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  • f-dot replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 7 years, 1 month ago

    A medical device I would consider to have significant risk, are contact lenses. Everyday millions of people (guessing, don’t quote me), put contacts into their eyes instead of wearing glasses, but have you considered the risk they are taking? If the wearer fail to wash, clean/disinfect, or properly store their lenses, they risk infection. This could be small infection, or could become something more serious like keratitis (causes blindness).
    Although not throughly investigated, contact users have more of a risk. The Keratitis does have an annual cost of 175 million in direct health care expenses (not limited to contact wearers).
    To prevent this risk, or at least lower it. I would have people start wearing daily contacts. This would ensure there is no cleaning necessary, only proper storage and making sure your hands are clean. Without the hassle of cleaning a repeated lens, there would be less infection. Risk would have to be evaluated by the number of reported cases annually given all types of contact users to assess the effect of daily vs. monthly on preventing infection.