That kind of story is what infuriates many medical safety advocates, who say that learning gained from adverse negligence and medical malpractice outcomes is often of continued value only within the facility where it occurred. In other words, and while important knowledge has been gleaned that can help to reduce medical error, it is far from routinely disseminated and applied nationally.
]]> Enter the National Transportation Safety Board (NTSB), which is envied across the world and lauded for the safety review processes and follow-up actions it takes regarding aviation problems. Other industries regard the NTSB as a model for safety enhancement. Increasingly, medical groups, facility administrators and safety regulators in the medical industry view that NTSB protocols and processes can also work to bring about strongly positive changes in the medical field.Key to such an outcome is widely sharing what becomes known. As noted above with the Quaid example, that doesn't happen with regularity in the medical industry.
It does with aviation, and that starts, say commentators, with the strongly independent and nonpartisan nature of the NTSB. Cases are promptly investigated, with high-level and detailed reports written. Those reports are then distributed throughout the industry and actively studied and debated among pilots, mechanics and airline administrators. The industry as a whole is made quickly aware of problems and solutions.
Many in the medical industry covet such a process with medicine, and believe that it could go far toward reducing patient errors.
What they say is centrally needed is an NTSB-type organization that has truly national reach and strong investigative acumen.
Source: American Medical News, "Celebrities make pitch for patient safety panel," Kevin B. O'Reilly, May 14, 2012
]]>The mother arrived at the hospital in August 2008 with her unborn child already in some distress. Expert witnesses at the trial testified that a prompt delivery would have resulted in no lingering issues for the child, but delivery was delayed for close to 80 minutes after the doctor committed an error that a spokesperson for the woman called "shocking."
]]> That error consisted of pronouncing the baby dead following an ultrasound examination. Notwithstanding that determination, though, a follow-up ultrasound performed by other hospital staff members discovered that the baby was alive, and an emergency cesarean section was immediately performed.The time lapse turned out to be material, though, with the delay resulting in cerebral palsy.
The jury found that the delay would not have resulted but for the fact that the hospital was using outdated ultrasound equipment and did not have a trained ultrasound specialist on hand to perform the procedure.
Jury members blamed that on the hospital, not the doctor, finding the latter not liable in the matter.
The award includes payments for the baby's pain and suffering and for the emotional distress caused the mother by the incident. The damages also include amounts for the future medical care of the child, who is now three years old.
Source: Philadelphia Inquirer, "Phila. jury awards $78.5M in medical malpractice case," Chris Mondics, May 6, 2012
]]>Many thousands of those persons undergo operations in U.S. hospitals each year, and researchers say that, where there is an increased chance of miscommunication based on language misunderstanding, the risk of surgical error, medication error and allegations of medical malpractice rises.
]]> A recent study conducted at two pediatric emergency rooms in Massachusetts suggests that having professionally trained in-house interpreters available can appreciably reduce medical errors and potentially adverse consequences for patients' health.The study was based on observations of exchanges between medical staff members and a number of Spanish-speaking patients and their families.
The findings reveal, unsurprisingly, that having an interpreter at hand reduces the risk of translation errors and, further, those errors are further reduced commensurate with the amount of professional training that an interpreter has.
Although about 12 percent of translation gaffes noted in the study could have had "clinical consequences" even when a professional interpreter was available, say the researchers, that number was doubled when only a family member or other amateur -- e.g., a bilingual hospital staff member -- was translating.
Federal law requires that translation services be available in some form -- through a personal interpreter onsite or via phone or video-based services -- in every hospital that receives federal funding.
The study authors say that having this service available needn't be prohibitively expensive, with the cost per patient being only about $25 when hospitals band together to offer phone and video services.
Source: MSNBC, "Study: Interpreters in ER limit medical errors," April 17, 2012
]]>The heart device industry is extremely profitable (with an estimate of about $10 million annual sales) and dominated by just a few players, namely, the following: Medtronic, St. Jude Medical and Boston Scientific. Those companies are the major makers of heart defibrillators, devices that have increasingly come into play in medical malpractice allegations and wrongful death cases.
