Category: Hospitals

Categories : COVID HospitalsTags :

One in Ten COVID Cases Infected After Hospital Admission

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Photo by Gustavo Fring from Pexels

In the UK’s first wave, more than one in ten COVID hospitalised patients acquired the disease in a hospital according to researchers conducting the world’s largest study of severe COVID.

Dr Jonathan Read from Lancaster University with colleagues from other UK universities led the research into hospital-acquired infections (HAIs) which was published in The Lancet.

For the study, researchers analysed records of COVID patients in UK hospitals enrolled in the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) Clinical Characterisation Protocol UK (CCP-UK) study, who became ill before 1st August 2020.

The researchers found that at least 11.1% of COVID patients in 314 UK hospitals were infected after admission. The proportion of hospital-acquired infections also rose to between 16% and 20% in mid-May 2020, well after the first wave’s peak in admissions.

“We estimate between 5699 and 11 862 patients admitted in the first wave were infected during their stay in hospital. This is, unfortunately, likely to be an underestimate, as we did not include patients who may have been infected but discharged before they could be diagnosed,” the researchers said.

“Controlling viruses like SARS-CoV-2 has been difficult in the past, so the situation could have been much worse. However, infection control should remain a priority in hospitals and care facilities,” said Dr Read.

Dr Chris Green, University of Birmingham, said: “There are likely to be a number of reasons why many patients were infected in these care settings. These include the large numbers of patients admitted to hospitals with limited facilities for case isolation, limited access to rapid and reliable diagnostic testing in the early stages of the outbreak, the challenges around access to and best use of PPE, our understanding of when patients are most infectious in their illness, some misclassification of cases due to presentation with atypical symptoms, and an under-appreciation of the role of airborne transmission.”

According to the type of care provided, there were notable differences in infections. Lower proportions of hospital-acquired infection were seen in hospitals providing acute and general care (9.7%) than residential community care hospitals (61.9%) and mental health hospitals (67.5%).
Professor Calum Semple, University of Liverpool, said: “The reasons for the variation between settings that provide the same type of care requires urgent investigation to identify and promote best infection control practice. Research has now been commissioned to find out what was done well and what lessons need to be learned to improve patient safety.”

Source: Lancaster University

Categories : Hospitals Lab Tests and ImagingTags :

Joint Statement Says Prior Radiation Should not Affect Decisions to Image

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Previous radiation exposure should not be considered when assessing the clinical benefit of radiological exams, according to a statement by three scientific groups representing medical physicists, radiologists, and health physicists.

Medical radiation exposure is a hot topic. People receive average annual background radiation levels of around 3 mSv; exposure from a chest X-ray is about 0.1 mSv, and exposure from a whole-body CT scan is about 10 mSv. The annual radiation limit for nuclear workers is 20mSv.

The American Association of Physicists in Medicine, along with the American College of Radiology and the Health Physics Society, issued a joint statement opposing cumulative radiation dose limits for patient imaging, saying that there could be negative impacts on patient care. The statement opposes the position taken by several organisations and recently published papers.

“It is the position of the American Association of Physicists in Medicine (AAPM), the American College of Radiology (ACR), and the Health Physics Society (HPS) that the decision to perform a medical imaging exam should be based on clinical grounds, including the information available from prior imaging results, and not on the dose from prior imaging-related radiation exposures,” the statement reads.

“AAPM has long advised, as recommended by the International Commission on Radiological Protection (ICRP), that justification of potential patient benefit and subsequent optimization of medical imaging exposures are the most appropriate actions to take to protect patients from unnecessary medical exposures. This is consistent with the foundational principles of radiation protection in medicine, namely that patient radiation dose limits are inappropriate for medical imaging exposures.

“Therefore, the AAPM recommends against using dose values, including effective dose, from a patient’s prior imaging exams for the purposes of medical decision-making. Using quantities such as cumulative effective dose may, unintentionally or by institutional or regulatory policy, negatively impact medical decisions and patient care.

