Hyman William A
Texas A&M University, USA.
Biomed Instrum Technol. 2011 Sep-Oct;45(5):412-5. doi: 10.2345/0899-8205-45.5.412.
An ongoing issue with respect to medical device recalls is getting the information to the right people in a timely manner so that appropriate action can be taken. For Class I recalls, this is often addressed by one or more means of professional and public communications, including after-the-fact posting of such recalls by the U.S. Food and Drug Administration (FDA). One resource that could be included in a recall strategy is the recalling company's own website where the information could be readily available in close association with other information on the product, and where it would be readily found by someone making a product specific inquiry. However an investigation of 13 Class I recalls from the 4th quarter of 2010 shows that only four of these included a web presence, and even among these, the recall information was not necessarily easily found, nor closely linked, to other product information.
医疗器械召回方面一个一直存在的问题是及时将信息传达给合适的人员，以便能够采取适当行动。对于I类召回，这通常通过一种或多种专业和公共沟通方式来解决，包括美国食品药品监督管理局（FDA）事后发布此类召回信息。召回策略中可以纳入的一个资源是召回公司自己的网站，在该网站上，召回信息可以与产品的其他信息紧密关联且随时可供获取，并且在有人针对特定产品进行查询时能够很容易被找到。然而，对2010年第四季度的13起I类召回事件进行的调查显示，其中只有四起涉及网络发布，而且即使在这四起事件中，召回信息也不一定很容易找到，也没有与其他产品信息紧密关联。
