News: Medical e-News Round-Up - Issue 42

This issue covers:

India’s new medical device regulations

A proposed draft of new legislation for medical devices has been released by India's Health Ministry, according to the website, India Briefing.

The Drugs and Cosmetics (Amendment) Bill is expected to be submitted to the country's parliament later this year, and would make India’s regulations the same as the European Medical Device Directives.

According to the article…"the new legislation would simplify import procedures and affect change across many areas including: manufacturing, sales, distribution and clinical trial of medical devices.”

It will also establish a Medical Devices Technical Advisory Board. Full details here.

288 success at Hitachi

Leading healthcare equipment manufacturer Hitachi Medical Systems UK Ltd uses Rigel 288 analysers to reduce the time it takes for engineers to test the electrical safety of its ultra sound scanners in service in the UK.

The Rigel 288 enables engineers to quickly check the safety of around 500 scanners while they are in use to ensure compliance with the recurrent and post repair test requirements of the new IEC 62353 standard for medical devices.

Bluetooth technology enables Hitachi’s engineers to carry out cable-free data transfer and safety labelling, without the cumbersome plugging and unplugging of leads and cords.

Wellingborough-based Hitachi Medical Systems is part of the Hitachi Group that designs, manufactures and supplies advanced medical equipment and solutions to healthcare markets worldwide. Roy Cartwright, Hitachi’s technical support manager, said: “We have been impressed with what the 288 offers in term of quality, versatility and ease-of-use.

“Robust and fully functional means the 288 meets the demanding requirements of field testing, while its portability, flexibility and added value features are very good. All in all, it’s an impressive and unique product that makes the job of electrical safety testing a whole lot easier.”

Global refurbished medical equipment market to hit more than $9 billion by 2019

The global refurbished medical equipment market is expected to grow at a compound annual growth rate (CAGR) of 12.5 percent and reach $9.37 billion by 2019, according to a new MarketsandMarkets report.

The market includes operating room, medical imaging, cardiology, intravenous therapy systems, endoscopy equipment, patient monitors, defibrillators, intravenous therapy systems, intensive care and neonatal intensive care units, blanket warmers, autoclaves, suction pumps, sequential compressor devices, stretchers, cath labs, stress test systems, heaters/coolers, dry imagers and beds.

Financial challenges are increasing the global interest in low-cost refurbished medical equipment and growing privatization in the health care sector is also driving the market. But at the same time, the market is restricted by the lack of standard policies for the sale and use of refurbished medical equipment and a public institutional stance against purchasing the equipment.

In 2014, North America made up most of the global market, followed by Europe, but the Asia-Pacific region is projected to gain momentum and grow at a CAGR of 13.7 percent from 2014 to 2019. That is being driven by privatization, reduced reimbursement rates, a growing population base and an increase in low budget hospitals and clinics.

The emerging markets, including India, Brazil, and Mexico hold great potential for refurbished medical equipment companies. Medical tourism is growing in those regions and there is also an increase in the population bases and privatization.

As of 2014, the global refurbished medical equipment market was dominated by GE Healthcare (UK), Philips Healthcare (Netherlands), and Siemens Healthcare (Germany), which together accounted for about 41% of the market. www.dotmed.com/

Total capability at EBME

Rigel Medical will be showcasing its advanced range of electrical safety analysers and vital signs simulators, which provide accurate solutions for testing medical devices and equipment, at EBME (30th April 2015) in Milton Keynes.

Event details at www.rigelmedical.com/events

New technologies will cut healthcare costs

In a report issued by market research firm IBISWorld, industry analyst Sarah Turk predicts that burgeoning digital technologies will pay substantial dividends for healthcare by 2020, both reducing healthcare costs and improving access to care.

She focuses on three key modalities in her report: telehealth, mobile health (mHealth), and interoperability.

Telehealth technology may help “mitigate the burden of the projected shortage of 20,400 primary care physicians by 2020,” Turk says. She notes that while many healthcare providers already engage in telehealth, the technology’s potential “has yet to be fully harnessed”.

Similarly, she says, mHealth—the “use of mobile applications and devices to exchange medical information, data or to provide clinical services”—will also transform healthcare information technology. Combined with the rise of telehealth, mHealth will move healthcare away “from relying on inpatient care and … toward outpatient, namely in-home, patient-monitoring services.”

However, for these advances to occur, the healthcare industry must overcome the challenge of interoperability. Due to the lack of “interoperability standards for medical equipment and related software,” Turk says, “the implementation of new technology may pose … an arduous task for healthcare providers.”

More at www.ibisworld.com

Check your Pulse

Finally, make sure you collect your copy of the latest edition of The Pulse, Rigel Medical’s medical industry publication. We look at the new edition of IEC 62353 which applies to ‘Medical electrical equipment – recurrent test and test after repair of medical electrical equipment’ and answer some of your questions in our regular ‘Question Time’ slot.