MHRA Registration

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.

 

What is an EC Declaration of Conformity?

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.

Rapid delivery, why bother?

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!

Why might nursing home groups need 24/7 cover for air mattresses?

Within nursing homes, the pressure care mattress is one of the most critical items for the safety of frail residents, at high risk of pressure care injuries.

If there is a mattress failure out of hours, its swift resolution is imperative for both the resident and the duty staff otherwise

  • The residents condition is at risk and deterioration / injury / decline can result
  • The staff have to take special measures to obtain a mattress from another home or implement additional care, i.e. turning 1/2 hourly

We hear many stories of maintenance workers, carers and nurses having to come back into work late at night then drive from home to home (within a care group) to collect a spare mattress from elsewhere in a breakdown situation.

Caremed Alrick has built an infrastructure that mirrors the needs of our care group clients, with a true 24/7 service for air mattress replacements round the clock.

One call to our 24/7 customer care line 01926 889677 and within 90 minutes, day or night, your replacement air mattress will be on its way with one of our out of hours delivery team, to help keep your residents safe and giving peace of mind to your care and maintenance team.

To find out how to become a Caremed Alrick 24/7 customer, call us on 01926 889677 or email us here

Falls Prevention – how can I implement early detection? (And get rid of trailing cables)

Check out our quick video for some ideas and advice around early detection and falls prevention, to increase patient safety. It’s also a shame when a resident who is at high risk of falls is surrounded by trailing cables for sensor mats! There is thankfully a solution…

FAQ’s – Sertain™ Critical Care Seating

We keep a record of Frequently Asked Questions here at Care-Med and share them with customers to make their jobs Easier, Quicker and Safer.

FAQ #1 “Why do you call your chairs “platforms for care”?

  • Because our Sertain™ chairs are more than just a chair – they are designed to cross the boundary between a bed and a chair, with features like layflat, hi-lo and removable sides. A Sertain™ is a platform for standing transfers, lateral transfers, therapy, rest and mobilisation.

FAQ #2 “Is it safe to wheel the Sertain™ chair around the hospital and even outside?

Yes of course; the chair is designed for use as a portering device and has large 150mm tracking and braking wheels. Outside is fine too as long as the surface is smooth (no grass, gravel or big kerbs please). The ability to move even critically ill patients out of the ward environment, and into the cafe or out into the fresh air, has made a huge difference to many lives since the early 90’s!

We’ve got a lot more FAQs to share with you…look out for #3 and #4 next week.

Why you need to be bothered about MedTech Compliance!

WHAT IS NON-COMPLIANCE AND WHY DOES IT MATTER?

In the Medical Equipment market, there are sadly many anomalies which lead to non-compliance, sometimes deliberately, sometimes inadvertently which leads to unregulated equipment being placed on the market. Typical examples of non-compliance are:

  • Having no CE marking at all
  • CE marking inappropriately, i.e. claiming conformity to “furniture” or “machinery” regulations, rather than Medical Device Directives
  • Non-registration with MHRA
  • Limited or non-existent product safety testing
  • Stating a Safe Working Load yet having no testing methodology or audit trail

MHRA uses manufacturer’s own descriptions and marketing materials to assist in determining whether an equipment item is a medical device or not. So if literature is full of references like this:

  •  “excellent for stroke patients”
  • “adaptable for different postural and pressure care requirements” …. and so on,

…but the products displayed, are not CE marked, are not built to Medical Devices Directives, have passed no safety tests, strength tests, and have no demonstrable means of complying with anything other than “domestic furniture regulations”, what happens if there is an incident?

This is not scaremongering – underneath the burden of red tape, regulations and auditing processes that ethical medtech manufacturers abide by, are the following considerations:

  1. Patient Safety
  2. Prevention of Injury
  3. Caring for others whether they are our staff, patients or visitors to our premises

So when you are looking at a new supplier for Medical Equipment – new chairs, beds, mattresses, don’t just look at the brochures – look under the bonnet and make sure everything is as good as it looks on the surface! This is all basic stuff but you may be surprised to find out that many medical chairs (particularly) are on the market under a “furniture classification”, which is insufficient.

Further reading:

  • Requirements for manufacturers to register with MHRA – view
  • Medical devices: how to comply with the legal requirements – view

  • Care-Med MHRA registration – Alrick  & Wintur