US biolab accidents going unreported – The Intercept

Some have reportedly involved deadly pathogens, and hundreds of cases have been kept from public view.
Directors of America’s biolabs have admitted to hundreds of dangerous accidents in the past two decades, but even incidents involving exposure to deadly viruses have been kept from public view, an investigation by The Intercept has revealed.

“People have it in their minds that lab accidents are very, very rare, and if they happen, they happen only in the least well-run overseas labs,” Rutgers University molecular biologist Richard Ebright told the media outlet. “That simply isn’t true.”
One such incident occurred in 2016, when a graduate student at Washington University in St. Louis accidentally pricked her finger with a needle after injecting a mouse with a recombinant strain of the Chikungunya virus, The Intercept said. The student didn’t tell her supervisor about the accident until after becoming ill and seeking treatment at a local hospital emergency room.

The university disclosed the accident and infection to the NIH, where the report was kept under wraps until The Intercept came calling six years later.

To read more click here.

Preventing needlestick injuries to healthcare workers

Employees who work in residential care, assisted living facilities, hospitals, or clinics are at an increased risk of needlestick injuries. While a needlestick itself isn’t a serious injury, it can lead to serious and sometimes fatal bloodborne pathogen infections. Hepatitis B, hepatitis C, and HIV can be spread through needlesticks. Staff members who care for patients are certainly at risk, but it’s important to remember anyone at a facility that uses needles could suffer from a needlestick, including office and housekeeping staff, if needles aren’t disposed of properly. 

Preventing needlesticks

Employers should provide employees with training and readily available sharps disposal sites to help protect them from needlesticks. Here are a few specific tips to help keep employees safe:

  • Whenever possible, utilize needles with automatic safety devices.
  • Offer and encourage employees to get a hepatitis B vaccine.
  • Provide training on facility-specific procedures for utilizing needles safely.
  • Establish procedures for employees to report any needlestick injuries and provide first aid and bloodborne pathogen testing.
  • Instruct employees to avoid recapping needles.
  • Establish a procedure for employees to report any needlestick hazards they come across in the workplace and take steps to address these hazards promptly.needlestick injuries 1

The Occupational Safety and Health Administration (OSHA) has specific hepatitis B vaccination requirements for employers whose workers could be exposed to bloodborne pathogens in the course of their job duties. Read our article to learn more about these requirements. Employers must provide their employees with adequate personal protective equipment (PPE) as well. By working to prevent needlesticks and providing vaccines and PPE, employers can protect their workers from serious illness and possible death. (Kayla Eggert)

11 pandemics that changed the course of human history, from the Black Death to HIV/AIDS — to (maybe) coronavirus

Pandemics have afflicted civilizations throughout human history, with the earliest known outbreak occurring in 430 BC during the Peloponnesian War.
Many of these pandemics have had significant impacts on human society, from killing large percentages of the global population to causing humans to ponder larger questions about life.
Here are 10 of the most momentous pandemics that altered the course of human history, as well as coronavirus, a potential pandemic in the making.

Click here to read the entire article.

Show Me the Evidence

A Twitter follower wrote me this: “hospital making me use ‘safety scalpel’ w/retractable sheath. I’ve almost cut myself x 2. Do you know of any data about it?”

I got interested because I like to question things. I wondered, “Is this yet another rule without foundation?”

I thought I would have to do an exhaustive search to find any studies on whether so-called safety scalpels (scalpels with retractable or otherwise protected blades) really are safer than standard scalpels.

To my surprise, a 2013 paper in the Canadian Journal of Surgery reviewed the literature on the subject. The authors, from the University of British Columbia, found no studies that addressed the use of safety scalpels and harm reduction.

In their discussion, the authors point out that the introduction of safety scalpels might have the opposite effect on safety due to factors such as personnel not being familiar with how safety scalpels work and that they have never been subjected to rigorous evaluation by failure mode and effects analysis. And injuries related to the use of safety scalpels have been reported.

In his book Normal Accidents, Yale sociology professor Charles Perrow mentioned a concept called “risk homeostasis,” which says that instituting safety measures may lead to people becoming overconfident and taking risks in other ways. For example, some skiers and bicyclists wearing helmets may take more chances, and serious injuries in these sports have not decreased.

