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October 22, 2014
5 Min Read
Any product recall is bad. But that is especially true in medtech--where the life of patients is often at stake.
Whether it's striving for simplicity in design or recognizing that people are capable of countless mistakes while using something, Qmed has collected feedback from our audience and added it to our list of dos and don'ts.
The causes for such dangerous and potentially deadly errors leading to Class I recalls are varied, whether it is an underestimating of the potential for human error or lacking good manufacturing practice.
Here are recalls that were especially serious this year, whether it was because of loss of life or the widespread nature of the recall:
1. Thoratec LVAD Patients Confused over Controller
The FDA on April 1 issued a Class I recall designation over Thoratec's advisory involving four patient deaths related to its HeartMate II left ventricular assist device (LVAD).
The issue actually has nothing to do with the LVAD itself, but rather is related to patients and caregivers who were unable to understand instructions and lacked the training needed to hook up a back-up system controller in cases of device alarm or malfunction.
Besides resulting in four deaths, such difficulties also caused lost consciousness or reduced blood flow for five other patients, according to Pleasanton, CA-based Thoratec and the FDA.
The FDA elaborates on what happened:
"All reports were linked to patients whose HeartMate II LVAS device was originally attached to an older model of controller, the EPC System controller. When the Pocket System Controller became available, patients were switched from the EPC System Controller to the Pocket System Controller. However, these patients did not receive intensive training on connecting the new controller."
HeartMate II, as shown on Thoratec's website
Later in the year, Pleasanton, CA-based Thoratec announced it had replaced CEO Gary Burbach with Keith Grossman, the man who previously led the company for a decade.
2. GE Healthcare Infant Resuscitators with Assembly Error
GE Healthcare recalled a host of infant resuscitators from the past five years over a serious error during the assembly process.
The FDA announced Feb. 28 that it has designated the recall as Class I. FDA officials think the resuscitators could potentially seriously injure or kill infants because oxygen and air wall inlet fittings on their back panels were reversed during assembly.
The FDA says: "These recalled products may interfere with oxygen delivery resulting in inaccurate oxygen regulation in newborns (neonates) and may lead to low blood oxygen (hypoxia) or high blood oxygen (hyperoxia). This may cause death in neonates, particularly those who are critically ill. Preterm and low-birth weight babies are also at increased risk in terms of morbidity and mortality."
The Giraffe Stand-alone Infant Resuscitation System, as shown on GE Healthcare's website.
3. A Serious Flaking Guidewires Issue
The FDA over the past 12 months has announced Class I designations involving coated guidewire recalls at Medtronic and Medline.
On April 1, Covidien, issued a voluntary recall of 650 of its Pipeline embolization devices and Alligator retrieval devices after internal testing revealed coating delamination. It was just in August that the FDA approved changes to the manufacturing process for the PTFE coating on the Pipeline's delivery wire. (A Covidien spokesman declined to elaborate what the manufacturing changes were.)
Flaking can create a serious, life-threatening situation because dislodged coatings could become lodged in the lungs or the heart.
The recalls are serious because they are taking place in such a wide variety of products.
A primary culprit in these recalls involves the adhesion issues that have cropped up with polytetrafluoroethylene (PTFE).
PTFE used to not have such issues, but then the U.S. Environmental Protection Agency required that manufacturers eliminate the suspected carcinogen perfluorooctanoic acid (PFOA) from their PTFE formulations by 2015. (Dupont invented PTFE, naming it Teflon, but no longer promotes Teflon-branded PTFE coatings for medical device applications.)
The newer PTFE simply isn't sticking to stainless steel wires the way it used to.
Some failing wires experience PTFE delamination. (Image courtesy of Surface Solutions Group)
4. A Widespread Defibrillator Electrodes Recall
Covidien recently announced a defibrillator electrodes recall, but the Class I-level recall has nothing to do with the mechanical functioning of the electrodes themselves.
Rather, the case is another tragic example of how devices are not always used the way the designers intend them to be used.
The recalled electrodes--more than 600,000 Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes--do not connect with Philips FR3 or FRx AED units. But health providers and other users were apparently unaware and connected them anyway, even though it was Philips brand electrodes that were specified in the equipment manual.
Covidien says it has received two instances where customers attempted to use a Covidien electrode with a Philips FR3 AED unit, with the mismatch potentially contributing to the death of one patient.
Refresh your medical device industry knowledge at MD&M Minneapolis, October 29-30, 2014.
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