“This position statement applies to the use of metrics to longitudinally track a patient’s dose from medical radiation exposures and infer potential stochastic risk from them. It does not apply to the use of organ-specific doses for purposes of evaluating the onset of deterministic effects (e.g., absorbed dose to the eye lens or skin) or performing epidemiological research.”

The Radiological Society of North America also endorses the position.

The AAPM emphasises the importance of patient safety in their position. Radiation usage must be both justified and optimised and benefits should outweigh the risks.

“This statement is an important reminder that patients may receive substantial clinical benefit from imaging exams,” said James Dobbins, AAPM President. “While we want to see prudent use of radiation in medical imaging, and many of our scientific members are working on means of reducing overall patient radiation dose, we believe it is an important matter of patient safety and clinical care that decisions on the use of imaging exams be made solely on the presenting clinical need and not on prior radiation dose.

“AAPM is pleased to partner with our fellow societies—the American College of Radiology and the Health Physics Society—to bring a broadly shared perspective on the important issue of whether previous patient radiation exposure should play a role in future medical decision making.”

The AAPM cites the International Commission on Radiological Protection, which stresses that setting radiation exposure limits to patients is not appropriate. This is partly due to a lack of standardised dose estimates.

The position only addresses stochastic risks from radiation exposure, which are chance effects whose risk for a given imaging exam, like cancer,is unrelated to the amount of prior radiation. Deterministic effects, incremental, direct exposure responses, such as skin damage, result from different biological mechanisms and are not included.

The AAPM compiled a list of answers to frequently asked questions on the topic of medical radiation safety along with references to research papers which support the organisation’s position.

Source: News-Medical.Net

Categories : HospitalsTags :

‘Vast Majority’ of Urine Tests Before Planned Surgery Unnecessary

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Source: Vidal Balielo Jr on Pexels

“The vast majority” of urine tests conducted prior to scheduled surgeries to check for infections “were not plausibly indicated,” according to US researchers in a study of claims data.

Though the individual tests were inexpensive at $17 each, over the study’s 11-year duration they came to $50 million, plus another $5 million for antibiotics prescribed to patients with no clinical signs of infection.

“Patients and society bear the risk of inappropriate antibiotic use, which can result in adverse drug reactions, increased risk of infections such as Clostridioides difficile, and emergence of antibiotic resistance,” wrote authors Erica Shenoy, MD, PhD, of Massachusetts General Hospital in Boston, and two colleagues in a JAMA Internal Medicine research letter, published in the journal’s ‘Less Is More’ series which highlights overused tests and treatments.

Once, preprocedural urinalyses were routinely done to check for infections that could increase complication risk. However studies have since shown that such testing rarely improves outcomes or even changes clinical management. Organisations such as the Infectious Diseases Society of America and the US Preventive Services Task Force have recommended against testing and prescribing for asymptomatic infections except in certain narrow indications.

To see just how common the practice has been, the researchers used data on some 13 million procedures performed from 2007 to 2017 from Medicare and the IBM Watson Marketscan database of commercial insurance claims, spanning 14 specialties. The researchers did not count kidney and urological surgeries since urinalysis is recommended by guidelines for most such procedures.

Urinalysis was deemed appropriate for the others when urinary tract symptoms, fever, or altered mental state was mentioned. Without those codes, the procedures were “not plausibly indicated.”

While 75% of surgeries in the data did not involve preprocedural urinalysis, suggesting good adherence, in the 25% that did, fully 89% across all types of surgery had no apparent indication; with the lowest non-indicated testing rate being 84%.

The results show that traditional practice patterns “remain entrenched”, according to the researchers, who called on insurers to take more steps to be more aggressive in denying claims for unneeded testing.

Limitations included incomplete patient data as patients may have had legitimate indications for testing and antibiotic prescriptions that were not recorded with the relevant diagnostic codes. Also, about half of the 11-year study period preceded the movement to limit ‘low-value’ testing.

Source: MedPage Today

Categories : Hospitals Mental HealthTags :

Heavy Workload Reduces Outcomes and Turns Positives into Negatives

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Source: CC0

Employee wellbeing in healthcare is reflected in patient satisfaction, and a new study found that a heavy workload, even positive challenges such as learning new things are experienced as increased stress.