Since there is no proof that safety scalpels are effective in reducing injuries, there seems to be no rationale for regulatory agencies or hospitals to mandate their use.

Surgeons complain that safety scalpels do not have the correct feel, quality, or precision of standard scalpels.

The paper noted that at least 24 different safety scalpels have been developed and approved for use in the United States. An Internet search confirmed that there are at least that many types of safety scalpels on the market.

As a byproduct of their investigation, the Canadian authors found that the use of hands free passing techniques for sharps, double-gloving, and avoidance of using hands as retractors have been shown to be effective in reducing sharps-related injuries. Devices that allow for safer removal and replacement of scalpel blades may also be of value.

I attempted to find a specific directive about scalpels in the Needlestick Safety and Prevention Act of 2001 but was unable to do so. If the act says anything about scalpels, perhaps someone could let me know.

Safety scalpel use is far less than expected. In 2011, the magazine Outpatient Surgery and the International Sharps Injury Prevention Society surveyed 186 operating room clinicians and found that 60% of respondents were not using safety scalpels at their hospitals. OSHA is apparently not fining many institutions since 95% of those who answered said they had never been fined.

The use of safety scalpels appears to have been based on an unwarranted assumption that safety scalpels are safer.

It is possible that safety scalpels do reduce the incidence of injuries, but it is equally possible that the rate of injuries in the same or even worse than with standard scalpel use.

So, to paraphrase Rod Tidwell, show me the evidence.

Click here to read the source document. 

Patient safety and retained surgical items

In 2015, the Canadian Patient Safety Institute recognized 15 “never events” for hospital care in Canada, meaning that their rate of acceptable occurrence is zero. The criteria to determine a never event were that it met the standard of being serious, recurring, identifiable and avoidable. Retained surgical items and wrong surgical procedures are high on the list, numbers one and three.

Imagine finding out months or even years after having abdominal surgery, and enduring excruciating pain, that a sponge or some other foreign object had been left in your body. Or waking up from surgery to learn the wrong body part had been removed or the wrong procedure was performed. Knowing when and how never events occur has been recognized as key to preventing them from occurring again.

In the first of this two-part series, let’s explore the scope and prevalence of retained surgical items (RSI) in Canadian hospitals.

What are retained surgical items?

Recently, there has been increased media attention in Canada on RSI, which refers to any medical equipment, tools or supplies unintentionally left inside someone after an invasive procedure (e.g., vaginal birth or surgery). RSI most commonly occur in operating rooms, labour and delivery units and interventional radiology settings.

Too often, we hear of forgotten “soft goods” (e.g., gauze, sponges, or towels), sharp tools, instruments, miscellaneous items (e.g., gloves or cautery tips) or medical devices (e.g., guidewires or catheters) left in body cavities. If not identified and removed quickly, RSI can lead to pain, infection and even death in the post-operative phase.

How prevalent is this issue?

According to the World Health Organization (WHO), globally, surgical errors account for 27 per cent of the most common adverse safety incidents. Alarmingly, the Canadian Institute for Health Information identifies that although medical patients outnumber surgical patients by almost 3/1, the overall harm rate is similar: surgical patients represent 19.8 per cent of the admitted patient population with a harm rate of 7.6 per cent, whereas medical patients represent 56.6 per cent of the inpatient population, with a similar harm rate of 6.2 per cent.

In 2016, the Canadian Medical Protective Association and the Healthcare Insurance Reciprocal of Canada (HIROC) co-led a collaborative, 10-year review of surgical safety. Neurosurgery and orthopedic surgery had the highest incidence of harm, with the risk being highest in non-trauma, non-oncology surgical procedures.

Obese patients were shown to have an increased risk for RSI, as were those undergoing long surgical procedures and procedures involving high wait times and high patient turnover. In addition, intraoperative blood loss over 500 millilitres for adults and seven millilitres per kilogram for children, multiple procedures or multiple surgical teams, emergency procedures, unplanned changes to surgical procedures and procedures occurring over breaks or at shift change were identified as high risk.

