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US FDA plans overhaul of decades-old medical device system

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WASHINGTON — US health officials say they plan to overhaul the country’s decades-old system for approving most medical devices, which experts have long criticized for failing to catch problems with risky implants and medical instruments.

The Food and Drug Administration announced plans Monday aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing.

The FDA’s pledge came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. The probe, led by the International Consortium of Investigative Journalists, analyzed more than 8 million device-related health records, including death and injury reports and recalls.

Matthew Perrone, The Associated Press

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Trevor’s Story: I Have Anxiety and Depression. Where Can I Get Help?

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Trevor has suffered from anxiety and depression for a while. He had no idea where or how to get help with this. In discussing this with his doctor, he was referred to a Mental Health Counselor at Red Deer Primary Care Network.

Trevor says, “I, the skeptic, didn’t expect that I would get much help but did decide to work with the counselor. I needed to do something. We had 6 sessions together. The counselor provided me with insight on things that should have been so obvious to me but they weren’t. You don’t know what you don’t know. The counselor provided me with very practical and valuable tools. I came away with a different, more positive way to think about things. And it was just great to have a non-judgmental person to listen to me. It is a relief to just be able to tell someone who was really listening about my struggles.

These sessions were so valuable. I am in a much better state than I was. My struggles are not over but I manage to get through each day using the tools and improved mindset that I learned.

If anyone else is struggling like me I recommend no matter if they think it won’t help  just go, go in with an open mind. Even if you just feel you need someone to talk to you will get valuable tools to help manage your situation.”

To learn more about the RDPCN programs, visit www.reddeerpcn.com

Read more Success Stories from the Red Deer Primary Care Network.

Looking After Myself

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Looking After Myself

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Sue Ann went to the doctor. While the doctor addressed the issue at hand, he also did a bunch of tests. Sue Ann was in the 225-pound weight range and not surprisingly when the test results came back her blood sugar value was very high. The doctor started her on metformin right away and went through some trial and error to get the right dose and combination of mediation for her condition. She started out losing about 10 pounds every 6 weeks.

Before she knew it, she was down 30 pounds. She met with a dietitian to learn the best healthy eating strategies.  She now journals her food intake and plans her meals. She met with the RDPCN family nurse to learn more about her blood sugar and how her lifestyle choices affect it, to plan her exercise activities and for overall support and motivation. Sue Ann states she often loses motivation at about 3 months into any lifestyle intervention but this time she has the drive and support to keep going.

Sue Ann has made great progress. Sue Ann has a deteriorating spine syndrome so losing weight has really decreased her back issues. She feels so much better, more energetic and more confident. She has gone from a size 18 to a size 10 and lost 3 inches off her top, her waist and her hips. Her blood sugar is now in the normal range. She has a plan and is willing to put in the hard work to accomplish her plan. Her doctor says she likely will be able to come off her medications next year- another motivating factor. Sue Ann is very thankful to all the team members that have helped her make these positive changes!

To learn more about the RDPCN programs, visit www.reddeerpcn.com

Getting My Blood Glucose Back in the Normal Range Gave Me Tears of Joy

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