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Advances in Medical Device Sterilization

How and Why Healthcare Professionals are Adapting the Way They Care for Their Equipment 

All medical devices require sterilization between use:

Unfortunately for patients, not all medical devices receive adequate sterilization before they are used. Improper sterilization of medical devices, scopes and equipment can spread potentially life-threatening infections in hospitals and medical facilities. More recently, there have been reports of improperly sterilized medical equipment in outpatient facilities, clinics and doctor’s offices. In other words, the health risks associated with infections from improperly sterilized and cleaned medical devices extend well beyond the traditional hospital environment.

As a result of the roughly 1.7 million cases of healthcare associated infections, there is a cost of around $20 billion per year, and more importantly, nearly 100,000 deaths. CDC interventions and guidelines implemented throughout 103 ICUs and 67 hospitals resulted in a 66{86fff9176df7dae354d5829d6a21a9cac1dae155d05f447306f9bfa827f3a396} reduction in infections though an 18 month period. One major result of negligence in the medical field is improper sterilization methods or tools, leading to completely avoidable and unjustifiable patient deaths.

Two of the most common devices that require sterilization are endoscopes and duodenoscopes.



An endoscope is a flexible tube with a camera which is illuminated in order to take images deep within the body and to aid in a nonsurgical procedure known as endoscopy. Doctors then have the ability to view these images of the digestive tract on a TV monitor.


Similar to endoscopes, duodenoscopes are flexible, lighted tubes that are inserted through the mouth, throat, and stomach into the top of the small intestine (duodenum), instead of being inserted through the rectum like endoscopes. These devices are used in procedures called upper gastrointestinal endoscopies (UGI), which allow a doctor to analyze the linings of the esophagus, stomach, and the first part of the small intestine also known as the duodenum.

Duodenoscopes also take part in over 500,000 procedures, called endoscopic retrograde cholangiopancreatography (ERCP), per year. These ERCPs combine UGIs and x rays to treat problems of the bile and pancreatic ducts, serving to be the least invasive way of draining fluids from the pancreatic and biliary ducts resulting from tumors, as well as gallstones and other ailments. Due to the more specialized nature of the duodenoscopes, they are more complex and can be more difficult to disinfect and clean between uses.

What is Medical Device Sterilization?

In order to provide a safe environment for patients, it is important that healthcare professionals follow strict guidelines for medical device sterilization. Through the use of various techniques such as radiation, chemicals and heat, devices are sterilized in order to kill disease-causing microorganisms and eliminate transmissible bacteria and spores.

Most devices manufactured today are constructed to be able to undergo steam sterilization methods. Plastic instruments require low temperature sterilization methods, which has resulted in an increase in the prevalence of such systems in the healthcare industry. Due to the effectiveness of steam sterilization, it remains among the most widely utilized methods; steam sterilization is relatively inexpensive, effective in treating fabrics, and is microbicidal and sporicidal.

There are three tiers of decontamination and their necessity depends on the function of the particular device. The levels of decontamination are cleaning, disinfection, and sterilization.  

As a general rule, instruments which enter the body must be sterilized. Scalpels, hypodermic needles, and artificial pacemakers are examples of devices which require this level of decontamination.

A History of Sterilization:

The history of antiseptics goes back as far as the ancient Egyptians, who would use pitch, tar, and resins in their embalming processes. In 1450 BC, Moses was said to use purification by fire. The Greek infantry would sometimes battle in the nude, knowing that pieces of clothing could cause infections if caught in wounds. During the middle ages from 900 to 1500 AD, sterilization and antiseptic development was virtually nonexistent, as the plague devastated Europe. As science and technology grew more advanced, so too did mankind’s knowledge of disease and infection. With this realization, new methods of sterilization were invented and helped usher in a new age of medicine.

What Techniques are Used for Medical Device Sterilization?

Autoclave/Steam– Autoclaves use steam sterilization technology leveraged with intense heat and pressure to sterilize equipment and supplies. Using temperatures of around 132 degrees Celsius or 270 degrees Fahrenheit, these autoclaves sterilize equipment for up to twenty minutes. The steam is advantageous in killing bacteria and microbes that simply boiling water or using chemicals fail to do.