In 2017, the Organisation for Economic Co-operation and Development identified the worldwide average for retained surgical items as 3.8 per 100,000 medical and surgical discharges. Canada’s average was 2.57 times higher, rising from 8.6 to 9.3 in 2014 to 2015 and to 9.8 per 100,000 in 2017. In 2017, Quebec had the highest rate of RSI at 15 cases per 100,000. Canada has seen positive increases in its adverse events reporting, which may be a contributing factor to increased rates of RSI in Canada.

How do we solve this issue?

In 2009, the WHO created a 19-point checklist to assist with increasing patient safety. According to the Operating Room Nurses of Canada, the WHO Surgical Safety Checklist has improved patient safety and is now used by the majority of surgical providers worldwide. The checklist is multidisciplinary and identifies roles. Surgical staff are required to count all soft goods like sponges and gauze pads, sharp tools such as needles and scalpel blades, surgical tools and miscellaneous items before and after each surgical case.

The Canadian Patient Safety Institute adapted the WHO checklist to include additional safety measures, which we will explore in depth in the next part of this series.

This is the first of a two-part series. Part two: “Patient safety and retained surgical items: Malpractice and negligence.”

Click here to read full article.

Trash or recycle? Here is how to properly dispose of medical sharps

WISCONSIN — In 2019, almost 40 percent of Wisconsin’s recycling facilities reported that sharps were the top contaminant in the recycling stream.

The Wisconsin Department of Natural Resources is reminding residents that medical sharps, such as needles, syringes, and lancets, cannot be thrown away in the trash or recycling bins.

There are over 300 sharps collection sites throughout the state.

“By disposing of sharps at designated collection sites, you are preventing needlestick injuries to workers at solid waste and recycling facilities,” said DNR Waste Reduction and Diversion Coordinator Jennifer Semrau. “Even when sharps are in containers, the equipment at recycling facilities can break them open, exposing workers doing hand sorting to sticks from used needles.”

Workers that receive needlesticks have to undergo months of testing.

There are several ways to properly dispose of household sharps:

  • Take your sharps to a registered sharps collection station
  • Contact your doctor, clinic or local hospital; many healthcare facilities accept sharps
  • Call a local pharmacy, hospital, public health department or solid waste or streets department about local options
  • Reduce the amount of sharps you have to dispose of by clipping the needles off the syringe.
  • Needle-less syringes can be tossed in household trash

Extending Sharps Safety Beyond Hospitals

Drug delivery device designers must consider patient capability in home environments rather than the typical devices engineered for healthcare professionals.


Needlestick injuries have fallen 30% since implementation of the U.S. Needlestick Safety and Prevention Act (NSPA) in 2001, but sharps injuries still remain a major occupational hazard.

Every year, hospital-based healthcare personnel endure 320,000 needlestick injuries and other sharps-related injuries, roughly 1,000 sharps injuries per day. And, as self-administration in non-clinical settings continues to climb, needlestick prevention and best practice procedures must be transferred to the home environment. While typically designed with healthcare professionals in mind, manufacturers increasingly need to consider patients’ capabilities and the home environment during product design.

The wave of biological therapies fueling self-administration frequently must be administered via subcutaneous injection, requiring regular and accurate administration. Biologicals are well-suited to self-administration through prefilled safety syringes, eliminating dependency on a healthcare professional and putting patients in charge of their medication regimes.

With the safety syringe market growing, designers must focus on safety and recognize that certain features make devices more dangerous than others. Devices with hollow-bore needles or syringes that retain an exposed needle after use are very high-risk; 80% of needlestick injuries can be prevented with design. Disposable delivery devices such as pre-filled safety syringes for subcutaneous delivery are becoming a key sharps injury prevention tool.

Growing market
Globally, Market Data Forecasts estimates the pre-filled syringes market worth more than $772 million in 2018, expected to rise to more than $1.1 billion in 2023 – a compound annual growth rate (CAGR) of 8.1% – while the safety-engineered pre-filled syringe market is expected to grow at a 9.6% CAGR.

