This is the first of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.
By John Tingle
As the dust begins to settle around the COVID-19 pandemic, a clearer picture is beginning to emerge of possible litigation trends against the United Kingdom’s NHS (National Health Service) for actions taken during the crisis.
Many NHS services have been reduced or suspended during the crisis. Negligent delays in treatment are a common cause of action in clinical negligence and medical malpractice cases. Legal claims could be made by patients who argue that they have suffered, and continue to suffer, because of lack of access to care and treatment due to COVID-19 NHS emergency restrictions. These claims raise tort, public law and human rights concerns, and some law firms have already been approached by patients asking for advice in this area.
Two recent studies on the usability of electronic health records (EHRs) use the same standardized metric report, but come to very different conclusions.
One study, using data generated by vendors, found satisfaction to exceed the average benchmark for products across industries (a “C” grade), while the other study, using data from a representative sample of practicing physicians, reports satisfaction as failing (a “F” grade). In this piece, we explore the likely reasons for this discrepancy and propose a path forward.
Despite a troubling history, rofecoxib (Vioxx) may be making a comeback.
The voluntary withdrawal of rofecoxib (Vioxx) from the market in September 2004 marked the end of a controversial era for a once highly profitable and widely used drug. It also marked the beginning of years of high-profile product-liability litigation that would cost Merck billions.
By John Tingle
After months of heavy criticism of the World Health Organization, President Donald Trump announced on Friday that the United States would end its relationship with the WHO.
As the organization shoulders sustained disparagement from President Trump, it is worth highlighting the critical work the WHO has done over the years. This post will focus on the role the WHO has played in promoting patient safety around the world and in the United Kingdom National Health Service (NHS) through useful materials and key initiatives.
By Beatrice Brown
There is currently a dire shortage of personal protective equipment (PPE) at hospitals across the United States, especially in areas that have been hit the hardest by COVID-19.
PPE is essential to protecting those on the front lines of the pandemic – the President of the American Medical Association (AMA) has said that without adequate PPE, we may face a shortage of clinicians to treat COVID-19 patients, in addition to other shortages of critical resources.
Without adequate PPE, are clinicians morally obligated to provide care to patients who are either presumed positive for COVID-19 or who definitely have the virus?
Here, I argue that to treat patients without adequate PPE is supererogatory but not obligatory. In other words, this is a noble and praiseworthy act, but clinicians should not be obligated to perform these heroic acts, nor should we blame them, morally, for their decision to refuse to provide care.
By Adriana Krasniansky
In many medical circumstances, clinicians and caregivers may choose not to leave a patient alone. For example, a patient may present a fall risk, experience confusion and agitation, or be at risk of self-harm. Traditionally, in such situations, a hospital assigns the patient a sitter, or a caregiver who provides patients patient supervision and companionship.
The need for sitters in hospital settings is rising, as patient loads increase and fewer patients have family members who are able to stay with them for long periods of time. Sitters are also a considerable investment for hospitals; one community hospital reported employing 14 sitters a day, totaling $425,000 in costs annually. Many healthcare networks are exploring the possibility of TeleSitters, or virtual monitoring systems to support patient care. In this article, we review the national adoption of TeleSitters and point out benefits and considerations to their implementation. Read More
By John Tingle
History has not served the NHS (National Health Service) complaints system well
History has not served the NHS complaints system well. There have been many reports about NHS complaints going back well over two and a half decades, saying the same or similar things about the system. Many have argued and continue to argue that the NHS complaints system needs to be much more responsive, simpler in operation and less defensive. It is fair comment to argue today that the NHS complaints system is still plagued with endemic and systemic problems. The NHS has never been able to gets its health care complaints system right.
Two contemporary reports, one published in 2018 and the other in 2020, give support to the view that the NHS needs to do much more to improve how patient complaints are handled. Read More
By John Tingle
Unfortunately, it’s never too long before a major NHS patient safety crisis hits the newspaper headlines in the United Kingdom. The Shrewsbury and Telford Hospital Trust (SATH) maternity scandal has just become a major breaking U.K. patient safety news story.
Shaun Lintern reports in The Independent:
Hundreds of families whose babies died or were seriously injured at the Shrewsbury and Telford Hospital Trust do not even know their cases have been identified for investigation in the biggest maternity scandal to ever hit the NHS… Dozens of babies and three mothers died in the trust’s maternity wards, where a ‘toxic culture’ stretched back to 1979, according to an interim report leaked to The Independent this week.
Patient Safety Scandals
By John Tingle
The Accident and Emergency (A&E), the Emergency Room, is the bellwether NHS speciality from which all the other clinical specialities appear to be judged. Long reported delays and missed targets in the A&E (Emergency Room) lead to a public, media clamoring that the NHS is a failing public service. The independent regulator of health and social care in England, the CQC (Care Quality Commission) recently published findings from a national survey of more than 50,000 people who received urgent and emergency care from 132 NHS trusts (hospitals).The survey looked at people’s experiences, from decision to attend, to leave, using Type 1 (major A&E) and Type 3 (urgent care centers, minor injury units, urgent treatment centers) urgent and emergency care services.