News: Medical e-News Round-Up - Issue 23

This issue covers:

Infusion pump market growth

The European infusion pump market is set for modest growth, spurred by pumps that allow for better patient pain management and subsequent shorter hospital stays, according to the Millennium Research Group’s 2013 report on the sector.

Furthermore, patients are increasingly receiving treatment in non hospital settings, which will help drive sales of infusion pumps commonly used in those settings such as disposable and electronic ambulatory pumps.

Infusion pumps with enhanced safety features are in greater demand to reduce medication errors. More expensive than standard pumps, their increased adoption will boost revenues and help offset price declines in Europe. The report includes selling price and revenue information, market limiters and a look at the competitive landscape.

More at www.mrg.net

Rigel passes the MoD Camp Bastion test

Hundreds of medical devices at the Ministry of Defence’s Camp Bastion military hospital in Afghanistan are being checked for electrical safety using testers provided by Rigel Medical.

The equipment, which includes ECG machines, patient monitors, defibrillators, CT scanners, power chargers and electrically operated beds, are tested by a military medical, dental and veterinary (MDSS) technicians as part of an in service maintenance programme for safety using the Rigel Medical 288 field service kit.

Using the portable analysers also enables checks to be completed on the electrical safety of medical fridges at Camp Bastion used to store emergency blood and plasma supplies.

The Rigel 288 is the industry’s leading and smallest automatic safety analyser and provides fast and accurate testing of patient, enclosure and earth leakage as well earth continuity and insulation resistance. The compact design offers improved portability and ease-of-use for the technicians undertaking the tests.

After testing, the analyser indicates pass/fail and prints out a bar-coded label, which can be attached to the tested device providing a clear indication of electrical safety. The information collected and stored by the tester is downloaded to a PC database, which provides enhanced electronic recording and management of medical device safety testing programmes.

This can be used for reports detailing the equipment tested, when the inspections were carried out and which items passed or failed. A certificate, which can be displayed advising that the appliances at the hospital have been properly tested for electrical safety, can also be provided.

Staff Sergeant Mark Rothwell, who provides project and in service support for the MDSS technicians, said the Rigel 288 is an extremely reliable tester, capable of withstanding the harsh conditions of the Afghanistan climate.

“Clearly, it is important to have a robust analyser which can operate effectively in one of the most intense, hot and dusty environments in the world, ensuring that electrical equipment won’t fail and is safe for use by both patients and medical staff.

“I’m also impressed by how lightweight the 288 is. This makes it extremely easy for the technicians at Camp Bastion to carry around and deploy where and when required.”

The 288 used in Afghanistan forms part of a field service kit provided by Rigel Medical to offer an accurate solution for testing devices for electrical safety to appropriate standards including IEC 62353 IEC/EN60601-1, VDE 0751-1, AS/NZS 3551, AAMI, NFPA-99, MDA DB 9801-2006.

FDA warns over device cyber threats

The US Food and Drug Administration (FDA) is urging medical device makers and health care facilities to make sure there are proper safeguards in place to protect their medical devices from cyber threats.

The warning is directed specifically at biomedical engineers, health care IT and procurements staff, medical device user facilities, hospitals and medical device manufacturers.

A cyber attack can be caused when malicious software created to disable or damage computers and computer systems is introduced into medical equipment, as well as unauthorised people gaining access to configuration settings in hospital networks and equipment.

Most medical devices today contain embedded computer systems that are configurable, which means they can be altered or tweaked and therefore vulnerable to cyber-security breaches.

The threat has become more serious over the last 15 years as a growing number of medical devices are interconnected through hospital networks, the internet, smartphones and other medical devices. Every new type of connection increases their vulnerability to malicious attacks.

The FDA says that it has become aware of the cyber-security vulnerabilities and incidents and is urging medical device manufacturers to be on the lookout for potential risks and hazards related to their products, including cyber-security risks. Manufacturers are also responsible for making sure appropriate mitigations are in place to guarantee patient safety and to make sure the device performs properly.

Read in full at www.medicalnewstoday.com

Uni-Therm has single source testing covered

Rigel’s Uni-Therm’s wide array of internal resistors, ranging from 0 - 5115Ω, in 5Ω steps, offer not only extremely accurate and detailed power curves but also safe working practise by providing all necessary resistors within a single enclosure.

Testing of patient plate contact quality monitoring (CQM) 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.

Compliant with IEC 60601-2-2 and compatible with products from electrosurgical device manufacturers Olympus KeyMed, Erbe, Bowa, Eschmann and Covidien among others, Uni-Therm verifies and calibrates all major electrosurgical generators while guiding the user through all test procedures quickly, automatically and all safely.

The instrument measures 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 to allow testing and calibration of high current vessel sealing technologies and with a duty cycle of up to 100%, making the analyser an extremely versatile test instrument for calibrating and performance testing of conventional and high power electrosurgical generators.

Product features include built-in memory, test automation, comprehensive data management facilities and a wide range of in-built low inductance resistors, while a large full colour screen displays step-by-step instructions to ensure the correct connection to the device under test.

There’s more in Rigel’s free guide ‘An Introduction to Electrosurgery’ which is available at www.rigelmedical.com/uni-therm, email info@rigelmedical.com or contact +44 (0)191 587 8730.

Medical device regulations: MEPs propose hundreds of amendments

The new medical device regulations could differ significantly from the original draft report proposed by the European Commission or the version introduced by Rapporteur Dagmar Roth-Behrendt.

This emerged as the Committee on the Environment, Public Health and Food Safety (ENVI) debated the device regulations and MEPs added recent amendments to the regulations. Not only were there more than 900 amendments but also several different amendments to the same clauses in some cases, according to life science lawyer Erik Vollebregt.

In addition, Roth-Behrendt and IVD regulation Propel Rapporteur Peter Liese added amendments to each other’s proposals. It seems that the only thing everyone can agree on is that there needs to be more oversight over notified bodies.

Despite Roth-Behrendt’s call for a PMA system for innovative medical devices in her report, the likelihood that such a system will be approved is small, said Vollebregt. Many ENVI members openly objected to such a system during the debate, even though some argued for it. The fate of the final version of the new medical device regulations will start to clear on 10 July when ENVI votes on the amendments. The Parliament will vote on the new regulations in November.

Erik Vollebregt offers detailed insight into these developments on his blog medicaldeviceslegal.com

Make a date to complete the picture

Rigel Medical will be exhibiting at Welch Allyn’s ‘Completing the Picture 2013’ symposium on 3 July at the Heritage Motor Museum, Warwickshire.

The annual educational symposium for biomedical engineering and clinical procurement departments in the UK aims to increase levels of professional development among engineers and clinical procurement specialists along with improving knowledge and awareness of clinical issues affecting the industry now and in the future.

It will be a great opportunity to see Rigel’s extensive product range, so make an appointment with our staff on this date by emailing us at info@rigelmedical.com or for more info visit www.rigelmedical.com/events.