In other news it would seem that FDA’s work is never ends. Recently, official from the Food and Drug Administration were forced to recall a series of machines produced by Custom Ultrasonics. FDA recalls sterilization machines after discovering that most of them did not meet up health standards.
Custom Ultrasonics is a company specialized in creating machines that are able to disinfect medical endoscopes after they are used in various procedures. After discovering that the devices are not up-to-date on public health protocols, the FDA decided to pull back nearly 2800 machines from the hospitals. Moreover, it seems that this isn’t the first time Custom Ultrasonics engaged FDA in open conflict.
In 2007, FDA discovered the same misconduct in the company’s health protocols. Naturally, the company was finned, and they were forced to stop shipping sterilization equipment. After a while, things seem to have come to a standstill, but it seem that Ultrasonics did not learn its lesson. Hence FDA’s swift and decisive response.
A couple of weeks ago, health inspectors were dispatched to local hospitals in order to check up on some allegation according to which there could be an outbreak of harmful bacteria due to some infected equipment. The inspectors who were on the case said that the accusations were pleadable, and the equipment was indeed susceptible of infecting patients with harmful bacteria.
An official investigation was set in motion, during which health officials discovered that the faulty apparatuses belong to the same Custom Ultrasonic, the same perpetrator from 2007. However, it seems that the company had more on its hands than a couple of broken gizmos.
The health officials working for the FDA declared in a press conference that, back in April, an inspection was scheduled to take place at the company’s headquarters. Once again the inspectors found out that the company does not abide by safety protocols required for handling medical equipment. Their main issue is that they cannot present sufficient evidence regarding how they wash and sterilize their equipment.
Doctor William Maisel, the deputy director at FDA, declared in the same press conference that FDA’s decision was based on the fact that the company continues to violate health guidelines. A consent decree was issued in the name of Custom Ultrasonics.
Meanwhile, FDA’s inspectors are overseeing the recall action in order to make sure that all faulty machinery has been withdrawn from hospitals. By pulling back defective sterilization machines and replacing them with new ones, officials want to make sure that there is no chance of bacterial infection.