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(c) 2015 Jon L Gelman, All Rights Reserved.

Sunday, May 3, 2015

Synchromed II Implantable Infusion Pump Systems: FDA Consent Decree To Limot Use

Medtronic, Inc. cited for manufacturing violations

The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufacture.

The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe us

The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment.

The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.

Once Medtronic receives permission from the FDA to resume the design, manufacture and distribution of these products, the company must continue to submit audit reports so the agency can verify the company’s compliance. In addition to these audits, the FDA will monitor the company’s activities through its own inspections.

The FDA first approved the Synchromed II Implantable Infusion Pump Systems in 2004, and first identified problems with the manufacture of these pumps in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients.

Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s Neuromodulation facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications.

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Patients who are implanted with a Synchromed II Implantable Infusion Pump System should maintain regular follow-up appointments with their physicians. Patients who experience a change or return of symptoms, or hear a device alarm, should contact their physician immediately.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Friday, May 1, 2015

WHO Reports Widespread Asbestos Exposure Continues In Europe

WHO
WHO (Photo credit: Wikipedia)
The WHO (UN World Health Organization) reports that 1 in every 3 Europeans are still exposed to asbestos.

About one third of the 900 million people in the WHO European Region live in countries that have not yet banned the use of all forms of asbestos, and this potentially exposes them at work and in the environment. In countries where asbestos is banned, exposure persists from past use. Exposure to asbestos can cause cancer of the lungs, ovaries and larynx; mesothelioma; and asbestosis and the most efficient way to eliminate these diseases is to stop the use of all types of asbestos. At its closure, the high-level meeting on environment and health in Haifa, Israel, urgently calls upon all European countries to eliminate asbestos-related diseases.

"We cannot afford losing almost 15 000 lives a year in Europe, especially workers, from diseases caused by exposure to asbestos. Every death from asbestos-related diseases is avoidable," says Dr Zsuzsanna Jakab, WHO Regional Director for Europe. "We urge all countries to leave the Haifa meeting to fulfil their 2010 commitment and develop policies by the end of this year that will eliminate asbestos-related diseases from the face of Europe. There is very little time left for that."

Elimination of asbestos-related diseases was one of the major issues discussed at the Haifa meeting. Over 200 representatives of European countries and international and nongovernmental organizations attended the meeting to evaluate overall progress on environment and health in Europe.
An "eye-opener" report: progress toward the elimination of asbestos-related diseases

The report Progress toward the elimination of asbestos-related diseases, presented at the meeting, indicates that asbestos, a group of natural fibrous minerals, is responsible for about half of all deaths from cancers developed at work. According to new estimates, deaths from mesothelioma in 15 European countries cost society more than 1.5 billion euros annually (see table in Annex).

While 37 of the 53 Member States in the Region have banned the use of all forms of asbestos, the remaining 16 countries still use asbestos, especially for building materials, and some continue to produce and export it. Even after its use has ceased, asbestos lingers in the environment, so it needs to be safely removed and disposed without delay.

"Asbestos is known as a silent killer as health disorders from exposure to it usually appear after several decades. This means that many more people are expected to fall sick and die in the coming years throughout Europe", says Dr Guénaël Rodier, Director, Division of Communicable Diseases, Health Security and Environment. "This new report assesses how far European countries have got in eliminating asbestos-related diseases and provides recommendations for the future."

In one week, the Chemical Review Committee of the Rotterdam Convention will consider listing chrysotile or white asbestos, the most common form of asbestos, among the substances for which importing countries have to give their consent to the exporting party for the trade to occur.

"Elimination of asbestos-related diseases is a priority for Israel. Already in 2011 we have passed a law prohibiting the use of new asbestos, requesting removal of existing friable asbestos and guiding disposal of asbestos cement,", says Mr David Leffler, Director-General, Ministry of Environmental Protection for Israel. "An asbestos waste removal project is conducted in Western Galilee where by December 2014, 80 thousand cubic meters of waste were cleaned in 221 sites. Databases on asbestos-related diseases are considered key to monitor asbestos' health effects and are regularly maintained."
Paving the way ahead for better environment and health in Europe

All European countries present at the meeting renewed their pledges to work towards meeting the time-bound targets they adopted in 2010. This includes concrete steps to:
strengthen or establish partnerships with different stakeholders and processes, and utilize already existing policy instruments and tools;
  1. enhance the understanding and use of economic arguments to support action on environment and health; and 
  2. harmonize with the forthcoming post-2015 sustainable development agenda.

