Medical Archives - Page 8 Of 34

Is EU MDR harming medical device innovation?

The extensive technical documentation requirements of the EU’s Medical Device Regulation (EU mDR) are curbing opportunities for early device development according to industry leaders.

At the Outsourcing In Clinical Trials: Medical Devices Europe 2023 meeting on February 21-22, Philips clinical project manager Deborah Ann Schuster shared some of the pain points that companies are encountering since implementation of the new rules.

In addition to time and resource constraints, Schuster said physicians and SMEs are disincentivised to begin prototype testing and trials due to the huge increases in technical documentation required by the EU MDR.

“Before the MDR was implemented, the key innovators of medical devices were able to easily set up an investigator-initiated trial,” said Schuster. “But now the requirements for the submission of technical documentation to begin these trials is way more challenging. EU MDR requires the innovators to prepare time-consuming documentation and they need much more manpower and funding to comply with the regulations.”

As most device innovation comes from startups or research groups, Schuster explained that this is having a negative impact on the large companies.

“The drivers of innovation are often the potential users, meaning physicians and physician researchers. They come up with the idea for a new device, or suggestions to improve existing devices and often those researcher physicians are the ones who develop the first prototypes. So, one of big challenges we are seeing with the MDR is in innovation of novel devices.”

To navigate these challenges, Schuster said some companies are looking for alternatives, including leveraging flexibility within different EU competent authorities.

In Slovenia, an infrastructure of CROs and trial sites is building for early development studies as the country has some flexibility compared to other.

However, other companies are looking further afield and opting to leave Europe for the US, she added.

“I assume that many companies will move to the US because prototype innovation and testing is way easier than it is here. For our Munich Philips team this is not an option because shipping outside of Europe for a second prototype will make our studies even more complex, but for other companies, it could be an option. But what we want here in Europe is to keep the innovation and keep the early development where it has been invented.”

The EU MDR and IVDR regulations became effective in May 2017 but have become applicable over a transition period, to allow time for companies to acclimate to the new requirements. In , the European Commission implemented a proposal to extend the transitional period to certify medical devices under the MDR. The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements.

For high-risk devices, the transition period to the new rules will be shorter (extended to December 31, 2027), whereas the medium and lower risk devices will have a longer transition period (extended to December 31, 2028). The proposal also introduces a transition period for Class III implantable custom-made devices. Manufacturers will have until May 26, 2026, to certify such devices.

Supply chain, operations, outsourcing and other key topics will be discussed with industry experts and leading speakers at Arena International’s upcoming Clinical Trials events across the globe.

Intermountain Health joins medical research initiative

Utah-based Intermountain Health has been selected to join a nationwide initiative working to speed up implementation of potentially groundbreaking research in health care.

Intermountain is one of 42 health care organizations brought on board by the National Patient-Centered Outcomes Research Institute to contribute to the Health Systems Implementation Initiative.

Providing up to $500,000 for an initial project that helps to prepare health care organizations with future strategies, the Health Systems Implementation Initiative aims to accelerate the use of published research, cutting down what Intermountain said is an estimated 17-year lag between publishing medical research and its use in health care facilities.

Further funding for health care systems involved in the initiative will be provided if health care organizations support other projects promoting evidence from the National Patient-Centered Outcomes Research Institute.

With every implemented project, health care organizations can receive funds ranging from $500,000 to $5 million.

Dr. JP Valin, the chief clinical officer at Intermountain Health, said, “We believe that every patient … deserves to get the best care and the treatment and the most up-to-date and state of the art care that’s being delivered.”

He said the 17-year lag from the time medical research is conducted to when it’s implemented in a facility is because of the process to learn new practices.

Currently, to keep up to date on new treatment and care, Valin said, medical professionals read through journals and attend conferences, which can be a somewhat lengthy process. Then, the research can begin to seep into medical training to benefit patients.

Intermountain has been putting forward an effort to share information faster. Intermountain, Valin said, “has done that through the work of its Healthcare Delivery Institute, which we’ve had for decades now, as well as our clinical programs work.”

Intermountain’s ability to quickly share information has been nationally recognized, and the contribution to the Health Systems Implementation Initiative will only further encourage the sharing of health care research, Valin said.

The Health Systems Implementation Initiative aims to create a platform where researchers from around the country can share their findings, deploying best-care practices in a facility where health care professionals can gather and share more information to improve patients’ health, said Valin.

Valin said, “Then we can publish that (information) and share that more broadly around the country.”

