In light of the U.S. Food and Drug Administration’s look to possibly speed up the availability of medical devices; the agency is turning its focus on recent breakdown in quality issues of six medical devices.
Since March, when the six medical devices quality concerns began, the cluster of issues have risen alarms about potential injury or even death to patients.
These serious possibilities has caused the FDA to take action:
A) Covidien Surgical Devices:
The FDA issued a Class 1 designation after Covidien stepped up by choosing to recall two of their devices, used in brain related procedures, because of flaking of their outer coatings (PTFE). http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm394137.htm
The FDA is concerned about the possibility of a stroke or death, if a piece of the coating should make its way through the blood vessels in the brain.
Covidien reports that only one incident has been registered with them and no deaths or injuries. They are requesting that consumers return unused devices to the company.
B) Dräger Ventilators:
Although no patient injuries were reported to the company, it reported that the batteries on its Evita V500 and the Babylog VN500 ventilators diminish quicker than expected. The company has indicated that they will replace the batteries for free.
But the FDA warns that the battery charge indicators might register as having power but the battery still be dead.
C) Spacelabs Anesthesia Delivery
It was in March that Spacelabs began a recall of its Arkon Anesthesia Delivery System with the 2.0 software. It appears that the software might trigger the shutdown of the system, thus putting the patient’s life in jeopardy and necessitating the need for immediate physical ventilation. The FDA noted the recall as Class 1: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm384921.htm
Spacelabs received one report regarding the issue and the company is reaching out to the hospitals, using the system, to upgrade the software at no charge.
D) Abbot Blood Glucose Meters
Here it is the test strips that is used with meters that might cause death or very critical illness. The FDA sites the erroneous readings from the strips might place diabetic patients in jeopardy.
The FDA designated a Class 1 concerning Abbott’s FreeStyle, FreeStyle Flash Blood Glucose Meters and the Insulet OmniPod. http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm380500.htm
The company has requested users of the meters to stop using the devices and to contact Abbott to receive a new meter. New test strips will be sent for patients using the FreeStyle meter in the OmniPod Personal Diabetes Manager.
E) Thoratec LVAD
It was in early April that FDA announced a Class 1 recall on the HeartMate 11 Left Ventricular Assist Device. (LVAD) The action was taken after the death of four patients and the serious injury to five other patients. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm391322.htm
All negative reports were in regard to the HeartMate 11 LVAS device, which was switched to the newer Pocket System Controller. The deaths were not attributed to the device but to confusion over the controller operating instructions by doctors, patients and caregivers. The lack of succinct, clear, directions along with the lack of thorough training for connecting a back-up controller system.
Thoratec notified the FDA and contacted its users of the device via email in early March. The company is currently revising its labeling and advising all users of the HeartMate 11 LVAS Pocket System Controller to get new training and thoroughly review the instructions.
F) McKesson Technologies, McKesson Anesthesia Care.
A Class 1 designation was given to McKesson Technologies, Inc.’s recall of the Mckesson Anesthesia Care by the FDA. The FDA noted that data from one patient was added to another patient’s data while the computer based anesthesia assessment & monitoring system was being used.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394294.htm Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions “Expedited Access PMA” or “EAP” for short. FDA NEWS RELEASE April 22, 2014.)