“The Investigation and Review of Iatrogenesis”: American Patient Safety Documentary and Symposium

【The Investigation and Review of Iatrogenesis】: American Patient Safety Documentary and Conference

【Stones from other hills may serve to polish the jade】 On 18th,October, we held the American patient safety documentary and symposium with Taiwan Patient Safety Culture Club at KbroCinamas, Taichung City. The topic is “The Investigation and Review of Iatrogenesis”. The TPSCC and friends in medical field shared the meaning of medical device safety education, and used the experience of America to discuss how advanced medical device will impact patient safety in Taiwan. It is generally believed that the U.S. FDA has the most rigorous controls on medical devices before they hit the market, but in fact the documentary reveals that there are still many uncertainties in the system, even social chaos and potential problems. Just as the Ministry of Health and Welfare announced the draft "Measures for the Notification of Serious Adverse Events of Medical Devices" in October this year, the TPSCC immediately took the lead holding a symposium in response to the Ministry of Health and Welfare, calling on people to face up to the potential risks of medical devices and know how to inquire appropriate information to protect themselves.

When the draft was announced, this symposium timely echoed the government with the attention to patient safety. The chairman of TPSCC, Chan Liao Mingi, indicated that about two months ago, he had the opportunity to watch this American patient safety documentary. It discussed the profit orientation of the American medical device industry, described how this billion worth industry put the risks on patients and exposed the dark side of innovative medical products on the market. Mentioned in this film, the female contraceptive device Essure, the hip joint prosthesis made of cobalt-chromium alloy and the Da Vinci surgical robot and other medical equipment have caused many problems. The follow-up development is very worthy of concern for the TPSCC to view and discuss, so this symposium with documentary is held.

Chairman Chan Liao Mingi hopes that the TFDA (Taiwan Food and Drug Administration) will launch the critical incident notification system soon in the future. For medical devices that may seriously harm the human body, manufacturers have the obligation to report and timely recall or take the product down from the shelves. As for patients and doctors, they can consider voluntary notification. Since Taiwan’s notification culture is not yet mature, we hope the broadcast of this documentary can be turned into a comprehensive health education, letting Taiwan’s notification culture will gradually get on track. Also, we hope the registration and post-sale monitoring system of medical device with abnormal information are made public, in order to achieve the goal of strict control of patient safety.