Ease of use and risks minimization are integral to successful device designs, offering reliability while minimizing the number of use steps required. A rheumatoid arthritis patient, for instance, must securely hold and safely operate the delivery device to ensure complete medication delivery. Older patients may also be less dexterous and could struggle with devices that have not been thoroughly reviewed by a robust human factors testing process. Automatically retracting needle mechanisms used in pre-filled safety syringes and auto-injector devices are easy to use and safe, and may significantly reduce the risk of dosage errors. Additionally, pre-filled syringes designed to prevent the plunger rod from being completely removed avoid drug spillage and wastage. Effective visual, audible, or tactile cues also alert the user that the correct dose has been successfully delivered.

Finally, it is one thing to have a great product concept, but value is undermined if problems arise further down the supply chain. Manufacturers should also be careful not to design over-engineered products with too many complexities that may present problems during development and manufacture. To ensure a high-quality experience for the end-user, manufacturers must pay attention to device design.

Read the full story here

The ‘London Patient,’ Cured of HIV, Reveals His Identity

A year after the “London Patient” was introduced to the world as only the second person to be cured of H.I.V., he is stepping out of the shadows to reveal his identity: He is Adam Castillejo.

Yes
Six feet tall and sturdy, with long, dark hair and an easy smile, Mr. Castillejo, 40, exudes good health and cheer. But his journey to the cure has been arduous and agonizing, involving nearly a decade of grueling treatments and moments of pure despair. He wrestled with whether and when to go public, given the attention and scrutiny that might follow. Ultimately, he said, he realized that his story carried a powerful message of optimism.

“This is a unique position to be in, a unique and very humbling position,” he said. “I want to be an ambassador of hope.”

Last March, scientists announced that Mr. Castillejo, then identified only as the “London Patient,” had been cured of H.I.V. after receiving a bone-marrow transplant for his lymphoma. The donor carried a mutation that impeded the ability of H.I.V. to enter cells, so the transplant essentially replaced Mr. Castillejo’s immune system with one resistant to the virus. The approach, though effective in his case, was intended to cure his cancer and is not a practical option for the widespread curing of H.I.V. because of the risks involved.

Only one other individual with H.I.V. — Timothy Ray Brown, the so-called Berlin Patient, in 2008 — has been successfully cured, and there have been many failed attempts. In fact, Mr. Castillejo’s doctors could not be sure last spring that he was truly rid of H.I.V., and they tiptoed around the word “cure,” instead referring to it as a “remission.”

Still, the news grabbed the world’s attention, even that of President Trump.

And by confirming that a cure is possible, it galvanized researchers.

“It’s really important that it wasn’t a one-off, it wasn’t a fluke,” said Richard Jefferys, a director at Treatment Action Group, an advocacy organization. “That’s been an important step for the field.”

For Mr. Castillejo, the experience was surreal. He watched as millions of people reacted to the news of his cure and speculated about his identity. “I was watching TV, and it’s, like, ‘OK, they’re talking about me,’” he said. “It was very strange, a very weird place to be.” But he remained resolute in his decision to remain private until a few weeks ago.

For one, his doctors are more certain now that he is virus-free. “We think this is a cure now, because it’s been another year and we’ve done a few more tests,” said his virologist, Dr. Ravindra Gupta of the University of Cambridge.

Read the full story here. 

 

More than 9 in 10 surgeons encounter a needlestick injury

According to a new global survey 95% of surgeons have either been personally affected by a needlestick injury or have seen a colleague experience one – increasing their risk of infection.

The survey looked at key opinions from 510 surgeons across six countries relating to infection prevention and the role of high quality gloves in improving patient and clinician safety. In particular, it demonstrated the importance that surgeons place on high quality gloves in the fight against needlestick injury and exposure to blood-borne viruses, like HIV.

The survey – the first of its kind undertaken – was conducted by SERMO for Mölnlycke, a world-leading medical solutions company.

Virus from needlestick injury
An estimated two million needlestick injuries occur among health workers each year, resulting in increased exposure to HIV, Hepatitis C and other blood-borne viruses. A needlestick injury can occur when a needle or other sharp instrument accidentally penetrates the skin, yet the underreporting to occupational health departments is well established.

The survey revealed that 93% of surgeons think that high quality gloves reduce the chance of exposure to blood-borne viruses and 83% said that the quality of gloves affects their sense of being protected from getting a needlestick injury.

