Medical e-News Round-Up - Issue 33

This issue covers:

Multi-Flo for IEC 60601 compliance

Meeting the needs of IEC 60601-2-24, covering particular requirements for the safety and performance of infusion pumps and control, the high performance Multi-Flo infusion pump analyser incorporates proprietary measurement technology for the latest in infusion pump testing and features variants of one, two and four independent channels.

Instant high and low flow verification, bolus volume, occlusion and back pressure measurements are provided by Rigel Medical’s Multi-Flo infusion pump analyser while each 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 Multi-Flo can accurately detail any changes in flow, volume and pressure rates, providing a real-time picture of the quality of infusion.

A rugged and compact all-in-one housing with integrated infusion programme memory makes the Multi-Flo a fully stand-alone instrument while an onboard memory stores test data and allows fast transfer to the PC for traceability.

Multi-Flo can also be used with Rigel’s Med-eBase PC software to provide enhanced and easy control and configuration as well as electronic recording and management of medical device safety testing programs. Asset information can be quickly and accurately inputted directly via a compact Bluetooth barcode scanner or an optional USB keyboard. Full details at www.rigelmedical/multi-flo

European medical device uncertainty

New clinical data requirements in the European Commission's proposals for the revision of European regulations for medical devices will have an enormous impact on all involved parties - most importantly, patients.

Maria E. Donawa writing in European Medical Device Technology discusses some of these requirements, including the proposed amendments from the European Parliament (EP).

European regulation of medical devices, including in vitro diagnostic (IVD) devices, is undergoing significant revision. On 26 September 2012, the European Commission published a proposal for regulation of medical devices (Ref. 1) and a separate proposed regulation of IVD devices (Ref. 2).

The proposed regulations are subject to the European ordinary legislature procedure, which requires examination and adoption by the EP and Council of the European Union (Council).

On 22 October 2013, the EP voted to accept 347 amendments to the European Commission’s proposal for medical devices and 254 amendments for IVD devices (Ref. 3). This was not, however, a formal legislative vote; instead, the formal vote was held on 2 April 2014, which resulted in the EP adoption of the text of 22 October 2013. This action closed first reading of the ordinary legislature procedure, requiring that the adopted text be forwarded to the Council, the Commission, and national parliaments.

EP elections, however, held last month (May 2014), will mean that newly elected EP members will need time to familiarise themselves with both proposals. In addition, the Council must complete work on its own position on the Commission proposals and EP amendments.

Considering the most likely scenario, the proposed regulations probably will not be adopted before late 2015, meaning that the new requirements are unlikely to become mandatory before 2018. Read the article in full at www.emdt.co.uk/

Going for growth with new sales manager

Paul Weaver has joined Rigel Medical as its new sales manager.

He will be responsible for the development and management of key accounts and distribution activity across the UK and Europe and brings more than 20 years sales experience to the role based at the company’s Peterlee head office.

The European medical devices market is one of the most advanced in the world and Paul will be drawing on his test equipment background and export sales experience to develop new business for the company’s range of high performance analysers, simulators, testers and accessories.

This will include expanding market coverage and support for the brand as well as looking to develop new OEM, distribution commercial opportunities and improve levels of customer support.

John Backes, associate director – Rigel Medical, said: "Paul’s background and sales expertise will be a major asset as we continue to grow and look to move Rigel to the next level through increased turnover.

"It is a particular exciting time for him to come onboard as we continue to see demand from all sectors for high quality medical device testing product, support and expertise."

Hitachi benefits from Rigel 288s

Leading healthcare equipment manufacturer Hitachi Medical Systems UK Ltd uses Rigel Medical 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 288 enables engineers to quickly check the safety of the scanners while in use to ensure compliance with the recurrent and post repair test requirements of the IEC 62353 standard for medical devices.

Compliant with IEC 60601, the high performance Uni-Therm is capable of verifying and calibrating the electrosurgical equipment while guiding the engineer through all test procedures automatically and most of all safe.

Manufacturers of medical electrical equipment must test to electrical safety standards to ensure that equipment is intrinsically safe, so Hitachi has to undertake the on-going periodic testing of its population of over 500 scanners - in fact, its engineers test every machine at least twice a year.

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 for our engineers a whole lot easier.”

RoHS compliance looms

Medical device companies looking to sell their products in Europe must comply with the Restriction of Hazardous Substances (RoHS) directive by July 2014. Similar legislation can also be anticipated in China, Japan, and North America.

One of the main requirements of RoHS II is to restrict six hazardous substances in electrical and electronic equipment:

Lead
Mercury
Cadmium
Hexavalent chromium
Polybrominated biphenyls (PBB)
Polybrominated diphenyl ethers (PBDE)

These requirements will apply to medical devices from 22 July 2014 and any products failing to comply with RoHS II should not be placed on the EU market after this date. In vitro diagnostic medical devices have an extra two years to meet the requirements, with a compliance date of 22 July 2016.

Working in partnership with the Department for Business, Innovation and Skills (BIS), the National Measurement Office (NMO) is the UK market surveillance authority responsible for enforcing the RoHS regulations in the UK.

For more information on the RoHS and to find contact details for queries see the NMO pages of GOV.UK www.gov.uk/

Rise of the machines

A new study from MarketsandMarkets projects shows that the global market for medical robots will grow to nearly $4 billion by 2018. The market last year was estimated at just under $2 billion.

The report categorises the global medical robot market into five segments: surgical robots, rehabilitation robots, non-invasive radio surgery robots, hospital and pharmacy robots, and other types. The surgical robots accounted for the largest share in 2013.

North America accounts for the largest share of the global market, followed by Europe and Asia. However, the study projects that the fast-growing Asian region will see the most substantial increase in the use of medical robots in the next four years.

According to the report, the leading manufacturers in the medical robotics market are Intuitive Surgical (US), Accuray (US), MAKO Surgical Corp (US), Mazor Robotics Ltd (Israel), Hansen Medical (US), Titan Medical (Canada), and Health Robotics SRL (Italy).

Go to www.marketsandmarkets.com/ for full report.