ANCC-MSN VCE test - ANCC (RN-BC) Medical-Surgical Nursing Updated: 2024
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Exam Code: ANCC-MSN ANCC (RN-BC) Medical-Surgical Nursing VCE test January 2024 by Killexams.com team
ANCC-MSN ANCC (RN-BC) Medical-Surgical Nursing
Exam ID : ANCC-MSN
Exam Title : Medical-Surgical Nursing Board Certification Examination
Questions : 125 (25 unscored)
The ANCC Medical-Surgical Nursing board certification examination is a competency based examination that provides a valid and reliable assessment of the entry-level clinical knowledge and skills of registered nurses in the medical-surgical specialty after initial RN licensure. Once you complete eligibility requirements to take the certification examination and successfully pass the exam, you are awarded the credential: Registered Nurse-Board Certified (RN-BC). This credential is valid for 5 years. You can continue to use this credential by maintaining your license to practice and meeting the renewal requirements in place at the time of your certification renewal. The Accreditation Board for Specialty Nursing Certification accredits this ANCC certification.
There are 150 questions on this examination. Of these, 125 are scored questions and 25 are pretest
questions that are not scored. Pretest questions are used to determine how well these questions will
perform before they are used on the scored portion of the examination. The pretest questions cannot
be distinguished from those that will be scored, so it is important for a candidate to answer all
questions. A candidate's score, however, is based solely on the 125 scored questions. Performance on
pretest questions does not affect a candidate's score.
Category Content Domain Number of Questions Percentage
I Assessment and Diagnosis 52 42%
II Planning, Implementation, and Evaluation 58 46%
III Professional Role 15 12%
TOTAL 125 100%
I Assessment and Diagnosis
1. Health history collection
2. Physical assessment (e.g., disease process, review of systems, activities of daily living)
3. Psychosocial assessment (e.g., developmental stages, suicide risk, abuse, substance use disorders)
4. Cognitive assessment (e.g., neuro status, developmental age, impairment)
5. Diagnostic and laboratory testing (e.g., patient preparation, response to abnormal values, medication considerations)
6. Nursing diagnosis identification and prioritization
1. Fluids and electrolytes (e.g., imbalances, disease-related, blood products)
II Planning, Implementation, and Evaluation
1. Nursing care planning (e.g., interventions, modifications, outcomes)
2. Postoperative complication prevention and management (e.g., bleeding, infection, emboli)
3. Patient teaching (i.e., learning preferences, barriers, and confirmation)
1. Education Topics (e.g., self-management, acute and chronic conditions, population specific)
2. Patient safety measures (e.g., screening tools, infection prevention, restraints, medical equipment)
3. Non-pharmacologic treatments (e.g., complementary and alternative medicine, diversional activities)
4. Medication interactions and adverse effects (e.g., pain management, polypharmacy, drug-drug, food-drug)
5. Health and wellness promotion (e.g., screenings, vaccinations, healthy lifestyle modifications)
III Professional Role
1. Therapeutic communication (e.g., patient- and family-centered care, cultural competence)
1. Nursing ethics (e.g., evidence-based practice, advocacy)
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ANCC (RN-BC) Medical-Surgical Nursing
The nurse includes the important measures for stump care in the teaching plan for
a client with an amputation. Which measure would be excluded from the teaching
A. Wash, dry, and inspect the stump daily
B. Treat superficial abrasions and blisters promptly
C. Apply a shrinker bandage with tighter arms around the proximal end of the
D. Toughen the stump by pushing it against a progressively harder substance
(e.g., pillow on a foot-stool)
Apply a "shrinker" bandage with tighter arms around the proximal end of the
affected limb. The shrinker bandage is applied to prevent swelling of the stump.
It should be applied at the distal end with the tighter arms. Applying the tighter
arms at the proximal end will impair circulation and cause swelling by reducing
Which nursing action is the first priority during a generalized tonic-clonic seizure
A. Observe and record all events that occur before, during, and after the seizure
B. Maintain a patent airway by turning the head to the side
C. Protect the client from injury
D. Monitor vital signs, with special attention directed to respiratory status
The first priority is to protect the client from injury. Do not restrain the clients
arms or legs, but make sure he or she does not hit anything. Protect the head with
the nurses hand, a towel, or a jacket. During the initial tonic phase, the client
usually stops breathing for up to minute. There is no cause for alarm, as
spontaneous breathing will, in most clients, return with no harm. In the absence of
breathing, airway patency by this position change (Choice B) is not the first
priority. Muscle contraction will prevent positioning of the head. A padded
tongue blade, once indicated during a seizure, is also no longer used. Choices A
and D are appropriate nursing actions after the seizure has ended.
Levin, age 27, was driving home when his car collided with another moving
vehicle. He obtained multiple injuries and a concussion. The paramedics placed a
hard neck brace to immobilize the spine. Upon arriving at the hospital, X-rays are
inconclusive because of swelling. To assess and care for the skin under the collar,
the nurse should:
A. Place the client flat and supine; remove the anterior section of the collar,
turning the head to the right or left to remove the back section.
B. Have the client sit up in a chair to remove the front and back sections without
turning the head from side to side.
C. Have at least one nurse stabilize the head in line with the torso, while the other
nurse removes the collar sections.
D. Wait until the X-rays are conclusive for any trauma before assessing the skin
or providing skin care under the collar.
The head and neck are maintained in an aligned position at all times and
supported. The collar is hard and can cause skin breakdown. The collar liner
should be changed daily and the underlying skin cleansed. Turning the head from
side to side may cause injury to the spine (Choice A). Choice B is incorrect
because the client may be experiencing weakness and there is no support for the
neck if the collar is removed. The collar liner must be changed and the skin
cleaned daily to prevent breakdown (Choice D). The presence or absence of a
spinal injury may not be determined in less than 24 hours.
