Every day of the year, American patients present to a hospital or other medical facility in need of help. Some need urgent, emergency care that was not planned ahead of time. Others are undergoing a scheduled procedure or testing to help identify a problem or issue. No matter why someone needs medical help, though, they should be able to rest assured with the knowledge that the devices used in their care are clean and sterile.
However, recent reports have indicated that sterility is a serious issue with some endoscopes, and in particular duodenoscopes, and that patients are paying a very high cost as a result.
Recent years have seen a rash of outbreaks of superbugs related to the use of duodenoscopes in medical settings, so-called antibiotic resistant infections that can be very serious or even fatal in some cases. A report issued by the Senate Democratic staff investigating such infections since 2010 concluded that up to 350 patients may have been infected at 16 hospitals. The report, released by the House Committee on Oversight and Government Reform, notes that the exact number of infections is difficult to determine due to suspected underreporting but that more than twelve deaths have been tied to superbugs after a scope was used on a patient.
Recently, the Food and Drug Administration ordered an immediate and mandatory recall of System 83 Plus machines, manufactured by Custom Ultrasonics, Inc., due to their association with many of the superbug outbreaks. The System 83 Plus machines serve to clean duodenoscopes and other types of medical scopes between uses through a combination of water, disinfectant, and sound waves. Of the 16 hospitals that experienced superbug outbreaks associated with scopes, nine of the facilities used Custom Ultrasonics, Inc. machines to sanitize their scopes. Of those hospitals that have been named, four declined to state whether they were still using Custom Ultrasonics, Inc. machines to clean their scopes, including Advocate Lutheran General Hospital in Park Ridge, Illinois.
Adding to the confusion of the issue is an unusual stance taken by the FDA. About six months ago, the FDA stated that the System 83 Plus units should all be recalled immediately to protect patient safety and that the sanitizing machines should no longer be used. But shortly thereafter, the FDA backtracked on its position, stating that Custom Ultrasonics, Inc. had been compliant with some other guidelines and that the machines could remain in use at the current time for medical scopes but not for duodenoscopes. Patients in Chicago and across the nation are left wondering about the links between these machines and the spread of deadly superbugs, whether these machines are safe for use in the cleaning of any medical scopes, and whether they should be concerned if they are one of the estimated 500,000 Americans who will undergo a scope procedure this year.
Presently, prospective patients and their loved ones should look into the facilities where they plan to have testing done and should discuss any safety concerns they may have with their physicians. Often, patients fail to realize that they are the consumers and they have choices when it comes to their healthcare, instead assuming that they are confined to the treatment path established by the first doctor they see.
If you are concerned about superbugs in a medical setting or about the cleaning of scopes and duodenoscopes, make sure you are your own best advocate by discussing all possible options with your medical team and making sure you are fully informed about all the risks of a procedure before you make a decision as to whether to undergo a specified test.
Prior Blog Entry:
Road Debris Causes Countless Chicago Car Accidents, Chicago Personal Injury Lawyer Blog, published May 31, 2016.
Endoscope Cleaning Machine Tied to Superbugs Still Being Used, Claims Journal, published May 31, 2016.