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Topic Title: Electrical safety testing medical devices
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Created On: 15 September 2013 08:45 AM
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 15 September 2013 08:45 AM
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jencam

Posts: 608
Joined: 06 May 2007

In the dim and distant past a local hospital operated a lackadaisical approach to the testing of medical devices. Every year service engineers from the medical physics department would visit each ward and perform a functional test and an electrical safety test to IEC 60601 on all devices they could find then stick a Next Test Due label on it. The functional test was not always clearly defined and it could vary from engineer to engineer and also according to how much time was available and whether the device could be removed from service or not. Some engineers followed the service manual to the dot and performed calibrations and measurements with the approved test equipment whereas others just gave a device a quick test in the ward.

A few years ago the hospital changed its policy on testing medical devices where every device is now allocated to one of three groups.

The first group is for devices that are to be tested annually and involves a functional test and calibration (either according to the service manual or a procedure devised by medical physics), followed by an EST to IEC 62353.

The second group is for devices that are serviced by the manufacturer or an external company, which also carries out an EST on them.

The third group is the 'Repair Only' devices. These are only seen to by the service engineers from medical physics when they break down and no longer have an annual EST.

All medical devices in the first group have to have an annual EST regardless of whether they are class I or class II. Some service engineers have argued that there is little point in carrying out an EST to class II devices unless there are electrical connections to patients. An unknown number (but it could be as many as a thousand) devices in the third group are class I, and many of these will remain in use for several years without having an EST because they will only be given one if they break down. Some service engineers have argued that all class I medical devices should be given an annual EST even if they do not require a functional test.

Throughout the hospital are hundreds of electrical appliances - such as fridges, kettles, radios, and table lamps - that are looked after by estates rather than medical physics and all of them are given an annual PAT test.

The decision to place a medical device in the first or third group is based on risk assessment. However, the risk posed to a patient from a device malfunctioning is independent from the risk of a device giving them an electric shock. For example, there is a higher risk of receiving an electric shock from a class I electrically height adjustable chair than from a class II infusion pump. The infusion pump is given an EST along with its annual calibration and test but the chair isn't given an EST until it goes faulty.

Can any sufficiently knowledgeable people comment on this practice? If service engineers from medical physics no longer carry out an annual EST to IEC 62353 on devices in the third group then should estates staff PAT test them? If it is acceptable that a thousand or so class I medical devices never have an EST unless they break down then are estates staff wasting their time and effort on PAT testing table lamps?
 26 December 2013 04:06 AM
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plcautomation

Posts: 4
Joined: 23 December 2013

Implantable Active Medical Devices such as pacemakers, defibrillators and cochlear implants.
Active Medical Devices such as emergency medical equipment, diagnostic and dialysis equipment.
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