Jump to content
  • articles
    9,854
  • comments
    83
  • views
    12,512,181

Contributors to this article

About this News

Articles in the news

Fears Covid surge will force care homes to impose harsh visiting restrictions this winter

A surge in Covid cases over winter could lead to harsh visiting restrictions being reimposed in care homes and hospitals, MPs and campaigners have warned.

Families are still facing a “postcode lottery” of Covid restrictions in care homes, with visiting times restricted and personal protective equipment (PPE) obligatory.

However MPs are worried that some will reimpose even harsher measures if Covid cases rise this winter.

Daily global Covid infections are projected to rise slowly to around 18.7 million by February, up from the current 16.7 million average daily cases this October.

MPs are calling for the government to enact legislation that would enshrine the right for an essential care giver to be present with their loved ones in care settings.

Liberal Democrat MP Daisy Cooper said that one of her constituents, Lynn, was not allowed into a hospital A&E ward to see her husband Andy when his dementia deteriorated over Christmas last year.

The hospital refused to let Andy have any visitors for two weeks until Ms Cooper intervened. When she was allowed in, Lynn was distraught to find that Andy had lost a significant amount of weight in the weeks he was isolated.

Ms Cooper continued: “We have come a long way since last Christmas, and since the start of the pandemic, but as winter approaches the NHS and care settings are once again expected to struggle with a surge in Covid cases.

“It is not inconceivable that what happened to Lynn and Andy could happen again to them and to many others.”

Read full story

Source: Independent, 30 October 2022

Further hub reading

Read more
 

Fears Covid may leave thousands in UK with severe kidney disease

Tens of thousands of people may require kidney dialysis or transplants because of coronavirus, according to experts who warn the long-term effects of Covid are causing an “epidemic in primary care”.

Up to 90% of coronavirus patients admitted to hospital may still experience symptoms two to three months later – from breathlessness to joint pain, fatigue and chest pain – scientists told the Lords science and technology committee on Tuesday.

Donal O’Donoghue, a consultant renal physician at Salford Royal NHS trust, said damage to the kidneys was of major concern. It is believed the virus may attack the organ directly, he said, while the kidneys could also be injured by body-wide inflammation caused by the virus.

“Normally we see maybe 20% of people that go on to intensive care unit need to have a form of dialysis. During Covid it was up to 40% – and 85% of people had some degree of kidney injury,” he said. “No doubt that is happening out in the community as well, probably to a lesser extent.”

Tom Solomon, professor of neurology at the University of Liverpool, told the committee more needed to be done to support Covid survivors. “[GPs] are seeing lots of patients who are left over with problems from their Covid and they need to be able to refer them to get help in understanding what is going on,” he said, adding: “This is really the current epidemic in primary care.”

Read full story

Source: The Guardian, 15 September 2020

Read more

Fear over high rates of diabetes foot amputations

Major differences in the rate of foot amputations for people with diabetes in England are incredibly concerning, patient groups say.

Such amputations are a sign patients have not received adequate care, as poorly controlled diabetes increases the risk of foot ulcers and infections.

One in 10 areas had "significantly higher rates", government data shows. There was nearly a five-fold difference between the best and worst when taking into account risk factors such as age.

The government data - published by the Office for Health Improvement and Disparities - looked at the three years leading up to the pandemic.

It is believed up to 80% of foot amputations could be avoided with better care.

Diabetes UK said the figures "shined a light on the scale of the crisis facing diabetes care" and it warned access to support was likely to have become worse during the pandemic.

A report produced by the charity earlier this month said lives would be needlessly lost because of disruption to services over the past two years.

Diabetes UK chief executive Chris Askew said the latest figures were "incredibly concerning".

"The majority of these major amputations are preventable, but many people living with diabetes are struggling to access the care they need - and in areas of higher deprivation, people are experiencing worse outcomes. These inequalities must be addressed."