Flash– Flash sterilization is used when the device cannot be sterilized or packaged safely prior to patient use. This is a rapid form of steam sterilization which can be used on unwrapped devices for around three minutes.

Dry heat– The use of dry heat sterilization causes the denaturation of proteins in organisms, drying of cells and incineration of bacteria and microbes. This method relies on dry heat instead of moisture to achieve sterilization effects.  

Radiation– Gamma radiation is the most common form of radiation sterilization. This process destroys many types of microbial cells, making it a very effective method for medical devices. Radiation is used widely in the sterilization of metallic medical devices such as scalpels, due to their simple designs which cannot be damaged by the process.

Why Medical Device Sterilization is Important:

It might seem obvious, but when patient safety is at risk, it is incredibly important to stress the issue of medical device sterilization. There are many medical facilities that have had equipment sterilization issues and a large percent discovered these problems when patients contracted infections and became ill. While the solutions to the problem of improper sterilization are certainly not easy to implement, they are critical.

In healthcare locations there is actually a history of noncompliance with medical device sterilization methods, leading to unnecessary infections and even patient deaths. In 2016, the average rate of noncompliance was around 50{86fff9176df7dae354d5829d6a21a9cac1dae155d05f447306f9bfa827f3a396} between several settings. Hospitals were at 51{86fff9176df7dae354d5829d6a21a9cac1dae155d05f447306f9bfa827f3a396} noncompliance, Critical access hospitals were at 58{86fff9176df7dae354d5829d6a21a9cac1dae155d05f447306f9bfa827f3a396}, Ambulances 43{86fff9176df7dae354d5829d6a21a9cac1dae155d05f447306f9bfa827f3a396} and office based surgical settings were 53{86fff9176df7dae354d5829d6a21a9cac1dae155d05f447306f9bfa827f3a396}.

For businesses in the healthcare field, public realization of these rates could prove to be a logistical nightmare. Aside from the bad publicity and loss of business associated with the rates themselves, there are many safety issues which are highly likely. Patients are at a significantly higher risk of infection and the potential for outbreaks of infection within a localized area is increased. Other consequences include loss of Joint Commision and Centers for Medicare & Medicaid Services accreditation and status.

So how do healthcare practitioners combat this epidemic of improper sterilization? By leveraging the right combination of people, procedure and technology, hospitals and medical facilities can dramatically reduce or eliminate equipment sterilization problems.

The problems with Using Traditional Brushes for Sterilization:

  • Insert Molded Tips: Insert Molded Tips are made by placing the end of a twisted wire brush into an injection mold. Problems with injection molded brush tips include:

Detachment: The tip can fall off the twisted wire brush, causing scratching, poking and scarring.

Protrusion: The core wire might protrude through the plastic surface which can cause scratching, poking and scarring.

Orientation: The tip orientation can be inconsistent.

Expense: The manufacturing process is expensive, requiring costly molds and prolonged development time.

  • Light Cured Acrylic Tips: Light Cured Acrylic Tips are another traditional type of protective brush tip. They are made by dipping the end of a twisted wire brush into plastic or acrylic and using ultraviolet light to cure the substance into a tip.

Protrusion: The core wire can protrude through the acrylic surface which may cause scratching, poking and scarring.

Rough surface: The surface texture might be rough.

Inconsistency: Tip dimensions can be inconsistent.

Petroleum-based: The manufacturing process involves hazardous fumes, extended curing times and is petroleum-based.

  • Hand Crimped Tip Brushes: An old but still popular type of protective brush tip is the Hand Crimped Tip. These are made by pressing small metal caps onto twisted wire brushes by hand. Although an initial look at these brushes may make them seem like a good fit for medical device sterilization, the process in which they are produced actually contains inherent flaws which can create major safety problems. Hand Crimped Brush Tips have issues such as detachment, orientation inconsistencies, and high expenses compared to similar products.

