Over the last 12 months, the U.S. Food and Drug Administration (FDA) has issued multiple recalls for anesthesia machines from multiple vendors. These FDA recalls were initiated by the manufacturer due to some type of defect that violates FDA regulations. Most of these recalls fall under FDA recall classification Class II.
The FDA categorizes medical device recalls into three classifications:
Class I: a reasonable probability that the use of the product will result in serious consequences or death
Class II: a reasonable probability that the use of the product may cause temporary or reversible health consequences
Class III: use of the product is not likely to cause health consequences
Voluntary recalls the norm
When a manufacturer issues a recall, it must notify customers and report the problem to the FDA. The FDA then notifies the public of the manufacturer recall. According to the FDA website, “Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under 21 CFR 810, Medical Device Recall Authority.”
Not all medical device recalls require removal of the device from the market. Many issues call for a correction such as an adjustment, inspection, modification, relabeling, or repair. The corrective action required can vary depending on the classification or degree of hazard presented by the medical device. Once the manufacturer initiates a recall, the FDA evaluates the health hazard presented and assigns a recall classification.
Ventilation and gas delivery flaws
Review of the anesthesia machine recalls reveals defects or flaws in the design or of a component of these systems. These flaws involved the ventilation and gas delivery systems.
The vendors have stated that they will replace the defective part(s) and that the customers should ensure they are prepared for a failure until the systems are repaired.
Get it in writing
MD Buyline recommends when purchasing a system that currently has an FDA recall that the customer obtain a written statement of the status and resolution actions taken by the vendor to address the issues.
We also recommend that the customer negotiate up-time guarantees to ensure the new system will be in working condition. Customers should evaluate and update their contingency plan in the event of a system failure. Identify which systems are affected by the recall and clearly mark those systems.
Once the FDA determines the product “no longer violates the law and no longer presents a health hazard,” the FDA will terminate the recall. For a list of Medical Device Recalls, you can search the FDA database.