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Medical Device Safety

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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 USA(sm) 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/
An_Analysis_of_the_FDA_\MAUDE_Database_and_the.99315.aspx
    

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.
LFM Healthcare Solutions, LLC.   View Presentation

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

Collage of Patients Developing Advanced Stage Cancer from Uterine MorcellationDr. Hooman Noorchashm and Dr. Amy Reed on the dangers of Uterine Morcellation:   Health Watch USA Meeting.  June 25, 2014.  (Picture to the right shows a collage of patients who developed advanced stage cancer from uterine morcellation.  Those with a ribbon have died.) 

  • Segment 1:   Hooman Noorchashm MD, PhD on the morcellation disaster: A root cause analysis and perspective. YouTube Video: http://youtu.be/n6226ic0Mpk

  • Segment 2:   Amy J. Reed MD, PhD on the morcellation disaster: A physician, patient, and mother of six, gives her personal perspective.  YouTube Video: http://youtu.be/gIwxfkXGekw 

  • Segment 3:  Dr Noorchashm presents his research and perspective leading to a plan of action to ban the procedure of morcellation and revising the 510K medical device approval process.   YouTube Video:  http://youtu.be/Qvg5OXaiEiM 

Dr. Stephen Tower, presenting on adverse events associated with Metal-on-Metal Hip Implants
HW USA Meeting.  Apr. 2, 2014  
YouTube Video https://www.youtube.com/watch?v=mw6iDg0A6Ys

Lisa McGiffert from Consumer Union on the Safety of Medical Devices
Webcast/Radio.   Oct. 22, 2013   
Listen to Webcast of Radio Show (Jack Pattie) Presentation

Joleen Chambers from FiDA on the Safety of Medical Devices      Failed Implant Device Alliance
HW USA Conference.  Nov. 1, 2013  http://www.healthwatchusa.org/conference2013/chambers/20131101-chambers.htm