Category: Hospitals

Categories : COVID HospitalsTags :

ECG Readings Can Predict Worsening and Mortality in COVID and Influenza

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Specific and dynamic changes on electrocardiograms (ECGs) of hospitalised COVID patients with COVID or influenza can help predict a timeframe for worsening health and death, according to a new Mount Sinai study.

Published in the American Journal of Cardiology, the study shows that shrinking waveforms on these tests can be used to help better identify high-risk patients and provide them more aggressive monitoring and treatment.  

“Our study shows diminished waveforms on ECGs over the course of COVID illness can be an important tool for health care workers caring for these patients, allowing them to catch rapid clinical changes over their hospital stay and intervene more quickly. […] ECGs may be helpful for hospitals to use when caring for these patients before their condition gets dramatically worse,” said senior author Joshua Lampert, MD, Cardiac Electrophysiology fellow at The Mount Sinai Hospital. “This is particularly useful in overwhelmed systems, as there is no wait for blood work to return and this test can be performed by the majority of health care personnel. Additionally, the ECG can be done at the time of other bedside patient care, eliminating the potential exposure of another health care worker to COVID.”

Researchers did a retrospective analysis of ECGs on 140 hospitalised COVID patients across the Mount Sinai Health System in New York City, and compared them with 281 ECGs from patients with laboratory-confirmed influenza A or B admitted to The Mount Sinai Hospital.  
For each patient, the researchers compared three ECG time points: a baseline scan done within a year prior to COVID or influenza hospitalisation, a scan taken at hospital admission, and follow-up ECGs performed during hospitalisation.

They manually measured QRS waveform height on all electrocardiograms – changes in this electrical activity can indicate failing ventricles. The researchers analysed follow-up ECGs after hospital admission and analysed changes in the waveforms according to a set of criteria they designed  called LoQRS amplitude (LoQRS) to identify a reduced signal. LoQRS was defined by QRS amplitude of less than 5mm measured from the arms and legs or less than 10mm when measured on the chest wall as well as a relative reduction in waveform height in either location by at least 50%.

Fifty-two COVID patients in the study did not survive, and 74% of those had LoQRS. Their ECG QRS waveforms reduced approximately 5.3 days into their hospital admission and they died approximately two days after the first abnormal ECG was observed.

Out of the 281 influenza patients studied, LoQRS was identified in 11 percent of them. Seventeen influenza patients died, and 39% had LoQRS present. Influenza patients met LoQRS criteria a median of 55 days into their hospital admission, and the median time to death was six days from when LoQRS was identified. Overall, these results show influenza patients followed a less virulent course of illness when compared to COVID patients.

“When it comes to caring for COVID patients, our findings suggest it may be beneficial not only for health care providers to check an EKG when the patient first arrives at the hospital, but also follow-up ECGs during their hospital stay to assess for LoQRS, particularly if the patient has not made profound clinical progress. If LoQRS is present, the team may want to consider escalating medical therapy or transferring the patient to a highly monitored setting such as an intensive care unit (ICU) in anticipation of declining health,” added Dr Lampert.

Source: The Mount Sinai Hospital / Mount Sinai School of Medicine

Categories : COVID HospitalsTags :

Prone Positioning Reduces Need for Mechanical Ventilation

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A ‘meta-trial’ of 1100 hospitalised COVID patients requiring high-flow nasal cannula oxygen therapy suggests that prone positioning soon after admission can significantly reduce the need for mechanical ventilation.

While acute respiratory distress syndrome patients have been placed prone for years by critical care specialists, this study provides clinical evidence needed to support the use of prone positioning for patients with COVID requiring high-flow nasal cannula oxygen therapy.

The findings, published today in the Lancet Respiratory Medicine, were conducted on severely ill COVID patients between April 2020 and January 2021.

“Breathing in the prone position helps the lungs work more efficiently,” explained the study’s lead author Dr. Jie Li, associate professor and respiratory therapist at Rush University Medical Center. “When people with severe oxygenation issues are laying on their stomachs, it results in better matching of the blood flow and ventilation in the lungs which improves blood oxygen levels.”

Prof Li noted that several interventions are available to improve oxygenation in critically ill patients, but that there was little outcomes-focused clinical evidence to show that prone positioning prior to mechanical ventilation is beneficial.

Adult patients with COVID needing respiratory support from a high-flow nasal cannula agreed to participate in this clinical trial, and were randomly assigned to the supine or prone positioning groups. They were asked to stay in that position for as long as they could tolerate. Both positioning groups received high-flow oxygen therapy and standard medical management.

Patients were continually monitored to determine if mechanical ventilation was needed. This study’s data showed that patients in the prone positioning group were significantly less likely to require mechanical ventilation (33% in the awake prone positioning group vs 40% in the supine group).