Troy, 27 years old, suffered from multiple injuries after his car crashed into a
moving vehicle. He was then rushed to a nearby hospital where his left leg was
amputated below the knee. After surgery, the physicians orders include elevation
of the foot of the bed for 24 hours. The nurse observes that the nursing assistant
has placed a pillow under Troys amputated limb. The nursing action is to:
A. Leave the pillow, as his stump is elevated
B. Remove the pillow and elevate the foot of the bed
C. Leave the pillow and elevate the foot of the bed
D. Check with the physician and clarify the orders
The orders call for bed elevation (this is done to reduce edema and prevent
hemorrhage). A pillow under the stump may lead to a flexion contracture of the
hip joint, so this is contraindicated. Also, further teaching is indicated so that the
nursing assistant understands why the pillow is contraindicated.
A client is scheduled for an electroencephalogram (EEG) early in the morning.
The nurse working the night shift prior to the procedure would write a note to do
which of the following per protocol order in the early morning on the day of the
A. Instruct the client to refrain from washing the hair
B. Hold the daily dose of anticonvulsant
C. Place the client on NPO status
D. Reinforce client teaching that the test is only mildly uncomfortable
Antidepressants, tranquilizers, and anticonvulsants are generally withheld for 24
to 48 hours before an EEG. The client does not have to be on NPO, but should
avoid stimulants such as coffee, tea, cola, alcohol, and cigarettes. Pre-procedure
care for EEG involves teaching that there is no discomfort and shampooing the
S. McCormick, R.N., is one of several persons who witness a vehicle hit a
pedestrian at fairly low speed on a street. The person is dazed and tries to get up.
The leg appears fractured. Ms. McCormick would plan to:
A. Try to reduce the fracture manually
B. Assist the person to get up and walk to the sidewalk
C. Leave the person for a few moments to call an ambulance
D. Stay with the person and encourage the person to remain still
With a suspected fracture, the client is not moved unless it is dangerous to remain
in that spot. A fracture is not reduced at the scene (Choice A). Choice B is
incorrect because before the client is moved, the site of fracture is immobilized to
prevent further injury. Choice C is incorrect because the nurse should remain with
client and have someone else call for emergency help.
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I never miss my monthly pedicure, and by the time I leave the hair salon my next appointment is already on the books. Even my regular date with my dental hygienist for a cleaning never gets missed. Itâs other preventive things on the to-do list that seem to get put off, and put off, and put offâŠ
So for the benefit of us allâand to begin the year with a focus on better healthâhere are three tests we need to schedule now. And unlike a pedicure or a hair appointment, these three could save your life.
Despite pink ribbons everywhere each year, breast cancer awareness campaigns, sports teams boosting awareness by dressing in pink, and encouragement from celebrities with breast cancer such as Cynthia Nixon, Christina Applegate, and Julia Louis-Dreyfus, the majority of women in this country do not get mammograms. In a latest survey of women over 40, 23% of women said they had never had a mammogram and 59% did not get one annually. Diagnoses of breast cancer have increased every year over the past two decades or so. Why, when known risk factors such as genetics have not changed? What has changed is that women are living longer, and the older a person is, the more likely they are to get breast cancer. And over the past few decades obesity rates have increased, alcohol use by women has gone up, and people are less activeâall these are established risk factors for breast cancer. And while the effect of hormone disrupters in the environment is controversial, those chemicals are likely to have had an impact too.
Hereâs what isnât controversial: Though the number of cancer diagnoses is increasing, the number of deaths from breast cancer is decreasing. The women least likely to die are those who are diagnosed when their cancer is at an early stage. And mammography is the best strategy for early detection.
Most people donât have a problem admitting that they need glasses, but for many, nothing says âIâm really old!â like a hearing aid. Yet one in seven middle-aged people is hard of hearing. By age 75, about half the population has hearing loss.
Still, only 16% of people between the ages of 20 and 69 who need hearing aids use them, according to the National Institute on Deafness and Other Communication Disorders. And while being a little hard of hearing might be a bonus in some situations (think hanging out with adults who donât share your politics), most people would prefer not to miss out on what everyone else is saying. So if every time you go to a restaurant you need to mime to communicate, or you find that youâre nodding and smiling only to discover that your coworker just told you their mother died, itâs probably time to get your hearing checked. Aside from avoiding social faux pas, there are compelling health reasons to visit an audiologist, starting with brain health: A 2023 study funded by the NIH was conducted on nearly 1,000 hard-of-hearing adults ages 70 to 84 who had a higher-than-average risk of developing dementia. Half were given hearing aidsâand that group had an almost 50% reduction in cognitive decline over a three-year period. Multiple other studies have confirmed that people who use hearing aids have lower rates of depression, anxiety, and loneliness.
Hearing affects balance as well, so hearing aids also decrease the risk of falling down and breaking a hip. This means getting hearing aids can literally save lives, as about one in three adults 50 and older who suffer a hip fracture dies within a year.
This may get the prize for the least popular test even though itâs been proven that proper screening significantly reduces the risk of colon cancerâand in the past 15 years thereâs been an alarming upward trend in the number of young people diagnosed with the disease. Thereâs a long list of excuses people use to avoid getting it done, with âColon cancer doesnât run in my familyâ at the top. But genetics accounts for only 5% to 10% of colon cancer cases. Then thereâs the âI canât face the prepâ excuse, and I get it, nobody wants to gag down two liters of vile-tasting stuff that triggers hours of pooping. Well, thereâs one improvement: The FDA recently approved a new prep drink (Suflave) that does the job just as well and tastes delicious (or at least they say it does).
