Archive for: Sterile Matters

Pentax duodenoscopes voluntarily recalled for design and labeling updates

By: February 7th, 2018 Email This Post Print This Post

The FDA announced today that it has cleared the updated design and labeling for Pentax ED-3490TK duodenoscopes and that the scopes will be recalled so the manufacturer can make design changes meant to reduce leakage of patient fluids — thus limiting the spread of infection — and update product operations manuals.

In 2015, the FDA issued a safety warning against Pentax and two other duodenoscope companies. The warning stated that a design flaw prevented the scopes, which are designed to be used on multiple patients, from being cleaned properly, creating an infection risk. Duodenoscopes are flexible, lighted tubes that threaded through the mouth, throat and stomach into the top of the small intestine (duodenum).

A subsequent Senate investigation revealed that dirty scopes were the direct cause of 25 infection outbreaks, sickening dozens of patients and leading to the death to at least 21 people. The FDA bore some of the blame for deciding to not alert the public to the threat until after its 17-month investigation into the matter.

After the manufacturers revised their reprocessing instructions, the FDA in 2016 deemed the duodenoscopes safe for healthcare facilities to use again.

The FDA stated in today’s news release that since then it has been working with the manufacturers to “modify and validate their reprocessing instructions to further enhance the safety margin of their devices,” and “show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.”

Specifically, the FDA asked that Pentax reduce the potential for leakage of patient fluids into ED-3490TK’s closed elevator channel and under the distal cap.

Now that Pentax has done this, the FDA recommends that facilities acknowledge their Urgent Medical Device Correction and Removal notification disclaimer icon and identify affected products, return the field correction response form, and indicate if they do not have any affected duodenoscopes or operations manuals, and remove and dispose of older operations manuals once the new ones are received.

For more information on today’s news, check out the FDA’s official release here.

Sterile matters: Consider stretch goals to push beyond comfort zone

By: May 31st, 2011 Email This Post Print This Post

Stretch goals, a new trendy phrase,  have a lot merit, in my opinion.

Goals are sometimes too lofty, but in today’s challenging times within healthcare, we need a new way to concourse tough circumstances. Stretch goals just might be part of the answer.

All too often we either do not set our goals high enough, or they are set in a way to not ever be truly attainable.

Stretch goals are different and very relevant outside of the traditional business world. With healthcare currently mired in challenging circumstances, new types of goals and how we approach them is needed. They can help to combat the lack of tangible resources for less obvious skills deficits from people in critical roles and anything that can be imagined in-between these two that are plaguing our facilities.

You might be asking yourself just what stretch goals are and how you can create them?

Simply, they are goals that push a person (or an organization) to move beyond their comfort zone, but not so far that they become impossible to reach. Too often many want to either coast through the day or achieve the near impossible.

To secure great results, overall, lots of smaller successes are usually needed. It is then that a person or a group has a good foundation to build toward arger and more rewarding outcomes and wins.

Remember, creating a workplace, designing a ultimate endpoint, doesn’t happen instantly. The more individual pieces of the whole that begin to align, through stretching slightly past your comfort level, the more you are augmenting your skills and becoming a better asset to your organization. That is exactly when real successes become possible.

Sterile Matters: Systems thinking in healthcare

By: March 1st, 2011 Email This Post Print This Post

Healthcare entities are complex entities. They are comprised of numerous departments that can be dependent on another. This requires a unique approach to its operational execution. It requires management to help ensure business is conducted in fashion that ensures all of its interdependent units are working well both independently and jointly. It requires “systems thinking.”

Often departments, especially more technical in nature, tend to work in near isolation. This causes several concerns:

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Sterile matters: When a technician just isn’t making it

By: February 2nd, 2011 Email This Post Print This Post

Talent selection is difficult for most managers. It is an extremely important when the employed talent has the ability to cause harm to another by the quality, or lack of it, of their work. Sometimes the right fit for an organization or a particular department is not known until the employee has been apart of the team for a bit of time. Regardless, when the fit does not work or no longer works the situation must be handled. However, handling it can be tricky, but not impossible.

