Medical e-News Round-Up - Issue 3
9th May 2013

This issue covers:

Senate passes medical device tax repeal amendment

The US Senate has reached a deal on how to fund the government which includes an amendment that expresses support for the repeal of the medical device tax.

"Momentum is clearly growing in Congress to repeal the medical device tax as Senators continue to hear from their constituents that the impact is real — the tax is slowing economic growth and costing thousands of jobs," said Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance (MITA), in a statement. "MITA encourages Congress to prevent further job loss and protect essential research and development by promptly repealing this harmful tax."

The amendment passed with 79 votes and will proceed to the House for a vote.

The medical device tax was included in President Obama´s 2010 health care reform law to help raise roughly $30 billion over 10 years to offset the cost of reform. Beginning this year, the 2.3 percent excise tax applies to the sale of medical devices by manufacturers and importers, and manufacturers are required to pay an estimated $194 million per month in medical device payments.

The medical device industry, which includes MITA, the Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA) and others, has been fiercely opposed to the 2.3% tax from the start, and welcomed the passage of this latest repeal amendment.

"We encourage leaders in Congress and the administration to seize on this momentum and act to repeal this harmful tax," said Stephen J. Ubl, president and CEO of AdvaMed.


FDA moves to improve the quality of automated external defibrillators

The U.S. Food and Drug Administration has issued a proposed order to help manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalised, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.

AEDs are portable, electronic medical devices that automatically re-establish normal heart rhythms with electrical stimulation when they sense potentially life-threatening cardiac arrhythmias.

Although these devices have saved lives over the years, the FDA has received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of these devices. Manufacturers have also conducted dozens of recalls. The problems the FDA is seeing with AEDs are preventable and correctable. The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers.

“Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we’re committed to working with manufacturers to address these issues.”

The FDA will make sure that automated external defibrillators remain available so that they can continue to save lives. Although there have been problems associated with AEDs, their life-saving benefits outweigh the risk of making them unavailable during the classification process.

Ultimately, the proposed review process will allow the agency to more closely monitor how these devices are designed and manufactured. This will go a long way towards improving this life-saving technology.

More at

Public-private partnership speeds patient access to medical device technologies

The U.S. Food and Drug Administration is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment and review of new medical devices.

The Medical Device Innovation Consortium (MDIC) is an independent, non-profit corporation, which receives input from industry, government, and other organisations. MDIC will prioritise the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathways to market for these innovations.

Regulatory science – the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – is critical to the medical device industry and to public health. Advancements in regulatory science not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market.

The MDIC will bolster the country’s investment in regulatory science research by pooling people, funding, resources, and ideas to develop new tools, models, and methods that may be utilised to better and more efficiently evaluate new devices. FDA staff may collaborate with the MDIC on MDIC-supported research and other projects.

“By sharing and leveraging resources, MDIC may help the industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.


Check out the new Rigel Uni-Therm

Advanced verification and calibration of electrosurgical generators is provided by Uni-Therm, the IEC 60601 compliant instrument that accurately measures performance levels including high frequency leakage, high current, power distribution and patient return plate alarm testing.

A high power load bank enables performance testing up to 8A RMS with a duty cycle of up to 100% making the analyzer an extremely versatile test instrument for calibrating and performance testing of conventional and high power electrosurgical generators.

Remote electrode monitoring capability is carried out using a rotary encoder, which also controls the potentiometer, scaling up and down in manual or automatic mode to capture the alarm using the on-screen dedicated fast key. Data can be stored onboard for future traceability. The large array of internal resistors, ranging from 0-5115Ω in 5Ω steps provide not only the most accurate and detailed power curves, the Rigel Uni-Therm also advocates safe working practise by providing all necessary resistors within a single enclosure.

Bluetooth-enabled technology allows wireless connectivity to PCs and other equipment for the fast and convenient downloading of test data and the uploading of the electrosurgical device’s power curves and the manufacturer’s test specific programmes. Output waveforms can be examined through a built-in scope output which allows for easy confirmation of the desired waveform shape.

More information here.


Pulse Issue 3 - Expert news and advice from the experts

Rigel has over 30 years´ worth of expertise in medical safety testing and we want to share it with you.

The third issue of Pulse contains:

  • Whats on - Find out where and when you can see the exciting new Rigel products as we plan to travel across the globe
  • Industry news - See what´s been happening in the industry
  • Technical article - Read an introduction to Electrosurgery and request a free booklet
  • Product spotlight - Be one of the first to see the new Uni-Therm Electrosurgical Analyser
  • Case studies - See how an Optical company sees the benefits from using the Uni-Therm
  • Questions & Answers - We ask our expert to answer questions from our readers

Pulse magazine is available to view online here.


Register for your free invitation to AAMI 2013 Conference & Expo by May 10th

Rigel Medical will be exhibiting at the AAMI Conference & Expo, Long Beach, CA on 1-3 June 2013.

Come and visit our experts at: Booth 737 where we will be exhibiting our range of new products including the Multi-Flo infusion pump analyzer, the Uni-Therm high current electrosurgical analyzer and Uni-Pulse defibrillator analyzer.

You can register for your free 3-day visitor pass to the exhibition here.

* To obtain a complimentary Expo Plus Registration *($55 value), please submit the Online Registration Form by May 10, 2013.


Do you use Rigel Medical equipment? - If you think you may have a story for future e-news bulletins, please let us know by contacting us here.


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