Endoscope/ Duodenoscope Superbug Infection Lawsuit and complication

Medical procedures offer us hope for relief from pain and/or an improvement in the quality of our lives. That is why when things go wrong it can be so devastating. Infections are a very real and ever present risk that are involved in any surgery or procedure.

What caused  your Antibiotic Resistant Infection?

Each year over one million people suffer, or die, from infections (1) that they acquire as patients in a healthcare setting. As our use of antibiotic medications increase so to does the amount of medication resistant strains. That is, bacterium that have developed a resistance and can survive antibiotic therapy, also known as “super bugs”.

These types of infections can occur for many reasons, not the least of which is improper sterilization during a medical procedure. If you or someone you love has been affected by a preventable medical infection you should evaluate your options. Legal action may be recommended to compensate you for your pain and suffering.

The following text will explore what causes these “super bugs” to thrive and infect the human system. We will also discuss the possible role that the medical facility plays in their propagation. As well as, what you should do if you believe that your serious infection was caused by healthcare negligence.

(1) https://www.healthline.com/health-news/aging-healthcare-acquired-infections-kill-nearly-a-hundred-thousand-a-year-072713

Superbugs

Before we can understand how “super bugs” effect us we must first understand what they are.

Bacteria

Sickness is often caused by a strain of harmful bacteria that colonizes and propagates somewhere in your system (bacterial infection). It can drain your energy, cause aches and pains and other traditional cold or flu like symptoms. In extreme cases they can cause serious disability and even death.

Antibiotics

Antibiotics fight these bacterial infections. The different variety of antibiotic medicines work against different and specific strains of bacteria. They cause the bacterial cell to die through a specific action.

Example: A certain type of antibiotic interferes with a bacterial cells ability to maintain its cell wall. As a result, the cell wall is faulty and the bacterial cell dies.

Scientific studies (2) have proven antibiotic therapy to be very effective in wiping out entire colonies of bacteria within an individual. Since the first known antibiotic was discovered, penicillin, they have saved countless lives through methods such as this.
(2) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2896384/

How Does Normal Bacteria Become a Superbug?

A “superbug” is a strain of bacteria that has developed resistance to a certain type of antibiotic medicine. This is observed when a medical professional prescribes a patient an antibiotic that has been observed to destroy whatever kind of bacteria is making you sick and the sickness only gets worse.

Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most well known “super bugs”. This strain infects through various routes and can cause severe complications, amputations, or death.

Through the evolutionary process this bacteria changes its DNA so that the antibiotic will no longer kill it. Even with prescribed antibiotic therapy the bacteria will both survive and thrive. This resistant bacteria then propagates itself and can cause more complications. Often, it seemingly disappears only to cause more, severe, complications.

Research that explains this process in depth can be found at http://emerald.tufts.edu/med/apua/about_issue/about_antibioticres.shtml

What does this mean to you?

These resistant bacteria often causes much more than a cold. These “super bugs” can, and usually do, wreak havoc on a person’s system. They can cause lengthy hospital stays and a host of other consequences that can have life long implications on your health and well being. This is the reason that the Center for Disease Control(CDC) calls antibiotic resistance the “biggest public health challenge of our time”(3).

(3) https://www.cdc.gov/drugresistance/biggest_threats.html

How do “Super Bugs” Infect Humans?

These strains of bacteria can infect us in a variety of ways, both inside and outside of a healthcare setting. However, many of these infections occur inside of a hospital setting.

The CDC states that 5-10 percent of all patients in the United States suffer from a hospital acquired infection. That is 1.7 million per year and causes approximately 99,000 deaths per year. They also are responsible for billions of dollars in medical costs. (4)

Duodenoscopes

The FDA reports that nearly 500,000 medical procedures are performed in a calendar year utilizing duodenoscopes. Duodenoscopes are an integral part of diagnosing various diseses and play a large part in treament of those diseases. Howev, if the parts of the duosenoscopes are nhot propery and carfully cleaned this can cause fatal or life altering infections from one patient to another.

It has been reported that infections caused by the improperly cleaned duodenoscopes can spread antibiotic resistant superbugs.

For many patients, procedures that employ the use of duodenoscopes can carry with them a large risk for infection. Duodenoscopes are tubes that are used in a variety of medical procedures and can be inserted through the mouth or stomach. They are used in approximately 500,000 procedures per year.(5)

They are made from a flexible material and can be a breeding ground for bacteria. If they are not sterilized correctly, the bacteria can propagate on the surface of the duodenoscope. Once it is inserted into the patient it can move into their tissue and begin a serious infection.

Improper cleaning and sterilization of duodenoscopes is negligent and can make it easier for resistant bacteria to spread.

