Is the cardiac device you use in everyday practice the same as the technology approved by the FDA? That is one of several safety questions raised this week.
Researchers reported in JAMA that many of the cardiac implantable electronic devices stocked in hospitals and implanted in patients are cousins—possibly quite distant cousins—of the devices that initially had passed muster with regulators. The agency allows iterations of an approved device to go through a variety of review tracks rather than require an expensive and time-consuming clinical trial.
The process lets manufacturers introduce design and material improvements, for instance, and get them to physicians and patients more swiftly. The issue is when, through a series of changes, the device appreciably differs from its original. The authors recommended physicians weigh their options carefully when faced with new device models.
Hospitals and cardiovascular physicians should take heart in results from a study in the New England Journal of Medicine that assessed trends in adverse events in patients hospitalized for acute MI, congestive heart failure, pneumonia and conditions treated by surgeries. The rates of adverse events for acute MI and heart failure dropped between 2005 and 2011 while rates for pneumonia and conditions requiring surgeries did not.
The authors attributed the decline for the two cardiovascular conditions to initiatives to improve patient safety and national programs. It is conceivable that the then-approaching initiation of Medicare penalties for higher than expected hospital readmissions played a role in this reversal by raising awareness of safety and quality-of-care issues; but the penalties apply to heart failure, acute MI and pneumonia.
Perhaps a myriad of good practices, some modest but still impactful, have helped hospitals and cardiologists prevent or minimize adverse events. What has—and hasn’t— worked for you?
Cardiovascular Business, editor