Patient safety merits new review for modified medical devices, physician says

For patient safety, the U.S. Food and Drug Administration (FDA) should require that clinical data be submitted as part of a more rigorous re-evaluation of medical devices that are modified after approval, according to UC San Francisco physician scientists in a commentary published online March 24, 2014 in the Annals of Internal Medicine. According to authors Rita Redberg, MD, UCSF professor of medicine, and UCSF second-year medical student Sarah Zheng, such a requirement could prevent deaths due to insufficiently tested device modifications.

"The need for rapid approval of design improvements to marketed devices must be weighed against the possibility of introducing unknown risks to patient health from such modifications," the authors wrote in their commentary.

In addition, Redberg said, "A requirement that post-marketing clinical data, including adverse events, be collected and deposited into a public data base would allow for the best identification of patients who could benefit from a device, without slowing market entry."

The growing medical device industry is expected to generate $228 billion in sales by 2015 for technologies ranging from orthopedic knee replacements to cochlear implants, to infusion pumps. Many devices are invasively installed within the body, and the potential complications when they fail can be great.

Examples of avoidable outcomes, according to Redberg and Zheng, include hundreds of failures and five deaths arising from use of the modified Sprint Fidelis defibrillator electrical lead wire made by Medtronic, Inc., prompting a recall, and a similar recall of defibrillator leads marketed by St. Jude Medical, Inc., after 227,000 had been implanted in patients.

The FDA evaluates safety and effectiveness of new, high-risk medical devices before they are marketed, through a process known as premarket approval (PMA). This procedure involves the submission and review of clinical-trials data. However, modifications of existing devices may be approved without additional clinical data, through a less rigorous procedure called a PMA supplement.

"Companies often submit changes to a device one supplement at a time instead of submitting multiple changes in a single application," Redberg and Zheng stated in the commentary. "As a result, each submitted modification is evaluated separately, a process that makes it difficult, if not impossible, to take into account the cumulative effects and interactions of multiple modifications."

The Medtronic and St. Jude Medical devices were modified multiple times through PMA supplements without additional clinical data submission, the authors noted.

Clinicians may favor use of a device based on original research on a much earlier version, with no knowledge of substantial, untested modifications that have been made to the currently available device, they said.

The authors advocated for clear labeling of devices to highlight modifications to physicians and alert them to unevaluated risks.

Story Source:

The above story is based on materials provided by University of California - San Francisco. The original article was written by Jeffrey Norris. Note: Materials may be edited for content and length.

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Is Europe equipped with enough medical oncologists? Horizon still unknown

Jan. 17, 2014 — The European Society for Medical Oncology (ESMO) has welcomed a recent survey that shows the number of medical oncologists in Western Europe appears to be keeping pace with the rising toll of cancer.

But the society has also warned that a worrying lack of information about the situation in Eastern Europe must be urgently addressed.

Published in the Annals of Oncology this week, the survey provides the first detailed information on the current number of medical oncologists in 12 European Union countries, mostly in Western Europe, and their predicted availability by 2020.

Around the world countries are struggling to ensure their medical oncology systems can deal with the increase in cancer cases, says ESMO Press Officer Solange Peters, a lung cancer expert from the university of Lausanne, Switzerland. Until now, nobody could say what the situation was in Europe.

The survey, led by Evandro de Azambuja from Jules Bordet Institute, Brussels, shows that Austria, Belgium, Bulgaria, Finland, France, Germany, Hungary, Italy, The Netherlands, Portugal, Sweden and the UK will probably have enough medical oncologists over the next eight years since data collection to meet the needs of an increasing cancer patient population.

The study provides the current ratio of cancer cases to medical oncologists for each country, and shows the annual increase in the total number of medical oncologists.

However, despite repeated attempts, researchers were not able to gather adequate information from the 15 other EU Member States, making it impossible to paint a full picture of the situation in Europe.

"ESMO is willing to help countries work together to make this kind of data available for all of Europe," Peters says. "We need a complete picture and the current one is insufficient to draw firm conclusions."

"It is vital that we collect this data and we continuously monitor it, to optimise the medical oncology system in every European country," says the ESMO spokesperson.

"In the long term, we hope that it might be possible to build a Europe-wide system that will ensure we have a full picture of the needs across Europe, also beyond 2020, to guarantee optimal care to cancer patients" she says.

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UN humanitarian chiefs strongly condemn attacks on medical personnel and facilities by all parties to the Syria conflict

6 December 2013 | New York/Geneva - We strongly condemn attacks on health and any other civilian facilities in Syria and are deeply concerned by the serious implications for patients, health personnel and provision of critical medical supplies.

This brutal conflict continues to result in substantial damage to health facilities across the country. Over 60% of public hospitals have been damaged or are out of service, while a similar proportion of ambulances have been stolen or badly damaged. At a time when hospitals are overwhelmed with patients, it is vital that these facilities be protected and medical staff be allowed to provide urgent medical, surgical and obstetric care to patients without any risk.

Health facilities must be respected and protected in all circumstances - they should not be used for military purposes. Attacks against health facilities can be considered a war crime under international law.

