EBME Forums
Posted By: RoJo "Hospitals warned over shoddy wiring" - 29/05/03 11:40 AM
The BBC are running a news item about medical equipment being connected to poor wiring. It obvoiusly derives from the MHRA Alert MDA/2003/015. eek
But I expect there will be a knee jerk reaction from senior people in the hospital. Be prepared with your SENSIBLE answers.

Here is the link to the BBC site and the story.

http://news.bbc.co.uk/2/hi/health/2946094.stm

Robert
Posted By: RDS@MES Re: "Hospitals warned over shoddy wiring" - 29/05/03 12:13 PM
Robert

Excellent 'professional' posting have just come back from holiday and read through the EBME Website 'Serious Issues' postings.

Your posting is just the sort of information exhange that should be carried out. I will now be prepared for return to work.

Many thanks
Posted By: WOM Davis Re: "Hospitals warned over shoddy wiring" - 30/05/03 11:40 AM
Some thoughts on multiple socket extension board checks and tests.

I would appreciate any feedback comments.

Bill

Recent Safety Notices highlight electrical hazards associated with the widespread use of mains extension blocks (Multiple Portable Socket-Outlets) in clinical environments.

MDA SN 2002(26) – Use of mains extension leads
SHS SAN(SC)02/34 - Electrical extension leads: electrical hazards (Scottish)
MDA/2003/015 – All medical electrical equipment

Risks can arise when medical electrical equipment is connected to other medical or non-medical electrical equipment, or when it is connected to the supply mains by a shared extension lead. Commonly found examples include (but are not restricted to): a patient monitor connected to a computer, an endoscope connected to a domestic video recorder, several items of medical equipment on a trolley sharing a common extension lead.

Such combinations are often referred to as "medical electrical systems" and may be assembled temporarily or more-or-less permanently. Medical electrical systems pose risks that may not have been taken into account in the design of individual items of equipment, even where the equipment involved is fully compliant with its relevant safety standards or is CE marked.

A British Standard (BS EN 60601-1-1:2001) exists to address these additional risks; all healthcare providers should be aware of and endeavour to implement it. All multiple socket outlets on medical equipment systems should conform to BS EN 60601-1-1 :2001 “Connection of equipment used in medical practice to a Multiple Portable Socket-Outlet shall only be possible by using a tool, or the Multiple Portable Socket-Outlet shall be supplied via a separating transformer”

The use of ANY mains extension lead (Plug Ramps) should be subject to a risk assessment.

 The use of Multiple Portable Socket-Outlet should be avoided as far as possible.
 The Multiple Portable Socket-Outlets shall be of Class 1 and comply with IEC 60884-1
 Multiple Portable Socket-Outlets shall not be placed on the floor and should be mounted in such a way as to prevent ingress of liquids and to avoid mechanical damage during normal use.
 The party assembling or modifying a Medical Electrical System should calculate the power consumption making sure it's consumption is consistent with the power that the Multiple Portable Socket-Outlet can support.
 All mains extension leads should be regularly tested by suitably qualified persons with regard to their safe condition and suitability for the intended purpose prior to use in clinical environments.

There appears to be no specific Multiple Portable Socket-Outlet inspection and testing requirements or advice. Adopting the philosophy that a Multiple Portable Socket-Outlet block is a flexible (spur) extension of the electrical mains installation, tests and checks to demonstrate compliance to BS7671 may be appropriate.

The Following test protocol was derived from various references e.g. The Electricians Guide to the 16th Edition IEE Regulations by J Whitfield ; www.pat-testing. by www.plugtest.co.uk: EN 60601-1-1:2001; EN 60601-1 : 1990.

All test equipment used should conform to the appropriate British Standard safety specification (BS EN 61010 for electronic types, and BS 5458 for electrical instruments).

Draft suggested multiple socket board checks/tests

Visual Inspection :- Mains Plug; Flexible cable; Distribution block
Identify signs of:- damage, overheating, burning odours, fluid ingress, where appropriate indicator neon and switch functions.

Internal inspection; cord security, polarity, connections, correct size fuses (appropriate to rating for cable and equipment power consumption), BS, IEC 60884-1 marked, security of covers, anchorage at the equipment/trolley.

Protective conductor continuity
 All protective and bonding conductors must be tested to ensure that they are electrically safe and correctly connected. The test resistance is measured between the mains plug earth pin and each of the distribution socket earth terminals.
 Any accessible metal parts which could become live in the case of failure in basic insulation should be checked.

The Pass readings should normally be less than 0.1 Ohms

A standard low resistance ohmmeter Instrument conforming to BS EN 61557-4 will comply.
Basic instrument accuracy required is +/- 5%
Test voltage ac or dc, between 4 V and 24 V
Test current not less than 200 mA
Able to measure to within 0.01 Ohms (resolution of 0.01)

Testing insulation resistance
A low resistance between phase and neutral conductors, or from live conductors to earth, will result in leakage currents, the resistance between poles or to earth must never be less than 20 M Ohms.
Mains fuses must be housed and intact, and any distribution block switches in the On position.
Where Neon indicators are in circuit erroneous readings may de observed.

