EBME Forums Forums Management Medical Equipment Management Use original or compatible SpO2 Sensor and ECG?

HI, all.

Just wanna know that how many of EBMEs are using compatible SpO2 Sensors and ECG leads. Is there any document or guide line from MHRA mention about this?



Thanks

Jerry

Are you addressing this question to the biomed world in general, Jerry, or just the UK National Health Service?

I think the International Standards relating to Pulse Oximeter accessories in particular (including SpO2 probes and extender cables) make it clear that their performance needs to be validated for the monitor that they're intended to be used on and that they must meet certain safety requirements.

The purpose of these standards is to ensure that the manufacturer ascertains performance and publishes this and to promote safety. Following standards allows manufacturers to demonstrate they're following good practice thus it makes it easier to justify that they meet the requirements of the MDD, progress through whatever route to conformity is necessary, and can therefore apply the CE mark and release their product onto the market.

As far as I can interpret it this means all the checks that the OEM would have to carry out on their SpO2 probes and extenders apply to 3rd party manufacturers of SpO2 probes and extender cables as well - for each device they state their products are compatible with. SpO2 probes and extender cables are considered an intrinsic part of medical systems, in fact, thus medical accessories/devices in their own right that are CE marked as such.

Unless a 3rd party probe or extender manufacturer can give a similar declaration of conformity, to the MDD & relevant standards or equivalent, for their in-house manufactured probes and extender cables intended for use with a particular OEM pulse oximeter, that the OEM manufacturer is obliged to give, then I'd be wary of using 3rd party probes.

This is mainly because of the potentially controversial issues surrounding SpO2 related performance and safety issues related to the probe itself, e.g. EMC/vibration/low-perfusion performance, SpO2 probe temperatures, clinical validation of SpO2 measurement performance on patients of different types, etc.

As far as I'm aware some 3rd party repairers of probes and transducers will only go so far with repairs since they consider extensive repair as re-manufacture of OEM probes and this "new product" would require full validation in terms of performance & safety as per the relevant standards (or at least equivalent, or better).

This effectively prevents their organisation releasing a new product (repaired probe that's may now be altered from its original specifications - even if it's just different cable or a non-OEM plug or socket) that may not meet the MDD/adhere to the necessary standards (or better) onto the market after repair.

What if, for example, someone replaced an SpO2 I.R. LED without ensuring the calibration of the probe was verified or replaced an shielded extender cable with non-shielded cable? Not every repairer replaces OEM manufactured spares with like-for-like components - some use their own judgements rather than applying the necessary standards and then fail to test to the requirements that the OEM manufacturers are obliged to.

My advice to purchasers would be to deal with the OEM and try to obtain a discount before turning to 3rd party suppliers. We have enough problems with fairly reputable OEMs providing the necessary information RE: compatibility, calibration information, etc, so it's actually easier to try to negotiate cheaper OEM supplies based on scales of economy and let them retain some liability - rather than take on liability, ourselves, if we choose the wrong 3rd party supplier and there are issues.

Luckily we are standardising on particular technologies supplied by specific manufacturers so we have a significant amount of demand to justify 50% discounts on purchases and more. Why use 3rd party stuff when the OEM product can be purchased for less or the same price?

What I'm saying is that it's only a bargain, in my opinion, if it's like-for-like in terms of performance & safety, it's cheaper and the 3rd party manufacturer can prove this in the same way the OEMs have to.

I had some issues about 3 years ago with ECG cables from a 3rd party source that were intended to be fully compatible with OEM ones and a third of the price. In fact they did not function properly because the internal connections were not terminated correctly. It took a while for the users to pick up on this and it took my time and a few visits from the 3rd party supplier to sort the faulty goods out.

My concerns were whether this was an isolated incident, wrong labelling, wrong picking, or whether this model of ECG leads had ever been tested/validated with the anaesthetics monitoring that the 3rd party supplier stated they were compatible with.