Patient safety
According to the study 81% of surgeons believe that high quality gloves impact overall patient outcomes and 89% agreed that high quality gloves improve patient safety in the operating theatre.

When asked about glove failure during an operation, 78% of surgeons responded that it increases the risk of surgical site infections.

Commenting on the survey findings, John Timmons, Clinical Staff Nurse and International Medical Director, said: “Each year, millions of surgeons and their teams risk exposure to life threatening blood-borne viruses and this ground-breaking survey highlights the value that surgeons across the globe place on high quality gloves. Surgeons clearly recognise their role in both ensuring the safety of surgeons and improving outcomes for patients.

“Surgical gloves are one of the key factors that prevent infections in the operating room and should not be viewed as a commodity. High quality means fewer glove failures, yet we are increasingly seeing healthcare systems around the world prioritise price over quality.”

Health care-associated infections (HAIs) are the most frequent adverse event in healthcare delivery worldwide. Hundreds of millions of patients are affected by HAIs worldwide each year, leading to significant mortality rates. Of every 100 hospitalised patients at any given time, an estimated seven patients in developed countries will acquire at least one HAI or needlestick injury.

What is the safety Culture like at YOUR Healthcare Institution?

I recently read several critical analyses of safety cultures, or the lack thereof. Safety doesn’t just happen—it must be created by an organization and starts from the top down. One report discussed the global oil company BP’s oil refinery safety program. In 2005, the Texas City refinery explosion killed 15 people and injured more than 100 others. The analyses question how the British company would change the lack of safety culture at all five of its U.S. refineries. “Culture is forever,” said former U.S. Senator Slade Gorton of Washington, one of the 11 members of the panel led by former Secretary of State James A. Baker III. “To change hearts and minds and … the attitudes individuals have toward their jobs is difficult and a human task, and it’s never complete.”

Another disaster report discussed the January 28, 1986 Space Shuttle Challenger disaster that occurred over the Atlantic Ocean off the coast of Central Florida at 11:39 a.m. EST. Seventy-three seconds into its flight the Space Shuttle Challenger disintegrated after an O-ring seal on its right solid rocket booster failed. When the O-ring failed it allowed flames to leak from the solid rocket booster which shot out and caused structural failure of the external tank. A few seconds later the orbiter was destroyed along with all seven crew members.

Other major accidents that could have been avoided include the disasters at Three Mile Island and Chernobyl. The immediate causes of these accidents were initially identified as human error or technical failure. Further investigations revealed there were issues beyond the immediate causes. These issues relate to wider considerations of the organization.

One investigation report of the Chernobyl nuclear power plant mishap stated: “… their belief in safety was a mirage, their systems inadequate, and operator errors commonplace … From the top to the bottom, the body corporate was infected with the disease of sloppiness.”

Is our belief in healthcare worker safety in our institutions a mirage? The definition of safety culture suggested by the Health and Safety Commission in the United Kingdom is: “The safety culture of an organization is the product of the individual and group values, attitudes, competencies and patterns of behavior that determine the commitment to, and the style and proficiency of, an organization’s health and safety programs. Organizations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventative measures.”

What are the patterns of behavior at your facility? Does your institution support a safety culture or suppress it? The death of the seven astronauts aboard the Space Shuttle Columbia on February 1, 2003, was the result of leaders who failed to foster a culture in which discussions about potential risks could take place without any threats of reprimand. Is your institution creating an atmosphere that allows nurses, physicians, operating room technicians, custodians and others to make you aware of safety risks without risking their jobs?

Safety Culture—What Is It?

A safety culture influences the overall attitudes and behavior of an institution. We are all familiar with companies where the leadership and management style help the whole organization focus on the institutional mission and goals. As these goals filter down through all levels of these organizations, work processes are adapted to meet these goals. As these goals are adapted, they become the accepted norms for the workplace.

Employees and management share a commitment to ensure the safety of each other. Organizations that can put together a safety culture will find this value permeates all aspects of the work environment. Everyone is encouraged to take responsibility for their own safety as well is the safety of others.

How is the safety culture at your institution?