]]> Following adverse publicity in 2005 related to charges that Guidant -- subsequently acquired by Boston Scientific -- had failed to warn doctors of serious problems with its defibrillators, the industry vowed to do better. A promise was made to establish medical advisory boards -- independent bodies removed from company politics and set up to investigate product issues and alert the public to dangers.St. Jude is now being pointed at by persons from across the medical universe, who say that several serious issues regarding its Riata lead -- a wire that connects a defibrillator to a patient's heart -- have resulted in approximately 20 patient deaths. The lead has short-circuited in many instances and also broken through its outer coating.
Given such serious and longstanding problems, coupled with an insufficient alert to the public concerning the problems with Riata, critics ask a very direct question: Where is the evidence that an independent medical advisory board has been brought into the process to play an investigatory and oversight role?
St. Jude has criticized a recent report from an outside team that highlights Riata's problems and questions its safety. Surgeons are widely asking why that is the case, and why similar problems with defibrillators are reoccurring over the years.
Investigation into the Riata's problems has now ratcheted up, with St. Jude finally having sent an alert to doctors late last year and advising the FDA.
Many questions linger and are potentially troublesome. About 130,000 people still use the Riata lead, and concerns are now surfacing that the product's insulation could erode and short-circuit the device.
Source: New York Times, "Device malfunction casts doubt on industry pledge," Barry Meier and Katie Thomas, April 18, 2012
]]>In 2011 alone, 13 high school athletes in the United States suffered brain injuries that led to permanent disability. That's a huge jump from past years, where that number stayed in the single digits.
]]> Experts suggest that part of the problem concerns how coaches and athletic trainers teach fundamentals to young football players. The current trend puts 1.1 million high school players in Ohio and elsewhere in the United States at risk of serious injuries that could have serious short- and long-term effects.The study concerned data and reports covering more than 48 years of football-related injuries. It found that, since 1977, 67 percent of football-related injuries occur as athletes make tackles. Although head-to-head contact has been banned from the high school level since 1976, many high school football players continue to lead with their heads, resulting in serious injuries.
Between 2001 and 2010, football-related disability resulting from brain injuries increased 25 percent from the previous decade. Combating these injuries, according to experts, requires coaches to be better educated on the symptoms of concussions and more willing to pull players from games when head injuries occur.
Referees at the high school level also need to be more focused on illegal tackling and contact and penalize players who engage in potentially dangerous actions.
Source: Medical Daily, "Football-related catastrophic brain injuries increase," April 18, 2012
]]>This is so, they say, because massive jury awards result in insurers charging doctors hefty malpractice premiums, the costs of which are passed along to consumers. Reform advocates contend that recovery caps and tightened court access will lower those premiums, which will lead to lower insurance rates for subscribers.
]]> A leading consumer advocacy group calls that line of reasoning both bogus and devious. In fact, the Center for Justice & Democracy (CJD) says it is a "dubious argument" that is easily debunked by taking a look at what is presently happening in California. That is the state where, nearly 40 years ago, lawmakers first placed malpractice caps on recoveries for injured victims of surgical error, misdiagnosis and other acts of hospital negligence.What has occurred in that state as a result of that action is far from what was promised, the advocacy group says. In fact, the caps have led to a swollen insurance bureaucracy that withholds all but tiny payouts and has been crassly enriched by the damage limits.
The CJD points to what it says really brings about positive changes for consumers, specifically, a tough insurance commissioner who challenges large malpractice insurers and rejects their rate rationales, calling instead for reductions.
That is what is happening in California and should serve as an embracing wake-up call and model for true reform throughout the rest of the country, maintains the CJD. In California, state Insurance Commissioner Dave Jones required medical insurers to file documents with his department and, after reviewing what he deemed to be excessive rates, pressured several of the largest malpractice insurers to substantially lower their rates.