Read full story

Source: BBC News, 27 April 2022

Read more

Fear and trauma - the long waits for cancer care

There has been a sharp rise in long waits for cancer therapy in the past four years, BBC analysis shows.

The number waiting more than the 62-day target time for therapy in the past year has topped 67,000 across England, Northern Ireland and Scotland - twice as many as the same period in 2017-18.

Waits are also getting worse in Wales, but data does not go that far back.

The national cancer director for the NHS in England said staff were striving to catch up on the backlog of care, but experts warned the problems could be putting patients at risk.

Steven McIntosh, of Macmillan Cancer Support, told the BBC that the delays were "traumatic" and people were living "day-by-day with fear and anxiety".

He said the situation was "unacceptable" and could even be having an impact on the chances of survival.

Describing the NHS as "chronically short-staffed", he said: "The NHS doesn't have the staff it needs to diagnose cancer, to deliver surgery and treatment, to provide care, support and rehabilitation."

Read full story

Source: BBC News, 9 November 2022

Read more

Fear and anger of cancer patient, with months to live, whose chemotherapy was delayed due to strikes

A cancer patient with months to live has spoken of her fear and anger after chemotherapy was delayed by this week’s strikes.

Flora White, 51, began chemotherapy last month, which is required fortnightly to shrink a tumour so it can be surgically removed.

But it has now been set back, after the appointment she was due to have with her oncologist the day before was cancelled as a result of strikes.

Ms White said that until she got the devastating news about her own delays she had thought cancer patients would be protected from the impact of industrial action.

“It’s hard to deal with as it is, let alone the extra worry and stress,” she said.

“Your treatment being cancelled and delayed, they don’t understand how they’re affecting some people.”

Earlier this week,  Prof Karol Sikora, a leading consultant oncologist, said it was “against the ethics of medicine” for doctors to strike, as he urged medics to think again.

“If you miss cancer and someone goes for another two years without a diagnosis, it’s as good as leaving someone in the gutter bleeding ... people will die,” he said.

Read full story (paywalled)

Source: The Telegraph, 21 September 2023

Read more

FDP AI tool at centre of regulatory row

A federated data platform AI discharge tool hailed as “potentially transformational” by Wes Streeting is at the centre of a spiralling regulatory row, HSJ  can reveal.

The main concerns centre around whether the tool had been classified as a medical device by the Medicines and Healthcare Products Regulatory Agency, given that it was generating patient discharge summaries that, if incorrect, could impact continuity of care.

There have also been concerns about the information governance implications of using patient data to develop and validate the tool and whether this was being considered as direct care.

Read full story (paywalled)

Source: HSJ, 15 December 2025

Read more
TAGGED
 

FDA: Potential risk of strangulation in children who use enteral feeding delivery sets

The US Food and Drug Administration (FDA) is warning healthcare providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the use of enteral feeding delivery sets. The feeding set tubing can become wrapped around a child’s neck and cause strangulation or death. The FDA has received reports of two toddlers who died after being strangled by the tubing. 

Recommendations for parents and caregivers of children who use enteral feeding delivery sets:

  • Be aware that the feeding set tubing can get wrapped around a child’s neck, which can lead to strangulation or death. 
  • To the extent possible, avoid leaving the feeding set tubing where infants or children can become entangled.
  • Discuss with your child's health care provider:
  • If your child has been tangled in their tubing before.
  • Steps you can take to help ensure that tubing does not get wrapped around your child’s neck, such as keeping the tubing away from the child as much as possible.
  • Any other concerns you may have about the risk of strangulation from feeding set tubing. 
  • If your child is injured by feeding set tubing, please report the event to the FDA. Your report, along with information from other sources, can provide information that helps improve patient safety.