All parties must respect their obligations under international humanitarian law to protect civilians, health facilities and health professionals during conflict and to permit the supply of vital humanitarian aid, such as medicines, vaccines and medical equipment to reach the most needy communities. It is of the interest of both parties in the conflict and of all Syrian people to preserve the neutrality and the functionality of health infrastructure.

Despite the insecurity and serious access challenges the United Nations and partners have helped vaccinate more than 3.3 million children against measles and polio in recent weeks. Over 8000 women have received reproductive and maternal health services, while medical supplies and training have been provided to ensure that hundreds of thousands of people with chronic health problems are treated.

We and our humanitarian partners continue to call for a halt to the violence and for all those with influence over the parties to urge immediate compliance with international law. And we ask that all our partners increase our common efforts to draw attention to these inhumane acts and to protect innocent women, men and children.

For further information, please contact:

WHO Geneva
Gregory Hartl
Telephone: +41 22 791 4458
E-mail: hartlg@who.int

OCHA New York
Amanda Pitt
Telephone: +1 917 442 1810,
E-mail: pitta@un.org

OCHA New York
Clare Doyle
Telephone: +1 646 288 6331
E-mail: doylecm@un.org

UNICEF New York
Rita Ann Wallace
Telephone: +1 212 326 7586
Mobile: +1 917 213 4034
E-mail: rwallace@unicef.org

UNICEF New York
Kent Page
Telephone: +1 212 326 7605
Mobile: +1 917 302 1735
E-mail: kpage@unicef.org

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WHO supporting Philippine Government with arrival of medical supplies after Typhoon Haiyan

12 November 2013 | MANILA, Philippines - Field hospitals, medical personnel, medicines and other medical supplies are arriving in the Philippines as countries and nongovernmental organizations around the world come to the support of the Philippines in the wake of Typhoon Haiyan. In support of the Government of the Philippines, WHO is coordinating all health-related aspects of the emergency response to ensure the supplies are moved quickly to where health facilities and supplies are most damaged, such as Tacloban, Cebu and the west coast of Leyte.

WHO and its staff are working around the clock to support the Government in coordinating the incoming relief supplies from more than 30 international humanitarian health organizations to ensure there is minimum duplication of materials and medicines arriving at any one location, and that hospitals, personnel and supplies get as quickly as possible to those places where they are needed most.

Within 3 days of Typhoon Haiyan hitting the Philippines, field hospitals with medical teams from Belgium, Israel, Norway and Japan are currently on the ground. More teams from Australia and Germany are expected today and tomorrow.

Other country governments and nongovernmental organizations that have pledged their support include: Canada, Finland, Hungary, Indonesia, the Netherlands, New Zealand, Norway, Singapore, Spain, Switzerland, the United Kingdom, the United States of America, and Viet Nam. The field hospitals will be set up at locations where local hospitals have been destroyed. They are fully self-sufficient – bringing all of their own food, water, electricity, medical supplies and personnel.

The health needs in this disaster are significant. In addition to responding to injuries and trauma, “regular” health needs will also need to be met in very challenging circumstances. For instance, it is expected that 12?000 babies will be born this month in the affected areas. People with noncommunicable diseases such as diabetes or heart disease will need to continue receiving their regular medication. WHO is working with the Government and partners to provide necessary assistance.

WHO has already deployed medicines and supplies to perform 400 surgeries and cover the basic health needs of 120?000 people for one month. Special diarrhoeal disease kits with medicines and supplies to treat 3000 cases of acute diarrhoea are also en route, since contaminated water is a frequent cause of diarrhoea.

With another tropical storm expected to hit the Philippines later this week, the need for safe water and sanitation facilities is critical. WHO is working with other humanitarian organizations to secure urgently needed water purification tablets.

Crowded living conditions and contaminated drinking water can lead to the spread of infectious diseases which can exacerbate health problems. The key is catching these diseases early before they can spread. WHO is also helping the Government to strengthen its early warning alert and response network (EWARN) to rapidly detect disease outbreaks and other public health threats.

For more information, or for an interview with Dr Julie Hall, WHO Representative, please contact:

Rachel Parry
Communications
Telephone: +63 949 766 5478
E-mail: manilakings@gmail.com

Christy Feig
Director of Communications
Telephone: +41 79 251 7055
E-mail: feigc@who.int

Gregory Hartl
Coordinator, News and Social Media
Telephone: +41 79 203 6715
E-mail: hartlg@who.int

Tarik Jasarevic
Communications Officer
Telephone: +41 79 367 6214
E-mail: jasarevict@who.int

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EU lawmakers back strict new approval system for medical devices

By Charlie Dunmore

BRUSSELS (Reuters) - European Union lawmakers backed a strict new approval system for high-tech medical devices on Wednesday, raising industry fears of added delays in getting new products to market that could dull Europe's competitive edge.

Members of the European Parliament's environment committee voted in favor of a new pre-market authorization system of randomized clinical trials for implantable devices, covering everything from hip replacements to artificial heart valves.

