Medical e-News Round-Up USA - November 2011
This issue covers:
- MEDICA success
- Let’s hear it for IEC 62353
- New draft guidelines for US
- Top table for Rigel 62353
- IEC 60601 deadline approaches
MEDICA success
Rigel Medical has had a successful MEDICA 2011, reporting considerable interest in the new UNI-PULSE defibrillator analyzer launched at the show.
The compact, lightweight and portable Rigel UNI-PULSE is able to test the correct performance of all mono and biphasic defibrillators and boasts a large colour display able to show all measured values as well as a real time energy discharge curve.
The new MULTI-FLO infusion pump analyzer, available next year and meeting the need for high and low flow, occlusion, back pressure and bolus measurement, also garnered considerable interest from stand visitors.
John Backes, divisional manager for Rigel Medical, said: “MEDICA’s an important launch pad for our new products.
“The new features and benefits of UNI-PULSE and MULTI-FLO impressed customers and specifiers. Feedback, insight and suggestions from visitors will also be incorporated into new product development as we move forward next year.”
Let’s hear it for IEC 62353
Following MEDICA, Rigel Medical’s John Backes - a member of the International Electrotechnical Commission (IEC) SC62A WG14 committee and a leading expert in the field of electrical safety testing - is keen to start the IEC 62353 debate. If you’ve got something to say, John would love to hear from you. Join in at the LinkedIn IEC 62353, a practical solution discussion group at http://www.linkedin.com/groups?gid=3579699
New draft guidelines for US
The FDA has issued draft guidance aimed at fostering early-stage development of medical devices within the US to help stimulate domestic innovation and contribute to medical research.
The guidance document contains new approaches towards early feasibility studies, which are conducted in a small number of patients early in device development, while also providing appropriate human subject protections.
The FDA said the studies are necessary to resolve final design issues before the device is ready for a large clinical trial that is typically required for product approval. The FDA is seeking a small number of companies that could pilot the new approaches in the guidance. The results of the pilot will help to inform the final guidance.
More about The draft guidance ‘FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations’ at http://sideeffectslawsuitsnews.com
Top table for Rigel 62353
Medical equipment manufacturer TRUMPF Medical Systems Ltd is using the Rigel 62353 to enable its nationwide team of field service engineers to carry out electrical safety testing to ensure the operating tables it supplies to hospitals are safe for use by both patients and staff.
This means that important electrical safety tests are being undertaken as an integral part of TRUMPF’s after sales support, saving time and boosting customer service levels.
Five units have been specified by TRUMPF’s UK operation, combining the benefits of an automatic and manual tester with advanced data logging to provide improved asset management capability.
Additional units have been supplied to the company’s head office in Germany, reflecting strong demand for Rigel products in important European markets.
Alasdair Owen, service manager for TRUMPF Medical Systems Ltd, said: “The Rigel 62353 enables us to comply properly with the requirements of the European standard for in service testing of products.
“It’s a very intuitive instrument, offering a single-button test solution which engineers, who have busy service schedules to complete, really appreciate.
“This means that they don’t have to stay on site any longer than absolutely necessary, avoiding any inconvenience to hospital staff and services.
New OSHA laboratory safety guidance
The transition period for the Third Edition of the medical electrical equipment standard (IEC 60601 – 1:2005) finishes next May.
So it makes sense for manufacturers to start designing against this new greatly expanded standard now to avoid costly re-design further down the line and ensure their products can continue to be sold on the European market.
It would also be wise for end-users and purchasers in the medical laboratory environment to be aware of the requirements that suppliers of their products must now meet.
One such requirement is the incorporation of the concept of ‘risk management’ and the requirement to keep a detailed Risk Management File (RMF). This is essential, as many of the tests are required to demonstrate compliance with the standard make reference to the RMF.
A leading supplier of medical equipment has specified Rigel Medical’s 62353 safety analyzer to improve the electrical testing of its powered operating room tables.