I know the whole idea of signing up for a procedure that involves baring your butt to a stranger (who then inserts a really long tube) may be as appealing as getting a root canal, but anyone who has been diagnosed with colon cancer will tell you that doing an icky prep routine and having an embarrassing procedure is far better than having surgery and chemotherapy. Yes, there are loads of excuses for putting it off, but I donât recommend that. Itâs unclear why so many people are getting colon cancerâmost experts attribute it to obesity, physical inactivity, smoking, and (possibly the biggest factor) an unhealthy diet of ultra-processed foods that alters the bacteria in the gut. Itâs projected that by 2030 colorectal cancer will be the leading cause of cancer-related death in people ages 20 to 49, which is why new guidelines from the United States Preventive Services Task Force recommend that initial screening should start at age 45 rather than 50 (as had been recommended before) for asymptomatic people at average risk.
So no more excuses: Schedule your mammogram, hearing test, and colonoscopyâitâll be a great start to both a healthier year and a healthier life.
ChatGPT is still no House, MD.
While the chatty AI bot has previously underwhelmed with its attempts to diagnose challenging medical casesâwith an accuracy rate of 39 percent in an analysis last yearâa study out this week in JAMA Pediatrics suggests the fourth version of the large language model is especially bad with kids. It had an accuracy rate of just 17 percent when diagnosing pediatric medical cases.
The low success rate suggests human pediatricians won't be out of jobs any time soon, in case that was a concern. As the authors put it: "[T]his study underscores the invaluable role that clinical experience holds." But it also identifies the critical weaknesses that led to ChatGPT's high error rate and ways to transform it into a useful tool in clinical care. With so much interest and experimentation with AI chatbots, many pediatricians and other doctors see their integration into clinical care as inevitable.
The medical field has generally been an early adopter of AI-powered technologies, resulting in some notable failures, such as creating algorithmic racial bias, as well as successes, such as automating administrative tasks and helping to interpret chest scans and retinal images. There's also lot in between. But AI's potential for problem-solving has raised considerable interest in developing it into a helpful tool for complex diagnosticsâno eccentric, prickly, pill-popping medical genius required.
In the new study conducted by researchers at Cohen Childrenâs Medical Center in New York, ChatGPT-4 showed it isn't ready for pediatric diagnoses yet. Compared to general cases, pediatric ones require more consideration of the patient's age, the researchers note. And as any parent knows, diagnosing conditions in infants and small children is especially hard when they can't pinpoint or articulate all the symptoms they're experiencing.
For the study, the researchers put the chatbot up against 100 pediatric case challenges published in JAMA Pediatrics and NEJM between 2013 and 2023. These are medical cases published as challenges or quizzes. Physicians reading along are invited to try to come up with the correct diagnosis of a complex or unusual case based on the information that attending doctors had at the time. Sometimes, the publications also explain how attending doctors got to the correct diagnosis.
For ChatGPT's test, the researchers pasted the relevant text of the medical cases into the prompt, and then two qualified physician-researchers scored the AI-generated answers as correct, incorrect, or "did not fully capture the diagnosis." In the latter case, ChatGPT came up with a clinically related condition that was too broad or unspecific to be considered the correct diagnosis. For instance, ChatGPT diagnosed one child's case as caused by a branchial cleft cystâa lump in the neck or below the collarboneâwhen the correct diagnosis was Branchio-oto-renal syndrome, a genetic condition that causes the abnormal development of tissue in the neck, and malformations in the ears and kidneys. One of the signs of the condition is the formation of branchial cleft cysts.
Overall, ChatGPT got the right answer in just 17 of the 100 cases. It was plainly wrong in 72 cases, and did not fully capture the diagnosis of the remaining 11 cases. Among the 83 wrong diagnoses, 47 (57 percent) were in the same organ system.
Among the failures, researchers noted that ChatGPT appeared to struggle with spotting known relationships between conditions that an experienced physician would hopefully pick up on. For example, it didn't make the connection between autism and scurvy (Vitamin C deficiency) in one medical case. Neuropsychiatric conditions, such as autism, can lead to restricted diets, and that in turn can lead to vitamin deficiencies. As such, neuropsychiatric conditions are notable risk factors for the development of vitamin deficiencies in kids living in high-income countries, and clinicians should be on the lookout for them. ChatGPT, meanwhile, came up with the diagnosis of a rare autoimmune condition.
Though the chatbot struggled in this test, the researchers suggest it could Strengthen by being specifically and selectively trained on accurate and trustworthy medical literatureânot stuff on the Internet, which can include inaccurate information and misinformation. They also suggest chatbots could Strengthen with more real-time access to medical data, allowing the models to refine their accuracy, described as "tuning."
"This presents an opportunity for researchers to investigate if specific medical data training and tuning can Strengthen the diagnostic accuracy of LLM-based chatbots," the authors conclude.
Internal medicine and rheumatology specialist Siobhan Deshauer, MD, reviews the case study of a pregnant woman who was hospitalized.
Following is a partial transcript of the video (note that errors are possible):
Deshauer: Hey, guys. I'm Siobhan, an internal medicine and rheumatology specialist. Today, I'm going to tell you about Emma. She is a 31-year-old woman who landed her dream job, first violinist in a prestigious orchestra, and she has never had any health issues until recently.
Emma and her husband have been struggling to get pregnant over the past 2 years and she is now seeing a fertility specialist. Anxious to find a treatment that would work for her, Emma also started seeing another health practitioner who recommended various supplements that she was told were safe and effective. Unfortunately, she has been hiding this from her doctor and little did she know that decision would land her in the hospital and change the next few years of her life.
Over the past few weeks, Emma has had abdominal pain, nausea, and vomiting. She had a glimmer of hope thinking she might be pregnant, but the tests kept coming back negative. Her symptoms just kept getting worse and it was starting to affect her ability to perform at the orchestra. She was sure that her colleagues were starting to notice. After one particularly poor performance, she decided to go to the doctor. Her doctor checked her vitals, ordered some blood work, along with an abdominal ultrasound. Everything looked fine, so her doctor thought it might just be stress from the new job, but the pain and nausea worsened to the point that she was barely able to eat anything.
