to go around on device companies, hospitals, clinicians, on basically everybody.”

Fluid droplets found inside a gastroscope, which tested positive for bacterial growth. (Courtesy of Ofstead & Associates Inc., American Journal of Infection Control)

Despite the potential risks, medical experts caution patients not to cancel or postpone lifesaving procedures involving endoscopes. These snake-like devices often spare patients from the complications of more invasive surgeries.

“Patients should speak to their provider and think about the risks versus the benefits,” said Haas, who is also director of epidemiology at Lenox Hill Hospital in New York City.

The Food and Drug Administration and Olympus Corp., a leading endoscope manufacturer in the U.S. and worldwide, both said they are reviewing the study.

Last month, the FDA issued warning letters to Olympus and two other scope makers for failing to conduct real-world studies on whether health care facilities can effectively clean and disinfect their duodenoscopes. The FDA ordered the manufacturers to conduct those reviews in 2015 after several scope-related outbreaks in Los Angeles, Seattle and Chicago made national headlines.

Olympus spokesman Mark Miller said the Tokyo-based company intends to “meet the milestones set forth by the FDA. … Patient safety has always been and remains our highest priority.”

The latest study examined 45 endoscopes, with all but two manufactured by Olympus. The other two were Karl Storz models.

Last year, researchers visited three hospitals, which weren’t named, and performed visual examinations and tests to detect fluid and contamination on reusable endoscopes marked ready for use on patients. One hospital met the current guidelines for cleaning and disinfecting scopes, while the other two committed numerous breaches in protocol.

Nevertheless, 62 percent of the disinfected scopes at the top-performing hospital tested positive for bacteria, including potential pathogens. It was even worse at the other two — 85 and 92 percent.

Researchers observed damage inside scopes that could hinder high-level disinfection. Above, the lining of a gastroscope had come loose. (Courtesy of Ofstead & Associates Inc., American Journal of Infection Control)

The study painted a troubling picture at the two lower-performing hospitals, which were well aware researchers were watching.

Among the safety issues: Hospital technicians wore the same gloves for handling soiled scopes fresh after a procedure and later, when they were disinfected and employees wiped down scopes with reused towels. Storage cabinets for scopes were visibly dirty and dripping wet scopes were hung up to dry, which is a known risk because bacteria thrive on the moisture left inside. The two hospitals also turned off a cleaning cycle on a commonly used “washing machine,” known as an automated endoscope reprocessor, to save time.

“It was very disturbing to find such improper practices in big health systems, especially since these institutions were accredited and we assumed that meant everything would have been done properly,” said Ofstead, chief executive of the medical research firm Ofstead & Associates.

Ofstead and her co-authors recommended moving faster toward sterilization of all medical scopes using gas or chemicals. That would be a step above the current requirements for high-level disinfection, which involves manual scrubbing and automated washing. A shift to sterilization would likely require significant changes in equipment design and major investments by hospitals and clinics.

In their current form, many endoscopes aren’t built to withstand repeated sterilization. Some also have long, narrow channels where blood, tissue and other debris can get trapped inside.

In some cases, disposable, single-use scopes are an option, and new products are starting to gain acceptance. In other instances, certain parts of a scope might be disposable or removable to aid cleaning.

The Joint Commission, which accredits many U.S. hospitals and surgery centers, issued a safety alert last year about disinfection and sterilization of medical devices in response to a growing rate of noncompliance. In 2016, the Joint Commission cited 60 percent of accredited hospitals for noncompliance and 74 percent of all “immediate threat to life” citations from surveyors related to improperly sterilized or disinfected equipment.

Michelle Alfa, a professor in the department of medical microbiology at the University of Manitoba, said accreditors may need to conduct more frequent inspections and endoscopy labs should be shut down “if they don’t get their act together. These results are totally unacceptable.”