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MDR and new loan store decontamination requirements

You may already be aware of the Medical Devices Regulation (MDR) that comes into full force from 26 May, and you might have thought that it is just something that only applies to manufacturers of medical devices and therefore not given it much more consideration. However, the MDR does have a direct impact on loan stores.  This article concentrates specifically on how this new regulation impacts on the decontamination of equipment that goes through loan stores.

Knowing that regulation changes can be quite daunting, we also lay out the key next steps that loan stores should take to keep themselves on the right side of the MDR.

Until now medical devices such as wheelchairs, hoists, bathing and toileting equipment, and pressure care equipment have been regulated under the Medical Devices Directive (MDD). This was replaced in 2017 with the Medical Devices Regulation (MDR)¹, which comes into full force from 26 May 2020.

The MDR is EU law, and was enacted with a 3 year grace period to give time for people to become compliant.  The UK has to follow EU laws until 31 December 2020.  However, since the EU laws have also been converted into UK legislation, we will continue to need to follow these regulations until such time that Parliament may decide to rescind and/or replace it.

There’s a number of changes introduced in the MDR that are relevant for the whole medical device supply chain, including loan stores. The one we are going to focus on here is the new definition of medical devices, which now includes equipment used for the cleaning, disinfection, and sterilisation of medical devices: where before these weren’t necessarily seen as medical devices and therefore didn’t attract any special attention from a regulatory point of view, these pieces of equipment are now defined as medical devices in their own right.

What does this mean for loan stores?

This means that any decontamination device, bought from 26 May onwards that is marketed as a device to be used for the cleaning, disinfection, or sterilisation of medical devices, itself needs to be classified as a medical device. If it is only used for the cleaning then it can be classified as a Class I medical device. However, if it is to be used for disinfection and/or the sterilisation of medical devices then it needs to be classified at least as a Class IIa device. This includes washer-disinfector machinery, the chemicals used to clean and disinfect, and other types of machines used to perform disinfection of equipment.

How can I tell if a piece of equipment is a medical device or not?

As a general rule, on the packaging at least, it should carry a CE mark. However, care needs to be taken as CE marks don’t only apply to medical devices, but also to electrical devices, toys, etc. To be sure, it should be stated in the product’s instructions for use and the manufacturer is required to state on the product that it is a medical device. To be able to tell if it is Class II, the easiest way is to see whether there is 4-digit number under the CE mark – this number is the number of the Notified Body that has issued the Declaration of Conformity for its being a Class IIa or above (the CE mark by itself indicates it is a Class I device).

What do I need to do now?

The first thing will be to assess how much of the equipment you are handling and decontaminating is and will be classed as a medical device (some devices such as commodes will not be a medical device under the MDR definition), and whether an item is a medical device or not depends on the manufacturer’s claims for it under the MDR.

If it is a small percentage of your total stock, then you may be able to implement a specialised process to handle these items separately. However if you have any significant amount of medical devices (which may well be the case for most loan stores), then you are going to have to look at how to ensure the products you use for decontamination are compliant with the MDR.

If you are looking a buying a machine for use from 26 May 2020 onwards, under Rule 16 of the MDR you need to specify that it needs to be certified as a Class IIa medical device. If it is using chemical disinfection it should be compliant with BS EN ISO 15883 Parts 1 and 7. (If it is using thermal disinfection then it should: be compliant with Part 6 rather than Part 7, but many items passing through loan stores will not tolerate the higher temperatures of thermal disinfection.) You also need to specify that the chemicals to be used in the machine are appropriately CE marked as well.

If you already have a machine or you perform manual decontamination, then you’ll need to perform a risk assessment of using a non-compliant machine/process, and look to adopt best practices to mitigate the risks. You’ll also need to set out a road map as to how you are going to become compliant. The kinds of best practices you might consider introducing in the meantime would be to: perform an annual or quarterly validation of the machine’s cleaning and disinfection capabilities, implement some form of routine monitoring, and you might look to employ MDR compliant chemicals.

What if I don’t comply?

This is a question that most organisations will ask when faced with new regulations, and discover they have not put aside a budget to cover compliance with them. What would happen if someone using a piece of equipment decontamination in your store were to contract an infection and your machines and processes were audited? This question needs to be taken up with your Commissioners or other funders.

BES Healthcare Ltd would be pleased to work with you around any assessment of your facilities that may be required, and help construct your business case for the provision of compliant equipment if that is required. Please contact the team at info@beshealthcare.net.

References

1. The MDR can be downloaded from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745