The risk is the severity of the harm caused and the likelihood of that harm occurring in a certain percentage of the patients who use your device. Now that you know what the potential harms are for your medical device, you can estimate the risks of each individual harm. Related Reading: Is Your eQMS Built for ISO 14971 Risk Management Compliance? 2. Make sure to include any harm to the environment, property damage, or harm to other people as well as harm to the patient using your device. What are the potential risks or harms that could happen during each step? Think about each step your patients will go through when using your product. ISO 14971 Annex C provides a list of examples to help you identify potential harms.
The first step to creating your risk matrix is to identify the potential harms your medical device could cause to patients who use it.įor example, potential harms can include: debilitating side effects, short-term injury or impairment, loss of a limb, or loss of life. Now let's take a look at the 5 steps you should follow to create your own Risk Matrix. You can find out more about Qualio and why it’s the best eQMS for medical device manufacturers here: Qualio: The first cloud management system for the entire Life Sciences ecosystem. As you can see from what happened to Johnson & Johnson, you need to maintain meticulous records, and an eQMS such as Qualio can help you do that. A risk matrix is combined with other tools to quantify risk and the potential sources of harm.Īlso, keep in mind that it’s important to choose an eQMS that makes complying with ISO 14971 a breeze. How to Set Up an ISO 14971 Risk Matrix in 5 Simple StepsĪn ISO 14971 risk matrix is a tool you create to assess and categorize the potential risks and harm your medical device poses to patients who use it. We'll show you how to set up your own ISO 14971 risk matrix in just a few steps. Johnson & Johnson’s vaginal mesh implants caused hundreds of women to suffer from debilitating side effects, such as infections, chronic pain, and the inability to have intercourse.Īnna Katzman, the Federal Court Justice, said that there was an “overwhelming” amount of evidence that the implants were not tested properly.īuilding a tool to assess risk will give your company confidence and consistency - plus it can help keep your organization out of trouble. Johnson & Johnson lost a class-action lawsuit and was forced to pay $2.6 million in damages because they failed to provide sufficient data to prove that their vaginal mesh implants were safe. Without a solid ISO 14971 risk assessment methodology in place, defining risk can sometimes be like answering the question, "How big is big?"
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