Finally, after a horrible episode of vomiting, her husband brought her to the emergency department. Her blood work showed mild anemia. Her red blood cells were a bit too low. After her vitals were normal and her imaging was normal, she was sent home with an iron supplement and told to follow up with her family doctor in about 2 weeks.
Over the next few days, her symptoms just continued to progress. She had to call in sick from work and was spending most of the day in bed exhausted and in pain. But Emma didn't want to go back to the hospital, wait for hours, and then just get sent home again. Then one day she was getting out of bed, she became so dizzy that she fell to the ground on her knees. Her husband heard the sound, ran upstairs and found her on the ground. That was it. They were heading back to the hospital.
In the emergency department, her heart rate was a little bit fast, but it was her blood work that was alarming. Emma's hemoglobin was much lower than before, so low that she required a blood transfusion. Emma was actually relieved to hear that they had found something to explain her symptoms, but the question remains why was her hemoglobin dropping so dramatically? The emergency doctor explained that she might be bleeding from her stomach. That would explain her abdominal pain and the drop in her hemoglobin. The plan this time was to admit her to hospital.
A few hours later, a tired-looking internal medicine resident came to assess Emma. When asked about medications, Emma responded that she is taking levothyroxine, a thyroid supplement, and follitropin alfa injections for infertility. When asked about supplements, she only mentioned her prenatal vitamins.
Now, remember Emma is also taking supplements for infertility, but she didn't want to tell the doctor because she was thinking about being judged and she couldn't imagine that it was relevant in this situation. Emma's blood tests not only showed that she was anemic with too few red blood cells, but that the cells were too small. We call this microcytic anemia. In situations like this, her bone marrow should be going into overdrive, pumping out as many new red blood cells as possible, but another test called the reticulocyte count proved that this wasn't the case for Emma.
When I see a patient like this with microcytic anemia, a whole bunch of causes come to mind. But by far, the most common cause is iron deficiency, especially in a young woman. Think about iron deficiency like this: either you're not eating enough iron, your body is not absorbing that iron, or you're bleeding and then losing the iron.
Emma's blood work is consistent with iron deficiency with a ferritin level lower than expected. This suggests that she has a low amount of iron stored away in her body and maybe the bone marrow wasn't creating enough red blood cells because it didn't have enough iron available. But iron deficiency itself doesn't cause abdominal pain, so her doctors wondered if she might be bleeding somewhere in her abdomen, maybe a bleeding peptic ulcer.
In the emergency department, Emma already had a CT scan of her abdomen and an ultrasound, both of which were normal. You may be surprised to learn that often a CT scan or an MRI won't actually find the cause of a GI bleed. Often the bleeding is coming from an erosion in the protective layer of the gut and you really need to camera down the GI tract to be able to see that.
The next day she was wheeled down to the endoscopy suite and sedated. First, a camera was inserted into her throat, no signs of bleeding. Then she had a colonoscopy and again totally normal. Okay, so no bleeding in the GI tract where we can see.
Another thing we have to consider in a woman who is having abdominal pain and unexplained anemia is endometriosis, which is a disease where tissue similar to the lining of the uterus grows elsewhere in the body. Just like the uterus does, the tissue thickens up, breaks down and then bleeds with each menstrual cycle. This could be a hidden source of blood loss. It can also cause severe pain, especially in the pelvis, and it can also cause infertility. This could actually tie together all of Emma's symptoms including her latest diagnosis of infertility. Endometriosis is notoriously difficult to diagnose and it can be missed on imaging, which is why surgery is often needed to help make the diagnosis. Emma agreed to go ahead with the exploratory laparoscopy and a few days later she was taken to the operating room.
She was put under general anesthetic and the surgeons got to work. They poked small holes in her abdomen and inserted a small tube with a light and camera attached. They also insert another tube that pumps air into the abdomen. This raises up the abdominal wall so it's possible to look around at the organs and then operate if necessary.
The surgeon carefully examined each of Emma's organs, looking for any signs of endometriosis, which would look something like this. But they only found one abnormality, a simple cyst on her ovary, far from a slam-dunk diagnosis and probably unrelated to her symptoms. But nonetheless, the surgeons took a biopsy of the cyst and sent it off to the pathology lab to be examined. But if it doesn't look like endometriosis, what else could it be?
Emma's medical team went back to the drawing board to rethink her case. She eats a diet containing enough iron. She has no signs of malabsorption and they couldn't find any signs of bleeding, so maybe the blood work showing iron deficiency is just a red herring and there is another cause for her anemia that hasn't been considered. Could this be a production problem, an issue stemming from the bone marrow where the red blood cells are made? Well, there is only one way to find out, going straight to the source.
Emma was prepped for a bone marrow biopsy where a needle is inserted into the bone to take a trial of the semi-solid tissue inside. Making over 500 billion blood cells per day, our bone marrow is constantly working hard to keep us alive. Now, it's a waiting game. The results from the bone marrow won't be back for a few weeks, so Emma was discharged home with a diagnosis, anemia NYD (not yet diagnosed). But on a positive note, her abdominal pain had improved and as she was leaving the hospital she was told to restart her usual home medications and to come back if things got worse. When she got home, she restarted her fertility injections and those fertility supplements again.
Emma was still really tired and soon she developed a new headache and she was never someone to get headaches. Plus, tinnitus, that high-pitched ringing in her ears that just wouldn't go away. She kept track of her symptoms until she had her follow-up appointment 2 weeks later. Hearing about her new neurological symptoms, the internal medicine team decided to expand their diagnostic search to include another rare cause, porphyria.
This is a very rare group of conditions that affects how your body makes heme, an important part of hemoglobin, and some patients experience porphyria attacks, which can include anemia, neurological symptoms, and abdominal pain. It was a stretch and they knew it. But if you never look for those rare causes, you'll never find them, so her doctors ordered a urine test to screen for the disease.