Recommendations for healthcare providers:

  • Review this topic and the information noted above with your colleagues, care teams, and caregivers of pediatric patients who use enteral feeding delivery sets, to ensure they are aware of the potential risk of strangulation with the associated tubing and are taking appropriate measures to keep the tubing away from the child as much as possible.
  • When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety.
  • If a patient experiences an adverse event related to enteral feeding set tubing, you are encouraged to report the event to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Read full story

Source: FDA, 8 February 2022

Read more

FDA warns of rise in reports of child poisonings linked to cough medicine

Poison control centres in the USA have seen an increase in reports of children ingesting a type of prescription cough medicine, a study published by the Food and Drug Administration (FDA)found.

From 2010 through 2018, reports of paediatric poisonings involving the drug, benzonatate, increased each year, the study found. Benzonatate, sold under the brand name Tessalon, is prescribed to treat coughs caused by colds or the flu. It is not approved for children younger than 10 years old.

The findings, published in the journal Pediatrics, were based on more than 4,600 cases reported to poison control centres. 

The reports included children who were unintentionally exposed to the drug, as well as children who abused or misused it intentionally. 

The proportion of cases with serious adverse effects was low. However, accidental or inappropriate use of benzonatate, which comes in gel capsules, can lead to serious health problems in children, including convulsions, cardiac arrest and death.

The findings should galvanise doctors to be more careful when they prescribe these kinds of medications, said study author Dr. Ivone Kim, a pediatrician and senior medical officer at the FDA.

Cough medications "should be treated like any other medication that can have serious side effects," Ameenuddin said, "which means not giving it to children without specific medical direction."

Read full story

Source: NBC News, 15 November 2022

Read more
 

FDA warns of potential to miss notifications on smartphone-compatible diabetes devices

The Food and Drug Administration released an alert notifying patients of a safety concern using diabetes devices such as continuous glucose monitors, insulin pumps and automated insulin dosing systems that rely on a smartphone for delivering alerts.

The agency said it received medical device reports in which users reported alerts were not being delivered or heard in situations where the users thought they configured the alerts to be delivered. Some instances may have contributed to serious harm, including severe hypoglycaemia, severe hyperglycaemia, diabetic ketoacidosis and death.   

The FDA issued recommendations for users and said it is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations are evaluated prior to use. It is also working with manufacturers to ensure settings for smartphones and mobile medical applications are continuously tested and that updates are communicated quickly and clearly to users.

Read full story

Source: US Food and Drug Administration, 5 February 2025

Read more

FDA warns about fake Ozempic in US supply chain

The Food and Drug Administration (FDA) has urged patients and doctors to check that their Ozempic prescriptions are legitimate after the agency seized several hundred units of fake versions of the diabetes drug in the US.

Novo Nordisk, the maker of Ozempic and the weight loss drug Wegovy, told the FDA on April 3 that counterfeit 1-milligram injections were being distributed outside its authorised supply chain in the US, the agency said in a news release. That means it likely entered the market through unofficial means, like unauthorised distributors or resellers.

The agency said it’s aware of six adverse event reports linked to the lot — however, none of them appear to be associated with the counterfeit product. The agency and Novo Nordisk are testing the fake products to identify whether they’re safe. Genuine Ozempic can come with side effects, including stomach problems, so it's not clear whether the adverse events were caused by typical use.

Read full story

Source: NBC News, 14 April 2025

Read more

FDA warnings and reports of ‘internal bra’ complications may lead to a surge in breast mesh lawsuits

Breast mesh implants promoted as “internal bra” supports have become the subject of legal and regulatory scrutiny. Not cleared for this use by the FDA, the mesh implants have been linked to higher rates of infections, reoperation and implant failure.

The “internal bra” technique uses synthetic or biologic mesh in combination with other breast surgeries to lift breasts and enhance results. In November 2023, the FDA released a safety communication emphasizing that no surgical mesh products are cleared or approved for use in breast surgeries. Despite this, mesh products have seen increased off-label use for internal bra techniques in breast surgeries with implants.

There are approximately 100,000 breast reconstruction surgeries per year and more than 300,000 breast augmentation surgeries per year in the US. The use of breast mesh in these procedures could put people at risk of higher complication rates.

Read full article.