(4)https://www.cdc.gov/washington/~cdcatWork/pdf/infections.pdf
(5)https://www.fda.gov/medicaldevices/productsandmedicalprocedures/reprocessingofreusablemedicaldevices/ucm454630.htm

Pentax Duodenoscope Recall

The CDC alleged in 2013 that some duodenoscope and endooscope medical devices contained design defects that could potentiall cause drug resistant bacteria in medical patients even though all manufacturer recomended cleaning protocal was followed. Pentax instituted a voluntary recall of the ED-3490TK duodenoscope medical device. After performing modifications to the design of the medical device and modifying the labeling of the product, the ED-3490TK duodenoscope was allowed back on the market in 2018.

“In February 2016, PENTAX issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and continues to recommend that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them, if you have not already done so.

Since the February 2016 communication, PENTAX provided the FDA with additional information related to a potential risk associated with the design and manufacturing of the ED-3490K duodenoscope. Cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.

To inform their customers of this issue, PENTAX distributed a Customer Notification Letterdisclaimer icon on January 17, 2017 that:

  • Explains the design issue and describes the potential for infection risk associated with the ED-3490TK duodenoscope.
  • Outlines PENTAX’s strategy to closely inspect the distal cap area of all customers’ ED-3490TK duodenoscopes.
  • Stresses the importance of following the reprocessing instructions according to the device label.
  • Recommends that users closely inspect their duodenoscope and remove from use duodenoscopes that show signs of physical damage.
  • Offers support to customers who need further assistance.

The validated manual reprocessing procedures for the ED-3490TK duodenoscope outlined in the February 2016 Safety Communication remain the same. Health care facilities should continue to meticulously follow these validated instructions when reprocessing Pentax’s ED-3490TK duodenoscopes, paying close attention to any physical damage. These reprocessing instructions when followed correctly, are intended to effectively clean and high-level disinfect the duodenoscope channels, elevator area, and exterior of the device, and should reduce the risk of device contamination.” https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm537092.htm

 

Olympus Duodenoscope

The Federal Drug administration notified Olympus about concerns the FDA had with the duodenoscopes manufactured by Olympus.

“Our inspections revealed that the duodenovideoscope Olympus TJF Type Q-180V is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant deviations include, but are not limited to:
1.    Failure to report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example, Complaint #GIR/OBV-11055 references 16 patients who contracted a Pseudomonas aeruginosa infection, of which some resulted in abscesses, after undergoing an endoscopic procedure with your firm’s devices. Your firm submitted one MDR (MDR #8010047-2015-00218) to account for all the patients involved in the event. Your firm failed to submit an initial MDR for each event referencing patients sustaining abscesses as a result of contracting a Pseudomonas aeruginosa infection after undergoing an endoscopic procedure involving your firm’s devices. Your firm became aware of the event on May 16, 2012. The referenced MDR and all additional MDRs associated with the event were received by FDA in 2015, which is beyond the 30 calendar day timeframe.” https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm458510.htm

 

“In addition, Olympus is initiating a voluntary recall of the original TJF-Q180V model from health care facilities to replace the elevator channel sealing mechanism at the tip of the scope with a new sealing mechanism; the new mechanism is designed to reduce the risk of fluid leakage into the elevator channel. The company estimates it will be able to correct the mechanism in the approximately 4,400 TJF-Q180V models currently used in health care facilities throughout the country by August 2016.

While awaiting repair, health care facilities may continue to use the Olympus TJF-Q180V, but they‎ should meticulously follow the manufacturer’s reprocessing instructions.” https://www.fda.gov/medicaldevices/productsandmedicalprocedures/reprocessingofreusablemedicaldevices/ucm454630.htm

What Should You do if You Have Been Effected by a Hospital Acquired Infection

An infection can alter your life for good, and can even cause death. If a hospital’s negligence led to pain, suffering, or death of you or a loved one, you should explore your legal options and rights. You may deserve compensation from various entities, including the hospital.

Often, you will need to file a lawsuit to receive the compensation that you deserve. This can be a very difficult and long process. Hospitals employ a team of highly paid lawyers to handle these matters. In order to prove your point you will need to find representation also.

Luckily, there are attorneys that focus on this area of law. They have the education and experience needed to fight for the compensation that you deserve. A skilled attorney can be a valuable ally in some of your most trying times. They can inform you of your options, and try to help you return to as normal a life as is possible.

In Summation

Antibiotic resistant bacteria, “superbugs” have become a serious problem, according to the CDC. These infections can cause lifelong complications including death. They can be very difficult to eliminate and often require multiple, lengthy, hospital stays. Hospital negligence is often top blame for these infections through insufficient hygiene and sterilization procedures.

If you have been effected by these “superbugs” you should not hesitate to contact a lawyer who has experience in handling these types of cases. They are familiar with how the courts work and can use their experience to help get results. You do not have to face this difficult challenge on your own.