Risk Assessments play a central role in Medical Device development. All medical device manufacturers apply risk management (they should because they have to!). All of them claim to be compliant with ISO 14971. And all of them do it differently.
I have worked with a large number of clients and I have seen more Risk Assessment variants than I can count. Some are good, some have, let's say, "potential".
From this experience, I can deduce a few best practices that will reduce the risk assessment effort considerably.
Here are my top five tips:
Don't brainstorm to identify risks
You are required to identify and assess ALL potential risks. How do you find them ALL? That can be a daunting question for someone new to the medical device industry.
However, the solution is to be structured i.e. to use a structured approach to systematically identify risks. There exists several known methods to do this, including:
- Task Analysis (analysing the use process)
- System Analysis (analysing the system through decomposition)
- Using the ISO 14971 annex questions
- Using existing risk reports of similar devices
Regardless of the approach selected, brainstorming should not be one of them. There are a number of well-known reasons for this, the most important one being that you will miss important risks.
Next time around, try a structured technique. You will identify more risks. I promise.
Use both top-down and bottom-up Risk Assessments
Some companies rely on EITHER bottom-up OR top-down risk assessment techniques and miss out on the fact that both approaches deliver vital and often DIFFERENT risks.
Top-down risk assessment techniques (such as PHAor Task Analysis) can be done early in the development process without much knowledge about the actual design of the device. It is a great tool for early identifying use errors and probably misuse.
Once the device design is known, the selected design itself must be analysed for risks (such as materials used, geometry, movements and energy emittance etc.) through a bottom-up risk assessment. FMEA'sare very popular and well designed for this purpose. Both these techniques complement each other and should be conducted by any serious medical device manufacturer.
Don't keep Design Controls and Risk Management in separate systems
Design drives risk. And Risk drives design. This will become apparent when you need to follow up on the implementation and verification of mitigations as well as the further analysis if mitigations introduce new risks. The glue between the design and the risks is the traceability. The effort of managing this traceability in a paper-based documentation system will be VERY high (those of you who have done it will nod now!).
So is applying software tools the solution? Not necessarilly, since proper traceability monitoring can not be done until the requirement management tool is integrated with the risk management tool (or vice versa). Only by automatically managing the traceability between the Risk Assessment Items and the Design Items, preferably in a single tool, can true trace monitoring be obtained.
Use reasonable probability and severity scales
I am glad to see a clear trend of tightening down the probability and severity scales during the risk evaluations. From previously having used up to 10 steps, the current trend tends towards five to six steps or less. People simply have a very hard time to judge whether a probability should be six or seven on a 1-10 scale and spend too much time pondering such questions. The option range is simply too large to be effective!
For the probability axis, I would like to endorse Dr. Johner approach of having each step representing 2 orders of magnitude. He explains this very well by saying, that apart from such a an approach lets the probability axis span over more than 8 order of magnitudes, "...the factor 100 indicates the precision which we can appreciate... If you ask a group of people, how long it takes (on average) for a hard disk to be defective, the estimates vary between 2 years and 10 years. But everyone realizes that this average is greater than one month and less than 10 years. And between these two values is about a factor of 100."
Make use of existing mitigations
In many cases, the risk assessment is carried out when the design is already known. In such cases: when coming up with mitigations for your identified risks, use the already existing mitigations in your current design!
I bet your current design already contains a whole bunch of design decisions that are risk mitigations without you really considering them as such. The absolute majority of design teams I have encountered are very, very good in designing innovative and safe devices. However, many of the design decisions taken are based on previous experience, industry state-of-the-art, or simply old habits having been refined over time. Since these engineer are often better designers than document writers, they simply do not see their design (often already in place) through the lens of risk management.
Bottom line: your current design already contains of an uncovered treasure of existing mitigations. Try to use your existing design as mitigations when performing your next risk assessment.
Performing Medical Device Cybersecurity Risk Assessments is something we Medical Device Manufacturers must get used to. And the sooner the better, During 2016 and 2017 a mounting number of health associated cybersecurity incidents have been reported. Cybersecurity breaches may well become THE main safety concern in our industry within the next few years. Increased regulation on this matter is to be expected.