Source: Drugwatch, 30 October 2025

Read more

FDA to okay second omicron-targeting booster for some, officials say

Federal regulators have decided to authorise a second omicron-specific coronavirus vaccine booster shot for people who are at least 65 or have weak immune systems in an effort to provide additional protection to high-risk individuals, according to several officials familiar with the plan. 

The Food and Drug Administration is expected to announce the step in the next few weeks, and the Centers for Disease Control and Prevention is expected to move quickly to endorse it, said the officials, who spoke on the condition of anonymity because they were not authorised to publicly discuss internal discussions. Eligible individuals will be able to receive the dose as long as it has been at least four months since their first shot of what’s known as the bivalent booster, which targets omicron subvariants BA.4 and BA.5 as well as the original novel coronavirus. The expectation is that consumers will consult with their health-care providers about whether to get the extra booster, the officials said.

John P. Moore, a professor of microbiology and immunology at Weill Cornell Medicine in New York, said an extra booster could benefit people who are in poor health or have an impaired immune system. But he was skeptical everyone older than 65 needs it. Boosters lead to “a short-term boost against mild infection but protection against severe disease is still pretty robust” because of previous shots, he said.

Read full story (paywalled)

Source: Washington Post, 3 April 2023

Read more

FDA says it will limit access to Covid-19 boosters for Americans under 65

The Food and Drug Administration (FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy Americans under 65 without clear evidence of clinical benefit – a shift, critics say, that will make access difficult for people who are not high risk but want to be vaccinated against the disease.

Top officials at the FDA outlined a new framework for approving Covid-19 vaccines, saying that the US would make the boosters available for Americans over the age of 65 and for adults and children above the age of 6 months with at least one condition that increases their risk of severe Covid-19.

The newly installed FDA commissioner Marty Makary and Vinay Prasad, the controversial director of the Center for Biologics Evaluation and Research, laid out the new guidelines in a commentary piece published in the New England Journal of Medicine.

They wrote that manufacturers would have to conduct randomized, controlled clinical trials before updated vaccines would receive approval for healthier people.

Elsewhere in the piece, the officials argued that the US is an outlier among countries in Europe and other high-income countries where Covid-19 boosters are recommended only for older adults and people at high risk. They estimate that more than 100 million Americans will still qualify for the annual shots under the new terms.

Read full story

Source: The Guardian, 20 May 2025

Read more

FDA rolls back warning labels on HRT products for menopause, citing misinformation

The Food & Drug Administration (FDA) will remove broad “black box” warning labels from hormone replacement therapy (HRT) for menopause. 

The action, announced Monday, follows a comprehensive review of scientific literature by an expert panel at the agency in July, officials said, as well as a public comment period. Manufacturers are now expected to update and reprint their product labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia. 

“The label was designed to frighten women and to silence doctors,” Health and Human Services Secretary Robert F. Kennedy Jr. said on stage during the announcement on Monday morning. “The consequences have been devastating.” 

The FDA will not remove the boxed warning for endometrial cancer for systemic estrogen-only products. Its labeled recommendation will be to start HRT within 10 years of menopause onset or before 60 years of age for systemic HRT. 

Use of hormone replacement therapy (HRT) plummeted quickly after a flawed, now infamous 2002 study. While the study found a small increased risk of breast cancer among participants using HRT, described as less than a tenth of 1% per year for an individual woman, critics say its results were widely misinterpreted and blown out of proportion. A 2024 study found that only 5% of American women use HRT for menopause.

About 80% of women experience menopause symptoms that can last years, yet research has found women who initiate HRT before the age of 60 have a reduction in all-cause mortality. HRT may also reduce the risk of cardiovascular disease by up to 50%; Alzheimer’s disease by 35%; bone fractures by up to 60%, according to figures an HHS press release cited.

Echoing Kennedy, FDA Commissioner Marty Makary blamed the study and “medical group-think” for creating “a fear machine that still lingers.” No clinical trial has ever shown that HRT increases the risk of breast cancer mortality, said Makary, who was previously a surgical oncologist at Johns Hopkins.