Two weeks later Emma had another follow-up appointment to go through results. She was nervous, but hopeful that she might walk away with some answers this time. First, the surgical biopsy. It was normal, no endometriosis or cancer. Good. Next, the bone marrow results. It showed some increase in iron stores, but it was otherwise normal, so again no diagnosis.
Then a result that finally gave them a lead, Emma's porphyria screening show high levels of copper porphyrin III and delta-ALA. Okay. Now, porphyria screening is a whole can of worms that we don't have time to unpack right now, but the key point is that this particular result really narrows things down to either porphyria or lead poisoning.
Emma was sent back to the lab this time to have her blood lead levels drawn. Two days later, Emma got a phone call from her doctor's office. Her blood lead levels were off the chart. Finally, she has a diagnosis. Emma is suffering with lead poisoning. This explains all of her symptoms: abdominal pain, nausea, and vomiting. These are classic, early signs of lead toxicity.
Neurological symptoms take some time to develop, which explains why her headache and tinnitus came on later. This also explains her anemia. Lead accumulates in the bone marrow, blocking certain enzymes that produce heme, an important part of hemoglobin. Less heme means smaller red blood cells and it also limits the bone marrow's ability to create more cells, ultimately causing hypoproliferative microcytic anemia.
But why did her porphyria testing come back positive? Well, as lead blocks important enzymes that produce heme, that leads to a buildup of byproducts. Think of it like the conveyor belt in the factory that's making heme is broken and as a result there is a buildup of raw materials. Those raw materials are copper porphyrin III and delta-ALA. That's why her porphyrin screening came back positive. It's so cool, right? Everything leads back to lead poisoning. Had her doctors ordered a blood lead level earlier, it would have saved Emma so many needless investigations.
Siobhan Deshauer, MD, is an internal medicine and rheumatology specialist in Toronto. Before medicine, she was a violinist, which is why her YouTube channel is called Violin MD.
by Fred Schulte and Holly K. Hacker, KFF Health News
Living with diabetes, Carlton "PeeWee" Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.
The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.
The 59-year-old died suddenly on May 17, 2020, becauseâhis family believesâthe pump malfunctioned and delivered a fatal overdose of insulin.
"There's a big hole left where he was," said Gautney's daughter, Carla Wiggins, who is suing the manufacturer. "A big part of me is missing."
The wrongful-death lawsuit alleges the pump was "defective and unreasonably dangerous." Medtronic has denied the pump caused Gautney's death and filed a court motion for summary judgment, which is pending.
The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could "lead to an over or under delivery of insulin," which could "be life-threatening or may result in death."
As the recall played out, federal regulators discovered that Medtronic had delayed actingâand warning patients of possible hazards with the pumpsâdespite amassing tens of thousands of complaints about the rings, government records show.
Over the past year, KFF Health News has investigated medical device malfunctions including:
The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have "substantial equivalence" to a product already in the marketplaceâan approval process some experts view as vastly overused and fraught with risks.
"Patients believe they are getting an implant that's been proven safe," said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. "No, it hasn't," Sharlin said.
And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuriesâwhile injured patients face legal barriers trying to hold manufacturers accountable for product defects.
In a statement to KFF Health News, the FDA said it "has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices."
'Too little, too late'
The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.
In a news release that day, Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health, lauded the device as a "first-of-its-kind technology" that would give patients "greater freedom to live their lives" and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with "no serious adverse events," the release said. Shuren declined to be interviewed.
The FDA's enthusiasm didn't last. In November 2019, Medtronic, citing the ring problem, launched an "urgent medical device recall" of the pumps, which it expanded in late 2021.
During an inspection at Medtronic's plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren't investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.
Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.
Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.
In one pending case, a Las Vegas man using the pump allegedly fell into an "insulin-induced coma" that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.
The recall notice Medtronic sent to a 43-year-old Missouri man's home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. "Simply too little, too late," the suit reads. The case is pending, and Medtronic has yet to file an answer in court.
Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones "redesigned to reduce the risk of damage" and "fulfilled all pump replacement requests at no cost to customers."
In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.
Shortcut to market
The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easierâand less costlyâpathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has "substantial equivalence" to one already on the market, even if the prior product has been recalled.
Critics have thinking for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.
In July 2011, an Institute of Medicine report concluded that 510(k) was "not intended to evaluate the safety and effectiveness of medical devices" and said, "a move away from the 510(k) clearance process should occur as soon as reasonably possible."
More than a decade later, that hasn't happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.
The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don't realize devices cleared for sale typically have not undergone clinical trials to establish their safety.
"Doctors are shocked to learn this," she said. "Patients aren't going to know it when their doctors don't."
In response to written questions from KFF Health News, the FDA said it "continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices." The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalenceâwhat the agency refers to as "predicate" devices.
"We can't get detailed data," said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. "It's very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems."
Rothenberg cited the history of "metal-on-metal" artificial hip implants, which under 510(k) spawned many new brandsâalong with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.
Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.
According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.
Medtronic's subsidiary company COVIDien made its claim even though the device has completely different "guts" and operates using software and other "substantially different" mechanisms, according to the whistleblowers' suit.
In response, Medtronic said it "believes the allegations are without merit and has moved to dismiss the case." The case is pending.
The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.
One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that "the wheels for the ventilator cart may actually fall off the ventilator during transport," according to the suit.
Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.
The December 2021 recall of the PB 980 cited a "manufacturing assembly error" that the company said may cause the ventilator to become "inoperable."
Medtronic said in an email that the ventilator "has helped thousands of patients around the world," including playing a "critical role in the global response to the COVID-19 pandemic."
The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.
But FDA officials acknowledge that many serious adverse events go unreportedâjust how many is anybody's guess.
Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.
In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.
Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.
Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a "commonsense step we can take up front to mitigate risk, Strengthen certainty and save money later."
The FDA said it is working to "strike the right balance between assuring safety and fostering device innovation and patient access." Yet it noted: "Additional resources are required to establish a fully functioning active surveillance system for medical devices." For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.
In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.
Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was takenâby the company or by regulators.
The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.
By the FDA's own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump's retainer rings were reported to the agency. The FDA said the complaints "were part of the information that led to the compliance actions." The agency said it "approved design and manufacturing changes to the retainer ring to correct this issue" and "has reviewed information confirming the effectiveness of the modification."
"What is the threshold for the FDA to step in and do something?" said Mara Schwartz, who is a nurse, diabetes educator, and pump user. "How many deaths or adverse events does there have to be?"
In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.
Some countries don't trust the device industry to play such a key role in oversight.
Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.
That's not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what's already for sale.
Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.
The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country's health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to Strengthen it, court records show. Medtronic told KFF Health News that it had "worked closely" with the Australian group to resolve the problems. "We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions," Medtronic said.
Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.
One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it's not available to them.
While the FDA clears thousands of devices for use based on the "substantial equivalence" premise, manufacturers often tout "new and exciting features" in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.
These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.
Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has "limited resources to actively monitor the volume of direct-to-consumer advertising," according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.
While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.
Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.
Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn't have agreed to the procedure.
He lost when the judge cited a legal doctrine called "learned intermediary." The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device's risks and relay them to patients.
The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.
Greisberg, 81, felt sucker-punched. "They never gave me any warning about what could happen down the road," he said in an interview. "I never had a chance to have my day in court."
The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.
Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.
Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: "It's fine right now," court records show.
Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.
"It should never be put on the patient to determine if there is a problem," Wiggins said.
Medtronic has denied the pump failed and caused Gautney's death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.
Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.
Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.
Her lawyer, Scott Murphy, said that insulin pumps are "really wonderful" devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump's hazards.
"The risks get minimized and the benefits exaggerated," he said.
Â©2024 KFF Health News.
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Citation: Deep flaws in FDA oversight of medical devices, and patient harm, exposed in lawsuits and records (2024, January 2) retrieved 5 January 2024 from https://medicalxpress.com/news/2024-01-deep-flaws-fda-oversight-medical.html
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The body produces mucus to lubricate and protect certain parts of the body, including the urinary tract. Some mucus in the urine is normal, but an increase may be a sign of an underlying condition that needs medical attention.
However, too much mucus or mucus that has changed in color or consistency can signify an underlying condition that may need addressing.
Read on to learn more about mucus in the urine and when to see a doctor.
Mucus may be present in the urine for many reasons, including those below.
As the mucus moves through the urinary tract, it flushes out germs that may otherwise cause infection.
Mucus in the urine is thin and fluid-like, and it can vary in quantity. It is typically clear, white, or off-white. If a person notices large amounts of mucus or mucus that changes color, they might have an infection or another health issue.
Sometimes, people may think that there is more mucus in their urine when this mucus is actually coming from the vagina.
Cervical mucus, which leaves the body as discharge, varies in color, thickness, and quantity at different stages of the menstrual cycle, as well as during pregnancy.
Urinary tract infection (UTI)
UTIs are among the most common types of infection that doctors treat every year. Although anyone can get a UTI, they are much more common among females. According to the National Institute of Diabetes and Digestive and Kidney Diseases, about 40â60% of females will experience at least one UTI in their lifetime.
The symptoms of a UTI include:
Sexually transmitted infection (STI)
Other symptoms of these STIs include:
Irritable bowel syndrome (IBS)
IBS is a functional digestive disorder, which means that the digestive tract does not function normally despite showing no signs of damage or inflammation. IBS is the most common functional gastrointestinal disorder, affecting 10â15% of people worldwide.
One possible symptom of IBS is mucus in the digestive tract. This mucus is present in the large intestine, or colon, but after leaving the body through the anus, it may mix with urine in the toilet bowl and lead people to think that the mucus is in their urine.
Other common IBS symptoms include:
Ulcerative colitis (UC)
UC is a form of inflammatory bowel disease.
To combat damage to the colon, the body may produce excess mucus, which passes from the body in the stool. Again, it can mix with urine in the toilet, giving the impression that there is too much mucus in the urine.
Additional symptoms of UC include:
Stones that remain in the kidneys do not cause symptoms. However, if they move into the urinary tract, they can cause increased mucus, as well as:
In rare cases, mucus in the urine may be a sign of bladder cancer. However, it is unlikely to be the first symptom of the condition. Symptoms that usually present first include:
It is more likely that mucus in the urine is related to an infection, a digestive condition, or another cause.
Despite this, it is important to see a doctor as soon as possible to rule out severe causes such as bladder cancer.
Anyone who experiences excessive amounts of mucus in the urine or a general increase in mucus production should speak with a doctor.
Although it is common to have some mucus in the urine, too much might suggest an underlying condition that requires medical treatment.
To test for mucus in the urine, a doctor may perform a urinalysis, which involves checking a urine trial under a microscope. The procedure is straightforward and noninvasive, and a person will just need to provide a container of urine.
Many doctors will carry out a urinalysis as part of a routine checkup. They may also carry out this test if they suspect that an individual has a UTI.
The underlying cause of excessive or abnormal mucus in the urine will determine the treatment options.
Doctors will prescribe antibiotics for UTIs that are due to a bacterial infection. It is also important to drink lots of water to flush the bacteria from the system.
People who experience recurrent UTIs may need a 6-month or longer course of low dose antibiotics to prevent a new UTI from developing. If a person develops a UTI following sexual activity, they will typically require a single antibiotic dose.
