Could it be true that a machine used for medical procedures was tied to superbugs and is still in use? This is the accusation brought forward in a new Bloomberg article that discusses action by the United States Food and Drug Administration (FDA) that may allow this machine to still be in use. The machine was twice recommended to be taken off the market by the FDA after being tied to a deadly superbug outbreak. Still, though, the machine — used to clean certain surgical instruments using disinfectant, water, and sound waves — is in use for some instruments. The reason? According to the Bloomberg article, the FDA backed down from their recommendations.
The manufacturer, Custom Ultrasonics Inc., was ordered to pull 2,800 of their System 83 Plus machines from the market. The FDA had concerns regarding the compatibility between the device and disinfectants, as well as whether or not it can fully clean duodenoscopes and properly eliminate bacteria and microorganisms from the water. This is stemming from issues at a number of hospitals over recent years regarding antibiotic-resistant infections.
These incidents were investigated by the Senate Democratic staff. A report released by the House Committee on Oversight and Government Reform showed that up to 350 patients from dozens of hospitals have been affected by antibiotic-resistant infections since 2010. The exact number of patients was not determined due to reporting issues. However, there were more than a dozen deaths associated with the infections. Custom Ultrasonics has denied that their machines are unsafe because some of the outbreaks occurred at hospitals not using the manufacturer’s system.
Even before the recent outbreaks, the FDA has had reservations regarding Custom Ultrasonics. Investigations and inspections date back as far as 1991 with finding involving significant violations of federal rules. These alleged violations involved quality assurance while manufacturing and timely reporting of harm done to patients. Violations were brought up in investigations from 1992, 1995, 2005, and 2006. After being treated with endoscopes cleaned by the System 83 Plus machine, there were 13 patients who were tested for hepatitis C where results came back positive. According to prosecutors, the manufacturer learned of the infections in 2004 and didn’t report them for two years, despite the 30-day limit requiring the FDA to be notified in that time frame.
In 2012, the System 83 Plus device was ordered for a recall by the FDA due to recurring violations and consent decree. The FDA removed the recall order after conducting another inspection. Instead, they ordered the company to pay damages. In 2015, the FDA found that several of the machine’s aspects were not validated. The FDA even went as far as to call Customs Ultrasonics’ response to their concerns inadequate in an eight page letter. If the manufacturer did not comply, the agency threatened daily fines.
Again, the FDA backed off.
When questioned whether or not the System 83 plus machine was still in use at their facilities, four hospitals — in which an estimated 86 of the patients were infected with superbugs — declined to give a response. Two more hospitals claimed they were in the process of changing vendors and both claimed to have implemented stricter measures for devices that are harder to clean and were linked to the outbreaks.
This is a difficult situation to deal with because the planned recalls were called off. It is important to make sure the safety of the public is first and foremost the top priority of those manufacturing products, especially in the medical field. If they are negligent, anyone harmed should be able to take legal action.
If you need help with a legal matter involving medical malpractice or product liability, call our team at Bailey Cowan Heckaman PLLC today.