Another study lead author, Stephan Ehrmann, MD, PhD, said that “for the clinical implications of our study, awake prone positioning is a safe intervention that reduces the risk of treatment failure in acute severe hypoxemic respiratory failure due to COVID-19. Our findings support the routine implementation of awake prone positioning in critically ill patients with COVID19 requiring high flow nasal cannula oxygen therapy. It appears important that clinicians improve patient comfort during prone positioning, so the patient can stay in the position for at least 8 hours a day.”

Reducing the need for mechanical ventilation cuts down on resources needed. “Ventilators can indeed save the lives of people who are no longer able to breathe on their own. That said, we now have strategies to keep patients off the ventilator, saving those devices for the sickest patients who truly need them.” Prof Li added.

Source: Medical Xpress

Categories : Hospitals Medical Research & TechnologyTags :

New Medical Device Slashes Surgery Risk

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A new electromedical device provides important data about possible cardiovascular and pulmonary risks before an operation.

Before any operation, it is important to properly assess the individual risk: Are there perhaps circulatory or pulmonary problems that need special consideration? To what extent can special risks be taken into account when planning the anaesthesia? Previously, clinicians have had to rely on rather subjective empirical values or carry out more elaborate examinations when in doubt. To address this, a novel device has been developed by TU Wien and MedUni Wien to objectively measure the cardiovascular and pulmonary system fitness of patients.

Pre-op interviews are important—but subjective
Complications often occur after surgical interventions. In addition to blood loss and sepsis, perioperative cardiovascular and pulmonary problems are among the most common causes of death in the first 30 days after surgery.

To minimise this risk, anesthesiologists routinely talk to patients before surgery, in addition to measuring their blood pressure, performing an electrocardiogram, or conducting more laborious examinations. But assessing responses can be highly individualised. “There are also objectively measurable parameters by which one could easily identify possible risks,” said Prof Eugenijus Kaniusas (TU Wien, Faculty of Electrical Engineering and Information Technology). “So far, however, they have not been routinely measured.”

Just hold your breath
This new device uses multiple sensors to determine key metrics in a completely non-invasive way. All the patient has to do is hold their breath for a short time to slightly outbalance their body, which responds reflexively with various biosignals. “Holding your breath is a mild stress for the body, but that is already enough to observe changes in the regulatory cardiovascular and pulmonary systems,” explained Eugenijus Kaniusas. “Oxygen saturation in the blood, heart rate variability, certain characteristics of the pulse waveform—these are dynamic parameters that we can measure in a simple way, and from them we could ideally infer individual fitness in general, especially before surgery.”

Since the device is non-invasive, medical training is not needed to operate it, and has no side effects. The result is easy to read: A rough assessment according to the three-color traffic light system or a score between 0 and 100 is displayed. The measurement can also be carried out at the bedside without any problems for people with limited mobility.

“Our laboratory prototype is being tested at MedUni Wien in cooperation with Prof. Klaus Klein from the University Department of Anesthesia, General Intensive Care Medicine and Pain Therapy. We hope to bring the device to market in the next 5 years with the help of research and transfer support,” said Eugenijus Kaniusas.

Source: Vienna University of Technology

Categories : Cancer HospitalsTags :

Cancer Surgery Patients Have a Reduced Hospital Stay with ‘Prehabilitation’

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A new approach to improve their fitness for surgery reduced the length of hospital stay for cancer patients, according to a new study.

Termed ‘prehabilitation’, the study’s approach includes exercise, nutrition and psychological and social interventions to bolster physical and mental health before surgery.

The study, published in the Annals of Surgery, found that prehabilitation interventions of between one and four weeks reduced cancer patients’ stay in hospital by 1.8 days compared with usual care.

Study author Dr Chris Gaffney from Lancaster Medical School said: “Surgery is like a marathon in terms of stressing the body, and you wouldn’t run a marathon without training.”

The researchers found that as little as one week can still benefit patient outcomes, indicating that prehabilitation should be recommended to accelerate recovery from cancer surgery, as shown by a reduced hospital length of stay.

Study author Dr Joel Lambert, now a postgraduate student at Lancaster Medical School and a surgeon at East Lancashire Teaching Hospitals NHS Trust, said: “We think that it may also confer a survival advantage for cancer patients as they can get to follow up treatments like chemotherapy more quickly.

“We think that the patient groups most likely to benefit are the ones with lower levels of fitness at baseline. In the Northwest we have some of the most socioeconomically deprived populations in the UK. This subset tend to have more co-morbid conditions hence less fit.”  

The patients studied were those with liver, colorectal, and upper gastrointestinal cancer, and who are often less fit than other cancer patients.