That type of action -- not tort reform and its illusory promise of cost savings that, as an attendant cost, also shields bad doctors from liability for their mistakes -- is what protects consumers and renders health care costs reasonable, says the CJD.
Source: The Pop Tort, "The real world - California (insurance)," April 13, 2012
]]>The Mayo Clinic is doing something to reduce that type of surgical error and potential cause for a medical malpractice lawsuit. Ohio surgeons and medical facilities might want to pay due attention.
]]> Enter the bar-coded surgical sponge, which a chief medical officer for the Mayo Clinic Health System says "adds a layer of redundancy and takes out the element of human error."Typically, and in hospitals across the country, surgical nurses account for the sponges used during surgery. They note them at the outset and then manually count them when an operation is completed.
That works most of the time, but not always, with evidence of that being clear from the occasional -- and often sensational -- story that appears in the media regarding a sponge or other piece of surgical equipment left inside a patient's body following an operation.
In fact, something is forgotten and left unaccounted for in about one in every 6,000 surgeries. When the number of operations performed daily in the United States is considered, that margin of error -- which might seem relatively small at first blush -- quite clearly results in objects left inside many thousands of patients each year.
Mayo hopes to soon expand use of the sponges to hospitals regionally, and then beyond. The coded system costs only about $2 per operation. Moreover, it doesn't inject much additional time or effort into surgery, since nurses simply scan the used sponges at the same time as they are counting them.
Source: The Free Press, "Bar coding sponges safeguards against surgery mishaps," Robb Murray, March 16, 2012
]]>It didn't quite get that far, say authors in a report describing what medical personnel at a Wake Forest hospital in North Carolina found during a routine screening of samples dispensed by the Intellifill IV, because the contamination was discovered prior to being administered.
]]> The only reason it didn't, though, is that staff members were dutifully following through on quality assurance measures, pursuant to which they found the bacteria."To our knowledge, this is the first published report of a pharmacy robot being contaminated with Bacillus with resultant contamination of intravenous drug product," states the report.
Robotic medication-dispensing machines are in common use at many hospitals throughout the country, including medical facilities in Ohio. Their stated upside is in their ability to prepare and dispense needed intravenous medications quickly and accurately in a sterile -- often surgical -- environment. They are seen as tools that guard against surgical error.
The discovery of bacteria that can be dispensed through the machines along with the medication, though, casts strong doubts on assumptions that posit absolute safety in the delivery system.
Investigators say that the source for the contamination at the Wake Forest facility was in the machine's washing station and in its tubing. The product's maker does not have a cleaning protocol for these parts, which are not considered sterile. Cleaners often use only a spray bottle dispensing alcohol to clean these parts.
The report's authors say that this is not good enough and that the manufacturer should establish a more rigorous and formal cleaning and maintenance procedure.
"Quality assurance methods are critical to ensure ongoing patient safety," they note.
Source: Medical Xpress, "Research demonstrates bacterial contamination in pharmacy robots," April 4, 2012
]]>Ohio is one of those eight states reporting surgical site infection (SSI) rates, although it is noteworthy that out of hundreds of surgery types, infections from only about 10 procedures are reported. Ohio does not report complications resulting from spinal fusion, for example, nor for colon surgery, which has the highest rate nationally for SSIs. Only New York and South Carolina report that information.
]]> The variance among states in reporting infections is the subject of a recent report from Johns Hopkins researchers, who state a concern that lack of a national and mandatory reporting standard -- and for all types of surgeries -- is undermining the quality of medical care. They say it is further shortchanging consumers who must often make treatment choices based on sketchy information.The report is published in the Journal for Healthcare Quality. The study zeroes in heavily on the vast amount of discretion that hospitals across most of the country have in reporting SSIs, which result in about 8,000 deaths each year in the United States and cost the healthcare system about $10 billion.
The researchers say that full disclosure, and on a national level, will bring about informed consumer choices that will in turn lead to hospitals making quality improvement to ensure their continued viability.
