Medical e-News Round-Up Issue 38

New IEC 62353 edition

A new edition of IEC 62353, which applies to ‘Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment’, has been published.

The IEC 62353 covers the general requirements for testing equipment prior to it going into service, after modifications, after repair, and as part of a recurrent testing protocol, and provides details of the tests that should be performed under these circumstances. It also discusses the reporting of test results and how to evaluate your findings.

The standard is intended for use by equipment manufacturers, testing equipment manufacturers, regulatory authorities, equipment suppliers, service personnel and organizational equipment users. As a technical revision, the important changes are:

Clarification of clause 5.3.4.1 on the measurement of leakage currents (plus more information in Annex A)
Revision of the protective earth resistance requirements
The addition of expected minimum insulation resistance values in Table 2
The reordering of the testing sequence found in Annex B

More at http://webstore.iec.ch/

Join the 62353 LinkedIn discussion group

Catch all the latest news and thinking about IEC 62353 with John Backes, Associate Director – Rigel Medical and others at the LinkedIn debate. He wants to encourage ongoing debate and is keen to hear the views of others as the second edition comes into force. You can join him and others at www.linkedin.com

India considers relaxing FDI medical devices policy

India’s Government is looking at relaxing the foreign direct investment (FDI) policy for the cash-starved medical devices sector to attract more investments and boost domestic manufacturing.

Inter-ministerial consultations are on to liberalise the foreign direct investment policy for the sector “which badly needs foreign investment”, sources said.

Besides the Commerce and Industry Ministry, the Finance Ministry, the Health and Family Welfare Ministry and the Department of Pharmaceuticals are involved in the consultations.

FDI in the medical devices sector is permitted through the government-approval route and the industry has been demanding that it be put under the automatic route, they said.

“India badly needs FDI in the medical devices and equipment sector. The industry is not modern and there is no threat of mergers and acquisitions from multi-national firms as domestic companies are not big unlike drug firms. So it should not be subjected to FDI limits and other restrictions,” said a source.

Industry officials have maintained for long that in the current “restrictive regime”, no foreign investor would invest in the sector and to make the segment modern and self-dependent, the government should relax the FDI policy.

The sector currently falls under the pharmaceutical category and is accordingly subjected to FDI limits and other conditions, such as the mandatory government approvals.

Read in full at www.dnaindia.com

New PULS-R simulation finger

A new simulation finger which combined with its advanced hand-held UNISIM simulator, provides the world’s smallest, high performance all-in-one vital signs solution. The compact Rigel PULS-R universal SpO2 simulation finger can produce accurate SpO2 simulations in 1% resolution from as low as 30% using the pre-programmed manufacturer specific R-curves. It can also be configured to meet customer specific R-curves via a simple-to-use configuration tool. This improves the detection of degrading and inaccurate SpO2 probes, reducing incidences of failure and providing the user with peace of mind. When linked with the UNISIM vital signs simulator - capable of undertaking NIBP, SpO2, ECG, temperature, IBP and respiration functionality tests simultaneously - it provides improved and customised vital signs simulation and measurement. Administration time is also reduced as the data recording and storage is undertaken directly and automatically.

Medtech market outlook: Europe struggles to recover momentum

The operating environment for medical device companies is primed to become more challenging - but transparent - as a result of new legislation that will overhaul the EU medical device directives, according to an article published in the ‘European Medical Device Technology’ magazine.

In response to increasing safety concerns, the legislative changes envisage stricter and more detailed monitoring and enforcement requirements for both Notified Bodies and national Competent Authorities. More stringent approval procedures with additional clinical evidence requirements for high-risk devices will also increase the regulatory burden on manufacturers.

Longer and more costly approval procedures threaten to undermine the competitiveness of the European medical device industry, which comprises largely of small and medium-sized companies.

The EU Parliamentary elections in May 2014 interrupted negotiations. But the legislative process is expected to gain momentum over the coming months, although the German industry association Spectaris does not expect the new law to go into effect prior to 2018.

The industry may have been heartened by a recent statement from EU Commission President-Elect Jean-Claude Juncker that cautioned against hindering the ability of companies to innovate by overregulation. Nevertheless, companies are already facing a draft of regulatory measures to improve patient safety, including the new patient implant card, which will be mandatory in Germany by October 2015.

While Western Europe will continue to see steady demand for medical devices, healthcare providers will be forced to seek better value for their money, thereby creating a more challenging operating environment and further squeezing profit margins.

In response to these challenges, the industry is experiencing a period of consolidation to provide economy of scale to healthcare providers or pay lower corporate taxes. Recent mergers among major players include deals between Baxter and Gambro, Zimmer and Biomet, and Medtronic and Covidien. Other notable developments include Danaher’s acquisition of Nobel Biocare and Smith & Nephew’s acquisition of Arthocare.

The above is an extract from an article published in EMDT. You can read in full at www.emdt.co.uk.

MOD plugs into the benefits of 288 field service kit

Rigel Medical’s 288 field service kit is used to test dozens of devises at Ministry of Defence medical, veterinary and dental servicing centres around the world.

Using the new testers, military technicians can significantly reduce the time involved in undertaking electrical safety checks on devices and equipment used at the military healthcare facilities, using the barcode functionality that is available with the tester. Also, the 288’s ability to use barcodes and recall the test history of a device is invaluable.

The Medical and General Supplies Team (M&GS) specified the 288 kit after assessments by technicians at RAF Henlow in Bedfordshire.

One of the key advantages of the 288 is a light, portable and integrated barcode reader and printer which means equipment can be identified and records recalled quickly, meeting the needs of technicians operating across the MOD in a more demanding mobile environment.

The field service kit reduces the time taken to test the electrical safety and operation of a wide range of medical devices and equipment used in hospitals, operating theatres and other facilities.

It offers a flexible, easy-to-use and accurate solution for testing devices for electrical safety to appropriate standards and guidelines including IEC 62353 IEC/EN60601-1, VDE 0751-1, AS/NZS 3551, AAMI, NFPA-99, MDA DB 9801-2006.

A state-of-the-art bluetooth barcode scanner enables devices and equipment to be quickly and easily identified, while test results can be stored within the Rigel 288 safety analyser and printed wirelessly to the rugged battery operated Elite Test n Tag printer.

Traceability is improved as information can be downloaded into Med-eBase – the easy-to-use test solution software. This enables the user to store and manage test results, email html test certificates to clients and schedule new work orders, which can then be fully uploaded into the large on-board memory.

The kit comes in a hard wearing, impact and water resistant Pelican carry case featuring dedicated foam inserts to safely hold the instrumentation in place and provide optimum protection during transportation.

Catch us at MEDICA

And finally, don’t forget to visit us at MEDICA (Hall 11 / H11), where the PULS-R will be the highlight of our display of advanced medical device analysers, electrical safety testers and simulators.

Alongside the world’s smallest all-in-one vital signs solution will be the MULTI-FLO infusion pump analyser, which leads the way in high and low flow, occlusion, back pressure and bolus measurement and meets the requirements of IEC 60601-2-24.

Featuring variants of one, two and four independent channels, each MULTI-FLO channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,500 mL per hour with results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the analyser accurately details changes in flow and pressure rates, providing a real-time picture of the quality of infusion.

The UNI-SIM Vital Signs Simulator will complete Rigel Medical’s display for MEDICA which, says associate director John Backes, continues to be a key show for the company, adding: “This year, we look forward to revealing our world leading, all-in-one vital signs simulator solution, which will undoubtedly draw significant interest because of the rapid and accurate testing it provides.”