Detachment: The tip can fall off the twisted wire brush and cause scratching, poking and scarring.

Orientation: Due to the manual process, the placement of the tip on the twisted wire brush may be inconsistent.

Expense: This is a manual and expensive manufacturing process.

  • Fan Tipped Brushes:The Fan Tipped Brush is one of the original attempts at creating protective brush tips, and it is still used today. This is a brush where the bristles are “fanned” to provide aimal level of protection. These brushes have several serious problems…

Inadequate Protection: The fanned bristles are simply not adequate protection from scratching, poking and scarring.

Wire Exposure: The core wire can easily become exposed.

Limitations: Fan tips cannot be made in all diameters commonly needed for medical twisted wire brush applications.

New Twisted Wire Brushes for Medical Device Cleaning Solve these Problems:

The largest risk for medical equipment damage can occur during cleaning with a brush that is inserted into the equipment. Traditional brush tips can fall off, sharp core wires can protrude from the tip, and the tips can bend and break. Twisted wire brush manufacturer Sanderson MacLeod solved these problems by looking outside of the brush industry and collaborating with experts in materials joining engineering. Their engineering team conducted hundreds of hours of research, trials, and testing to create a new manufacturing process that uses high-energy, fusion-welding technologies. The result is an entirely new protective brush tip that melts the brush’s preconstructed core wire into a consistent, smooth, and inseparable protective tip, known as the Z-Tip.

In addition to this innovative design, Sanderson produced a brush tip with a mirror-like smooth surface, so the tip can’t fall off, the core wire won’t protrude through the tip, and the dimensions and orientation are always consistent. The Z-Tip twisted wire medical brush is created in one in-line, fully automated process, which reduces internal inspection time and costs.

The most important aspect of the Z-Tip is that it will not create microscopic scars while cleaning medical equipment. By preventing the scars that trap contaminants, the Z-Tip promotes medical equipment sterility. The Z-Tip is available for all commonly used twisted wire medical brush applications.

In Q4 of 2018, the classic Z-Tip design was augmented with a new feature aimed at providing individualized color coding systems. Introducing the Z-Tip+, which gives you all of the amazing qualities of the Z-Tip, combined with the ability to color-identify specific brushes for certain applications. By color-coding the tips, you’ll save time, reduce brush selection errors, and gain efficiencies in device cleaning.

Inseparable Protection Like You’ve Never Seen Before

Antimicrobial Brush Fibers:

Also currently being utilized by Sanderson MacLeod are brush fibers which have inherent antimicrobial properties. These brush fibers can prevent the growth of bacteria and reduce the risk of product contamination during the life cycle of the brush. By maintaining an antimicrobial brush, devices being cleaned will not be introduced to foreign contaminants during the cleaning process.

By using antimicrobial fibers, endoscope cleaning brushes may have increased protection from microbial contamination that could present a health risk to the patient. Further, using antimicrobial brushes can help assure that cell samples collected from patients have a reduced risk of contamination, leading to more accurate examination results.

As Mark N. Borsari, President of Sanderson MacLeod recently stated, “The medical industry is being more and more scrutinized in terms of how they’re taking care of their patients, making sure that their equipment is lasting longer. People are realizing that small things such as antimicrobial cleaning brushes do lead to major positive impacts for the patient.”

The Future of Medical Device Sterilization:

Sterilization of medical devices is an increasingly difficult task. Development of new and more complex devices demand more and more intricate methods of sterilization which can effectively clean and sterilize these new devices without damaging or compromising their integrity. New devices require ingenious methods of sterilization due to their incorporation of circuit boards, temperature sensitive materials and drug-device fusing technology.

Another factor which can affect the proper sterilization of devices is the significant cost of several of these methods. Although necessary for several devices, methods such as radiation and autoclave sterilization are very costly and can prove to be too expensive to effectively implement in certain situations. As the healthcare industry is placed farther under the microscope, medical professionals must seek to adapt and improve their current methods of sterilization.