“How could the medical establishment get it so wrong for so long?” Makary questioned. “Women deserve the same rigorous science as do men.”

Read full story

Source: Fierce Healthcare, 10 November 2025

Read more
 

FDA proposes revamping medication guides that come with prescriptions

The US Food and Drug Administration has proposed to add to what you get with your prescription drugs.

The proposed rule would require the prescriptions you get to come with a new kind of single-page medication guide with an easy-to-use set of directions and easy-to-understand safety information, a goal the FDA has been working toward for years.

One study found that nearly 75% of Americans have had trouble taking their medicine as directed. A lot of that is due to cost – people might not be able to afford their medicine, so they don’t take it – but some is due to confusion. They might get more than one kind of written information with their prescription, or the information they receive can be conflicting, incomplete or repetitive, the FDA said.

When people are confused or misinformed about their prescription, there is a good chance they will not take it or will stop taking it, and that can directly hurt their health.

“Research suggests that medication nonadherence can contribute to nearly 25% of hospital admissions, 50% of treatment failures, and approximately 125,000 deaths in our country each year,” the FDA says.

The agency said the new proposal is also meant to help fight the “nation’s crisis with health care misinformation and disinformation.”

Read full story

Source: CNN, 30 May 2023

Read more

FDA panel backs first over-the-counter birth control pill in US

The first non-prescription birth control pill in the US is on the way to approval, after a thumbs-up from an advisory committee of drug regulators.

The Food and Drug Administration (FDA) panel's unanimous vote is not binding, but means the agency is likely to formally approve the drug this summer.

Opill has been available, but only by prescription, for the past 50 years.

The push for over-the-counter access in the US comes amid Republican-led efforts to restrict access to abortion and contraception at the national and state level.

Advisors on the panel said they were mostly confident women of all ages would use the drug as appropriate without first consulting a healthcare provider.

"In the balance between benefit and risk, we'd have a hard time justifying not taking this action," said chairwoman Maria Coyle, an Ohio State University pharmacist.

"The drug is incredibly effective, and I think it will be effective in the over-the-counter realm just as it is in the prescription realm."

Read full story

Source: BBC News, 10 May 2023

Read more

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones

The US Food and Drug Administration (FDA) has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labelling of these electronic medical devices.

Pulse oximeters are small finger-clamp devices that estimate how much oxygen is being carried in the blood. Available both over the counter and by prescription, they grew in popularity during the Covid-19 pandemic. But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin.

 

One of the FDA's recommendations is to include “a diversely pigmented group of 150 or more healthy participants” in clinical studies of the devices, with at least 25% of participants falling within each skin color group on the system known as the Monk Skin Tone scale. Another is for manufacturers to “prominently display appropriate warnings” in the devices’ instructions, such as informing patients that “differences in skin pigmentation may cause differences in pulse oximeter sensor performance.”

Read full article.

Source: CNN, 6 January 2024.

Read more
 

FDA intends to put its most serious warning on Covid vaccines, sources say

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

A boxed warning, which appears at the top of prescribing information for medicines, is the agency’s most serious, designed to warn about risks such as death or life-threatening or disabling reactions that should be weighed against the intervention’s benefits. They can also be used when a risk might be lowered by using a medicine in a targeted way, such as only in certain groups.

Boxed warnings on opioids, for example, warn about risks of abuse, addiction, overdose and death. The acne medication Accutane carried a warning about the risks of birth defects when used during pregnancy. ACAM2000, a smallpox and mpox vaccine, has a warning about complications such as heart inflammation and encephalitis.

Read full article.

Source: CNN, 12 December 2025

Read more

FDA considers new approach to improve safe disposal of prescription opioid analgesics and decrease unnecessary exposure to unused medication

the U.S. Food and Drug Administration (FDA) announced it is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that pharmacists provide patient education on safe disposal of opioids. This potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy would provide a convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks and takeback events.