Anaesthetics monitors were intermittently switching from 3-lead to 5-lead configurations and vice-versa when they should have been monitoring anaesthetised patients for arrythmias as they were being induced and maintained under anaesthetic.
As I had to demonstrate the reason for this to the operators, then the supplier, then search for the faulty leads, on top of initially determining the reason why they were failing, this became expensive in time, inconvenient for the anaesthetists and myself, and a potential risk to patients when arrythmia monitoring was being suspended (no C-lead available) without warning as though a 3-lead cable had just been plugged in (without a disconnect) rather than a 5-lead cable.

Needless to say my recommendations are to go for OEM unless the 3rd party supplier can prove their product is 100% equivalent and tested to the same standard as the OEM is obliged to (and should declare conformity to).

Richard.

I would agree that it is important that the sensor can be verified as accurate and continue to be accurate across a range of reading. I think that Tyco are probably unbeatable on price for nellcorr and OEM. Make sure the clinicians agree - they have the ultimate responsibility.

Jerry, in response to your questions:-

Most EBME depts will use 3rd party suppliers for SPo2 / ECG cables. As you will be aware, this often spills over into other ranges of products - Batteries, giving sets, syringes, BP Cuffs, etc.

There is no guidance as far as I am aware, other than the generic repair guidelines that are used when carrying out repairs to the device itself i.e thou shalt not use non approved spares or try to bodge it.

In the case of consumables, it is generally accepted that 3rd party suppliers often provide identical products and can pass on greater bulk discounts.

When dealing with non identical products however, I would want to carry out evaluations both within EBME and clinically before switching, but thats part of the parcel of our job and the relationships we forge with the key clinical staff.

I think that if any guidance was declared against the use of 3rd party products that we would see a lot of valued suppliers to the NHS go out of business. Over the years, companies like Viamed, Medgraphics, Vital Signs, HLS, Proact, Euro Energy, Alexander, etc have provided great service to the NHS. Without companies like these we would have wasted a lot more of the taxpayers money.

Provided their products are at least of equal standard to the OEM there should be no reason why they should not continue to serve cost savings to the Trusts. It is a small niche of the market with low profit margins and high volume of turnover

Might I add that without competition we would also be paying full price for our currently supplied OEM products :p

There have been tactics in the past to use non standard connectors, patents, you name it!

Basically I agree with what Joe says but my opinion is that the OEM is the ideal source if running costs are not the only consideration. Performance, safety and price all need to be considered, together, prior to making a selection. EBMEs have to be careful on this one since it's the purchaser that may take on liability, RE: warranty issues and performance issues, not the 3rd party supplier (unless they make statements about their products that cannot be supported or are false).

To be a bit more specific in answering your question - Yes there is MHRA guidance - concerning management of batteries, including those from 3rd parties, and as I took pains to point out giving some recent experiences, rather than generalisations, in some of the standards it explicitly states that compatibility must be proven by whatever manufacturer. My point was that I tend not to be able to locate this evidence when I look at 3rd party product.

Conformity to the appropriate standard must be declared - specifically for 3rd party SpO2 probes and accessories. This means that the manufacturer must declare equivalent performance and safety to the same standard. This is where purchasers have to have clear information available to support this. We don't tend to recommend 3rd party consumables, e.g. ECG cables, SpO2 probes or batteries (for defibrillators or other critical applications) because we've had problems. Notice how the medical standards now include the term "Safety & Essential Performance" in their title.

My personal view is that if whole of life costing is actually being carried out on devices, at tender evaluation, or prior to purchase, then the cost of consumables, etc, should be factored into the purchase when making a decision what to buy - not necessarily by factoring in the cost of 3rd party consumables and accessories (since nobody knows how they're likely to perform, in volume, if there's none in circulation already, for example).

The ideal is one single supplier who's product is 100% compatible thus some liability remains with the manufacturer rather than the purchaser (for warranty, premature wer and tear of the device due to faulty consumables, spares, etc). At purchase the OEM manufacturer can be put under more pressure to agree to reducing costs of consumables but as Joe says, in the real world, it's competiton (or scale of economy as I stated), that keeps prices down.