Doctors will treat both gonorrhea and chlamydia with prescription antibiotics, as no home remedies or over-the-counter (OTC) treatments have proven effective for STIs. Sexual partners will also require treatment for the STI.
A person can reduce their risk of future STIs by always using barrier protection, such as a condom, during sexual activity.
As IBS is a chronic condition, there is no cure. However, several treatments are available to help reduce symptoms and Strengthen quality of life.
Certain dietary and lifestyle adjustments may also help, such as:
As with IBS, there is no cure for UC, although there are medicines that may alleviate the symptoms. Such medications include:
Severe cases of UC may require surgery to remove the colon and rectum.
Smaller kidney stones may not require any treatment, as they can pass from the body through the urine. Drinking more water can aid this process. The symptoms will resolve once the stone has left the body.
Doctors may treat larger stones with extracorporeal shock wave lithotripsy â a procedure that breaks up the kidney stone into smaller pieces so that the body can pass them more easily.
Surgery may be necessary to remove very large kidney stones.
As mucus is part of a healthy urinary system, moderate amounts are not a cause for concern. However, excessive amounts of mucus in the urine will need investigating so that a doctor can determine the underlying cause.
Most causes of mucus in the urine are easily treatable with medication, dietary changes, or other appropriate interventions.
Researchers from Lanzhou University have developed a wireless under-skin charger, revolutionising medical implants with its biodegradable and infection-reducing design.
Scientists at Lanzhou University in China have designed a wireless charging unit that can be installed under the skin for powering internal bioelectronic devices. Demonstrating promising results in rodent tests, this technology could revolutionise human medical implants, potentially removing the necessity for cumbersome batteries and complex wiring.
Why is the device needed?
The necessity for wireless charging devices arises from the limitations imposed by the battery capacity of most bioelectronic devices, such as sensors and drug-delivery systems. When these devices are connected to an external power source, thereâs a heightened risk of spreading infection. To counter this, scientists have innovated by creating flexible, under-the-skin chips that are biodegradable and capable of conforming to the tissueâs shape during surgical procedures. This advancement is detailed in a research paper published in the journal Science Advances.
How does the wireless device work?
The research team embedded their prototype into a biodegradable, chip-like implant that smoothly combines energy harvesting and storage capabilities. When connected to a medical device, this implant provides a steady power supply by funnelling energy through the circuit into a capacitor. In rat experiments, the wireless implant efficiently operated for up to 10 days and entirely disintegrated within two months, validating its biodegradability. The systemâs longevity could be enhanced by strengthening the protective polymer and wax layers that encase it.
Concerns and Limitations
Although the prototype shows promising results, there are hurdles to overcome before human trials. In drug-delivery tests involving rats, those with uncharged implants experienced some unintended passive drug release. Furthermore, the team is still developing a method to switch the device on or off actively; currently, it stops functioning only when its power is completely drained.
Future studies will focus on addressing the deviceâs size and ensuring its complete biodegradability.
On 7th October this year, Babita Rai, a 42-year-old government school teacher in Jamshedpur, Jharkhand, was admitted to the Tata Motors Hospital in the same city. Because of a 6 cm ovarian cyst she was scheduled for a hysterectomy and an oophorectomy (surgical removal of the uterus and ovaries respectively), two days later. According to her brother Rajesh, Rai felt a swelling on the left side of her stomach after the surgery. Four days later, on 13 October, Rai was dead from septic shock, Rajesh added.Â
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A 13 October case summary from the hospital indicates that Rai suffered perforation of the colon. Rajesh alleges that when the family tried obtaining records of the surgery post mortem, they found the consent form tampered with. He said the name of a senior laparoscopic surgeon â for whom Rai had provided her consent â had been struck through, and the name of a junior doctor written by the side.
Rajesh says that the senior surgeon could not make it on time, and the junior doctor decided to do the surgery herself instead of rescheduling. He also alleges that the hospital did not perform routine postoperative follow-up tests to ensure that there were no resulting complications. In other words, according to Rajesh, his sisterâs death was a result of âgross medical negligenceâ.
At the time of writing this piece, Rajesh has been seeking justice for his sisterâs death due to alleged medical negligence by writing to several government bodies, including the National Commission for Women, the National Human Rights Commission, the National Medical Council, and the Offices of the President and the Prime Minister.Â
He claims he is yet to receive a positive response.
Babita Rai is one of the millions of people whose death has been counted by relatives under medical negligence every year in India (according to a 2018 estimate, the yearly death count due to medical negligence stood at roughly 5 million).
In a latest development, Home Minister Amit Shah announced in Parliament last week that doctors will be exempted from criminal prosecution in cases of death due to negligence. However, according to Section 106(1) of the Bharatiya Nyaya (Second) Sanhita (BNSS), the rulebook set to replace the Indian Penal Code, doctors will continue to face a two-year imprisonment and/or a fine if convicted. This is lesser than the Sanhitaâs recommended punishment of five years for other cases of death by negligence (for example, by rash driving).
In his announcement to the Lok Sabha, Mr. Shah claimed that the Indian Medical Association (IMA), the largest representative body of doctors in India, had requested the Home Ministry for an exemption from criminal prosecution.
According to Dr. R.V. Asokan, the IMA president, the Association had first raised concerns about increasing criminal cases of negligence being filed against doctors in an April 2023 meeting. The agenda item A-2 from the meeting document deems criminal prosecution of doctors for medical negligence âirrelevantâ and demands that doctors be âexemptedâ from it.
After the April 2023 meeting, in September 2023 the IMA made a submission to the Parliamentary Standing Committee on the BNSS. According to the submission, the IMA reported around 98,000 deaths per year due to medical negligence in contrast with 52 lakh medical negligence cases filed against doctors. Further, the IMA also asked that a law criminalising violence against doctors be included in the BNSS since â75% of doctors and paramedics face violence as per IMAâ.Â
The IMA also estimated the economic loss due to violence against doctors to be in the order of billions of rupees per day.