Patients commonly report having unused opioid analgesics following surgical procedures, thereby creating unfortunate opportunities for nonmedical use, accidental exposure, overdose and potentially increasing new cases of opioid addiction. Since many Americans gain access to opioids for the first time through friends or relatives who have unused opioids, requiring a mail-back envelope be provided with each prescription could reduce the amount of unused opioid analgesics in patients' homes. Data show educating patients about disposal options may increase the disposal rate of unused opioids and that providing a disposal option along with education could further increase that rate.

Mail-back envelopes have several favorable characteristics. They do not require patients to mix medications with water, chemicals or other substances nor use other common at-home disposal techniques. Opioid analgesics sent back to Drug Enforcement Administration-registered facilities in mail-back envelopes do not enter the water supply and landfills (instead, they are incinerated). The nondescript mail-back envelopes provided would be postage paid, offering patients a free disposal option. Additionally, there are long-standing regulations and policies in place to ensure that mail-back envelopes are fit for that purpose and can safely and securely transport unused medicines from the patient's home to the location where they will be destroyed.

"The FDA is committed to addressing the opioid crisis on all fronts, including exploring new approaches that have the potential to decrease unnecessary exposure to opioids and prevent new cases of addiction. Prescribing opioids for durations and doses that do not properly match the clinical needs of the patient not only increases the chances for misuse, abuse and overdose, but it also increases the likelihood of unnecessary exposure to unused medications," said FDA Commissioner Robert M. Califf, M.D. "As we explore ways to further address this issue more broadly, the mail-back envelope requirement under consideration for these unused medications would complement current disposal programs and provide meaningful and attainable steps to improve the safe use and disposal."

Read full story

Source: Cision, 20 April 2020

Read more

FDA blocks publication of studies showing covid and shingles vaccines to be safe

Officials from the US Food and Drug Administration have blocked the publication of several studies of Covid-19 and shingles vaccines conducted by the agency’s own scientists, it has emerged.

Each blocked study showed the safety of widespread use of vaccines for both conditions.

A spokesperson for the Department of Health and Human Services has confirmed the move, first reported by the New York Times.

FDA scientists conducted the studies, in which they analysed millions of patient records, with the help of a data firm and millions in taxpayer dollars. Two Covid-19 vaccine studies were accepted for publication by medical journals, but in October 2025 the authors were told to withdraw them.

In February 2026 top FDA officials did not sign off two studies of Shingrix, a shingles vaccine. The abstracts required approval for submission to a conference on drug safety.

When questioned by The BMJ the Department of Health and Human Services (HHS), which oversees the FDA, defended the decision.

“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data,” Emily Hilliard, HHS press secretary, told The BMJ. “The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.”

Critics said the blocks on the studies were another example of antivaccine sentiment from the HHS head, US health secretary Robert F Kennedy Jr.

Read full story

Source: BMJ, 8 May 2026

Read more

FDA asks drugmaker Eli Lilly for more safety information on its new GLP-1 weight loss pill

A GLP-1 weight loss pill, already on sale in the United States, has hit a regulatory snag.

The Food and Drug Administration has asked U.S. drugmaker Eli Lilly to collect more long-term safety data on its once-daily tablet Foundayo, according to an 1 April letter published by the FDA Tuesday.

The FDA approved the pill under its programme to fast-track drugs using 72-week, Phase 3 trial data but still needs to look at years-long data to understand all of the potential risks.

At the heart of the request is whether taking Foundayo - made using a new active ingredient called orforglipron - could be linked to liver, heart and gastrointestinal problems.

“We have determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to assess a signal of a serious risk of retained gastric contents and to identify an unexpected serious risk for major adverse cardiovascular events, drug-induced liver injury and exposure to [Foundayo] during lactation,” the FDA wrote.

Eli Lilly has until the end of April to complete that clinical trial and until July to submit a final report.

