Here are seven types of problems we've noticed in recent medical device recalls that FDA has deemed as Class I.
1. Manufacturing Glitches
FDA announced this month that it has given Class I-status to a recall of St. Jude Medical Optisure dual coil defibrillation leads, used in defibrillators. The recall is but another reminder that manufacturing process defects can lead to grave consequences--especially for critical components such as leads for cardiac rhythm management devices.
In this case, a manufacturing error was cited as possibly causing damage to the insulation layer of one of the shock coils of the leads. Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the patient.
2. Material or Design Problems That Cause Products to Physically Break
Several recent recalls have been announced related to products or components physically breaking. There is a catheter that could break during insertion, a guiding sheath that break during insertion, a rotational artherectomy system with core wires that can crack and separate, and an artificial hip that can fracture.
3. Software Defects
Software problems continue to be one of the most common reasons for medical device recalls. Examples of recent software problems that have led to Class I-recalls include a Dräger recall of a battery power supply owing to a software problem that diminishes battery run times. The software can also interfere with the alarm. In addition, a software problem was implicated in a Covidien recall of a neonatal ventilator. In that case, a software error can cause the amount of air being delivered to the patient to be less than the amount specified by a doctor or nurse.
4. Power Switch Problems
A faulty power switch was implicated in the Class I-recall of a Dräger Perseus A500 anesthesia workstation, which could ultimately cause the device to stop working. A similar problem with a power switch was behind the recall of eVent Medical's LS, 5i, or 7i Inspiration ventilators.
5. Alarm Problems
The notion of alarm fatigue has gotten a lot of attention in recent decades, as clinicians gradually become desensitized to the alarms going off in hospitals. But alarms that don't sound can be especially risky as well, and this was the reason behind FDA to give Class I-status to the Hamilton Recalls G5 Ventilator, which may stop working without sounding an alarm.
In recent months, two other Class I-recalls were announced related to possible device failures that failed to trigger an alarm. For instance, the Syncardia Freedom Drive was recalled because a specific component of the device's drive mechanism could fail, causing the device to stop pumping without providing advanced warning.
6. Faulty Batteries
The popular press has scrutinized the potential for some batteries to explode in recent years. Simple power outages though can be just as catastrophic in medical devices, however. The potential for batteries to not work correctly was implicated in recalls of the Dräger Medical, Evita V500 and Babylog VN500 Ventilators last year. As the recall notes explain: "The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does not last as long as expected. The battery indicator light shows a sufficiently charged battery even when the battery is depleted."