Autoclaving and Sterilization are two processes that are used to sterilize medical devices. Both are safe processes, but there are some differences that need to be considered.
What are the Benefits of Steam Sterilization?
Steam sterilization is the most common method used in hospitals and other healthcare facilities to kill microorganisms. The process involves steam at a specific temperature, time and pressure. Sterilisation is performed in a variety of ways, including a flash cycle, pre-vacuum, a steam-air mix cycle, and specialty cycles.
In addition to the traditional process of sterilizing reusable medical devices, there are now specialty cycles that include longer cycles at lower temperatures. These are designed to ensure complete sterilization of delicate goods.
In order to monitor the performance of the sterilizer, various indicators are used. These include biological and chemical monitors. Biological indicators are typically affixed to the outside of the sterilizer pack. Their presence indicates that the autoclave process was adequate for microbial inactivation. Chemical indicators, on the other hand, are used to monitor time and temperature.
A logistic regression model was used to examine the relationship between the steam sterilization cycles’ effectiveness and the hospital variables. Variables that were examined included the type of autoclave, the length of the holding period, and the chemical and biological test results.
There was a significant association between the type of autoclave and the failure rate. It is not clear why. However, it is possible that the non-vacuum type autoclaves were not effective in dislodging air from the items.
Overall, fewer than half of the steam sterilization cycles reached 15 psi. This is the minimum pressure needed to achieve a sterilization temperature of 121 degC.
When a temperature sensitive tape indicator was exposed to 121 degC, it would change color. If this indicator was not visible, the item had not been sterilized. As a result, the waste load was decontaminated.
Biological indicators are more accurate than chemical indicators. They indicate that the sterilizer is able to kill resistant bacteria.
In this study, 189 steam sterilization cycles were evaluated for their effectiveness. Using biological and chemical indicators, the proportion of cycles that achieved a positive result ranged from 0% to 100%.
The study indicated that steam sterilization processes in Nepal need to be improved. A higher proportion of failures showed that there were a high number of non-sterile instruments. Changing practices could potentially reduce the burden of HAIs in hospitals.
What is Gamma or E-beam Radiation for Sterilization?
During autoclaving and sterilization, medical device manufacturers should be familiar with the effects of Gamma or E-beam radiation on plastics. The effects vary depending on the material. If used correctly, these radiation processes can result in the optimum functionality of the medical devices.
During the process, the polymer chains rearrange to create high crystallinity. This results in a reduction in molecular weight. In addition, the enthalpy of fusion changes. Because of this effect, the polymer can increase in biodegradability.
E-beam sterilization has several advantages over gamma irradiation. For one, it offers a faster turnaround time. Another advantage is the ability to sterilize a wide range of sealed packaging types.
Gamma irradiation is a popular sterilization method for medical OEMs. Some of the advantages include shorter processing times, a higher throughput, and a lower radiation dose.
Despite these advantages, there are some drawbacks. First, there is a need for regular monitoring and maintenance. Additionally, the process requires a significant capital investment. Furthermore, there is a need for extensive training and licensing.
X-ray and gamma sterilization processes are both governed by the ISO 11137 standard. The standard specifies requirements for validation and routine monitoring of the irradiation process.
To ensure the proper quality of the medical devices, the manufacturer must choose the right materials for the product. These materials have to be chosen wisely so that there are no adverse effects on the optical and thermal properties of the product.
Medical devices are a large industry with a wide variety of materials. Therefore, it is necessary to make sure that the manufacturer is educated on the effects of irradiation on plastics and other elements. As technology advances, more reliable and effective material options will become available.
Why Sterilization is Necessary for Medical Devices?
Improper sterilization of medical devices can result in the transmission of life-threatening pathogens to patients and health care professionals. As a result, proper cleaning and sterilization of devices is vital to preventing HAIs. This has led to a number of studies reporting infections related to ineffective sterilization practices.
Sterilization is defined as the destruction of all microbial life. The two most common methods for sterilization are steam and autoclaving. Steam sterilization uses saturated steam at high temperatures to kill all microbial life. In the case of autoclaving, the device is enclosed in a chamber heated to an appropriate temperature.
Steam sterilization is considered the most effective and cost-effective method. Moreover, steam sterilization has been found to be associated with a high proportion of sterilization failures globally. It is therefore important to understand the causes of improper steam sterilization.
A significant study was conducted to evaluate the effectiveness of steam sterilization practices in Nepal. Six hospitals had a dedicated area for reprocessing of medical devices. Regardless of hospital type, the total number of staff allocated for reprocessing medical devices was small. These included only one to three personnel.
Additionally, the proportion of steam sterilization cycles showing positive results was 46.8% to 87.2%. While this percentage was low, it was still statistically significant.
The study showed that there was an increased risk of HAIs from improper sterilization of surgical instruments. Surgical site infections are the most common types of HAIs. Other infections, such as catheter-associated infections, can also be caused by inadequate decontamination procedures.
Several reliable studies have also shown that there are instances of infection related to improperly reprocessed medical devices. Among these, the following were the most common: healthcare-associated infections, catheter-associated infections, surgical site infections, and catheter-associated urinary tract infections.
Ultimately, ensuring effective sterilization of reusable medical devices is the most important responsibility of health care providers. As antimicrobial resistance increases, the importance of sterility of reusable devices increases.
Costs of Autoclaves
When you’re looking to buy an autoclave for sterilization purposes, it’s important to keep in mind that costs are going to vary from machine to machine. They can range from a few hundred dollars to tens of thousands of dollars, depending on the model and features you choose.
One of the most critical factors to consider is the cost of ongoing maintenance. If your autoclave isn’t well maintained, you may have to deal with unexpected downtime and repair costs. Even if the machine is still in good working order, unchecked deterioration can result in damage that could impair your processing capabilities.
The price of an autoclave will depend on the manufacturer, its brand, the size and volume of the chamber, the class and other options, and the features it offers. It’s also worth considering the warranty terms on the product.
Autoclaves can be large, such as the ones used for glass and plastic packaging, or they can be portable, such as the ones used in dental clinics. They can be configured for different uses, including pharmaceutical industries, medical laboratories, tire manufacturing and other industrial applications.
Some models include water-saving systems that reduce water usage. Others can monitor water usage to ensure that your facility is complying with sustainability goals.
Whether you are purchasing a new or second-hand autoclave, make sure to factor in the ongoing maintenance and repair costs. Otherwise, the total cost of ownership will exceed the initial purchase price.
The type of autoclave you’ll need depends on your laboratory’s needs and the space available for the unit. Larger machines can process up to 625 pounds of instruments or materials per cycle, while smaller ones can sterilize just a few trays of instruments at a time.
The Bottom Line
Sterilization is an important part of the medical industry. Bacterial protection helps that check-ups, operations, and other processes go well. Everything must be cleaned properly. This keeps germs from being transmitted to patients who come in and out throughout the day. When a hospital operation is completed, any tools used or near used instruments must be sterilised. This protects all patients and personnel against sickness and germs.