Researchers from the Department of Psychology at the University of Jyväskylä in Finland explored how the staff of a healthcare district experienced increasing job demands, and how wellbeing at work was linked to these demands. The study also clarified whether the demands on employees were reflected in patient satisfaction.

More than a thousand employees took part in the study and evaluated their experiences in a survey measuring intensified job demands, work exhaustion, and work engagement. Additionally, nearly a thousand patients of the healthcare district evaluated their treatment by the healthcare staff.

In line with expectations, healthcare staff’s experiences of greater time pressure and workload were associated with greater exhaustion. An especially high risk of exhaustion was seen in those working in emergency care and nurses.

Additionally, experience of increased job planning demands shared by the working community was associated with greater exhaustion and lower customer satisfaction. This was particularly evident in the staff of leadership services.

“A surprising observation was that none of the intensification demands was positively connected with work engagement,” said Senior Lecturer Mari Huhtala. “In the light of previous studies, employees may find some demands such as learning new things positive challenges, especially when the demands are reasonable. However, this was not the case with the studied healthcare employees. It is possible the general workload in healthcare has led to these positive challenges being experienced as additional stress as well.”

Research data for the study were collected using an electronic survey in the third quarter of 2019. The study will continue in the third quarter of 2021 with the collection of follow-up data.

Source: University of Jyväskylä

Journal information: Huhtala, M., et al. (2021) Intensified job demands in healthcare and their consequences for employee well‐being and patient satisfaction: A multilevel approach. Journal of Advanced Nursing. doi.org/10.1111/jan.14861.

Categories : Hospitals Implants and ProsthesesTags :

Deaths From Medical Devices Are Underreported in the US

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Photo by Vidal Balielo Jr. from Pexels
Photo by Vidal Balielo Jr. from Pexels

Researchers have found that a number of deaths related to medical device adverse events were improperly categorised in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, according to a new study.

Flagging terms commonly associated with death, the study investigators used a natural language processing algorithm to identify 290 141 reports where serious injury or death was reported; 52.1% of these events were reported as deaths, and 47.9% were classified as either malfunction, injury, or missing (report was uncategorised), reported Christina Lalani, MD, of the University of California San Francisco, and colleagues, in JAMA Internal Medicine.

Overall, 23% of reports with a death were not placed in the death category, amounting to some 31 552 reports filed from December 31, 1991, to April 30, 2020.

Whether to classify the event as a malfunction, injury, death, or ‘other’ is up to the physician or manufacturer. According to the FDA, the reporter is required to categorise an adverse event as an official death if the cause of death is unknown, or if the device “may have caused or contributed to a death.”

The three most common product codes among the adverse event reports were for ventricular assist bypass devices (38 708 reports), dialysate concentrate for haemodialysis (25 261 reports), and transcervical contraceptive tubal occlusion devices (14 387 reports).

The natural language processing algorithm scanned through reports, identifying terms such as “patient died,” “patient expired,” “could not be resuscitated,” and “time of death.” Of the 70 terms that were associated with a death, 62 (88.6%) were found among miscategorised adverse event reports involving a patient death. And, out of all 62, there were 17 terms that had an estimated percentage of 100%, meaning that “every time that term was used, the patient had died, even though the reporter had not classified the report as death,” the team wrote.

Only 18 terms had sample sizes large enough for researchers to calculate confidence intervals; among them, the words “death” or “deaths” were linked to 12% of adverse event reports in which a patient died, but were classified as malfunction, other, or missing — the highest rate of all the analysed terms.

The researchers acknowledged a major limitation in that only reports with at least one death-associated term were included, in contrast to all the reports from the MAUDE database. Improperly categorised deaths likely contribute to an underestimate.

“The classification chosen by the reporter is vital, as the FDA must review all adverse events reported as deaths, which is not the case for other reporting categories,” the authors wrote. Improving the reports’ accuracy is crucial, since patient death frequency can prompt the FDA to pursue investigations into the device’s safety, they added.

