Medical e-News Round-Up - Issue 44
28th April 2015

This issue covers:

First medical device testing lab for India

India's first medical device testing laboratory is expected to come up in Gujarat by the end of this year. The Gujarat Food and Drugs Control Administration (FDCA) has initiated the process to establish a biocompatibility and medical device testing lab in Vadodara.

FDCA had raised the demand during a meeting with Engineering Export Promotion Council (EEPC), set up by the ministry of commerce and industry in Ahmedabad, for a medical device testing laboratory in the state.

HG Koshia, commissioner, Gujarat FDCA, said: "This will be the first government owned medical devices testing laboratory in India.

“The lab will help medical device manufacturers - who are paying a hefty sum for their products to be tested by international testing agencies - become self-reliant. It will be an affordable option for the medical device industry in the country.”

More at timesofindia.indiatimes.com/

Defib analyser

Optical company sees the benefits of Rigel Uni-Therm

Field engineers at Olympus KeyMed Ltd use the Uni-Therm analyser for improved in-service testing of electrosurgical devices. These items of equipment use electricity to produce enough heat to enable surgeons to cut body tissue or seal bleeding vessels during operations.

The Uni-Therm units are used to allow automation of the performance testing of Olympus’s electrosurgical equipment, resulting in greater efficiencies.

The testers enable engineers working at sites across the UK to accurately measure the performance of each device and complete high frequency leakage, high current, power distribution and patient return plate alarm testing.

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 safely.

Olympus is a leading manufacturer of advanced optical and digital equipment for the healthcare and consumer electronics sectors, leading the way in designing endoscopy and microscopy products among others.

Martin Wallace, head of field service, said: “The Uni-Therm incorporates an excellent range of features for a tester of its size, while the added value benefits, like improved connectivity and ease-of-use, are particularly impressive.

“The ability to import and export data is also a particularly beneficial feature, enabling us to store test information which can then be easily retrieved and used for quality control purposes at a later date.”

electrosurgical analyser

UK NHS open to global innovation

A worldwide call has been launched for innovators to partner with local health and care systems in trialling new technologies, digital services and other innovations with the potential to deliver big benefits to patients and taxpayers alike.

The National Health Service England (NHS) and the UK Government are calling for expressions of interest from innovators from any sector in the UK and overseas who want to test their ideas to deliver health services in better ways at scale, and in a real clinical setting.

The announcement is the latest stage of implementing the NHS Five Year Forward View, which set out additional steps the NHS will take to accelerate innovation in better ways of delivering health and care. It also builds on the UK Life Sciences Strategy and the NHS ‘Innovation Health and Wealth’ Proposals.

Too often, new technologies have been tested alone, in isolation from complementary innovations in how NHS services are delivered, limiting the value they produce. This programme will address this shortcoming of previous approaches.

Innovators from industry, the voluntary sector or the NHS itself are therefore being asked to put forward new technologies that, working in combination with innovations in health and care delivery, could offer better outcomes for patients as well as better value for taxpayers.

For example, this could mean equipping patients with wearable technology, combined with new patterns of working for clinical and nursing staff which aim to help patients manage long-term conditions, address any potential problems as early as possible, and help keep them out of hospital.

Life Sciences Minister George Freeman MP said: “The NHS Test Bed programme is about unlocking the potential of the world’s only fully integrated health system as the ultimate platform for assessing the real value of innovations. By doing this we open the door to making the UK once again the best place in the world to invest in and develop medical innovations.” Read in full at www.england.nhs.uk/

New German website

Rigel Medical is targeting further growth and support for its international customers with the launch of a new German language website.

The dedicated site at www.rigelmedical.de provides sections covering the company’s range of advanced electrical safety analysers and vital signs simulators along with technical datasheets and brochures. Additional guides and manuals will be available in future as the website expands and develops further.

The site includes enhanced search and navigation features providing ease of access to in-depth information on the Rigel range and help users to identify the right electrical safety tester for their requirements.

IMDRF proposes QMS principles for software as a medical device

In recent years, general-purpose devices such as personal computers, smartphones and wearables have enabled the proliferation of ‘software as a medical device’ (SaMD) products.

Now, the International Medical Device Regulators Forum (IMDRF) is considering a new document that explores how quality management system (QMS) principles can apply to software as a medical device (SaMD) development.

The move will see traditional manufacturers follow these principles for medical devices as well as any good software engineering practices that may apply. While many QMS principles that apply to traditional medical devices translate to SaMD, companies developing these products will also need to make some additional considerations:

User-based risks: Is the SaMD product appropriate for all intended users? For instance, are there risks posed by visual acuity for an elderly user, or for patients with peripheral neuropathy?

Application-based risks: Should a SaMD application be available on any device, or should it be restricted to certain devices in such a way that it could help to mitigate user risk?

Device-based risks: Is a device with a smaller screen such as a smartphone adequate for the intended application, can a smaller screen display a large set of information without losing the information or making it cumbersome to the users in a way that could affect patient safety.

Environment-based risks: Is continuity of use (and therefore, safety) of the SaMD product compromised when there are environmental disruptions (e.g., what happens with use interruptions, background noise and loss of network connectivity during use, etc.)

Security-based risks: Analysis should include evaluating the security threats to SaMD product software code during manufacturing, maintenance and in-service use. Analysis can also include intrusion detection, penetration testing, vulnerability scanning and data integrity testing to minimize system and patient risks.

Developers should also consider the risk posed by the platform or operating system (Windows, Mac OS, iOS, Android, etc.) a SaMD product is connected to including, designing SaMD products that take into account ‘unanticipated upgrades to the underlying platform’.

More at www.raps.org/

 

IEC 62353 guide

 

Connect to the benefits of the world’s smallest all-in-one vital signs solution

Discover all the advantages of the world’s smallest, high performance all-in-one vital signs solution with the simulation finger and hand-held UNI-SIM simulator combination.

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 UNI-SIM 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. More at www.rigelmedical.com/uni-sim

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