Device Recalls and Patient Reaction July 2, 2010
Posted by Laurie Racenet, RN, MSN, ANP in Uncategorized.Tags: Device recalls
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A few months ago some of Boston Scientific’s implantable cardioverter defibrillators were recalled after the company determined that manufacturing process changes had not been submitted for approval to the U.S. Food and Drug Administration. This got me thinking about device recalls in general.
Looking back at the Medtronic Marquis recall several years ago, I can remember getting numerous phone calls within hours of the announcement. As a result, I was expecting to get phone calls from patients by the dozens regarding the Boston Scientific recall. Instead, I received only a handful of them. Was this because Boston Scientific’s communications about the issue had reassured patients, or were patients becoming immune to device recalls?
It also seems that we have to work harder to be sure that patients have received the letters we send about each specific recall. I have no hard data to back up my claim; it is just my impression
So I am curious about what my colleagues think about this issue. Are we doing such a wonderful job of communicating device recalls that patients are less anxious, and therefore don’t feel the need to call? Or have we had so many recalls, and sent so many letters that patients are beginning to ignore us? What do you think?
Heart Rhythm Society
Laurie Racenet, RN, MSN, ANP
Michael Giudici, MD, FACC, FACP, FHRS
Heather M. Ross, DNP, ANP-BC, CCDS, CEPS, FHRS
Anne Dubin, MD, FHRS
John D. Day, MD, FHRS
Andrea M. Russo, MD, FACC, FHRS
Joshua M. Cooper, MD, FACC
Amit J. Shanker, MD, FHRS, FACC
Bruce Stambler, MD
David Wiggins, RN, BS BME, CEPS
Fred M. Kusumoto, MD, FHRS
Leonard Ganz, MD, FHRS
christinechiuman
Craig Delaughter, MD, PhD
Ariana Del Negro, Heart Rhythm 2010 Quality
Peng-Sheng Chen, MD, FHRS
MSKremers MD,FHRS
Ann C. Garlitski, MD, FACC, FHRS
Alan Cheng, MD, FHRS
Ulrika Birgersdotter-Green, MD
Christopher Clyne, MD, FHRS
Kathleen Blake, MD, MPH, FHRS
David Scher, MD, FHRS
Sanjay Deshpande, MD, FHRS
Interesting discussion.
I believe neither. I believe lack of understanding is partially to blame. After all, if all patients understood that a fractured lead may provoke an unwanted storm of inappropriate shocks or that replacing a recalled faulty battery will risk an infection years earlier than previously expected, we’d all be anxious.
I expanded on a response on my blog.
http://bit.ly/aw79n9
I believe there is a disparity in how each manufacturer reacts to negative information on devices and leads. In my experience, Medtronic has been extrememly proactive in contacting patients who are affected. Therefore, patients are much more aware of the negative pulicity. In our area during the recent Boston Scientific problems, it was difficult to see anything in the general media regerding the details. Boston Scientific representatives told us that there is no reason for patients to be contacted. With no contact from the manufacturer, patiens are less likely to even be aware that there are any issues with their implanted hardware.