An Eli Lilly spokesperson told The Independent that “patient safety is Lilly’s top priority” and that the company actively monitors, evaluates and reports safety information for all its medicines.

Read full story

Source: The Independent, 16 April 2026

Read more
 

FDA approves first bedside COVID-19 test by Danaher’s Cepheid

A Covid-19 test can deliver results in less than an hour has been approved under an FDA emergency authorization, marking the first test that clinicians can use at the bedside.

Cepheid, a Silicon Valley molecular diagnostics company that’s a unit of Danaher Corp., announced Saturday it received an emergency authorisation from the U.S. Food and Drug Administration to use the test, making it the 13th Covid-19 test the agency has allowed on the market as long as the public health emergency exists.

But it’s the first one that can be used at the point of care, meaning providers don’t have to send patient samples to a separate lab to be processed and then come back to the hospital or provider’s office. Cepheid said it expects to start shipping tests next week.

“An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources,” said David Persing, Cepheid Chief Medical and Technology Officer.

Read full story

Source: Bloomberg, 21 March 2020

Read more

FBI spotlights cybersecurity risks of outdated medical devices

On Tuesday, the FBI issued a report offering recommendations to address a number of cybersecurity vulnerabilities in active medical devices stemming from outdated software, as well as the lack of security features in older hardware.

Once exploited, the vulnerabilities could impact healthcare facility operations, patient safety, data confidentiality and data integrity. If a cyberattacker takes control, they can direct devices to give inaccurate readings, administer drug overdoses or otherwise endanger patient health.

The FBI noted in its briefing that a mid-year healthcare cybersecurity analysis found that equipment vulnerable to cyberattacks includes insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers, and intrathecal pain pumps.

Routine challenges include the use of standardised configurations, specialised configurations – including a substantial number of managed devices on a network – and the inability to upgrade device security features, according to the FBI's announcement.

The agency further adds that research has found an average of 6.2 vulnerabilities per medical device and that 40% of medical devices at the end-of-life stage offer little to no security patches or upgrades.

 

Read full story

Source: Healthcare IT News, 13 September 2022

 

Read more

Faulty pathology system causes ‘significant’ issues for GPs

An ongoing fault with an acute trust’s new pathology system has left GPs with ‘significant’ workload issues and ‘anxiety’ for patient safety. 

At the start of this month, University Hospital Southampton (UHS) trust transferred to a new pathology IT system which resulted in issues with processing blood tests and communicating results. 

Wessex LMCs said the trust has shown a ‘distinct lack of understanding’ of general practice, which has caused ‘large issues’ and ‘an enormous associated workload’ for GPs.

GPs in the area told Pulse that there was immediately a ‘massive backlog’ from 1 July, as blood test requests were sent using the ‘old forms’ which the lab could not process quickly enough. 

However, one GP partner, who wished to remain anonymous, said there was ‘absolutely no communication with primary care’ to clarify that the old forms should not be used. 

As a result of this backlog, UHS introduced a ‘temporary measure’ which told GP practices they could only request ‘urgent blood tests’, meaning all routine blood tests were suspended.

This restriction was lifted last week, and UHS has since cleared the initial backlog, however GPs told Pulse that they are still not receiving blood test results, and those they do receive are often not in the correct format. 

Another Southampton GP partner, who preferred to remain anonymous, said that on top of the initial backlog – caused by slow processing of old forms – there has also been a ‘significant proportion of path results that aren’t coming into GP systems’. 

In one surgery, around 70% of bloods requested in one week had not yet received results. The GP partner said that "results are being processed at the hospital" but GPs "can’t see them" as a result of faults with the system.  She continued: "We are trying to make clinical decisions based on results and we’re not seeing them […] It’s causing a significant degree of anxiety and concern for patient safety."

Read full story

Source: Pulse, 23 July 2024

Read more

© 2026 Patient Safety Learning. All rights reserved.

Patient Safety Learning is registered as a charity with the Charity Commission Registration number 1180689.

×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.