Friday, December 11, 2015
Session ST-4 “Risk Analysis for Medical Devices” presented by Joanne Archambault
Reviewed by Mery Molenaar
On this beautiful November morning in Miami, Florida, I am heading to the conference hotel to attend the second day of the ATA conference. I am excited that there are several science-related presentations on the schedule. Since I often translate user manuals for medical instrumentation, I am especially looking forward to today’s talk by Dr. Joanne Archambault about risk analysis for medical devices.
While the last people enter the room, Joanne welcomes us and starts out with her goal for today: to teach us about the risk management process used with medical devices. Joanne is a French to English translator who has worked as a project manager for the development of a novel medical device and directly with device manufacturers on translation projects, including risk analysis documents.
Why we should perform risk analysis
Clearly, all medical devices involve some degree of risk, so why do a risk analysis? First of all, it is required by law. It also offers manufacturers some protection from product liability and helps identify problems before the device is distributed. Furthermore, Joanne points out, it simply is the right thing to do.
The goal of risk analysis is not to completely eliminate the risk of a device, but to reduce the risks to acceptable levels that are “as low as reasonably possible.” This is not as easy as it seems, since a terminal cancer patient may accept a higher risk than, for example, a diabetes patient.
Risk analysis is performed during the design stage of a device before it is brought onto the market. Joanne briefly touches on the risk management standard for medical devices, ISO 14971, and the different standards in the US, Europe, and Japan, before moving on to an example.
Simulating the process
Here is how it works. The risk management process consists of several steps, including identifying and assessing risk, taking steps to reduce risk to an acceptable level, reporting, and finally gathering information during production and post-production. All this information is recorded in a risk management report.
Although clearly an expert in the field, Joanne is able to talk on a level that is accessible to a novice like me. She introduces a sample medical device to simulate the process and enlists input from the audience and help from Karen Tkaczyk, who volunteers to write the responses from the audience on a flip board, to complete the risk management spreadsheet.
Our fictional device is called “Silknee.” Silknee is a silk rope, available in different lengths, which is implanted in the knee to replace a torn knee ligament. The target market for the device is athletes with knee injuries.
The first step in the risk management process is risk analysis: what is the intended use of the device, what are the potential hazards, what is the harm done, how likely is this to happen, and what is the severity if this happens?
We already have defined the intended use of the device, so we quickly move on to identifying the hazards and determining potential hazardous situations.
What makes this session so much fun is Joanne’s ability to engage the audience. Together we brainstorm on possible potential hazards: the silk may break once implanted, it may not be sterile, the device may not be secured correctly, or a device of the wrong length may be implanted. The device may also be labeled or stored incorrectly. Joanne gives an example of a hazardous situation in which a box containing the device is delivered to a clinic here in Miami and left out in the hot sun. The exposure to high heat and humidity may cause the silk fibers to denature.
After each step, Joanne takes us back to the spreadsheet and shows us the next step in the process. We now need to determine the possible harm done in each of these hazardous situations. This can be physical injury or damage to the health of the patient, or damage to the environment. In case of the forgotten box in Miami, a patient could develop an allergic reaction due to the denatured silk or the device may fail once implanted.
To estimate the risk that a scenario like this actually happens, we determine the probability, or likelihood of occurrence, and the consequences, or severity of the harm. In short, Joanne explains, the risk can be estimated using a 3x3 matrix, with three probability levels (high, medium, low) and three severity levels (significant, moderate, negligible).
With this, we have only just completed step two of the risk management process. It becomes clear to me that risk management is a comprehensive and involved process. The information is now reviewed by the manufacturer and for each identified hazardous situation, the manufacturer decides if the risk is acceptable or whether measures should be taken to control or reduce the risk.
Let’s get back to our example: using the risk matrix, we determine that the risk of denatured silk due to high humidity and heat is not acceptable. The audience quickly offers some possible risk control measures: include a temperature indicator with the shipment, require temperature controlled packaging, include silica gel desiccant, or have warnings on the outside of the box.
All risks are now considered together to define the overall residual risk. The device can only be developed if the medical benefits of its intended use outweigh this overall residual risk. For our particular example, we conclude, after a warning about storage conditions has been included on the box, that the residual risk is acceptable.
The device is now ready for production, but the manufacturer will continue to collect and review information about this and similar devices during and after production as part of the risk management process.
I am leaving the session with a general understanding of how risk management activities are used to identify potential problems before they occur. Risk management is a creative process that involves identifying, evaluating and mitigating the impact a device can have on people and the environment. The goal is to make medical devices safer by incorporating risk analysis as a standard part of the design and development. Central to this process is the ISO 14971 standard. Risk management is an involved process that clearly benefits the patient as well as the manufacturer in the long run. Thank you, Joanne, for a very informative and engaging presentation.