The study interventions were grouped into three types

  • Multimodal prehabilitation: exercise, which included both nutrition and psychosocial support,
  • Bimodal prehabilitation: exercise and nutrition or psychosocial support
  • Unimodal prehabilitation: exercise or nutrition alone

The exercise interventions included aerobic, resistance, and both aerobic and resistance exercises at all levels of intensity, some supervised by a kinesiologist or physiotherapist, while others were home-based exercise regimes. These ranged from one to four weeks and all interventions were within the current NHS surgery targets for cancer surgery.

The researchers concluded: “Future studies should focus on identifying patients who would benefit most from prehabilitation and the mechanistic underpinning of any improvement in clinical outcomes. Studies should closely monitor nutrition intake to determine if the response to exercise prehabilitation is dependent upon nutritional status. Lastly, mortality should be monitored for 12 months post surgery to determine if prehabilitation has any effect beyond 30 or 90 days.”

Source: Lancaster University

Categories : HospitalsTags :

Sleep Deprivation Common in Surgeons, Impacting Performance

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New research has found that surgeons were sleep deprived prior to on-call shifts and afterwards even more so, and crucially, that sleep deprivation impacted surgical performance. 

The study is the first to focus on Irish surgeons and is published in the Journal of Surgical Research. A separate study found that short naps of 30 to 60 minutes do little to reduce sleep deprivation.

Focussing on the effects of being ‘on-call’, a frequent state for surgeons, the study explored subjective and objective metrics around sleep and performance using ‘on-call’ as a particular influencer for increased fatigue.

Surgeons frequently work 24 straight hours (or more) resulting in unavoidable sleep disturbance. This is partly due to historical associations of the Halstedian Era of Surgery to ‘reside’ in the hospital in order to properly learn, but also current staffing levels mandating surgeons to complete regular on-call work.

Participants were hooked up to electroencephalogram (EEG) machines and a validated modified Multiple Sleep Latency Test testing was used to objectively measure sleep on the morning of their on-call shift. The researchers also record other validated tests for subjective sleep and fatigue measurement. ‘Sleep latency’ refers to the time it takes to go from being fully awake to sleeping and is often an indicator of sleepiness. The surgeons in the study had early onset sleep latency before on-call, which was exacerbated further in post-call settings.

Performance was measured with standardised and validated tools. Technical performance of surgeons was assessed using the validated Simendo © surgical simulator, while cognitive performance was measured using the Psychomotor Vigilance Task (PVT) to assess objective alertness and reaction time, a known aspect of cognitive performance.

The study is the first to attempt to control for a series of confounding variables such as experience, quality and quantity of sleep, the influence of caffeine and circadian rhythm influences.

The study found that:

  • Surgeons had poor baseline sleep quality and were objectively sleep-deprived, even pre-call, when they should be in a ‘rested state’.
  • In all study participants, early onset sleep latency was seen in pre-call settings and worsened in post-call settings.
  • Early onset sleep latency was worse in trainees compared to consultants, though both groups experienced early onset sleep latency post-call.
  • As sleep-deprivation increased, diminished performance was seen in cognitive tasks and surgical tasks with greater cognitive components.
  • Higher levels of self-reported fatigue and daytime sleepiness were recorded post-call.

Technical skill performance was relatively preserved in acutely sleep deprived states but may be influenced by learning curve effects and experience in surgical tasks.

Existing models of surgical on-call were not conducive to optimising sleep for surgeons, the research found. But making changes for better sleep has challenges, such as loss of continuity of patient care, loss of trainee exposure, and reduced service delivery.

Dale Whelehan, PhD researcher in Behaviour Science at the School of Medicine and lead researcher commented: “The findings of this study tell us that current provision of on-call models preclude the opportunity for surgeons to get enough rest. Similarly, surgeons are sleep deprived before going on-call which further perpetuates the issue. The implications for performance suggest aspects of surgeons performance is diminished, particularly tasks which might be more cognitively demanding. 

“We need meaningful engagement from all stakeholders in the process, working towards the common goal of optimising performance in surgeons. This involves looking at the multifactorial causes and effects of fatigue. Part of that discussion involves consideration around how current models of on-call influence sleep levels in healthcare staff, and how it creates barriers to fatigue management in staff.”

Professor Paul Ridgway, Department of Surgery at Trinity, who supervised the study, said: “Our study is further evidence that the way we deliver emergency work alongside normal work in Ireland has to change. We need to learn from our colleagues in aviation who have mandatory rest periods before flights.”

Source: Trinity College Dublin

Categories : COVID HospitalsTags :

One in Ten COVID Cases Infected After Hospital Admission

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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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“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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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

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.