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Medical Device Safety
Action letter to CMS requesting that informing a patient of an implanted medical device's information and UDI should become a condition of participation (COP) for a facility. Dec. 12, 2019. Read Letter Read CMS Response Comment letter from 15 non-profit advocacy organizations regarding tracking and preserving the medical device’s Unique Device Indicator records, along with information regarding the distributor and prescribing physician. The UDI is a code which identifies the device. However, in the event the device is removed from the patient or the patient dies the records of the UDI may be deleted. In addition, there are no requirements for medical device implants to directly contain the UDI. Dec. 12, 2019. View Comment Letter The FDA MAUDE Database. Who is doing the reporting and how good are the reports. Lindsay Calderon, PhD describes the reporting requirements for the MAUDE Database and who is making the reports. Over 96% of reports are filed directly to the FDA by the manufacturer. Physicians file very few reports directly to the FDA, less than nurses and patients. Over all the reports were unstructured and a small minority of reports contained truly clinically useful data. Health Watch USAsm Conference Presentation Oct. 17, 2019 View YouTube Video: https://youtu.be/yKomHc_DWtw Kavanagh KT, Brown RE, Kraman SS, Calderon LE, Kavanagh SP. Reporter Occupation and Source of Adverse Device Event Reports Contained in the FDA’s MAUDE Database. Patient Related Outcome Measures. DOI: 10.2147/PROM.S212991 July 1, 2019. https://www.dovepress.com/articles.php?article_id=46767
Kavanagh KT, Kraman S. An Analysis of the FDA MAUDE
Database and the Search for Cobalt Toxicity in Class 3 Johnson &
Johnson/DePuy Metal-on-Metal Hip Implants. Journal of
Patient Safety: October 10, 2018 - Publish Ahead of Print
https://journals.lww.com/journalpatientsafety/Abstract/publishahead/ Letter In Support regarding the CDC's Action Regarding the High Incidence of Occult Cancer in Hysterectomy Specimens. "Review of Pre-operative Evaluation of Women Undergoing Hysterectomy and Myomectomy" Health Watch USA Position Letter. May 9, 2018 View Letter Sarah Robinson, PA. Although there is no existing test to rule out Sarcoma, if caught early without spread, Sarcoma is curative. Do say "NO" to your GYN surgeon who offers you a cosmetic "bikini incision" laproscopic hysterectomy, a surgery which uses the power morcellator tool to grind your uterus into smaller pieces removed from "keyhole" incisions. Your life may depend on it". Health Watch USA Meeting April 18, 2018. https://youtu.be/UGLeYr_dGEI Madris Tomes CEO of Device Events discusses shortcomings of the FDA's MAUDE Database along with the need for better and more timely post market monitoring of medical device safety. Health Watch USA Conference - Nov. 3, 2017. https://youtu.be/SecVj9_IKKc Stephen S. Tower, MD reports on 28 patients with cobalturia and encephalopathy associated with cobalt chromium hip implants. Health Watch USA Conference. Nov. 3, 2017. https://youtu.be/TlU-67zAwEs Robert Bridges, MD discusses the PET Scan changes in patients with encephalopathy associated with cobalt chromium hip implants. Health Watch USA Conference. Nov. 3, 2017. https://youtu.be/KBA25mvOf60 Joleen Chambers from FiDA (FAILED Implant Device Alliance) discusses several dangerous medical devices along with the lack of sufficient testing and post-market follow-up. Health Watch USA Meeting. Jun. 21, 2017. https://youtu.be/k1tA3H7i3s0 Evidence Mounts That Some Hip Implants Are Toxic to The Brain. News Relesase. June 6, 2017. View Release Amanda Rusmisell, The Essure Problems Group and Dangers Associated With the Essure Contraceptive device. Health Watch USA Meeting. Jan. 18, 2017. YouTube Video: https://youtu.be/zSVe5MQLTeA Dr. Stephen Tower, Complications of Wear or Corrosion of Chromic-Cobalt Hip Implants. Health Watch USA Conference. Nov. 4, 2016. YouTube Video: https://youtu.be/CpaQliphWAM Presentation Slides Without more monitoring, medical devices will keep harming patients Lexington Herald Leader. Aug. 14, 2015. We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices. View Op-Ed Dr. Hooman Noorchashm & Dr. Amy Reed on Uterine Morcellation and The Spreading of Cancer: Jack Pattie Radio Show / Webcast. May 12, 2015. YouTube Video http://youtu.be/IY4sFn5hybg
Lawrence F Muscarella, PhD on
the Prevention of Transmission of the ‘Superbug’ Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy.
2015, May 15. Dr. Stephen Tower, on the epidemiology and mechanisms of failure of total hip arthroplasty and associated heavy metal poisoning. Health Watch USA Conference. Nov. 7, 2014. You Tube Video: http://youtu.be/j0t_Kv3k70Y presentation slides
Dr. Stephen Tower, presenting on
adverse events associated with Metal-on-Metal Hip Implants
Lisa
McGiffert
from Consumer Union on the Safety of Medical Devices
Joleen Chambers from FiDA on the
Safety of Medical Devices
Failed Implant Device Alliance
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