Moves to tighten the rules followed a 2011 scandal involving France's now defunct Poly Implant Prothese (PIP), which for up to a decade made substandard breast implants with industrial-grade silicone that were used by hundreds of thousands of women around the world.

Some critics said the scandal was the result of Europe's current authorization system, which is less strict than in the United States where extensive testing is required before new products are approved for sale.

In response, the EU's executive - the European Commission - has proposed increased monitoring of device manufacturers and tougher government oversight of the 80 or so mostly private Notified Bodies that currently decide on product safety.

But Wednesday's committee vote went far beyond the Commission's original proposals, calling for the establishment of a new pre-marketing assessment system for high-risk devices, which would be identified on a case-by-case basis and only authorized with the approval of the European Commission.

Europe's 100 billion euro ($135 billion) medtech industry has said that would add years to the time it takes to bring new devices to market, removing a key advantage that EU companies enjoy over their U.S. rivals.

"The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe's 25,000 small and medium-sized device makers," EU trade group Eucomed said in a statement.

The body also questions whether the EMA will have the capacity to evaluate the 400 to 600 so-called "Class III", or high-risk, devices that currently reach the market each year in Europe.

Major makers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott, Allergan and Smith & Nephew.

Reflecting the deep divisions on the issue, Wednesday's parliamentary vote followed more than 900 amendments by lawmakers to the Commission's original proposal.

If the committee's stance is confirmed by the full parliament in the coming weeks, it will form the basis of the assembly's negotiating position in subsequent talks with EU governments to finalize the rules.

(This story corrects paragraph 6 to remove reference to European Medicines Agency)

(Editing by Ben Hirschler and Anthony Barker)

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First real-time detector for IV drugs may help eliminate medical errors

Sep. 19, 2013 — Today, computerized smart systems can deliver drugs intravenously in exact volumes to hospital patients. However, these systems cannot recognize which medications are in the tubing nor can they determine the concentration of the drug in the tubing. This lack of precise information can lead to medication errors with serious consequences.

Now, a new optical device developed by a team of electrical and computer engineering students at the University of Illinois at Urbana-Champaign (UIUC) can identify the contents of the fluid in an intravenous (IV) line in real-time, offering a promising way to improve the safety of IV drug delivery. The team, led by Prof. Brian T. Cunningham, interim director of the Micro and Nanotechnology Laboratory at UIUC, will present its work at The Optical Society's (OSA) Annual Meeting, Frontiers in Optics (FiO) 2013, being held Oct. 6-10 in Orlando, Fla.

The vulnerability of IV drug-delivery systems due to human error is a chief concern in hospital safety, Cunningham said. Errors can include incorrect dosage, unintentional substitution of one drug for another, and co-delivery of incompatible drugs.

"Up to 61 percent of all life-threatening errors during hospitalization are associated with IV drug therapy," Cunningham said, citing a recent report. "So for all the really good things hospitals can do, the data shows that mistakes can occasionally happen."

To approach this problem, Cunningham and colleagues turned to the very small -- to structures and processes at the nanoscale (one-billionth of a meter), where novel physical and chemical properties arise. The researchers use a technology called Surface-Enhanced Raman Scattering (SERS), a powerful analytical tool prized for its extreme sensitivity in obtaining molecular signals that can be used to identify chemicals. To determine the identity of a particular IV medication, researchers shine laser light onto a nanostructured gold surface that contains millions of tiny "nano-domes" that are separated from each other by as little as 10 nanometers. The nano-domes are incorporated into the inner surface of IV tubing, where they are exposed to drugs that are dispersed in liquid. They capture the light scattered from drug molecules that are in contact with the nano-domes and use SERS to determine the drug's molecular signature. Finally, they match the signature to known signatures for the drug in order to confirm the presence of a specific medication in the IV line.

While other groups have demonstrated excellent nanostructured surfaces for SERS, those developed by the Cunningham group are unique because they are inexpensively produced on flexible plastic surfaces by a replica molding process with nanometer scale accuracy.

Early data show that the Cunningham group's system can identify medications including morphine, methadone, phenobarbital, the sedative promethazine, and mitoxantrone, which is used to treat multiple sclerosis. The system is extremely sensitive: it can detect drugs in amounts 100 times lower than the clinically delivered drug concentrations commonly used. So far, the researchers have also shown their system can sense a two-drug combination, which has its own unique signature.

The next step is further evaluation for combinations of up to ten drugs being delivered at the same time. Computer algorithms are also being developed to automatically interpret the SERS spectra, and Cunningham's team reports that the system is now being evaluated for possible commercialization.

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2 molecular biologists get $500K medical prize

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ALBANY, N.Y. (AP) — Two molecular biologists have been awarded the annual Albany Medical Center Prize in Medicine and Biomedical Research.

James Darnell Jr. and Robert Roeder received the prize during a ceremony Friday and will share $500,000, the largest award in medicine and science in the United States. The two men performed pioneering research on how cells express their genetic information.

Roeder heads the biochemistry and molecular biology lab at The Rockefeller University in New York City, where Darnell is emeritus faculty.

The two winners were announced in March.