Participants in the Health Systems Implementation Initiative represent 800 hospitals nationwide, serving nearly a quarter of the U.S. population.

Including academic medical centers, community-based systems, integrated health care delivery and finance systems, safety net health systems, faith-based systems, public health care delivery systems, and a medical center within the Veterans Health Administration, the Health Systems Implementation Initiative is taking “groundbreaking” steps, said Nakela Cook, executive director of the National Patient-Centered Outcomes Research Institute.

Cook said these steps will “lay the groundwork for future expansion and broader implementation by demonstrating pathways to uptake and sharing lessons learned across health systems.”

This sharing and implementation of medical research has “never been done on this scale before across the country,” Valin said.

Valin hopes to continue implementing life-changing research to benefit patients nationwide.

Council takes action to mitigate risk of medical devices shortage

Today the Council adopted a regulation which extends the deadline for the certification of medical devices. This measure aims to prevent that medical devices which cannot be certified by the initial cut-off date become unavailable for European patients.

Today we have agreed on measures that will allow the industry to continue bringing essential medical devices to the market and ensure that patients have safe access to medical devices.

Acko Ankarberg Johansson, Swedish minister for health care

A staggered and conditional extension

Producers of medical devices will now have until 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices to meet the legal requirements.

The extension of the transition period will be granted under certain conditions. These ensure that only devices that are safe and for which manufacturers have already started the certification procedure will benefit from the additional time.

Removal of “sell-off” date

The regulation adopted today also reduces the risk of medical devices shortages by removing the “sell-off” date rule. The “sell-off” date is the end date after which devices already on the market but not yet with the final user should be withdrawn. Only devices that comply with the previous EU law on medical devices will benefit from this rule. Removing the “sell-off” date will allow safe medical devices to remain longer on the market.

Background and next steps

In April 2017, the Council and the European Parliament adopted two regulations to improve the safety of medical devices and in vitro diagnostic medical devices. Medical devices cover a broad array of products, ranging from hearing devices and wheelchairs to catheters and orthopaedic implants. One of the measures of the 2017 regulation is a more robust conformity assessment system of medical devices. The amending regulation adopted today does not change the requirements of the original regulations of 2017.

Under this system, by the end of the foreseen transition period of 26 May 2024, all medical devices have to conform with the new rules. But because, among other things, conformity assessment bodies suffer from capacity problems to (re)certify old and new medical devices there is a risk that at the end of the transition period a large share of devices will no longer be available to EU patients.

The decision to extend the implementation period will enter into force on the day of its publication in the Official Journal of the EU.

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Bacteria-killing viruses could combat antibiotic resistance, says UK scientist | Medical research

The use of experimental therapies based on bacteria-killing viruses needs to be rapidly scaled up in the NHS to combat the worsening threat of antibiotic resistance, one of the UK’s leading scientists has said.

Prof Martha Clokie, who has pioneered research into bacteriophages, or phages, at the University of Leicester, said the approach was helping a growing number of patients in compassionate use cases, and could become a routine treatment in future for conditions such as chronic UTIs and diabetic foot ulcers.

Clokie will be the director of the UK’s first phage library, due to open at Leicester next month, which she says will help fast-track the use of phages in the NHS and pave the way for the large clinical trials required for phages to become licensed treatments.

“The risk from antibiotic resistance is dire and getting worse … I find it really shocking,” Clokie said. “Unless we have clinical trials, phages won’t become mainstream as a medicine, and that’s where we’re aiming.”

Phages work by infecting bacteria cells and killing them, but they are very specific in which infections they can target. They have been used successfully in a growing number of one-off cases, including a British teenager who was dying from an intractable lung infection and was treated at Great Ormond Street in 2019.

Q&A

What are bacteriophages?

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Bacteriophages, or phages, are incredibly small viruses, just a few nanometres across. They are normally harmless to humans, but can be deadly for bacteria.

Phages work by penetrating the bacterial membrane and replicating inside the cell until it bursts open, killing the bacterium and releasing more phages. The key to harnessing them therapeutically is to find phages that are extremely efficient at killing the strains of bacteria causing particular infections.

In clinic, they can be inhaled through a nebuliser, sprayed on to the skin or taken orally, depending on the type of infection. To date, patients have typically been given bespoke therapies, but in future it is hoped that off-the-shelf cocktails of phages could be used to treat common infections, such as E coli and C difficile.

“I get fairly regular emails from doctors and patients wanting phages,” Clokie said. “Doctors have gone from being completely disinterested to ‘give me the phages now’ … There are people who need phages now because they’re dying.”

