Tag Archive for: medical innovations

Will Disposable Caps Solve Dirty Scope Problem?

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.  

 

Breathe Easier with Single-Use Bronchoscopes.

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.     

 

4 Reasons MedTech Outsourcers Should Look Closer At Cold Forming

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.

 

Discovering the Top 10 Medical Innovations for 2018

The top 10 medical innovations for 2018 were revealed at the [Cleveland Clinic’s Medical Innovation Summit] on October 23-25, 2017. It was the climax of the summit. This list was put together by a panel of Cleveland Clinic scientists and physicians overseen by Chief Wellness Officer Michael Roizen, MD. These are medical advances that will change healthcare across the world for 2018 and years to come. They were announced in order of expected impact.

1. Hybrid Closed-Loop Insulin Delivery System

Diabetes is one of the most common diseases in America today.  According to the American Diabetes Association, roughly 1.25 Americans already have Type 1 diabetes. This new innovation has been called the world’s first artificial pancreas. The hybrid closed-loop insulin delivery system can make dealing with Type 1 diabetes easier.

  •  1.5 million Americans are diagnosed with diabetes every year (American Diabetes Association).

 This new invention was approved by the FDA in 2016. It allows for direct contact between the ongoing glucose monitoring device and insulin pump to maintain blood glucose at a level never before seen. The technology takes over for the old “open loop” method. That practice required patients to use data from their own ongoing glucose monitor to figure out how much insulin to inject themselves with.  

 

2. Neuromodulation to Remedy Obstructive Sleep Apnea

The most common sleep disturbance across the board is sleep apnea. It is known to advance high blood pressure and the risk of heart disease or stroke. The CPAP device or, continuous positive airway pressure device, is the most well-known treatment for this ailment. However, over 40 percent of sleep apnea sufferers refuse to use it.

  • Sleep Apnea affects over 20 million Americans every night.

This latest innovation has created something subtler. It is an implant that will provide direct stimulation to open key airway muscles during slumber. This implant is operated by remote or a wearable patch and acts as a pacemaker of sorts. It uses a breathing sensor and battery-powered stimulation lead. They help to sync air intake with the action of the tongue. In clinical testing, these neuromodulation systems have shown encouraging results. Physicians hope this will mean a better night’s sleep for patients and their partners.

 

3. Gene Therapy for Inherited Retinal Diseases

Inherited retinal diseases are a group of rare blinding diseases. They are caused by genes passed down from family members. They can result in degrees of vision loss or total blindness. This year, the FDA is expected to approve a new treatment for inherited retinal diseases. It is a cutting edge new gene therapy that will deposit a new gene to targeted cells by viral “vectors.” This therapy proposes to treat conditions like congenital amaurosis and retinitis pigmentosa.

  • These rare genetic mutations currently have no FDA-approved treatments.

 This new therapy deposits a “normal” copy of the gene that results in a functioning protein. Scientists place this gene in a custom virus and this “vector” brings it to the retinal cells. In 2017, the FDA gave this treatment orphan drug status. Then a panel of U.S. health advisors recently advised its approval. Experts believe this approval could lead to orphan drug and breakthrough status for more gene therapies.  

 

4. A Never Before Seen Decline in LDL Cholesterol

Often called “bad” cholesterol, LDL, or low-density lipoprotein is the cause for fatty collections that can block arteries. Via a new course of medications, we have seen LDL levels drop by as much as 75 percent.

  • There are 400,000 coronary deaths every year and 102 million Americans affected by high cholesterol.

Studies have shown a 20 percent drop in risk of stroke, cardiovascular death, or myocardial infarction. Those patients took statins and a new class of cholesterol-lowering drugs (PCSK9 inhibitors) to discover these drastic levels of LDL reduction.

 

5. Creation of Distance Health Services

 Shrinking the distance between patient and doctor is always a prime concern of the medical industry. Removing hurdles means faster and more effective treatments. This helps provide the optimal outcome along with cost-effective savings.

 The world has seen a huge increase in mobile devices. Hospitals are preparing to enact distance health services in 2018. More and more patients have attachable mobile devices. These are able to relate medical information to doctors monitoring their condition from a distance.

  •  19 million people are expected to use remote monitoring devices in 2018.

 This new innovation could be world changing for patients that are physically challenged or are weak to infection.

 

6. Next-Gen Vaccine Platform

With our modern outbreaks of Zika and Ebola, it has become crucial to speed up the process of vaccine development. Vaccines and their treatment course are vital to stopping an epidemic before they start. Industry experts are now working to upgrade our entire vaccine infrastructure.

  • One vaccine can take $200 million and at least 10 years to develop.

They are developing practices that will allow us to produce new vaccines faster. They are also working on better delivery systems for vaccinations to huge populations. Experts are finding new ways to hone the practice of freeze-drying vaccines for shipping to remote locations.

 Companies are using things like tobacco plants and insects to construct new flu vaccines. There are cutting edge oral and edible vaccines being developed. As well as, intranasal vaccines and vaccine chips. With all of these new treatments and practices, we hope to be able to fight off current and new epidemics.

 

7. Targeted Breast Cancer Therapies

 Innovators are building a whole slew of new targeted therapies to treat breast cancer. We are seeing positive outcomes from PARP inhibitors for patients with BRCA1 and BRCA2 mutations. As well as, novel CDK 4/6 inhibitors for ER-Positive/HER-2-negative breast cancer.

  •  Breast cancer kills more than 40,000 American women every year.

 Innovative HER-2 targeted agents are also showing good signs in a subgroup of HER-2 positive patients. Scientists hope that these results will lead to higher survival rates possibly even leading to the end of chemo treatments for many breast cancer patients.

 

8. Improved Surgery Recovery

We all know the rule about not eating before a surgery and long-term bed rest during recovery. Well, all of that is now changing. The nationwide opioid epidemic and rise in hospital revisits has made healthcare experts rethink the old way of doing things. Recent research shows us that an Enhanced Recovery After Surgery, or ERAS, protocol can make a big difference.  

  •  ERAS can reduce blood clots, nausea, hospital stay, and speed up recovery. 

 This new protocol encourages movement post-surgery. It allows patients to eat before surgery and limits the use of opioids. Hospitals are now leaning towards alternative medications instead of the standard use of opioids. Experts have seen that these new processes can even reduce post-surgery complications. 

 

9. Centralized Monitoring of Hospital Patients

 When nurses and doctors have been on-call for long hours on end, they can often become too used to the constant noise. It’s called “alarm fatigue” and it can cause important warning signs to be missed. Studies show that nearly 45 percent of inpatient cardiac arrests are not marked properly.

  • According to the American Heart Association, fewer than one in four patients will survive an in-hospital cardiac arrest. 

 The answer to this challenge is centralized monitoring. It means that personnel who are off-site will monitor certain patient vitals. Blood pressure, heart rate, respiration, and more could all be watched off-site. All of this data is then combined to then trigger on-site actions. These off-site experts will filter out the trivial noises.

 

10. Scalp Cooling for the Reduction of Chemotherapy-Related Hair Loss

 Hair loss might seem like small potatoes compared to some of the other illnesses talked about here. However, the psychological well-being of a patient undergoing any treatment can have a profound impact on their outcome. Patient comfort is also a key part of treatment.

  •  According to pharmacytimes.com, at least 65% of chemo patients will suffer hair loss. 

 This new method is called “scalp cooling.” It reduces the temp of the scalp by several degrees. This is done directly before, during and after a chemo treatment. It has been shown to be very effective, specifically for female patients undergoing chemo for early stage breast cancer. This method was approved by the FDA in May of 2017.

 

For more information about the top 10 innovations for 2018, check out [Cleveland Clinic’s ConsultQD] page.