While there are multiple types of employees of poor or under performers, we are going to discuss just two: the wrong new hire and the once productive and now under/poor performer. Before you sever ties consider your circumstances and evaluate your options:

  • For the new hire, was your orientation program robust enough? Did you have the right type of training matched to your new hire? Was their role clearly defined and initial expected tasks expressed well? If not, is there time and internal skill to re-group and begin the process of orientation over?
  • For your seasoned member, what other factors could be contributing to their decreased performance? Have you objectively discussed the work performance change with this associate?

Have you documented your coaching and counseling sessions which should include three points:

  1. What the issue is?
  2. What is the expectation?
  3. Guidance for success.

Without these three elements, it really cannot be considered a coaching or counseling session.

There will be potentially many reasons as to why a technician may be under performing. Getting to the root of the issue is important. While it may not completely solve the issue, it is a good first start. Once you know why, it becomes a bit easy to try to overcome. However, if no attempts work, counseling and coaching remain ineffective, and then it might be important to consider alternatives.

Patients deserve the best care and this includes maintaining competent staff members that support direct patient care. Without it our patients really are not getting the best service possible.

Sterile Matters: Training material considerations

By: December 22nd, 2010 Email This Post Print This Post

In my last Sterile Matters I discussed the necessities of training. For this post, I am focusing on developing training tools.

Creating tools for training may initially seem like a daunting task for some. However, I have a few suggestions that might help to make the process a bit easier for you.

Some considerations to keep in mind before you begin to develop your tools:

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Study: Gloves most important in C. diff infection control

By: November 18th, 2010 Email This Post Print This Post

Researchers at the Washington University School of Medicine, St. Louis, MO, have discovered that by using personal protective equipment (PPE), specifically gloves, workers can help eliminate hospital acquired infections while handling patients infected with Clostridium difficile infection (CDI).

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Sterile Matters: Training is not optional

By: November 2nd, 2010 Email This Post Print This Post

Of the topics that we could discuss for “Sterile Matter,” training might just be one of the most important to highlight. Training is different than education. For this month, I would like to focus on the necessities of training for a few reasons:

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Sterile Matters: Scoping out endoscope challenges

By: October 8th, 2010 Email This Post Print This Post

There have been many reports of healthcare facilities having to notify patients to get tested for diseases such as hepatitis B and C and HIV because potentially contaminated devices used in procedures. Many times these incidents involve endoscopes.

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Sterile matters: Keeping your fingers free from needlesticks and other sharps

By: August 30th, 2010 Email This Post Print This Post

We all know the basics, from no re-capping of needles to using puncture proof/sharps approved biohazard disposal boxes. However, what about all of the other ways healthcare workers become stuck, punctured, cut, and otherwise exposed to used sharps?

It happens and it can happen to you or your workers.

Preventing needle sticks and other types of sharps injuries begins with the basics and a few reminders:

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Sterile matters: Keep your lungs happy using chemicals

By: August 12th, 2010 Email This Post Print This Post

Every day healthcare workers have the potential of becoming exposed to chemical vapors. Depending on the type of chemical, concentration, ventilation, length of exposure, and task  affects the severity of risk and/or injury to the workers, patients, visitors or yourself. This is nothing to take lightly.

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Sterile matters: A little more of this or that does not really help you, even if you think it smells cleaner

By: July 9th, 2010 Email This Post Print This Post

The saying “more isn’t always better” is true in the case of detergents and disinfectants. Cleaning solutions are not all the same. They have different purposes and require different application techniques. Failure to follow the exact manufacturers’ instructions not only potentially reduces the efficacy of the solution, but it also may be harmful.

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Sterile matters: No, you can’t just rinse it under a little tap water without gloves

By: June 8th, 2010 Email This Post Print This Post

The word “contamination” can be misleading for anyone not specifically trained in “sterile processing.” If something does not look grossly soiled after use on a patient, proper techniques can go by the wayside. This places the worker and the next patient in potential harm’s way.

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