The researchers pointed out an inherent conflict of interest as 95.9% of the reports evaluated in the study were submitted by manufacturers.

“It may not be in their interest to facilitate identification of serious problems with their own devices in a timely manner,” they wrote. “There have been multiple instances of delays by manufacturers in reporting serious malfunctions and deaths that were associated with medical devices, as well as complete failures to report.”

Therefore, it’s likely that a significant number of patients have been unknowingly treated with devices that were later revealed to be dangerous, Dr Lalani and colleagues noted. For example, they referenced the reporting failures that occurred from 2002 to 2013, when 32 000 women reported adverse events associated with the permanent birth control device Essure while the FDA only received 1023 adverse event reports from the manufacturer.

They concluded that patients and care providers should submit reports directly to the FDA as well as or instead of the manufacturer.

Source: MedPage Today

Journal information: Lalani C, et al “Reporting of death in US Food and Drug Administration medical device adverse event reports in categories other than death” JAMA Intern Med 2021; DOI: 10.1001/jamainternmed.2021.3942.

Categories : Hospitals Obstetrics & GynaecologyTags :

Nearly Half of Female Surgeons Experience Pregnancy Complications

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Long hours and delaying pregnancy to after 35 increase complication risk for female surgeons’ pregnancies. Photo by JESHOOTS.COM on Unsplash

A survey of female surgeons found that 48 percent had experienced major pregnancy complications, with even higher risks for those with more operation hours per week in the last trimester of pregnancy.

Women are entering the surgical field in increasing numbers but they continue to face well-known challenges related to childbearing. Surveys have documented pregnancy-related stigma, unmodified work schedules, brief maternity leave options, and little support for childcare and lactation needs after delivery. Due to a lack of childcare options in developed countries, many female trainees delay pregnancy until after 35, already a risk factor for pregnancy complications, researchers from Brigham and Women’s Hospital and elsewhere surveyed 1175 surgeons and surgical trainees from across the US to study their or their partner’s pregnancy experiences. They found that 48 percent of surveyed female surgeons experienced major pregnancy complications, with those who operated 12-or-more hours per week during the last trimester of pregnancy at a higher risk compared to those who did not. Their findings are published in JAMA Surgery.

“The way female surgeons are having children today makes them inherently a high-risk pregnancy group,” said corresponding author Erika Rangel, MD, MS, of the Division of General and Gastrointestinal Surgery. “In addition to long working hours, giving birth after age 35 and multiple gestation which is associated with increased use of assisted reproductive technologies – is a risk factor for having major pregnancy complications, including preterm birth and conditions related to placental dysfunction.”

The researchers found that over half (57 percent) of female surgeons worked more than 60 hours per week during pregnancy. Over a third (37 percent) took more than six overnight calls. Of the 42 percent of women who experienced a miscarriage (a rate twice that of the general population) three-quarters took no leave afterwards.

“As a woman reaches her third trimester, she should not be in the operating room for more than 12 hours a week,” Dr Rangel said. “That workload should be offset by colleagues in a fair way so that it does not add to the already-existing stigma that people face in asking for help, which is unfortunately not a part of our surgical culture.”

Male and female surgeons were asked to respond to the survey, which had been developed with obstetricians and gynaecologists. Nonchildbearing surgeons answered questions regarding their partners’ pregnancies. The investigators found that, compared to female nonsurgeons, female surgeons were 1.7 times more likely to experience major pregnancy complications, along with greater risk of musculoskeletal disorders, non-elective caesarean delivery, and postpartum depression, which was reported by 11 percent of female surgeons.

“The data we have accumulated is useful because it helps institutions understand the need to invest in a top-down campaign to support pregnant surgeons and change the culture surrounding childbearing,” Dr Rangel said. “We need to start with policy changes at the level of residency programs, to make it easier and more acceptable for women to have children when it’s healthier, while also changing policies within surgical departments. It is a brief period of time that a woman is pregnant, but supporting them is an investment in a surgeon who will continue to practice for another 25 or 30 years.”