They also agreed to address the environment and health challenges of the 21st century posed by:
complex risk factors: air, water, waste or chemicals;
complex systems of direct relevance to environment and health: food, energy or cities; and
matters of international environment and health security: disasters and climate change.

The conclusions of the high-level meeting in Haifa are an important milestone in the run up to the Sixth Ministerial Conference on Environment and Health planned for 2017.
The 16 countries that have not yet banned all forms of asbestos are: Albania, Andorra, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Kazakhstan, Kyrgyzstan, Monaco, the Republic of Moldova, the Russian Federation, Tajikistan, Turkmenistan, Ukraine and Uzbekistan.
The five time-bound targets adopted by countries in the European Region in 2010 are to: provide safe water and sanitation to all children by 2020; create healthy and safe environments for children in their daily life by 2020; make children's indoor environments free from tobacco smoke by 2015; safeguard children's environments from toxic chemicals by 2015; develop policies to eliminate asbestos-related diseases by 2015.

The seventh meeting of the Conference of the Parties to the Rotterdam Convention (RC COP-7) will be held from 4 to 15 May 2015, back-to-back with the twelfth meeting of the Conference of the Parties to the Basel Convention (BC COP-12) and the seventh meeting of the Conference of the Parties to the Stockholm Convention (SC COP-7).

Lab Worker Infected by Vaccinia Virus Infection Despite Recent Immunized

The US CDC reported:

Occupational exposures to orthopoxviruses in laboratories can result in infections. The most effective means of prevention are preexposure smallpox vaccination, training, and laboratory safety measures such as proper handling and disposal of needles. In addition, incident reporting and timeliness of seeking medical treatment for inadvertent exposures are critical components of laboratory response plans.

Wednesday, April 29, 2015

Bumble Bee Foods, Two Others Charged in Death of Employee Trapped Inside Industrial Oven

Los Angeles County District Attorney Jackie Lacey today announced that Bumble Bee Foods LLC and two others were charged with willfully violating worker safety rules, allegedly causing the 2012 death of an employee who became trapped inside an industrial oven at the company’s Santa Fe Springs plant.

Tuesday, April 28, 2015

A More Efficient Process

The NJ Appellate Court reversed a Compensation Judge's dismissal of an employee's claim petition citing, delay in adjudication, and an inadequate record at the trial record.

The reviewing court in an opinion reversing the trial judge and reinstating the case wrote that the motion had lingered for too many years, ie. 4 years, the record below on the motion was vague and incomplete, and the legislative intent for an efficient and liberally construed process was not met.

The Appellate Division cited a 30 year old decision declaring the need for a more efficient process to adjudicate workers' compensation claims.

Roderick v. Taxi & Limousine Three, LLC
Not Reported in A.3d, 2015 WL 1859321 (N.J.Super.A.D. 2015)

Monday, April 27, 2015

The Circus: OSHA Settlement

Ringling Bros. to enhance safety for all aerial acts after settlement agreement
9 employees injured in May 2014 fall in Providence, Rhode Island

Ringling Bros. and Barnum & Bailey Circus, will implement ongoing safety enhancements in aerial acts to protect employees against injuries like those sustained by its aerialists during a May 4, 2014, performance in Providence, Rhode Island. Feld Entertainment Inc., headquartered in Palmetto, Florida, owns the circus.

Saturday, April 25, 2015

Medical Costs: Why Target the Drug Industry Now

The pharmaceutical industry may indeed be a major factor in the future success of reducing workers' compensation treatment costs and improve the success rate of care. Such action will reduce the cost of medical treatment and likewise reduce permanent disability awards.

This week several landmark announcements were made regarding the treatment of mesothelioma and Hepatitis C. The pharmaceutical industry is making great strides if treatment and cure.

Perhaps targeting the drug industry at this time merely to reduce costs is short sighted. The entire program needs to be encouraged. 

US FDA: Designation for CRS-207 in Mesothelioma Treatment

Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease