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When it comes to the medical field, everyone is searching for those ‘silver bullet’ solutions that offer repeatable, consistent success and reduces operating expenses. Some of the most expensive tools and procedures are often the most conclusive when it comes to diagnosis. No one wants to accept a drop in performance, so the search for reusable medical devices continues. The most significant hurdle in this field of research is finding ways to reduce the infection risk, but the FDA and federal government believe they might have found a new solution in disposable caps for duodenoscopes.

 

What is a Duodenoscope and Why do They present an Infection Risk?

A duodenoscope is a flexible, lighted tube that is used to thread into the mouth, down the throat, into the stomach, and into the top of the small intestine. These tubes are used during a procedure called endoscopic retrograde cholangiopancreatography (ERCP). ERCP is a potentially life-saving treatment used to diagnose and treat issues in the pancreas and bile ducts. In the United States alone, there are more than 500,000 of these performed every year.

Because of the route these tubes travel, they prevent a high risk of infection even when they are cleaned before reuse. To someone with a compromised immune system, an infection from a procedure like this could become fatal. Duodenoscopes are complicated instruments and have many tiny moving parts. This makes it difficult to clean and guarantee disinfection.

 

What is the FDA Doing to Address this Public Health Risk?

The food and drug administration (FDA) takes infection control extremely seriously and has ordered multiple studies across the entire industry to figure out how widespread sources of infection like this are and how they can be addressed. If not thoroughly cleaned, duodenoscopes can spread infection from one patient to another.

In the fall of 2013, the CDC released findings that there was a likely connection between a multi-drug resistant form of bacteria and duodenoscopes. Upon investigation, the FDA discovered that these infections were occurring even when the proper cleaning and sterilization regulations were being followed.  

To address these dangers, the FDA has looked for new ways of making the cleaning process more thorough and easier to perform. In 2017, they cleared the first of a new approach to the sterilization process: disposable distal caps for duodenoscopes. The motivation for these new caps is to provide easier access for in-depth cleaning and reprocessing.

“We believe the new disposable distal caps represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, MD, acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health.

If the disposable caps prove effective, the philosophy behind them could be used to help clean other scope medical devices. These new caps are just one phase of the FDA’s efforts to reduce the risk of infection. Representatives from multiple health care facilities have met and implemented other strategies including:

  • Microbiological culturing
  • Further sterilization
  • A liquid chemical sterilant processing system
  • Repeat high-level disinfection

 

To learn more about the infection control efforts of the FDA and the advances in disposal medical technology, reach out to Remington Medical today.  

 

A bronchoscopy procedure is an endoscopic technique for examining the inner airways of a patient. It is performed for both therapeutic and diagnostic purposes. It involves a thin tube, a bronchoscope, being inserted through the nose or mouth and being fed down the throat into the lungs.

A procedure like this is typically performed to try and find the cause for an issue with the lungs, like a persistent cough or abnormal chest X-ray. This procedure typically has very few complications and, if they do occur, they are usually minor. Symptoms like difficulty swallowing, minor bleeding and fever are common. One of the primary concerns in this type of endoscopy is the risk of infection, and that is what a new study has addressed.

 

Are Single-Use Bronchoscopes Better Than the Reusable Alternative?

There was a recent study conducted and funded by 3M Company and supported by Healthmark Industries, that tried to assess the cleanliness level of reusable bronchoscopes after they had been cleaned and disinfected. The results of this study are especially vital to note because of the type of patient most often undergoing endoscopy procedures. By and large, patients having this procedure are already at high risk of infection from factors including:

  • Organ Transplant Status
  • Existing Critical Illness
  • Chronic Diseases
  • Immune-Suppression due to Malignancy

These risk factors make cleanliness and sterilization one of the primary concerns for any diagnosis or treatment tools. It was previously believed that reusable bronchoscopes would be more cost-effective since they could be sterilized and reused. However, this new study has shown a flaw in this strategy.

 

How Were These Bronchoscopes Tested?

This particular study was conducted across three large hospitals in the United States, which included two transplant centers. The researchers assessed 24 clinically used flexible tube bronchoscopes after they had been used and cleaned according to each facility’s methods and practices. The study found that all of the bronchoscopes were still contaminated in some way. They found signs of:

  • Retained Fluid
  • Brown, Red, or Oily Residue
  • Scratches
  • Damaged Insertion Tubes and Distal Ends
  • Filamentous Debris
  • Microbial growth, Including Mold
  • Stenotrophomonas Maltophilia
  • Escherichia Coli/Shigella

It was determined that two out of the three hospitals were using substandard reprocessing methods. However, even when strict guidelines were followed, the high-level disinfection was still not achieved. The results of the study recommended an update in quality management and reprocessing guidelines at all of the testing sites.  

 

Is Single-Use More Cost Effective than Cleaning Reusables?

One recommended, innovative solution for this issue is to simply switch to using single-use plastic bronchoscopes rather than continue to try and sterilize the reusables. According to a 2017 study, it is estimated that reusable bronchoscopes cost $424, and present a 0.7% chance of infection. While single-use technology requires on average $305 and shows a 0.0% risk of infection.

 

Reusing flexible endoscopes comes with costly hurdles like reprocessing and repairs. Since 2010, there have been steps forward in disposable bronchoscopes, and they have been through multiple generational stages. Each generation came with upgrades to the technology.

  • The 2nd generation was optimized for intubating.
  • The 3rd generation was focused on bedside bronchoscopy, had a suction channel, and came in three sizes; large, regular, and slim.
  • The 4th generation came with better image quality and a more durable design.   

 

To learn more about studies like this and other steps forward in medical device safety, look to Remington Medical. We have been invested in the disposable medical device industry since 1992.     

 

The good news is that the medical device manufacturing industry is on the rise. There is a steady and dependable demand for products across the country. The bad news is that this industry is still faced with a set of hurdles that will likely cause setbacks for those that are unprepared. It is challenging to stay informed on all of the advances and trends going on in MedTech today, but if you can stay up-to-date, you and your business will be much more prepared for the future when it comes.

 

MedTech Manufacturing Trends Of 2018

  • Workforce Issues: As we said before, the manufacturing industry is tracking some positive upward growth. However, this multi-billion dollar field is also seeing some workforce issues. In the past, manufacturers were looking for specialized talent that had at least three years of under their belts.

    Today, thanks to a labor shortage, manufacturers have found value in hiring entry-level workers with potential and offering the training they need to become medical device assemblers. This trend has shown that sometimes we must rethink the business model of hiring and training.
  • Competitive Wages: One of the advantages the manufacturing business has long held over other markets is their higher pay scale. The unfortunate news for the medical technology manufacturing sector is that other markets like retail and food service have started to raise their minimum wage. Prospective employees are now heading towards retail and restaurant work because they can make similar wages with a flexible work schedule. This trend is forcing manufacturers to offer more competitive wages across the board.
  • MedTech’s Unique Needs: The medical equipment industry is driven by innovation. As soon as a new product hits the market and is successful, the demand for it can skyrocket quickly. There is a built-in demand for new products and services while they are still in the manufacturing process. This has forced manufacturers to examine their supply chain and find the most efficient ways of assembling raw materials and getting their products in the hands of their customers. We must find ways to maintain quality and ramp up production.
  • The Era Of Automation: The process of manufacturing products is becoming increasingly automated in many sectors. One might think this is eliminating the need for a robust workforce, but the truth is that it is altering the type of workers that manufacturers are looking for. This digital transformation and machine learning mean that manufacturing jobs are becoming more tech skill-based. Employers are now looking for people with the ability to run, operate, and troubleshoot computer-directed machinery.
  • Challenging Regulations: There is a shifting tide of strict regulations across the globe that are affecting manufacturers here in the U.S. In previous years, manufacturers would first launch a product in European countries where the regulations were less strict. This would allow them to collect evidence to support the eventual approval by the Food and Drug Administration.

    Today, Europe is raising the standards of their regulations and putting one more hurdle in the path of manufacturers. The solution has been for manufacturers to hire auditors whose sole job is to keep up with regulatory standards and keep their programs on track.
  • Untapped Potential: The manufacturing industry is finally turning to one of their most untapped pools of talent: women. Aerotek reports that women make up about 47% of the U.S. workforce, but only 29% of the manufacturing labor force. Manufacturers are realizing that they can’t expect to find all of the talent they need in only 50% of the population. This has caused the manufacturing sector to increase their outreach to women to fill roles throughout the industry.
  • Veteran Experience: Another pool of talent that has been overlooked in the past are military veterans. Hundreds of thousands of service members are transitioning out of the service every year, and they are all looking for employment. These veterans even come with skill sets that are well-suited to the manufacturing industry. They are used to working in a team environment and have experience in service areas like logistics. Service members could be the workforce that comes to the rescue for the manufacturing industry.

 

To learn more about the medical device sector and what Remington Medical has to offer, contact us today.      

 

MedTech outsourcers are feeling an increasing amount of pressure to deliver reliable, cost-reducing solutions for their customers while still maintaining positive business outcomes. This tension means that these outsourcers must find alternative sources for the traditional products that we need. They need a way to produce equal or greater performance at lower costs. This mission is a tall order for much of the medical device manufacturing community.

 

What Is Cold Forming?

The cold forming process involves a technique where the application of force with a punch to a metal blank staged in a die. The force of the punch exceeds the alloy’s elastic limit which causes the plastic to flow until the metal blank assumes the shape bound by the punch and the die. One of the benefits of this process is that it does not damage the original metallurgical structure of the raw material as other methods do. In fact, the result of this process is stronger formed parts.

This is not a ground-breaking new method. It has been around for many years, but it has been overlooked for some time. Due to its low visibility in the industry, cold forming has largely been ignored by medical device companies. In this blog, we are going to discuss a handful of the reasons that MedTech outsources should start to consider cold forging as an effective alternative.   

 

The Advantages Of Cold Forming

  • Cost Savings: No matter what industry you operate in, the cost of production must be considered as the main priority. One of the most significant factors in favor of cold forming is that fact that it basically eliminates scrap or wasted materials. This forming process compresses the raw material rather than removing the excess. Getting rid of wasted materials cuts back on the costs of energy, labor, and recycling.  
  • Dependable Supply: Cold forming machines are able to run 24/7, and only one operator can manage multiple machines at the same time. This means that there are rarely any issues with meeting the demands of back orders or late deliveries. Your supply chain will run smoothly and be able to adapt to increased demands quickly.
  • Clean Operation: Very little lubricating oil is needed in the cold forming process. This makes the machines easier to clean and upkeep less extensive. The forming process itself creates less waste than most alternatives as well. All of this also means that cold forming is a more eco-friendly process.
  • Increased Durability: As we’ve explained before, the process of cold forming compresses the raw material which increases the tensile strength of the product. Many consumables in the healthcare industry require durability for their use, and this process delivers a stronger overall product.

 

The Other Possible Solutions

There are several possible solutions to this issue. Each one has its benefits, but in this blog, we have focused primarily on one possible solution. We still believe it is appropriate to mention some of the alternatives:

  • Screw machining is a resource in the medical device industry that delivers high-quality, repeatable, and tight-tolerance products.
  • Additive manufacturing like metal injection molding or 3D printing is also another possibility.
  • Cold forming is an often overlooked possibility that offers several advantages and is the topic we focused on today.

The Final Verdict On Cold Forming

The motivation behind this blog is to promote all of the advantages of cold forming in the medical device industry. Our goal is to offer possible new product design alternatives to engineers in the world of outsourced manufacturing. Despite all of its benefits, cold forming has often been overlooked. This technique could be used to lower costs, reduce waste, enhance product yield, and raise quality.


To learn more about cold forming and the process behind other medical device manufacturing methods, reach out to Remington Medical today.