Approval, Regulatory and Compliance Issues

@pryderi and all:
here is a google doc containing the Standard Operating Procedure, drafted by Pryderi. Anyone can make comments and suggestions. I’ll add version control through the History Function in Google Docs next… I’d suggest a Dr and Pryderi only have permissions needed to approve changes, and perhaps a Heath and Safety expert… Thoughts?

1 Like

@pryderi @swiftarf Update on Approval Process: a colleague in London is sending me a form that can be signed by a consultant to allow the use of anything the consultant is willing to sign off. Are you a consultant @swiftarf? If not, I’m in contact with Chris Subbe. I just texted him…

@andygoodman yes, I am a consultant. My department clinical director is quite happy to use our face shields in any case.

2 Likes

Great. This is the form.

A colleague who is experienced in designing injection mouldable parts has a design that could be used to produce large quantities, quickly. He’d probably do modifications to meet our needs, locally; if we have specific needs.

Once the design is frozen, the cost: £2-5k for the tooling, then the production can be managed by someone with a press. @Wyn do you know a company on the island with a press? If not, there are other options. I guess, there will be need to continue with 3D printing for 14 days then, if needed we could move to mass manufacture.

Thoughts?

Thanks for the link, but a visor is not a medical device.

From a regulatory perspective, they are, I believe. I worked on invasive device development and seem to recall even plasters fall under a similar classification.

“Face masks (surgical, medical, etc.) that incorporate a face shield or visor into their design are considered Class II medical devices and required to submit an FDA Form 510(K).”


I’ll look for a better reference, but I’m certain they are. I can ‘ask the expert’ tomorrow.

The MHRA is clear on it:

Some products may appear to have a medical purpose, but in fact are designed to protect the
user. Such products are usually considered to be personal protective equipment (PPE) rather than
medical devices. This will depend upon the intended purpose for the individual product concerned.
For example:
• masks for the protection of the user (e.g. from the environment) are not medical
devices, however, surgical masks (for use in an operating theatre) are medical devices
as they are intended to protect the patient rather than the user

The visors are intended to protect the healthcarer from the patient.

Masks and visors are different. Visors have an optical element; they could obscure vision during a procedure. Hence, there is risk to the patient.

FDA is American so it may account for the difference. Trust me, visors are PPE in the EU/UK!

Possibly. Though forgive me if I don’t take this on trust, I’ll speak to someone in the MRHA: in the invasive device development I did, the route always followed the FDA and the MRHA tended to follow the FDA.

Regardless, however: why are we waiting for approval if your clinical director has told you its fine? There are 10s of people desperate to help, people waiting for approval, yet it seems we have it.

You are correct: the MRHA take a softer line on visors. See quote below from MRHA documentation.

My view is that this classification is unfortunate, since in the case of an asymptomatic clinician the protection is both ways, for masks in particular, but that’s another matter.

  1. Personal protective equipment
    Some products may appear to have a medical purpose, but in fact are designed to protect the user. Such products are usually considered to be personal protective equipment (PPE) rather than medical devices. This will depend upon the intended purpose for the individual product concerned. For example:
    • masks for the protection of the user (e.g. from the environment) are not medical devices, however, surgical masks (for use in an operating theatre) are medical devices as they are intended to protect the patient rather than the user
    • latex / rubber gloves may be PPE or medical devices, or both – examination gloves and surgical gloves are medical devices. Gloves for other purposes would not be devices (e.g. for use in the home or in a laboratory). The key determining factor will be the principal stated purpose of the product by the manufacturer when he places it on the market
    • ionising radiation protective clothing: if intended for the protection of healthcare professionals will be PPE but if intended for patient protection would usually be medical devices
    • mouth guards are only medical devices when intended for a specific ‘medical’ purpose, for example as a retainer following orthodontic treatment or for use in the treatment of sleep apnoea. In most other cases these products will be PPE, including those intended for sports purposes
    • self-rescue apparatus
    eye protecting visors with no corrective function.
    It should be noted that amending Directive 2007/47/EC contained provisions for products that are intended to be used both as medical devices and personal protective equipment. In such cases the product should be CE marked as a medical device. However, the manufacturer must also fulfil the relevant basic health and safety requirements of Directive 89/686/EC on personal protective equipment.

There is evidence that regulations are being relaxed in reaction to the current situation:

To ensure our work is actually useful though we do need to let the BCUHB staff lead on what to produce.

If they are being stringent - FDA requirements - there may need to be a process defined/ a centralised point of guaranteed disinfection. I can contact colleagues in Creo medical in Newport if so, to ask for guidance.

What to produce: yes, always the end user.
How to produce: the FDA (or relaxed regs) tend to constrain.
(FDA is pure waterfall QA, with FMEA being a central method)

I can’t answer the specific detail, but I can say that work is being done to clarify this; at least, I’m aware that Chris Drew (BU Strategic Projects) and Nicky Callow (BCUHB Board) are liaising with Councils and BCUHB. I will update when I know more.

From the BBC Article about the 3DCrowd UK national visor scheme:

The face shields have not been formally approved by the UK government or the NHS, which have yet to respond to a BBC News request for comment.

But Ms Ashley told BBC News 3DCrowd UK they had been approved in the Czech Republic.

1 Like

I’ve asked on the 3DCrowd UK again about existing deployments and approvals. No real responses yet. There are definitely 3D printed visors out there in the wild but I can’t find out where.

I’m still getting the run around from BCU. I spoke to and had email contact with Simon Dean the chief exec yesterday so fingers crossed.

I hope we get something from the national group, but we’re also seeing if we can fast track the PPE approvals. In any case, approval or not, clinicians are going to use them if the alternative, official PPE isn’t available.

1 Like

The phase I’ve been pushing is: “Safe enough PPE is better than no PPE”. As you mentioned in another post @swiftarf, the ideal case is that none of this equipment is needed and official lines come through for front line staff. The scale of the interest and backorders make be doubtful though, especially for non NHS sites like care homes.

1 Like

We need to bring this issue forward now, two weeks it’s been in discussion.
BCU saying not their place to approve PPE.
There is a fast track process for approval - I’ve been in touch with them already.

It i also apparent that there is a way for Consultants/Clinical Directors to sign a form to accept them - @andygoodman and @swiftarf have been discussing this.

This form is the quickest route to “market” I believe is this form but it’s not the best.

Thoughts on this?
Pryderi