Monthly Archives: December 2015

Wishing you a happy holiday season

Wishing all of our friends, colleagues and clients a great Christmas, New Year and a wonderful start to 2016.  Merry Christmas reindeer smaller - dreamstime

 

Our offices are closed from 23rd December until 5th January 2016.

See you next year!

MHRA developing human factors guidance for medical devices

UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started to develop guidance on human factors for medical devices. We are curious to see how the guidance will fit with the FDA’s Guidance documents, published over the past few years.

The Agency has confirmed that the planned guidance will cover several topics;

  • Pre-market regulatory framework (including end users),
  • Post-market surveillance regulatory framework,
  • Standards,
  • Simulation / Usablity.

When draft guidance is published, we’ll be updating you on the content and implications for both medical devices and combination products.  Read on to understand more about what led to the announcement.

Origins of the MHRA Human Factors guidance

Development of the guidance is being managed by a task group set up by MHRA, with the involvement of notified bodies, academia, NICE, trade bodies and professional associations. The task group held its second meeting recently. At the meeting, Dr Brian Edwards of the Clinical Human Factors Group emphasised the need to consider the requirements of combination products, saying:

“It’s important to work together in particular areas where we have overlapping interests such as drug/ device combinations.”

Understanding Human Factors in medical device design

The task group was born out of a wider meeting held on 27th February 2015. The February meeting involved a wide cross-section of interested parties and considered how we can build better understandings of human factors into the design, regulation and use of medical devices, to promote patient safety.

The keynote presentation at this important event was delivered by Dr Ann Blandford, who we’ve had the pleasure of discussing human factors challenges with on several occasions over the past couple of years. Here’s what Dr Blandford had to say about the importance of human factors, at that event:


A patient perspective of the value of involving end users in device development was eloquently described by Fiona Loud of the British Kidney Patient Association:

Next steps for MHRA guidance on Human Factors

The task group will have a further two meetings to develop the draft guidance.

MHRA plan to follow up on the work already done, by sharing the draft guidance with a wider group in the Spring of 2016.

You might choose to check back here, or subscribe to our blog, to be among the first to hear about the content of the draft guidance when it is shared.

Pain in the arm

Whilst visiting a local pharmacy recently, I came across a notice that free flu jabs were available for qualifying NHS patients. This seemed like a much simpler way to get immunised than visiting my GP to find an appointment, then returning for the vaccination at some point in the future, particularly with the nightmare that is parking in our local town.

All I had to do was complete a simple form and, being in one of the groups that qualify for a free immunisation, I was able to have the jab right there and then. No waiting, no return visit.

So far, so good. The whole process of receiving the injection was (relatively) painless and the pharmacist friendly and competent, but several things struck me as unusual.

Imuvac IFU folded smallerFirstly, I was given the (Instructions for Use) IFU to take away, and encouraged to read it by the pharmacist. This was the first time in 7 years that I’d been provided with any information about the drug product I had been dosed with, let alone side-effects. Perhaps I should have been firm in asking previously, but that’s a topic for another time perhaps.

While in the pharmacy, I found the IFU was difficult to open. Luckily, I have full use of my hands, fingers and eyes, unlike many of the target patient population, yet it was still a challenge. As seems typical for pharmaceutical products, the IFU was on very thin paper, and folded in a way that seemed to actively combat attempts to open or re-fold. Bizarrely, the IFU was glued down, making it hard to actually unfold. Having been involved in packaging line qualification in a previous life, I appreciate all these features were probably there to aid assembly of the final product (pre-filled syringe, IFU and carton). I am, however, curious to know what was done with users to ensure they were able to use the IFU.

Imuvac IFU smallerFinally, having wrestled with the IFU to get it open to read, finding the key information took some searching. Hidden in amongst prescribing information were a few paragraphs that were of use to me, as the patient. Although there were some key steps required before injecting the drug, the pharmacist didn’t appear to once refer to the information about administering the drug.

Yes, I did read through the IFU, and have retained it in case I experienced any side-effects. However, I am perhaps unusual in doing so and persevering with finding the relevant information. Surely we can do better, and we should do better, we should chose to develop IFUs that are usable, readable by, and impart relevant information clearly to, the users and patients.

Of course, if the manufacturer of the vaccine in question would like to discuss developing a more effective IFU, I’d be happy to talk with them 🙂