Whether you’re new to risk assessments or consider yourself a seasoned professional, it is worth taking a step back for a reminder of the purpose of doing this and how to make your workflow efficient and effective.
“Risk assessment” is a broad term but when it comes to medical device development, there are two main categories; whole project assessments or device specific assessments driven by international standards.
A whole project assessment focusses on finding areas of risk within the development process so that the appropriate time and resources can be arranged. A medical device specific risk assessment uses the ISO 14971 standard which provides guidance for producing and maintaining a risk management file. This article concentrates on medical device specific risk assessments but also answers questions and addresses considerations that can be applied to any kind of risk assessment that needs to be carried out.
A risk assessment is a process used to identify, analyse, and mitigate risk in the design and development process to enable the sale of safe and successful products.
Identify - A risk is something that can cause harm to a person or can cause damage to property or the environment. The people that must be considered in a medical device assessment are the patient being treated, the user of the device and other people in the use environment. Identified risks must be recorded.
Analyse – Identified risks are qualified by probability and severity to decide if a risk is acceptable or not. A risk that is highly probable but that will not cause severe harm to people or the environment will require less attention than a risk that is not probable but could result in devastating consequences. Once the balance between probability and severity has been considered all risks that fall into the category of “unacceptable” must be mitigated.
Mitigate – When mitigating a risk, the intention is to reduce possible harm to the lowest reasonably achievable level. This does not mean that all risk needs to be eradicated. Almost every medical device contains inherent and unavoidable risk. A common mistake in risk assessments is the desire to remove all risk, but this is not necessary and can even hinder the design and development process. Exposure to radiation produced by an x-ray machine can be extremely dangerous especially in high quantities, but the benefit of using x-rays to diagnose infection or cancer makes the risk worthwhile. Risk assessment has come into play to protect personnel operating the machinery by introducing protective screens while the small doses of radiation absorbed by the patient are unavoidable, so further risk mitigation is not necessary.
Completing a risk assessment is important to everyone, whether they realise it or not. The product development team must find risks as soon as possible because when issues arise, they are time consuming, challenging, and expensive. The later in the project these risks identify themselves, the worse the effects of not completing a risk assessment will become. The benefit of saving time and money will come up again and again when working on a risk assessment. Identifying a risk during the early design process, may result in a significant design change and the overhaul of multiple component parts. These changes cost time and money in re-design, but it could be much worse. If the risk assessment was incomplete (or non-existent!) the design might progress to the point of injection moulding tools being produced. At this stage, the consequence of making changes it is not just re-design time, but also the cost of replacing tools that can be upwards of £10,000 per part.
Risk assessments are also important to the customers, patients and users of medical devices even though they don’t always notice it. Completing a risk assessment for a medical device encourages the use of international standards and makes the process of certification much smoother. The certification stamps on medical devices provide confidence and comfort to patients that their treatment is safe. The doctors’ practices and hospitals across the world that purchase medical devices require certification to ensure a safe environment and high quality equipment for staff and patients alike. Risk assessments are the building blocks of certification that prove the safety of a device to the certifying body.
Sitting down to a blank document is tremendously daunting, however now that it’s clear why risk assessments are so important, do not leave it for tomorrow. In the long run medical device development without a risk assessment might lead to a design riddled with risks that only rear their head at the last moment. If a personal drug delivery device turns out to be easy to dismantle and misuse or after careful design work a surgical device is too loud for the operating room, the product may not be suitable for the market. Address the risk now, reap the reward later.
If blank page syndrome is still keeping you down you are not alone! Here’s a top tip: dig out the ISO standard 14971 and head straight to Annex C. You will find a list of example hazards and events which might just apply to your device to start the ball rolling. Once you’ve created a few risk assessments, keep them to hand because they are useful to revisit when you find yourself looking at a blank page for a new project.
When it comes to idea generation and product development, working collaboratively is commonplace. However, when it comes to completing paperwork the opposite tends to be true - one person sits down in front of a document and starts to fill it out. This is a reasonable place to start with a risk assessment so that there is something on the page to discuss, but after a first draft has been drawn up pull together a review team to ensure all risks have been considered. As the saying goes, two heads are better than one and this is definitely the case when it comes to considering how the operator might misuse a device or which mechanical elements have a design weakness. There is no need to bring this team together for every minor change to the risk assessment but meet a few times during a project to re-evaluate and update the assessment.
Picking your team carefully is important. The right number of people with an appropriate background and level of involvement in the project are required. Too many people bring an unnecessary number of opinions to the table, three or four people in total will allow conversation to flow and provide more than one viewpoint on each topic. Ensure the team is made up of relevant individuals as this also helps provide a variety of opinions. Create a group where some people are directly involved in the project and therefore have a deep understanding of the device and its design intent as well as others who have knowledge of the field or manufacturing techniques but are not directly part of the project team. A well put together team will help build a broad and successfulrisk assessment.
The risk assessment should be a live document until project closure. In the time between a risk assessment being formulated and releasing data for manufacture, huge changes will be seen in the design of a device. As these changes occur, the risk assessment must be updated with it. Every change to the design comes with the potential for new risks and identifying them early will save time and money. There will be occasions when the risk assessment feels complete and others when it feels like it is dragging behind the development, but this is normal. Continually updating the risk assessment will not only allow the project to run more smoothly but will bring risk to the forefront of the team’s mind so that some risks are addressed and mitigated in real time rather than waiting for an output from the official risk assessment process.
A risk may arise that does not fit the prescribed risk assessment document format that has been created. It might be difficult to define the probability of user misuse or the severity of a risk might depend on a number of external factors. No matter what, all valid considerations should be recorded. It is not a problem to add notes to a document and there is no punishment for editing the risk assessment format as the project progresses but it is vital to make a note of all risks. If there is no immediate answer to a problem, this can be addressed in a team meeting.
Qualifying risk has two main components; probability of occurrence of harm and severity of harm.
A risk matrix is a valuable tool for qualifying risk according to these two components where, for any given risk, severity and probability are scored on a scale and the level of acceptability is determined. These matrices can be developed for individual devices or organisations depending on what is most relevant to the situation. Risk charts are great for picking up the most and least acceptable risks but can lose important points that fall somewhere in the middle. Risks that sit in the middle category of acceptability need to be investigated further and may require the introduction of residual risk (but that is another article!).
Creating a risk matrix that suits an individual project, organisation or field of work will speed up the risk evaluation process. Spend some time deciding what the scale should be and provide a definition for each level in the scale before analysing the identified risks.
Hopefully, these considerations are a helpful reminder of why the humble risk assessment is so vital to successful medical device development. So, the next risk assessment that comes up, be confident that it will be completed in an effective and efficient manner.
Jessica Haberman is a Design Engineer at IDC. She joined IDC after graduating from the University of Nottingham and has solid experience designing and developing products in a variety of fields including medical devices and consumer goods. Feel free to reach out to Jessica regarding this article at email@example.com