Clokie’s lab is preparing a phage cocktail for the doctor of a London-based patient with a chronic UTI, who is allergic to antibiotics and so does not have other treatment options. However, these one-off cases typically involve scientists spending months in the lab designing expensive, bespoke treatments.

“There’s always several months scrambling around trying to find the right phages,” she said. “The idea of having this systematic, well-curated collection is that … doctors will be able to access the right phages straight away.”

Students working in the lab at the University of Leicester. Photograph: Christopher Thomond/The Guardian

The lab already has a collection of about 2,000 phages stored in a freezer at -80C, and it hopes to increase this by about 1,000 samples each year. Phages occur ubiquitously in nature, but phage-hunting involves tracking down the ones that efficiently kill infection-causing strains.

“Wherever you have high numbers of bacteria, by definition you’ll have high numbers of phages,” Clokie said. “The most common place people look is human sewage.”

Clokie’s students have been sent out to dredge muddy estuaries and piles of horse muck in the quest for new species. A set of phages extracted from slime in a stream in Bradgate Park, Leicester, were found to be particularly good at targeting biofilms, which are often seen in chronic bladder infections and are among those under consideration for treating the London-based patient.

“It starts off incredibly low-tech,” Clokie said. But the advent of AI-based approaches means scientists are increasingly aiming to predict phage characteristics based on genetic sequencing, and how multiple phages might interact.

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Petri dishes in the lab. Photograph: Christopher Thomond/The Guardian

Clokie said that despite a growing awareness of the threat of antibiotic resistance over the past decade, the outlook had not improved and doctors were reporting an expanding list of infections showing multi-drug resistance, including E coli, pneumonia, gonorrhoea and the stomach bug shigella.

A critical problem, she said, was the weak economic incentives for pharmaceutical companies to develop new antibiotics, given the increasingly restricted use of the drugs. In recent years, several companies have redirected R&D efforts into more lucrative areas such as cancer drugs, despite the growing threat of resistance.

“People will be cured of cancer but die of sepsis,” Clokie said. “There’s a really interesting disconnect between how much people are prepared to pay for drugs for autoimmune diseases or cancer and what they’re prepared to pay for antibiotics.”

Clokie is among those calling for an update to regulations created with conventional drugs in mind, to make it easier to carry out trials that could pave the way for wider use of phages. “At the moment, you need a willing doctor who is prepared to put phages into a patient as an unlicensed medicine and if something goes wrong they’ll get their licence removed,” she said.

In future, cocktails could be designed to treat common infections rather than specific strains in individual patients. Clokie said the growing use of phages in agriculture – as an alternative to chlorine spray in potato production – shows that costs are not prohibitive.

“They’re not going to replace antibiotics but they can be used to protect and preserve our antibiotics,” she said. “We can use them in chronic settings and we can use them in combination with antibiotics. I see it being a really useful complementary treatment.”

Eastern District of Kentucky | Medical Equipment Company Pays $7 Million to Resolve False Claims Act Allegations

LEXINGTON, Ky.— United Seating and Mobility, LLC, d/b/a Numotion (Numotion) has paid $7 million to resolve civil allegations that it made false statements in connection with claims for reimbursement it submitted to Kentucky Medicaid, two of Kentucky Medicaid’s Managed Care Organization contractors (MCOs), MO HealthNet (Missouri Medicaid), and D.C. Medicaid.

Numotion is a national supplier of durable medical equipment (DME), such as hospital beds, manual wheelchairs, power wheelchairs and accessories, and gait trainers. The investigation involved DME that was “manually priced” by Medicaid payors in Kentucky, Missouri, and D.C. Those Medicaid programs reimbursed manually priced DME based on the cost Numotion actually paid the manufacturer for the equipment. Specifically, in Kentucky, reimbursement is based on “a manufacturer’s actual charges” billed to Numotion, or the “invoice price;” in Missouri, reimbursement is based on the “actual invoice of cost;” and in D.C., reimbursement is based on “original documentation reflecting all discounts.”

In the Settlement Agreement, the United States alleged that Numotion did not disclose all discounts Numotion received from, or the cost Numotion actually paid to, DME manufacturers when submitting claims for manually priced DME to Kentucky Medicaid, two Kentucky Medicaid MCOs (Aetna Better Health of Kentucky and WellCare of Kentucky), MO HealthNet, and D.C. Medicaid. Numotion’s failure to disclose all discounts, or the actual cost paid, resulted in these Medicaid programs paying Numotion higher reimbursements than it was entitled to receive. The United States contended that the conduct violated the False Claims Act, 31 U.S.C. § 3729(a)(1)(B), a federal law that prohibits knowingly making or using a false statement material to a false claim for reimbursement.