FDA has already published guidelines on its view on how medical device manufacturers ought to address cybersecurity in Medical Devices. The guidance outlines the documentation FDA expect to see in the premarket submissions as well as what is expected to be conducted for SOUPs and during postmarket activities.
At the core of this documentation lies the Cybersecurity Risk assessment. As already discussed, this type of risk assessment is slightly different to the typical Design Risk Assessment conducted during development.
To address this task, which many manufacturers will have to perform, we have developed a risk assessment template set specifically for documenting Cybersecurity risks and mitigations.
This template package is free to download and use for all Aligned Elements customers.
Are you interested in how the Cybersecurity Risk Assessment can be conducted and integrated with the rest of your Design Controls?
The Aligned Elements Cybersecurity Risk Assessment package contains:
- Risk assessment templates based on AAMI TIR 32, modelling Assets, Threats, Vulnerabilities and Risk Controls as Measures
- More than 30 Best Practice Cybersecurity Risk Mitigations ready to use
If you are looking for a Cybersecurity Risk Assessment Word Template, you can download an example here:
Cyber Security Risk Assessment Word Template
A smoother and faster IEC/ 60606-1 experience with Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist
The IEC/ISO 60601-1 "Medical electrical equipment" is the cornerstone document addressing many of the risks associated with electrical medical equipment.
The standard covers safety and performance requirements of medical electrical equipment and public health authorities in many countries recognize it as a pre-requisite for the market access. The standard is notorious for its depth and complexity and many manufacturers experience the task of ensuring compliance as challenging.
The safety testing, certification and global market access approvals done for IEC 60601-1 shall be conducted by an accredited Testing Lab. The manufacturer's collaboration with the Testing Lab is essential for a smooth and swift approval.
As of the 3rd edition of IEC 60601-1, a large number of risk management references were introduced in the standard. The Test Laboratory will request the manufacturer to demonstrate how the product's risk assessment covers the risks items stipulated in IEC 60601-1.
Poor preparation of this step can result in can delay the certification process, requiring an inordinate amount of time during the initial testing phase to correct the risk management files.
To facilitate this step, Aligned has developed an integrated assessment method in Aligned Elements, that assists the manufacturer in demonstrating compliance with these risks.
By assessing and connecting the IEC 60601-1 risk requirements with the product risk assessment already existing in Aligned Elements, a compliance assessment document can be automatically generated and presented to the Testing Lab.
Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist - How is it done
- The checklist contains approx. 80 risk checklist items from IEC 60601-1 which are imported into Aligned Elements.
- Each IEC 60601-1 risk checklist item contains the clause reference, the demonstration requirement, explanations and examples of what the risk intends to cover, all to facilitate the identification of the corresponding risk in the manufacturers risk assessment, already located in Aligned Elements.
- The manufacturer addresses each risk requirement, deeming it either as "not applicable" for his product (including providing a qualification for the answer), or applicable and then tracing the risk requirement to the corresponding existing risks in his own risk assessment.
- When completed, a Compliance Assessment Word Report is generated and can be presented to the Test Laboratory.
- With this compliance report, the Test Laboratory representative can quickly assess your IEC 60601-1 risk related complicance level
The benefit of the Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist is a massive reduction of time spent at the Testing Lab by leveraging your existing documentation!
How we developed the Aligned Elements IEC/ISO 60601-1 Risk Assessment Checklist
The Aligned Element IEC 60601-1 Risk Assessment Checklist has been developed in collaboration with former Eurofins Electrosuisse Test Laboratory Manager Karim Bader, currently serving in the swiss national working group CES/TK 62 for "Elektrische Apparate in medizinischer Anwendung" contributing to the development of the international standard IEC 60601-1.
Experts from Aligned will assist you in integrating the checklist into your current configuration and demonstrate its use.
If there is a need to further explain the IEC 60601-1 risk management requirements and identify findings that can be fixed, Mr. Karim Bader, an expert in this field is available to deliver the knowledge and confidence to ensure that your product will be certified without delay.