According to the government’s own advice:
“If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised representatives that have a place of business in the UK.”
It is interesting to note that there are well-known manufacturers, based in the UK, who sell their medical devices into nursing homes and hospitals, yet they are not registered with MHRA.
As well as being the right thing to do, registering with MHRA provides a route to traceability and product safety – the MHRA hold many responsibilities, amongst which is market surveillance and the power to issue safety alerts and product recalls.
By buying off an unregistered manufacturer, there is the potential to put patients and carers at risk with untraceable products, and with so much guidance available to manufacturers, importers and distributors from MHRA and other agencies, there are no excuses.
When purchasing medical equipment, amongst the many considerations should be whether the items being purchased have been built to the correct standards and relevant directives. An EC Declaration of Conformity, is a vital document that offers the buyer some assurances about the product they are buying. Here is how the HSE describe it:
“It is a formal declaration by a manufacturer, or the manufacturer’s representative, that the product to which it applies meets all relevant requirements of all product safety directives applicable to that product. It is a sign that a product has been designed and constructed for compliance with relevant essential requirements, and has been through the appropriate conformity assessment processes.”
It may be surprising that there are still items being placed on the healthcare market in the UK that are not supported by this formal documentation process. We recommend asking prospective suppliers to provide an EC Declaration of Conformity and not just rely on a ticking of the “CE mark” box on a standard PPQ form – at the end of the day, standards and directives are there for good reasons – in the case of medical equipment, they have been developed, refined and updated to make sure that patients and care staff are kept safe.
Look out for our forthcoming post soon, about another issue: MHRA Registration and why that is important too.
Caremed Alrick has a specific mission for our hire division:
“Accurately specified, impeccably clean, rapidly deployed equipment”, on a true 7 day service, to UK hospitals, in the areas of seating, showering / toileting, and early mobilisation.
Our hire range now includes:
- Sertain™ ITU and HDU chairs, the complete range – 160KG SWL to 350KG SWL
- Thekla Advanced Rehab & Early Mobilisation / tilt table chairs
- Tilt tables
- Tilt in space wheelchairs, including Rea Azalea and Innovys – all sizes
- Tilt in space care chairs, including our own TX30’s and Kirton chairs
- Transit wheelchairs including wide and extra wide versions
- Commodes and Shower chairs including tilt in space, electric hi-lo and bariatric
- Shower trolleys
- Floor level beds
- Specialist cushions, including the Valley Cushion
- Specialist packages including advanced presure care solutions
We are also willing to invest and our hire scheme has been built on customer feedback – if you need a certain item, or range of products, available to call off on a rapid delivery hire basis, please email our team and we’ll be glad to help.
When you really need something quick, sometimes it is a matter of convenience and “want”: “I need a new pair of trainers”, “I desperately want a new watch”…”I’d love a coffee”
However, in the care sector, it can genuinely be a matter of necessity and a residents well-being is at serious risk if not addressed, for example if an air mattress breaks down at night or during the weekend. In these instances, who will you call?
This morning, I was trying to place enquiries with two large medical retailers in the UK.
The first supplier had a hold message that assured me that the call was important and it would be answered soon – after 12 mins I hung up and tried again later – same result. The second supplier answered promptly but said that although the goods were in stock, they couldn’t be despatched for 5 days, even if I paid extra, or even if we arranged collection.
Caremed customers know they can phone us day or night on our usual office number, and specific accounts have been given their own dedicated number, we’ll respond, simple as that!
Some examples that have occurred recently…
Saturday 15th June, staff at a South London Hospital have sliced a power cable in half on a bed, call taken at 4:45pm – technician despatched at 5:30 pm, all fixed by 8:00pm
Monday 10th June, we had a call from a client in Aylesbury at 9:30pm – they’d had a power cut and requested assistance / advice on air mattresses. We provided advice and telephone support, and were on standby until later that night until the power failure was resolved.
Last evening (17th June) we received a request at 5pm for urgent falls sensors to go to a West Midlands client, by 6:48pm the sensors were delivered.
We could go on and on, there are numerous examples going back years – to date we have never refused an out of hours call out, ever.
If you’re struggling to find a reliable care equipment provider, remember that at Caremed, our infrastructure has been built to reflect yours, we sit down regularly and challenge ourselves “how can we make our service any better?” and we invest in our out of hours cover, to become your 4th emergency service. We are here to relieve the burden on your employees, no more late night drives to neighbouring homes to borrow a spare piece of equipment, no more listening to an answerphone message or waiting to hear back…
Long Term Care Groups – we’re here for you!