EBME Forums Forums Maintenance Technical Assistance Therapy Eqpt. Diamond Flowmeter

I have been told that although the Therapy Equipment Diamond range flowmeter is CE marked, it does not comply with UK standards. (It was the Penlon rep )Something to do with the way the probe is fitted into the body?
Has anyone else come across this or indeed had any good or bad experience with this product. 7 years warrenty covering defect and damage does seem like a good deal

From PETER PARKER:

The Therapy Equipment website documentation for the Diamond Range flowmeters, freely available on their website, indicates CE #86 - British Standards Institution as the nominated body, i.e. test-house, that has certified the product.

My first response to any heresay of this nature would be to question the motives of salesperson that allegedly criticises others' products to possibly promote their own products or services - rather than "pushing" the positive features of their own product/service/warranty. Of course I'd want to know if this person can backup what they say with hard evidence and is actually qualified and, in fact, authorised to make such statements on behalf of their company.

My next would be to speak to Therapy Equipment, just to ask if they can provide a certificate of conformance for the product in question, followed by inspection of a sample flowmeter whilst examining applicable standards to see for myself. Perhaps you could elaborate on what was said, Peter Parker (I assume this is not your real name).

I have seen the product and it is a very nice unit, very competatively priced. I can't say if it conforms to the BSI though,I don't have a copy of the relevant standard.

I do have access to copies of the relevant British/European standard BS EN 13220 Flow-metering devices for connection to terminal units of medical gas pipeline systems and all of the normative standards associated with it but I don't purport to be an expert in their interpretation. I am aware that many harmonised International (ISO), British (BS) or European (EN) standards are actually equivalent and a device must conform to appropriate standards if it is to be CE marked as such.

Thus I assume ISO 15002 Flow-metering devices for connection to terminal units of medical gas pipeline systems (the standard quoted in Therapy Equipment's literature) has equivalence to BS EN 13220. This big assumption aside, initially, I would be inclined to put my trust in the British Standards Institution ( #086 ) and a certificate of compliance, including a CE mark and notified body number, attached to the Diamond flowmeter, in preference to the alleged comments of a sales engineer or representative of a competitor.

The BS EN 13220 standard seems to indicate that there may be certain aspects of it that are meant to be informative only, for the time being, until special national conditions are withdrawn - awaiting studies. Thus manufacturers' may not even need to comply with certain clauses - even if British Standards are rigorously applied, e.g. gas inlet connector's compliance with BS EN 737 may not necessarily apply. As I said, I'm not purporting to be an expert and I'm making assumptions - those in the know can judge that - my interpretation may be wrong.

Perhaps now Peter Parker has "shot his bolt" and "spun his web" he'll be good enough to let us all know what aspects of non-compliance with the "UK standards" that the Penlon representative was allegedly referring to. I'm certain that Therapy Equipment and their customers would be interested to hear all about it. If such sales practices are going on then I wouldn't want to deal with representatives that have a go at "trashing" other's products rather than push their product's merits. It's really tedious when sales representatives try this approach to sales.

Peter Parker's comment that the range of flowmeters have CE mark but may not meet the British Standard has to be verified with Therapy Equipment.
It is important to note that CE marking does NOT endorse any product as meeting standards. CE marking is only awarded to companies that meet the manufacturing requirements and standards that allow them to sell and market within Europe, it does not mean that the products meet any specification standards.

This depends on the risk classification of the device as far as I'm aware - otherwise we'd be in a situation where every device, irrespective of potential risk it may present to patients, by virtue of how it is connected, physical effects it has on the patient, etc, would be CE marked and in use - simply based on the manufacturer's quality system meeting the required standards.

As far as I'm aware the notified body number, in conjunction with a valid certificate of conformance, gives an indication that a device, presenting a particular, potential, risk to patients meets the applicable BS/EN standards (this depends on the particular MDD annexes that apply, based upon the risk classification of the device; thus risk establishes the approach taken towards certification and whether manufacturing standards necessarily apply, I think).

The applicable manufacturing and quality system standards should be indicated on the certificate provided by BSI if they type tested the device. The question is which Standard does the flowmeter fail to meet - MDD annexes will indicate some "standard" that needs to be applied and the CE mark indicates conformity in the European market under MDD - that's the whole point of it I think.

For all practical purposes, the CE mark is meaningless and may be disregarded in any discussion vis-à-vis the quality of one device versus another. It proves nothing, and certainly does not bestow official endorsement of any product. If I’m wrong, how come it appears on almost every piece of c**p that I’ve seen recently?

I agree Geoff but once it's within the framework of CE and classified as a medical device it's up to good people like ourselves to report "issues" to the competent authority, i.e. MHRA, so they they or the manufacturer can take appropriate action, if necessary, to sort it out. It's better than the "bad old days" when, for example, equipment with American colour-coded mains parts was supplied in this country and other devices that I would classify as unsafe under any circumstances was being manufactured and sold by every TDH company out to make a few bob. What more acceptable alternative would you suggest Geoff?

The MHRA is not interested in quality only safety and then not as an absolute.
It is up to the purchaser to ensure the equipment is of sufficient quality for their needs. The MHRA are only interested in equipment not operating as it is supposed to. Even if a piece of equipment does something unsafe, as long as the manual says it will do it, the MHRA can do nothing, unlike the FDA in the US.
I reported a piece of equipment to the then MDA for not operating in what I considered a safe way. The man from the MDA agreed but said they have no power to insist on absolute safety only correct operation. Again it is down to the purchaser to ensure that they equipment functions exactly how they want it to.
The buck stops with the purchaser....us?
Robert

So MHRA are another useless government Quango or do they need to grow a Backbone and take a leaf out of the FDA book. MHRA have a look at the CAA, all avionics equipment has to be approved first before it can be used on aircraft. What is the point of the MHRA equipment evaluation?

Surely engineers have to be registered to work on medical equipment. Shouldn't Medical manufactures have licence (issued by MHRA) to sell the products? If I have to register to be known as a clinical technologist, manufactures register new equipment before it can be called medical equipment.

Maybe we should do away with CE mark and have a MHRA kite mark instead.

As an engineer it is very difficult to evaluate a new technology. There is no previous history to look back on. The item may work fine in the workshop or nurse product evaluation days when sales rep is showing the product. But two month down the road glitch comes along and cause problems. Bye this time you already paid for the product.

There are helpful website (www.ebme.co.uk) forum that have helpful information on most products.

A.M