Insulation resistance tester
Test voltage 500 Vdc
Capable of delivering a current of 1 mA
Basic instrument accuracy required is +/-5%

The insulation resistance between all three conductors, LINE to NEUTRAL and LINE/NEUTRAL to EARTH should be measured using a 500 V dc test supply, the measured resistance should normally be greater than 20M Ohms, lower readings require further investigation.

Separating transformer
Separating transformers shall be of class 1 construction and comply with the requirements of IEC60989. They require to be tested as a class 1 item of medical equipment.
Posted By: Sav Re: "Hospitals warned over shoddy wiring" - 30/05/03 3:16 PM
Any suggestions where I can obtain mutiple socket extensions compliant to IEC60884-1 and the necessary regulations in IEC 60601-1-1:2001(pg 26)

In the past I have purchased the robust one in the RS catalogue (stock number 193-809 pg 1-480), however I am not sure if it meets the above regulations and neither can RS tell me!!!!! HELP
Posted By: RoJo Re: "Hospitals warned over shoddy wiring" - 30/05/03 3:35 PM
Try Olson Electical
www.olson.co.uk
Robert
Posted By: Sav Re: "Hospitals warned over shoddy wiring" - 02/06/03 1:35 PM
thanks
Just FYI the RS type of individually switched multiple socket extensions when used in medical electrical equipment systems should have some form of cable strain relief fitted and check that the neons comform with the BSEN60601 scheme of colouring for illuminated indicator lamps.

Hope this helps
Robert, which particular extension lead am I looking at?

One of the ODP's here asked me a question a while ago about which one I would reccomend and I said he should contact MDA and ask their advice (pretty much to no avail).

I've seen and taken a number of homemade extension leads out of service over the past few years and I would like to do a blanket exchange of the ones we have.

At the moment we have some Orange permaplug extensions from RS (BS 1363/A certified) fitted with rail mount attachments to keep them off the floor.

Any suitable replacements would be most welcome.
Posted By: RoJo Re: "Hospitals warned over shoddy wiring" - 05/06/03 1:04 PM
I think there are two particular problems with extension leads and distribution boards.
The first is wiring. It is either poor to start with or becomes faulty with age and use. The recent MDA notice recommends that they are assetted and regularly checked and PAT tested. I think a regular visual inspection is definitely needed. I have found boards with wires in all sorts of condition. The MDA notice has pictures of some wonderful examples.
The second problem is the quality of construction of the distribution board. And this will answer your question. Cheap dis-boards have a busbar connecting all the appropriate sockets made of bent metal, over time this does not grip the pins properly as the metal is stretched and deformed. Each socket is not properly supported by the surrounding plastic which allows movement and leads to poor contact with the pins.
I remember a notice from the MDA several years back that said only dis-boards that had individual sockets mounted in a frame should be used. There are two types of these: one use standard wall type sockets in a housing (193-809 and similar from RS, and other sources) and the other has equipment mounted sockets (like those in safety testers) in a special housing. In each case the socket is a stand-alone item wired to the others.

I am not sure of the safety of putting several sockets on a wooden base as works electricians love to do. I think that you cannot mount electrical equipment directly on to a flamable backing. I would appreciate some clarification on that if anyone knows for sure.

In short spend money and get quality and safety. rolleyes
Robert
According to EN 60601-1-1 :2001, Page 26, Annex EEE, Section EEE.2 Multiple Portable Socket-Outlet

“The Multiple Portable Socket-Outlets shall comply with IEC 60884-1”

“The Multiple Portable Socket-Outlets shall be of Class 1 and the protective earth conductor shall be connected to the earthing contacts in the output sockets”

Bill
My above posting is ambiguous as the only reference I can find to IEC 60884-1 socket outlets is for European/Continental units. shocked
A further reference states; Standards “ IEC 60884-1 : Plugs and socket-outlets for household and similar purposes- General requirements.
The UK equivalent appears to be BS 5733, BS 546 or BS 1363 Part 1. Many units conforming are clearly not of Class 1 construction.
Until there is clearer guidance from BSI or MHRA Robert's above suggestions make sense to me.
Bill
Posted By: Roy Re: "Hospitals warned over shoddy wiring" - 10/06/03 6:27 AM
Contact Mr Jo Barratt at -
Grove Design, Unit 1 Marsland Street Industrial Estate, Hazel Grove, Stockport, SK7 4ER.
Tel. 0161 456 5677
They produce a multi-output extension unit which is CE marked and has been specifically designed for use in theatres. They also have a low profile unit for ICU / HDU / CCU etc which will fit under the bed (even the electric rise and fall design).
Both units are made from stainless steel with high quality sockets and fluid protection. They are on small castors so are both easy to move and are protected from fluid spills on the floor. The earth bonding is particularly good and even with a long mains lead easily meets the safety test of 0.2 ohms.
They're good - because we helped design them ! - and they are in use in all our theatres. They're not cheap, but then you get what you pay for and theatres isn't the sort of environment where "cheap" is the main criteria !
Posted By: John Nuss Re: "Hospitals warned over shoddy wiring" - 10/06/03 10:46 AM
Has anyone out there found a reliable source for medical grade isolation transformers that doesn't cost a couple of limbs?
© EBME Forums: Biomedical and Clinical Engineering Discussion Forums.