Lauren regulatory processes of the United States and

Lauren BartranENG 1123, Period 5David Lowery26 January 2018Summary #1SORENSON, CORINNA and MICHAEL DRUMMOND. “Improving Medical DeviceRegulation: The United States and Europe in Perspective.

” Milbank Quarterly, vol. 92,no. 1, Mar. 2014, pp. 114-150. EBSCOhost doi: 10.1111/1468-0009.12043.

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Sorenson and Drummond reveal that the regulatory processes of the United States and Europe leave much room for improvement (114+). Both the United States and Europe use an ineffective class system to determine the safety and effectiveness of medical products (Sorenson and Drummond 114+).  Sorenson and Drummond claim that “US and Europe evidence requirements for devices introduce not only risks to patients but also the wrong incentives to generate the needed evidence to better understand and evaluate the benefits and risks of new devices” (114+). There have been efforts for improvement based off of rising public demand for information on medical devices and regulation processes (Sorenson and Drummond 114+).

These efforts include providing comprehensive information on regulation requirements, processes, and research evidence to the public, although information on unapproved products remain private (Sorenson and Drummond 114+). Sorenson and Drummond claim that further improvements are needed to advocate safety and regulation (114+). It is proposed to provide a comprehensive database of products for the use of the public and medical professionals, along with the timely address of information requests and strict standards on the product usage (Sorenson and Drummond 114+).

Other improvements focus on the safety of products on the market, along with required stipulations for manufacturers to follow (Sorenson and Drummond 144+). Sorenson and Drummond declare that further review is needed to determine the effectiveness of these processes and what further steps should be taken to ensure products remain safe and patients informed (114+).


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