Scopes used in medical procedures can present a serious risk of puncture to vital organs or the depositing of bacteria that can cause infections. The injuries that the misuse or contamination of scopes and other probing tools can cause can be life threatening even if prompt treatment is received.
Scopes Can Cause Life Threatening Infections
The most recent instance of infections caused by contaminated scopes involves devices manufactured by the Olympus Corporation. The Tokyo based company is responsible for producing roughly 85% of the gastrointestinal scopes used in the United States. Olympus became aware of serious issues with the scopes after more than two dozen cases of contamination were discovered in France and Holland where the company’s devices are also used. Even after these instances of contamination became apparent, the company deliberately chose not to inform US doctors or regulators of the risks stemming from their usage.
It is estimated that the scopes exposed nearly 350 patients in 41 different medical facilities around the world to deadly bacteria and viruses between January 2010 and October 2015. These patients were exposed due to a design flaw within the scopes that allowed these contaminants to latch onto a portion of the duodenoscopes that was very difficult to sterilize.
Common Procedures with Deadly Results
There are more than 650,000 Endoscopic Retrograde Cholangiopancreatographic procedures conducted each year in the United States alone. This procedure is used to treat everything from gallstones and bile duct obstructions to cancer and problems with digestion. It is considered a common and routine procedure that does not usually require an overnight hospital stay.
Investigators with the US Senate Health Committee have determined that medical scopes manufactured by Olympus, Pentax, and Fujifilm were responsible for 25 infectious outbreaks between 2012 and 2015. According to their estimates, at least 250 people in 10 states were infected with potentially life threatening bacteria during this time. Roughly four out of every five scopes responsible were manufactured by Olympus. While this estimates are alarming, it should also be noted that investigators believe this number will go far higher as the investigation continues and more cases come to light.
Olympus became aware of design flaws with their scopes following a 2012 outbreak that took place in the Netherlands. Both the company and the United States Food and Drug Administration were aware that the scopes manufactured by Olympus were potentially deadly. However, neither the company nor the FDA warned physicians of potential problems until 2015. This warning was issued after three patients died following ERCP procedures at the University of California Los Angeles Ronald Reagan Medical Center.
Moreover, the FDA reports have blacked out all hospital names and outbreak locations. This lack of information makes it difficult for individuals to track the source and progression of the outbreaks. Coupled with this lack of information was a lackadaisical approach to cleaning procedures that were not amended or adjusted following the discovery of potential design flaws with the scopes. Had these procedures been amended, it would have eliminated a considerable number of the infections the devices caused.
Rule Change Could Have Saved Lives
It was not until 2012 that the FDA finalized rules requiring companies such as Olympus to stamp each of their scopes with a device identification number. This is a rule change that has taken more than a decade to pass, and as of now there are no deadlines for companies to comply with this new rule. The rule is intended to create a unique identification tool that investigators can use to help track the source of potentially deadly outbreaks.
Corporate Greed at Fault
Olympus put considerable effort forth to boost sales and conceal the dangers of their devices. The company was recently found guilty of a kickback scheme that induced nearly $600 million in purchases of surgical and other medical equipment. These sales created roughly $230 million in profits for the company. Among the devices they pushed on hospitals were the scopes that caused significant personal injuries and considerable harm to patients. The design of these scopes made it impossible for hospitals to properly sterilize them. This allowed bacteria and other contaminants to flourish on the scopes, thus infecting the next patient they were used upon.
Neglecting Patient Rights and Safety
A personal injury lawyer in MN can provide guidance on the proper course of action to pursue following exposure to bacteria and viruses. Patients have a right to know that the devices they are being treated with have potentially dangerous consequences. Individuals who were treated with these scopes may be eligible for compensation for the personal injuries, pain and suffering, and loss of income that resulted following treatment with the scopes manufactured by Olympus, Pentax, or Fujifilm. If the patient died, then surviving relatives may also be eligible to file a wrongful death suit against the company.