Cardiac Implanted Electric Device Recall Campaign

 
This research is part of a doctoral project that seeks to better understand patient preferences in the wording used in a FDA (Federal Drug Administration) recall campaign with implanted cardiac devices such as a pacemaker or ICD (implantable cardiac defibrillator). You may be aware that when a cardiac implanted electrical device has a malfunction of significant consequences the FDA may issue a recall letter. The goal of this short survey is to learn more about your preferences to the wording used in these FDA recall campaigns.

I greatly appreciate your time and willingness to complete this survey. You do not have to complete this survey if you do not want to. There are no questions in this survey which request you to identify yourself. Additionally, there is no way to identify you electronically through this website. Thank you for sharing your time and thoughts.

If you have any questions about the research study, please contact the Medical University of South Carolina IRB office at (843)792-4148. This research has been reviewed according to the Medical University of South Carolina IRB procedures for research involving human subjects.
1. Gender:
2. Age:
3. I have this type of device implanted:
4. I have or presently had a device subject to a recall:
Some medical devices are surgically implanted inside a human body, such as heart pacemakers. Sometimes after surgery, it is discovered that some of the implanted devices may have defects and they need to be recalled. These situations are different from most other kinds of recalls of defective products because the people that have these devices may need to visit a physician, and may need to have another surgery to remove the device.

However, “recalled” implanted devices are not always defective and may not need to be removed, but rather monitored more frequently by the physician. Thus there is some concern that people with the recalled device may panic unnecessarily. Here is the issue: Because users cannot simply “return” their surgically implanted device and may become anxious, do you think the word ‘recall’ should be used in these notices? Rank the following three statements using a 9- point scale where: (0) not at all appropriate, (2) somewhat appropriate, (4) appropriate, (6) very appropriate, and (8) extremely appropriate.
5. Rank the following three statements using a 9- point scale where: (0) not at all appropriate, (2) somewhat appropriate, (4) appropriate, (6) very appropriate, and (8) extremely appropriate.
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A) The word “recall” should be used for all defective and potentially hazardous food, medicines and implanted devices.
B) A different word other than “recall” should be used as part of the name for notices specifically concerning surgically implanted devices. The word “recall” should only be used for all other instances of potentially hazardous food, medicines, and (non-implanted) medical devices.
C) The word “recall” should not be used at all as part of the name of notices for potentially hazardous food, medicine, and medical devices. Rather, another name should be used to fit all kinds of defective products (including surgically implanted ones).