'Until we have transparency in health care, waste and errors will continue to burden the system with high costs while leaving the public frustrated with a system in which they are forced to walk in blind," says Martin Makary, MD, the lead author of the study.
Source: Forbes, "Lack of national reporting mandate for hospital infections hurts consumers," Gergana Koleva, April 5, 2012
]]>Such systems -- which enable a medical provider to order drugs electronically and peruse relevant information about a medication -- are intended to increase patient safety. Put another way, hospital officials see them as being instruments for reducing medication errors and acts of medical malpractice
]]> So far, they might not be delivering on expectations. That is the conclusion of a team of researchers from Johns Hopkins who studied the interactions of staff members at a Baltimore teaching hospital with a CPOE system called Meditech, in use at that facility for nearly a decade.A central finding of the study is that using the system is simply not a pleasant task for prescribers. Whenever a user orders a medication, a computerized drug warning alert appears on the screen that often contains a solid wall of detail that typically includes information such as the following: how the drug might interact with other medications a patient is already using; whether the drug might induce allergies in the patient; whether the drug is duplicative of another medication already being prescribed; and the adverse events that have been associated with taking the medicine.
The problem is that information is difficult to differentiate or place in any sort of hierarchy. With the Meditech system, researchers say, "all possible warnings appear on the same screen, in the identical font, with nothing to differentiate the potential severity of the adverse outcome."
That has led to what researchers call "alert fatigue" and users simply ignoring the warnings by overriding them. In the Johns Hopkins study, that happened a striking 96 percent of the time.
Source: Medpage Today, "Drug warning alerts largely ignored," Nancy Walsh, April 6, 2012
]]>A number of commentators have noted over the past couple years, though, that the hoped-for great leap forward is not without considerable costs. They point out that new technologies have visited medical harm on a great number of patients while such processes are working through growing pains en route to becoming firmly enmeshed in the nation's hospitals.
Medication error is a case in point, and nowhere is that more tragically displayed than in the case concerning a pharmacy technician's error at a Chicago hospital in late 2010.
]]> In that matter, an infant was subjected to a dose of sodium chloride more than 60 times the prescribed amount, owing to the technician's error in entering the wrong data onto a computer program.Much else was wrong that day, as well. Automated alerts in the IV machine were not properly activated, the label on the IV bag administered to the infant was incorrect, and a lab technician who did note the unusually high sodium level simply assumed it was incorrect.
A medical malpractice wrongful death suit filed by the baby's family has just concluded, with a settlement reached last week pursuant to which the hospital will pay the family $8.25 million.
The hospital promptly acknowledged mistakes following the death and instituted remedial policies aimed at preventing recurrences.
"This event has only heightened our focus on patient care," says a hospital spokesperson.
Source: Chicago Tribune, "Parents awarded $8.25 million in infant's death," Cynthia Dizikes, April 5, 2012
]]>The impressively entitled Ohio Children's Hospitals Solutions for Patient Safety Initiative (initiative) has a stated goal of reducing medication errors, surgical errors and all other adverse outcomes for children in all the nation's pediatric hospitals.
]]> The initiative was launched in 2009 with, initially, the participation of eight Ohio medical facilities. Those include children's hospitals in Cleveland, Akron, Cincinnati, Dayton, Columbus and Toledo.The projects that were first identified and focused upon by the participants involved ways to minimize medication error and reduce in-house acquired infections.
"Our vision is to make Ohio the safest place for kids to get health care, period," says Lashutka.
"Getting to zero is our ultimate goal," adds an executive with Akron Children's Hospital in discussing medical errors.
The initiative is being nationally noticed, especially for its claims that it has helped saved nearly 8,000 children from harmful medical errors and realized almost $12 million in savings while doing so. More than 100 administrators from across the country convened recently in Akron to get a closer look at the initiative's methodologies and results.
The founding participants in the initiative have also been given $4.3 million from the federal government to expand their safety program and processes to other hospitals across the United States. The goal is to add 75 more participants within a two-year period.
