Medical Device Safety

Insulin Nation (IN) have put together a series of articles around pump safety, with the latest one implying pumps in the EU may be less safe than those in the US. It raises some important points (as do the other posts in the series) and I thought it was worth taking a few minutes to pick things apart a little - and this is certainly not an in-depth analysis or breakdown. Nor is it a face-off between two different regulatory systems: both have their strengths.

For those on a mobile or with a (CE marked ;-) ) mouse with dodgy scroll-wheel, here's my two-pence:

• New EU Medical Device legislation is just around the corner, removing some of the variation between implementation of the existing Directives across member states
• I can't find evidence to support that, for Medical Devices in general, the safety record within one regulatory system is significantly better - or worse - than the other.

Zero risk is not achievable when it comes to pumping insulin (I'm reminded of that every time I fill my daughter's insulin reservoir with 3+ days worth of insulin). But, from what I've seen, the momentum towards a "better" balance of safety and patient access to innovative technology is there, and, personally, I welcome that.

I'll focus on the EU - and the UK implementation - as that's what I'm familiar with.

Current EU Framework

https://yellowcard.mhra.gov.uk/

Currently - and it'll change in the near future (see below) - EU, member states are required to implement the EU Council Directive 93/42/EEC. Within this document (believe me, I don't recommend you try and read it from start to finish...) it states:-

"The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.

This shall include:
— reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
— consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users"

In other words, it absolutely is about safety. It's about lots of other things too, including free-market access of course, but safety is at its heart I believe. It talks about both the device - including optimising design features to minimise risks - and also provision of training to use the device (i.e. the environment the device will be used in).

In the UK, the current EU Directive is wrapped up in the Medical Device Regulations (2002, with revisions since then) and that's one of the key pieces of legislation that the MHRA, as the UK's Competent Authority use.

Evidence of Impact on Safety
I guess this might be the $64m question (actually, this is probably the order-of-magnitude cost of getting a Class II device through the regulatory process...):

Is there any evidence of improved safety from one regulatory regime (e.g. FDA) compared to another (e.g. EU)?

At first glance, you could conclude that the EU's faster time to market (in general) for devices means they are paying less attention than the FDA to the important stuff. That, coupled with the current variation in implementation, could easily lead to the conclusion that Medical Devices in the EU are likely to be more unsafe than those issued with Marketing Authorisation in the States.

What we certainly will have, on the whole, are more mature products being released in the USA - they've had 1,000s of hours of real-world use and abuse in the EU market before they usually hit the US market.

One surrogate for this is the to look at the number of device recall notices (known as Medical Device Alerts in the UK). These can essentially be thought of as "things we should have thought about, but missed before it went to market..." They will relate to the whole environment the device is used in, of course, and not just the device, hence the inclusion of design and training the legislation.

BCG looked into these rates between 2005-2009 and found that there was "little difference between [the] absolute number of serious recalls between the US and EU regulatory systems." Interestingly, they also found alerts were issued, on average, three weeks earlier in the EU than from the FDA. Please remember this is not specific to insulin pumps. So does it prove both systems are great? No. Does it prove one is better than the other? No. Personally, I think this indicates that both regimes are performing to a similar level, in terms of protecting patients.

New Medical Device Regulations
Under the current legislation, each country within the EU is given a fair amount of flexibility regarding implementation of the EU Directive. But that is about to change. The proposed changes have been in public circulation on the web since 2012. These new, European-level Medical Device Regulations are due to be signed-off later this year (which means they'll come into force over the next three years). A nice summary of the changes is available here. A more detailed response from the MHRA (in 2012) is available here. The changes represent a significant tightening and harmonisation of standards across the participating states. That's got to be welcomed. But the authors have also been keen to support small and medium sized medical device manufacturers, for whom overly bureaucratic legislation would mean the end of otherwise commercially viable development and innovation.

The new EU Medical Device Regulations - as they are currently drafted - try to balance safety, innovation and commercialisation of Medical Devices. From what I've read and in the areas of MD development I have been involved in, I feel they do strengthen patient safety, but it's a difficult balancing act. And it's not just the EU that's been tweaking its regulatory framework - earlier in the year, the FDA, gave a much longer leash to developers of monitoring devices (such as the amazing NightScout movement).