Finally, the IMA also asked in its submission that the BNSS make a clear distinction between medical ânegligenceâ and medical âaccidentâ. While ânegligenceâ would refer to a ârecklessâ, âconscious and voluntary disregard of the need to use reasonable careâ on part of the doctor, an âaccidentâ would involve sudden and unexpected deaths of patients under medical care without conscious intention to harm on the part of the doctor.
The BNSS in its current form has not made any explicit distinction between medical negligence versus accident.
That said, several existing clauses in the BNSS may offer protection to some doctors from criminal prosecution. For example, clause 26 provides an illustrative example of acts done in âgood faithâ that are exempt from criminal prosecution:
A, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under the painful complaint, but not intending to cause Zâs death, and intending, in good faith, Zâs benefit, performs that operation on Z, with Zâs consent. A has committed no offence.
In a similar vein, clause 30 adds:
Z is thrown from his horse, and is insensible. A, a surgeon, finds that Z requires to be trepanned. A, not intending Zâs death, but in good faith, for Zâs benefit, performs the trepan before Z recovers his power of judging for himself. A has committed no offence.
Explaining the need to exempt doctors from criminal prosecution for negligence, Dr. Asokan said, â[the criminal prosecution of doctors] has become a form of harassment and doctors are mortally afraid of the criminal law.â âThis influences the decision a doctor makes in critical moments,â he added.Â
In other words, Dr. Asokan holds that exemption of doctors from criminal prosecution will provide the nation âbetter results in patient care.â
However, bioethicists, lawyers, and members of the public express concerns that a blanket exemption of doctors from criminal prosecution for negligence might lead to an increase in medical malpractice and put marginalised populations at an increased risk.
Rohin Bhatt, a Delhi-based bioethicist and lawyer, said that the conversation around medical negligence is incomplete without contributions from patients and patient advocacy groups. He believes that âpatient advocacy groups have not been given the voice they deserve [in this conversation].â
Further, he also argues that owing to the âpower imbalanceâ in the doctor-patient relationship, an act of negligence on the part of the doctor calls not for a lower punishment but a higher one. According to him, âit is because of unequal power balance in the doctor-patient relationship, [an act of medical negligence] calls for a higher punishment than the standard.â
Ayushmita Samal, a Delhi-based sexual and reproductive health researcher, added that a blanket exemption might lead to an increase in cases of deaths by medical negligence among women, queer, and transgender persons, and those who live in rural areas. As an example, Samal spoke of her auntâs death in 2015. A resident of a village in Bhadrak, Odisha, her aunt died of septic shock after a nurse-cum-midwife allegedly failed to detect a miscarriage. Samal feels that this could have been avoided had the nurse-cum-midwife taken her auntâs concern of not feeling the babyâs movement more seriously.
Geet, a Bangalore-based chartered accountant, arts therapy practitioner, and a non-binary person, added that they are concerned that a blanket exemption of doctors from criminal prosecution would compound medical malpractice against people from marginalised genders and castes. According to them, âin a country like India, where most doctors are upper-caste cisgender and heterosexual people, imagine to what extent they can go in ignoring the concerns of dalit, non-binary, and transgender persons in the absence of a legislation that criminalises malpractice!â
Geet charges that their mother, who died of uterine cancer â related complications in 2018, was a victim of medical negligence that included âhiding of information, not taking her concerns seriously, medical abuse, and fatphobia.â (Medical fatphobia is defined as the discrimination by medical practitioners against patients who are seen as overweight. According to reports, medical fatphobia may lead not only to emotional and psychological distress for patients, but also incorrect dosing of medicines on the part of the doctor.)
Both Geet and Samal also point out that in the absence of a legal recourse for patients when they suspect medical negligence, they may lose faith in the legal system. This, in turn, can lead to an increase in violent attacks on doctors.
As a next step, Dr. Asokan said that the IMA is looking to âdialogueâ with the government and the public in order to establish that exempting doctors from criminal prosecution is beneficial for patient care.
âWe will talk to the people. We are a young nation, and we can build this nation in our own way, on our own values and ethos. We will fight for the space we deserve in this country. In that we are determined,â he said.
On the other hand, Geet stresses on the importance of a nationwide survey before the government decides on medical negligence. According to them, âThe Home Minister must sanction a survey that seeks to understand the scope of medical negligence and patientsâ experience with the same.âÂ
Without reliable nationwide data on the same, any decision to exempt doctors from punitive consequences of their action will constitute a lopsided decision in favour of doctors, they added.
(Sayantan Datta is an independent science journalist and a faculty member at the Centre for Writing and Pedagogy, Krea University. firstname.lastname@example.org)
Carried out in co-operation with Somaliaâs Ministry of Health (MOH), the projectâs cost was $114,212 (QR416,302), an official statement from QRCS said.
The inauguration ceremony was attended by a QRCS delegation that comprised Dr Mohamed Salah Ibrahim, Director of the Relief and International Development Division and Rushdi Abdelkhaleq Bamasoud, Monitoring and Evaluation Expert as well as the hospitalâs management.
The 17-day project aimed to treat the poorest and most vulnerable patients across and around Mogadishu, especially the villages and camps hosting internally displaced people (IDPs).
It involved the screening, examination, and clinical diagnosis of 736 outpatients. 494 patients received laboratory tests and medical prescriptions, while 242 others underwent surgeries including 221 and 21 general and urology operations respectively.
Other activities included the rehabilitation of the hospitalâs main operating room, by installing surgical light and A/C; restoring walls, ceiling, and floor; and inspecting and maintaining the main power supply lines.
With these results, the project has exceeded the targets in the original action plan, which included 600 medical examinations, 200 procedures, 400 medical prescriptions, and postoperative care for the patients as well as capacity-building for local medical professionals.
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