Like any process, accountable items are reliant upon the individual practitioners. Our NHS is continually seeking to verify, evolve and make improvements to ensure the best patient care and safety possible. Retained instruments is what is referred to as a ‘never event’ within the NHS meaning that this is considered a serious incident that is preventable and strong guidelines and procedures are in place which should be adhered to. Therefore, Inspired Usability was asked to undertake a study and make appropriate recommendations for surgical item accountable items procedures within a local NHS Trust to ensure that its procedures were as robust and safe as possible.

Our visits to the Trust’s operating theatres enabled an appreciation of the work undertaken and the professionalism of the surgical teams.

It is a privilege to observe the surgical teams in action and reassuring to observe a safe and robust accountable items process which the teams are welcoming of continual evolution and improvement where identified.

ARTICLE HEADER IMAGE SOURCE: Image by Stefamerpik

Inspired Usability is pleased to have made a donation to IDAS and receive such a kind reply.

Dear Miranda,

Thank you very much for your kind donation of £900, which will help us to continue to provide refuge accommodation, community services and support for victims and survivors of domestic abuse.

The pandemic has been extremely challenging for many and we have seen an increased demand for our services.

During 2021 we dealt with over 20,000 referrals, with more than 22,000 calls to our helpline and provided direct support to more than 10,000 people.

Your generosity will enable IDAS to continue providing our vital, often life-saving services to women, men and children in Yorkshire who so desperately need our support.

Many thanks again for your kindness.

Yours sincerely,

Sarah Hill

CEO, IDAS

The FDA states that IFUs are developed for patients who use drug products when they have complicated or detailed patient-use instructions. They developed 22 recommendations for IFUs to help ensure that patients receive clear, concise information that is easily understood. Inspired Usability considered their recommendations and pulled together a list of general top tips:

1. Use lay language so as not to deter patients from reading the IFU

• Use nontechnical language which clearly states what action the patient should take, i.e. ensure the language is clear to a person with low literacy skills. To check the reading level of your content and improve readability, use the Hemingway app or the Flesch Reading Ease.
• Short words and sentences are easier to digest.
• An active voice can help, i.e. Shake the vial well’, rather than ‘You should shake the vial well’.
• Avoid abbreviations.

2. Add headings to help the reader navigate the sections quickly and easily

• Headings should clearly identify what the section contains.
• Add sub-headings if needed.
• Headings should be bold as this adds emphasis but remember to use sparingly or this can negate its effect.
• Use title case for headings – with the exception of the title of the IFU, ‘INSTRUCTIONS FOR USE’.

3. Choose an easy to read font

• Use sans serif in regular as it is more legible than a serif font, i.e. Arial.
• The font size should be a minimum of 10 points.

4. Use a step-by-step approach

• Breakdown your information into more easily digestible chunks, i.e. steps.
• Sequentially number the steps in chronological order.
• Use bold, i.e Step 1.

5. Use sufficient white space

• White space can be used to separate concepts and indicate change.
• Ensure the document does not appear cramped, overwhelming or too spread out. Bullets can be a useful tool to create uniformity throughout an IFU.

6. Images should support and accompany the text

• Develop clear and intuitive images which accurately reflect the product’s aesthetic.
• Line drawings are often clearer than photographs.
• Give images a title, i.e. ‘Figure 1’ as these can referenced in the text.

7. Colour coding

• Present text in black type on a white background to facilitate readability.
• Colour can be used for text and images provided all text and images maintain clarity and remain legible.

An example section from an IFU is shown on the right – there is good use of white space, visuals supporting the text and good use of bullets.

Remember – a good IFU can make the difference between a usable product and one that isn’t.

Get in touch today to find out how we can help you with the design, usability testing or expert review of your instructions for use and quick reference guides.

References

https//www.fda.gov/media/128446/download

Neulasta® (pegfilgrastim) Onpro® kit Healthcare Provider Instructions for Use: https://www.pi.amgen.com/united_states/neulasta/neulasta_ifu_hcp/#start

SENSEI® was conceived by Lightpoint Medical (or Lightpoint) by identifying new technologies that allowed affordable miniaturisation of a gamma probe, a keen desire to improve cancer surgical outcomes and a clear view of the changing radiopharmaceutical products in the pipeline. At the start of the project SENSEI® only existed as a computer model and then as a large bench top prototype, making usability testing a challenge.

The vision:

The reality:

Commitment to a Human Factors process

Lightpoint were fully committed to getting early and consistent feedback from end users, in this case, surgeons. We needed high fidelity simulation models to identify user needs throughout all stages of technology readiness and efficiently propel the development of SENSEI®. This would ensure radiation exposure was minimised and animal models were used only when necessary so the device would perform optimally for the surgeon in order to best benefit the patient.

Existing phantom or surgical training models available were either high cost, simplistic or required significant modification to replicate radiation uptake. To address this, Lightpoint designed a transitional phantom using a combination of ethnographic observation, interviews, CAD modelling and 3D printing, leveraging the benefits of a multidisciplinary team and participatory design with a urological surgeon.

For early device development and formative studies run by Inspired Usability the team created an optical phantom to replicate complex and challenging anatomical structures. The phantom was designed to simulate radiation uptake using infra-red LED’s concealed within silicone.

We upgraded the phantom for the final human factors validation to increase tissue fidelity and incorporated radiation sources so that production ready devices could be tested.

We worked with European surgeons in formative and validation studies, conducting various search and find tasks to evaluate the usability and performance of the device. These usability evaluations were essential in: informing device design, obtaining CE mark and FDA registration, and supporting the journey to clinical trials. But the most notable future impact will be improved outcomes for cancer patients.

A proud moment

Given the challenges we have overcome and what we have achieved together over the last 4 years, I am enormously proud of this award. Lightpoint was one of Inspired Usability’s first clients. We started working together at the beginning of 2017 on their miniature surgical gamma probe called SENSEI® and we continued to be their human factors partner for the lifetime of the project. This culminated in a successful human factors summative study, CE approval and authorised sale in the US. I have worked in medical device development for a long time, and I know how rare it is for a consultant to see a project from conception through to approval within this sector, so for this to happen while at the company I founded, rather than during working as an employee, is especially significant.

Another reason this was such a great project was due to working closely with Lightpoint. It was a truly collaborative project that combined skills from human factors consultants, designers, engineers, physicists, surgeons and many more. I believe it is the reason we showed real innovation and received the CIEHF and Human Factors Innovation Award 2021.

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