Source: Akron Beacon Journal, "Ohio's pediatric hospitals launch national patient safety initiative," Cheryl Powell, March 14, 2012
]]>There is a direct correlation between the stringency of a state's GDL program and the rate of car accidents and instances of attendant traumatic brain injury (TBI) -- too often fatal -- suffered by its teen driving population.
]]> That is the conclusion in a new study conducted by the Children's Hospital of Philadelphia and State Farm Insurance. Researchers say it accounts for why states with programs more rigorous than Ohio's GDL requirements have the lowest number of serious head injury and teen fatality rates stemming from motor vehicle accidents.The safety report seeks to draw attention to the fact that, while concussion-related episodes and other head trauma stories are often centered on youth participation in sports programs, a more serious problem when it comes to TBI is auto accidents.
And, indeed, it is a quite sobering concern. Study authors note that about 55,000 teen drivers and passengers were seriously hurt or killed in motor vehicle crashes in 2009 and 2010, with fully 30 percent of them suffering acute head injuries.
According to the Centers for Disease Control and Prevention, that makes car accidents the leading cause of teenage deaths in the United States that are related to brain injury.
Source: Forbes, "Car crashes are the leading cause of fatal head trauma," Jim Gorzelany, April 2, 2012
]]>Rypien is once again the leader of a band of NFL brothers, but this time on terrain and regarding a subject matter that he once could not possibly have even remotely envisioned.
The venue is a federal court in neighboring Pennsylvania, the subject matter a traumatic brain injury mass-tort lawsuit filed by 126 former professional players. Rypien is the lead plaintiff in the litigation.
]]>Rypien played in the NFL for more than a decade and states that he suffered "repeated traumatic injuries to his head" during that time.
The claim is closely similar for the other plaintiffs in the lawsuit, who together allege that the league knew of both the commonality and serious health effects associated with the concussions suffered by its players. As the instant lawsuit and other complaints filed against the league contend, the NFL sought to bury that knowledge and mislead both the players and the public.
We have informed our readers in past blog posts of the material developments in some of that litigation. We have also recounted some of the problems being faced by other professional leagues, such as Major League Baseball and the National Hockey League, and their remedial responses.
It is an issue of immense magnitude, and growing. One website that closely follows football-related concussion states that five wrongful death suits have been filed against the league, along with 46 other lawsuits.
Source: Washington Times, "Mark Rypien is lead plaintiff in lawsuit against NFL over head injuries," Nathan Fenno, March 27, 2012
]]>In fact, a report issued by the FDA last July cites a 500 percent rise in deaths and injuries relating to mesh use for prolapsed organs. Marketing of mesh implants states that the implants are a strong alternative to surgery for women with weakened pelvic muscles.
]]> Mesh implant maker Johnson & Johnson (J&J) now finds itself squarely in the middle of loudly escalating clamor surrounding its implant device, known as the Gynecare Prolift. That device has been widely popular for several years, with the company enthusiastically marketing and selling it domestically since 2005.That was illegal, say government regulators, who insist that sales prior to 2008 -- the year that the FDA granted approval for the device -- were flatly unauthorized.
The drug company and federal agency have been exchanging widely varying accounts of whether and when the device was cleared for sales. Johnson & Johnson spokespersons say that J&J was free to market Prolift without restrictions because it was already closely similar to a device already approved by the FDA. As noted, the FDA rejects that assertion.
The exchanges are far more than academic, given that 500-plus lawsuits have been filed against J&J alleging a number of serious harms associated with the implant. Many doctors are paying close attention to that, saying that they would never have endorsed Prolift if they knew it lacked regulatory approval and that its use would subject them to charges of surgical error.
Says one surgeon and professor of obstetrics/gynecology: "Most surgeons probably would have not used a completely new product if there was no oversight."
Source: Bloomberg Businessweek, "J&J marketed vaginal mesh implant without U.S. approval," David Voreacos, March 21, 2012
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