As part of the settlement, Numotion also entered into a 5-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General. The CIA requires, among other things, that Numotion implement a centralized risk assessment program, as part of its compliance program, and hire an Independent Review Organization to complete annual reviews of some of its Medicare and Medicaid claims.

“By hiding or failing to disclose discounts, to receive higher reimbursement from Medicaid programs across the country, Numotion prioritized its financial incentives, to the detriment of these Medicaid programs,” said Carlton S. Shier, IV, United States Attorney for the Eastern District of Kentucky. “Whenever the valuable resources of government health care programs are improperly dissipated to those who are not entitled, it diminishes the ability of these programs to meet the needs of their beneficiaries. We remain committed to doing our part to protect these programs from fraud, waste, and abuse and to preserve the taxpayer money that supports them.”

“When health care companies do not follow federal health care billing requirements, the integrity of those safety net programs can be undermined,” said Special Agent in Charge Tamala E. Miles of the U.S. Department of Health and Human Services Office of Inspector General. “Working with our law enforcement partners, the dedicated work of OIG’s investigators and attorneys has again resulted in the recovery of taxpayer dollars and better protection against improper billing in the future.”

The settlement resolves a lawsuit originally brought by L. Richard Parkey, a former Numotion employee, under the qui tam, or whistleblower, provisions of the False Claims Act. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. As part of this resolution, Parkey will receive approximately $1.05 million of the settlement amount.

This case was investigated by the U.S. Department of Health and Human Services, Office of Inspector General. Assistant United States Attorney Jennifer A. Williams handled the matter for the United States.

The case is United States ex rel. L. Richard Parkey v. United Seating and Mobility, LLC d/b/a Numotion, Case No. 3:17-cv-53-GFVT. The claims resolved by the settlement are allegations only, and there has been no determination of liability.

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China releases ‘landmark’ document on ethics reviews of life sciences, medical research involving humans

Chinese scientist He Jiankui presents his gene-editing experiment at the Second International Summit on Human Genome Editing in Hong Kong on Wednesday. Photo: AFP

China released a national regulation on ethics reviews of life sciences and medical research involving humans, which experts take as a “landmark document” since the illegal human genome editing case by the controversial scientists He Jiankui in 2018.

Life sciences and medical research involving humans includes research activities using humans’ biological samples and data to conduct research activities involving reproduction, growth, development and aging through physical, chemical, biological and traditional Chinese medicine methods.

It also covers experiments on human bodies with new technologies or new products, according to the regulation released on the website of the National Health Commission (NHC) on Monday.

Compared with the previous version released in 2016, the newly revised regulation expands the application scope from only medical institutes to colleges as well as scientific research institutes and clarifies regulatory duties of various related authorities, according to an explanation on the document by the NHC.

It also allows institutes that had not set up ethics review commissions to entrust a capable commission to conduct ethics reviews. Companies can also entrust a capable commission to conduct ethics reviews or supervision of a project.

The new regulation also gives detailed rules on the specific steps of the ethics review.

It stressed that ethics review commissions should regularly conduct reviews of life sciences and medical research involving humans and organize educating and training sessions for related research fellows, students and management personnel.

Ethics reviews should also be carried out timely under an emergency situation. For example, during the outbreak of an epidemic, such reviews should be conducted within 72 hours, with equal requirements in normal times.

Life sciences and medical research involving humans should be of scientific and social value and special attention should be paid to the research concerning fertilized eggs, embryos, fetuses or those that could be affected by assisted reproductive technology, the regulation noted.

Experts reached by the Global Times hailed the new regulation, saying it is a “landmark regulatory document” since the illegal human genome editing case by the controversial scientist He Jiankui in 2018.

In 2018, He, a genome-editing researcher at the Southern University of Science and Technology of China in Shenzhen, Guangdong Province, shocked the world as he claimed to have created the world’s first genetically modified humans.

He was sentenced to three years in prison in December 2019 for illegally conducting human embryo gene-editing intended for reproduction. He was reportedly released from prison in April 2022.

He made a high-profile comeback in early February as he attended an academic seminar focusing on the social values of CRISPR technology, sparking heated discussion on the ethical issues of scientific development.

He caught public attention again last week as the Immigration Department of Hong Kong Special Administrative Region on February 22 invalidated the Top Talent Pass visa it had issued to He for “false statements” less than a day after He told media he had obtained the visa.