Source: Brigham and Women’s Hospital

Journal information: Rangel EL et al. “Incidence of Infertility and Pregnancy Complications in US Female Surgeons” JAMA Surgery DOI: 10.1001/jamasurg.2021.3301

Categories : COVID HospitalsTags :

Minimal COVID Breakthrough in Vaccinated Healthcare Workers

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Photo by Sammy Williams on Unsplash
Photo by Sammy Williams on Unsplash

Results from a study of cases at Israel’s largest medical centre have shown that breakthrough COVID infection appears to be rare in vaccinated healthcare workers, though they still pose a further infection hazard. Breakthrough infections were correlated with neutralising antibody titres in the early days of infection, and were mild or asymptomatic.

The findings were published in the New England Journal of Medicine. Testing for symptomatic COVID as well as those who had been exposed to an infected person, out of 1497 healthcare workers, the researchers found 39 testing positive in PCR tests. The researchers also measured neutralising antibody titres of uninfected controls. Breakthrough infections were defined as testing positive for SARS-CoV-2 11 days after the second immunisation dose.

Of the 39 cases, 27 occurred in workers tested solely because of exposure to an infected person, 26 (67% of all cases) had mild symptoms at some stage, and none needed hospitalisation. The remaining 13 workers (33%) were asymptomatic. The researchers found that 85% of the 33 infections tested for variants of concern were caused by the Alpha variant.

Symptoms reported included upper respiratory congestion (36% of all cases), myalgia (28%) and loss of smell or taste (28%); fever or rigors were reported in 21%. On follow-up questioning, 31% reported having residual symptoms 14 days after diagnosis. Six weeks after their diagnosis, 19% reported having ‘long COVID’ symptoms. Nine workers (23%) took a leave of absence from work beyond the 10 days of required quarantine.

They discovered that neutralising antibody titres were lower than uninfected controls during the “peri-infection period”.

“Most important, we found that low titres of neutralising antibody and S-specific IgG antibody may serve as markers of breakthrough infection,” they said.

Most of the cases however had N gene Ct values, suggesting they had been infectious at some point, which likely would have gone unnoticed save for exposure screening, which means the vaccine protected them against symptomatic disease, but not infection.

“However, no secondary infections were traced back to any of the breakthrough cases, which supports the inference that these workers were less contagious than unvaccinated persons,” the researchers noted.

The study was limited, the researchers acknowledged, due to a small number of cases, the possibility of asymptomatic cases being missed, and the lack of generalisability from a younger, healthy population to the general populace.

The researchers concluded that in their study, they “found that although the BNT162b2 vaccine is extremely effective, rare breakthrough infections carry an infectious potential and create a special challenge, since such infections are often asymptomatic and may pose a risk to vulnerable populations.”

Journal information: Bergwerk M., et al. Covid-19 breakthrough infections in vaccinated health care workers, New England Journal of Medicine, 2021; DOI: 10.1056/NEJMoa2109072.

Categories : Cardiovascular Disease HospitalsTags :

Heart Failure Diagnoses Being Missed in Primary Care Settings

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Image by StockSnap from Pixabay
Image by StockSnap from Pixabay

A considerable number of heart failure diagnoses may be missed in primary care settings, a new Stanford University study suggests, with gender, racial and income disparities.

Black adults, women and individuals with lower net worth are significantly more likely to be diagnosed with heart failure in an acute care setting such as the emergency room or during a hospitalisation, according to a new study. This is true even if they reported symptoms of heart failure in a routine, outpatient health care appointment within the previous six months. The study was published in Circulation: Heart Failure, an American Heart Association journal.

“This national study raises concerns that many heart failure diagnoses may be missed in a primary care setting,” said Rebecca Tisdale, MD, MPA, co-first author and health services research and development fellow at the US Department of Veterans Affairs and Stanford University. “Our results suggest acute care diagnosis rates for heart failure may be reduced if signs and symptoms of heart failure are more closely assessed in a primary care setting, particularly among women and Black adults.”

According to the American Heart Association 2021 Statistical Update, an estimated 6 million Americans ages 20 and older have been diagnosed with heart failure, with mortality rates of over 20% within the first year after diagnosis. Previous studies have found that heart failure is frequently first diagnosed in an acute care setting.

