Authors: Maura Gouak, Sales Development Representative & Angela Alexandrow, Marketing Manager, Life Sciences
A member of our Life Sciences team, Maura Gouak, told us about her recent experiences with a medical device. In February, she was involved in a serious car accident that caused an injury requiring surgery. Working in the life sciences industry, specifically with medical device regulatory compliance, it truly brings the UDI (Unique Device Identification) story full-circle. Here is Maura’s story.
This year began with a life-altering experience that really made me think about what it means to be an informed patient. I was in a car accident that caused damage to my dashboard and deployment of the driver side airbag. In the process, my pinky finger was broken on my left hand. The emergency room recommended follow-up with my primary doctor or an orthopedic specialist. The specialist recommended surgery that required a plate and five screws in my pinky finger. Surgery was scheduled two days after the initial appointment.
Two months later, during a follow-up in May, I asked the specialist about the hardware of the pin. I asked, “do you have information about the manufacturer, the material it is made of, if there have been any reported problems, that kind of thing?” No information was available in the operating notes for my case. The specialist’s office offered to provide more information in my follow-up in July.
At my subsequent appointment, the doctor’s office offered the name of the manufacturer and the comment that they were ‘held to a gold standard’ for this type of medical device implant. That seemed vague to me. Exactly what did a ‘gold standard’ mean?
I realized that I had no information about the pin (a medical device) that had been implanted in my finger: no information readily available from the specialist’s office…what if something goes wrong? What if the material it is made of has weaknesses or toxicity? Could I be allergic to any of the component metals or plastics? Is this device from a reputable supplier and can it be traced in the supply chain?
So far, so good. My finger is healing and I have good mobility. We are still early in the process. Physical therapy is going well so far. I am told that if the metal starts to ‘catch’ or rub on any of the surrounding tissues, we can look at a second surgery for more correction in a year. The x-ray shows only a portion of the fracture, however, only within surgery can more delicate fractures be uncovered. You never know what the extent of damage is until the surgery and post-surgery therapy occurs.
Through this experience, I have considered how much a patient can be unaware of the finer details, especially when it comes to implanted medical devices. When you sustain an injury, it is natural to first be only concerned with recovering mobility and reducing pain. Later, you start to think of alternative outcomes and what complications could occur.
For a specialized finger surgery, I was very surprised that the orthopedic specialist had no specific information about my implant appliance. The ability to be fully informed with information about a medical device can become paramount if something goes wrong.
My Key Takeaways
• Had I known, I may have asked the surgeon to keep the packaging label of the medical device used for my future reference (just in case.) Knowing a manufacturer name, specific device name and version or model number is important. To know more about a medical device and its origins, it is best to understand some of the basics of what the codes mean on a device label. Devices that are in compliance with the US FDA and accredited by an issuing agency will carry specific identifying information. See an example here.
• I didn’t know a patient has the ability to report an adverse event due to a medical device. It turns out, yes, you can. The FDA has a formal reporting process for voluntary reporting from patients, health professionals and consumers through a MedWatch Voluntary Reporting Form.
• If I wanted to just ask ‘questions’ about a specific medical device, help is possibly available through the FDA Division of Industry and Consumer Education (DICE).
Medical devices change lives. I am so grateful that medical research, inventors and manufacturers continue to improve patient outcomes with new ways to help us heal and move forward from injuries. I am confident my mobility will continue to improve.
When it comes to medical devices, I value all the effort that goes into product development, quality, design and the markings and packaging standards that help move the device through the supply chain to healthcare settings and finally to patients.
I have learned a great deal about the UDI submission process as a member of the Reed Tech team but as a patient I have found UDI matters to everyone; manufacturers, distributors and patients!
Figure 1. Actual x-ray of pinky fracture with implanted pin and screws (M. Gouak)