| With the sheer number of medical procedures going | | | | manufacturer, along with a number of other things. |
| on in the US, things do go wrong from time to time. | | | | It is important to keep a sense of perspective when |
| Devices break, mistakes are made, packages fail, | | | | researching medical device adverse events. As |
| things don't do what they are supposed to do. These | | | | mentioned, the sheer number of product usages in |
| failures do not always result in medical device recalls, | | | | the population will result in periodic problems. In |
| but these events are reported to the Food and Drug | | | | addition, the full context of an adverse event is not |
| Administration for tracking. These adverse events | | | | always known. Misuse by surgeons, complicated |
| are referred to as MDRs, or Medical Device | | | | medical conditions, or even particular patient |
| Reporting, and are covered by specific regulations. | | | | morphology may introduce issues that prevent a |
| MDRs are submitted both by hospitals and | | | | medical device from operating as intended. |
| manufacturers. A manufacturer has ten business days | | | | For example, a typical joint replacement prosthesis |
| from the point of becoming aware of the incident to | | | | includes a polyethylene component that WILL wear |
| report the event to the FDA. From there, the FDA | | | | over time. Replacement patients usually require at |
| will track such events, and they have an expectation | | | | least one revision surgery in their lifetime to replace |
| that manufacturers will also monitor the frequency of | | | | this component. However, due to the potential for |
| MDRs and to take action if a trend begins to develop. | | | | litigation, manufacturers avoid placing an expected life |
| Actions may be a full-blown recall, or a field | | | | span on these components, as it varies greatly from |
| correction that will improve the safety and efficacy | | | | patient to patient, depending on body weight and |
| of a device. | | | | level of activity. As no life span is marketed, every |
| As a consumer, you can search all MDRs listed on the | | | | single revision surgery is considered an adverse event |
| FDA web site using MAUDE (Manufacturer and User | | | | and is reported as such to the FDA. This doesn't |
| Facility Device Experience). MAUDE will provide quite a | | | | mean anything is wrong with the product. |
| bit of information about a medical device adverse | | | | As a consumer, you should research medical devices |
| event, including the device name, a description of the | | | | in your life, but it also requires a lot of work to |
| event, the event date, the response by the | | | | understand the context of whatever information you |
| manufacturer, contact information for the | | | | uncover. |