The NPL (National Physical Laboratory) from England put online a guida to power measurement of medical ultrasonic equipment (based on IEC 61161) . It´s very detailed and will surely help people making these kind of measurements.

Link: http://www.npl.co.uk/server.php?show=ConWebDoc.2282

The navigation is a littleweird (each one of : Introduction | Radiation Force Balances | Measurement | Additional Information | Further Reading has various pages)

Another safety-related case - in India, an incubator short-cuited, which led to a blast on the related phototherapy unit, killing immediatelly the baby uinder treatment and injuring two others.

More info:

Baby dies in incubator fire

Infant killed in incubator fire in Ahmedabad

Thanks to Mariana for the tip.

Just to confirm the trend in guidance documents for end-users, on the same week that IEC published the guidance document for output tests and mantainance for ultrasound therapy equipment it published another document on mantainance, this time a general one.

IEC 62353 - “Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment” provides guidance to mantainance tests and tests to be made after the repairing of medical electrical equipment.

But why these tests have to be made? This is a concept that not everyone understands.

When a medical electrical equipment is designed, it usually (by means of regulatory requirements) conforms to IEC 60601 series of standards. The problem is, after the equipment is sold (meaning post-marketing) it still has to comply with the standards. For the end-user to verify this, it´s generally agreeded that some tests are necessary (and the IEC series has documentation requirements for these tests to be declared by the manufacturer).

For the general standard, these tests are usually tests regarding electrical safety (leakage current, earthing and dielectric strenght to test insulation). It can be argued that these tests do not verify 100 % conformance with the standard, an the surely don´t, but to do that would require tests of the full standard, and this would certainly destrou the equipment :-). This problem is dealt with in IEC 62353, as the standard do not asks for the destructive dielectric strenght tests, but instead asks for insulation resistance tests which is a good way, and not a destructive one, to test the insulation.

I think this document (and the US one) are real trend in the safety assurance of medical devices. No other document of this type is being drafted on the IEC but i think they´ll be required in the future, at least for the most problematic types of devices (IEC has already published some documents of this type, for example the ones related to electrosurgical units and guidance for staff on the handling of medical equipment).

The following link has a preview (you can also buy the standard there too): http://webstore.iec.ch/Webstore/webstore.nsf/0/1A42D899896A37C8C12572DD000B92CE

From the Medical Connectivity Consulting Website

ISO just published standard ISO/TR 21730:2007 - Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices. Abstract from the ISO website (i don´t have access to the standard so i could only copy it):

ISO/TR 21730:2007 provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities in a way that promotes effective electromagnetic compatibility (EMC) among the wireless technology and active medical devices through mitigation of potential hazards due to electromagnetic interference (EMI). The recommendations given recognize the different resources, needs, concerns and environments of healthcare organizations around the world, and provide detailed management guidelines for healthcare organizations that desire full deployment of mobile wireless communication and computing technology throughout their facilities. In addition, suggestions are included for selective restrictions in cases where healthcare organizations have decided that comprehensive management procedures are not feasible, practical or desirable at the present time. The recommendations herein distinguish between wireless technology controlled by the facility and used by doctors and staff for healthcare-specific communication and health informatics transport versus non-controlled (personal) mobile wireless equipment randomly brought into the facility by visitors, patients or the healthcare organization workforce.

Seems like a good reading to clinical engineers worldwide!

Read more at the Medical Connectivity Consulting Website: http://medicalconnectivity.com/2007/04/11.html#a979