“Patients diagnosed with heart failure in the emergency room or during inpatient hospitalisation often have more advanced heart failure and complications with worse prognoses than individuals diagnosed with heart failure in a primary care setting,” said Alexander Sandhu, MD, MS, lead author of the study, an instructor of medicine in advanced heart failure in the division of cardiovascular medicine and the Stanford Cardiovascular Institute at Stanford University. “Since earlier recognition and treatment may prevent some of the serious complications and costs of heart failure, our analysis focused on evaluating whether heart failure is identified before the patient is in the emergency room or the hospital.”

Drawing on a national database of health care claims from 2003-2019, the investigators evaluated if patients with new incidence of heart failure were diagnosed in an outpatient (primary care) or acute care (emergency room or urgent care) setting. The analysis included nearly one million adults ages 18 or older with a first-time heart failure diagnosis.

A large proportion of new heart failure diagnoses were found to have occurred in the emergency room or during hospitalisation, particularly among women and Black adults, yet many had potential heart failure symptoms in the months before their acute care visits. Delving further, the investigators found that:

  • Among patients with newly diagnosed heart failure, 38% were diagnosed in acute care settings.
  • Of patients diagnosed in the acute care setting, 46% had potential heart failure symptoms during primary care clinic visits in the previous six months, including oedema (15%), cough (12%), shortness of breath (11%), and chest pain (11%).
  • Heart failure diagnosis in an acute care setting was higher for women than men, and also higher for Black adults than white adults.
  • People with a net worth of under $25 000 had 39% higher odds of receiving heart failure diagnoses in an acute care setting compared to people with a net worth of over $500 000.

Disparities in heart failure diagnosis within clinical practices persisted nationally across race, gender and economic status, suggesting potential differences in either quality of care or local resource availability. In addition, acute care heart failure diagnoses increased by 3.2% annually during the 16-year study period.

Timely heart failure diagnosis can lead to earlier care with the slowing of heart failure progression and improved patient outcomes. However, previous research has shown that both women and Black adults are less likely to be referred to a cardiologist or to promptly receive advanced heart failure treatment.

“Further research is needed to better understand the factors influencing these disparities,” Dr Sandhu concluded. “It is important to note that we only analysed patients with health insurance, raising concerns that inequities may be even larger among people who are uninsured, marginally insured or those who have less access to care.”

Source: American Heart Association

Journal information: Sandhu, A.T., et al. (2021) Disparity in the Setting of Incident Heart Failure Diagnosis. Circulation: Heart Failure. doi.org/10.1161/CIRCHEARTFAILURE.121.008538.

Categories : HospitalsTags :

Tshwane Hospital, Left Unscathed by Unrest, Continues the COVID Fight

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Amidst the unrest which badly disrupted the provision of healthcare in many areas, Dr George Mukhari Academic Hospital was one of the lucky Gauteng metros left unscathed.

The hospital’s Acting CEO Dr Keneilwe Letebele said that protests did not extend as far as Ga-Rankuwa, north of Pretoria, which left the healthcare facility untouched by the violence and looting.

“Up until now, our hospital has not been adversely affected, possibly because there were not much protest marches happening in our vicinity,” said Dr Letebele.

Being out of the thick of the protests let the hospital remain focussed on dealing with COVID cases. Lessons they had learnt from the first two waves had helped them mitigate the high number of fatalities in the third waves.

“The situation is quite challenging but we have learnt some valuable lessons from the first and second wave experiences regardless of some differences.

“These lessons have helped us to adapt to the situation. What is important is that when the first wave engulfed us, it was a first experience for everyone but now we know what to expect and how to address some challenges,” she said.

Dr Letebele noted that they have 60 additional beds at their newly-built Alternative Building Technology (ABT) unit, which adds to the existing 280 beds dedicated to COVID.

However, the high number of healthcare workers testing positive for COVID had left them short of staff.

“Capacity is reduced due to staff being COVID positive. However, the department has increased the number of staff to manage the surge (in cases),” she said.

Meanwhile, Vuyo Mhaga, the spokesperson for Gauteng Premier David Makhura, said scientists have warned that although COVID numbers were beginning to fall in the province, it was not enough – and it might even reverse given current events.

“The province is concerned that there might be a change in the downward trajectory of new infections due to recent protest action.

“Daily new infections remain very high. Some of those infected do require hospital care. These protests might cause the province to take longer to flatten the curve,” said Mhaga.

Meanwhile, health bodies including the South African African Health Products Regulatory Authority (SAHPRA) have issued a joint statement warning against using looted medications.

“We would like to urge the public not to utilise any medicines that are not accessed through authorised health care institutions. You may report such illegal activity to SAHPRA or to law enforcement agencies,” the medical bodies said.

They also said that looting and violence from the unrest only worsened the COVID pandemic and set back the provision of equitable healthcare.

“We appeal to citizens looting and destroying the healthcare infrastructure and disrupting the provision of health care to consider the long-term consequences of their actions on the health of communities.

“Without health care services, the requisite medicines and vaccines, we will have unnecessary deaths and cause further pandemonium, including severe damage to the economy,” the bodies said.

Source: IOL

Categories : HospitalsTags :

Manufacturer Shuts Down its Robot Mid-surgery

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Photo by Piron Guillaume on Unsplash
Photo by Piron Guillaume on Unsplash

One of a series of lawsuits against the company that makes the da Vinci surgical robot alleges that the company shut down its robot mid-surgery, forcing the surgeons to switch to an open surgery.

Several hospitals have launched a legal battle against the company Intuitive Surgical, the manufacturer of the da Vinci surgical robot. They allege that the company’s monopoly position forces hospitals to buy its maintenance services and spare parts at inflated prices even though cheaper alternatives are available.

One hospital alleges that, after it said that it was considering a service contract with a third party, Intuitive Surgical remotely shut down its surgical robot “in the middle of a procedure”, forcing the surgeon “to convert the procedure to open surgery with the patient on the operating table”.

Separately, malfunctions of the instrument arms have been reported, requiring additional, sometimes larger, incisions in patients in order to complete the surgical procedure manually. Use of the robotic technology also requires longer operating and anesthesia times as well as several complications occurring from the use of the da Vinci Surgical System itself.

Intuitive Surgical sells its da Vinci surgical robot to hospitals for anywhere from $500,000 to $2.5 million each. However, a majority of Intuitive Surgical’s $4 billion of annual revenue comes from the parts and services that are required to keep the robots running. Its executives are among the most highly paid in the healthcare industry.
Franciscan Health, Valley Medical Center and Kaleida Health filed class-action lawsuits. These hospitals that claim Intuitive Surgical has a monopoly on minimally invasive surgical robots, giving the company a “near-stranglehold” on the parts and services market for the robots.

One lawsuit alleges hospitals cannot have their da Vinci robots serviced by third parties because Intuitive Surgical forces hospitals to sign “multi-year, exclusive servicing agreements” at rates that are much higher than other vendors’. Hospitals also allege they are coerced into buying new, expensive instruments and attachments for their robots (called EndoWrists) after 10 uses, even if the parts are in good working condition. A limited extension of these uses has been launched by the company. The lawsuit alleges that Intuitive Surgical engineers have threatened hospitals with turning the machines into “paperweights” should hospitals seek outside vendors for parts or repairs.

While Intuitive Surgical has faced antitrust lawsuits from third-party repair and service companies since 2019, these hospital class-action lawsuits are new.

In an email, an Intuitive Surgical spokesperson told MedPage Today that the medical robotics company “does not have the ability to remotely shut down a da Vinci system during a surgical procedure underway at hospital.”

“There is risk associated with deviating from the validated processes cleared by regulatory authorities,” the spokesperson stated. “Continued use beyond an instrument’s determined useful life may reduce safety, precision, and dexterity. Further, third parties may use incompatible or unvalidated parts or processes in servicing or repairing the systems, which could cause damage and put patient safety at risk.”

Source: Axios