Tag Archive: medical devices

  1. How to Properly Clean Medical Devices

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    When it comes to medical devices cleanliness is crucial. All medical devices, whether they are disposable, implantable or reusable, must be cleaned during the manufacturing process to remove oil, grease, fingerprints and other manufacturing soils. Reusable products must also be thoroughly cleaned and sterilized between each use to avoid infecting patients or causing illness. Reaching the right level of cleanliness does not come automatically. A well planned cleaning regimen must be developed and followed carefully.

    Developing a Cleaning Process

    Medical device manufacturers must provide proof that their products can be adequately cleaned as part of the FDA approval process. As a result, most manufacturers now incorporate setting up a cleaning protocol as part of the design and development phase.

    Factors to consider when setting up a cleaning regimen:

    • Soils: Choose a cleaner that will best attack the soils you are trying to remove. Enzyme cleaners are often used for medical device cleaning applications since they work well at removing organic soils. Protease enzymes in particular are a good choice for protein based organic soils like blood, fat, sweat, mucous, feces and tissue.

    • Surface: Titanium, plastic, ceramic, silicone and metal are some of the more common materials used in the manufacture of medical devices. It’s important to select a cleaner that is compatible with the substrate of the device you are cleaning. The cleaner manufacturer should be able to guide you and provide compatibility studies for their products.
    • Wash method: Common methods of cleaning medical devices include automatic washers, ultrasonic cleaners and manual washing. Factors such as soil, substrate, composition and end use of the device are taken into consideration. Regardless of the method used, it’s extremely important to be sure that all soils are removed from blind holes and internal passages of the device.
    • Temperature: In most cases, increasing the temperature is one of the best ways to speed up or improve the cleaning action. The temperature parameters that should be used for any individual cleaning application will depend upon the make-up of the medical device and the soils that are present, as well as your choice of detergent and wash method. Check with the manufacturer for the maximum suggested operating temperature for your detergent.
    • Dwell time: The length of the cleaning cycle contributes to the effectiveness of your cleaning application. In most cases, a longer dwell time will improve the results. However, all factors – soils, temperature, substrate, detergent and cleaning method must be taken into consideration.
    • Rinse step: Thorough rinsing should follow cleaning. Rinsing removes any excess detergent left on the item. For critical cleaning applications it is best to use deionized or distilled water, as rinsing with ordinary water may introduce new contaminates.
    • Validation procedures: Cleaning validation is a part of the regulatory compliance process for medical device manufacturing and reprocessing. Validation ensures that medical devices are washed according to previously determined standards and that all traces of soil and detergent are removed. Validation methods are unique to each detergent and should be available from most cleaner manufacturers.

    Download IPC’s “7 Step Guide to the Proper Usage of Critical Cleaners” for more information on establishing a cleaning regimen.

    Cleaning and Sterilizing

     What’s the Difference?

    Medical devices not only need to be clean, they also need to be sterile. Medical devices that are not properly cleaned and sterilized can lead to patient infection. Cleaning and sterilization are two distinct processes and both must be performed to ensure that medical devices meet safety standards.

    The CDC defines cleaning as “the removal of foreign material (e.g., soil, and organic material) from objects…normally accomplished using water with detergents or enzymatic products”. (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html). They describe sterilization as a process that “destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item”. (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/index.html). The CDC has established guidelines that are used to determine if a medical device is considered sterile. This is referred to as the sterility assurance level or SAL of a product and is defined as the likelihood that any viable microorganisms will exist on a device after sterilizing.

    Why do Both?

    Clearly we have two different, albeit related, processes. So, why do both? Cleaning the medical devices first ensures that they are free from soils and debris that can cause infection and reduce the efficiency of the sterilization process.

    The CDC guidelines explain that “Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective.” (https://www.cdc.gov/infectioncontrol/guidelines/disinfection/cleaning.html).

    If a surface is sterilized or disinfected before it is cleaned, the remaining soils can still contribute to the growth of harmful germs and lead to further contamination. Lingering soils on the surface of the medical device can serve as a barrier and impact the efficiency of the sterilization process. If the surface is thoroughly cleaned first, and validated for cleanliness, sterilization is much more effective.

    Interested in learning more about choosing the right specialty cleaner for your medical device cleaning application? Contact one of International Products Corporation’s (IPC) technical specialists or request a free cleaner sample for testing. All of IPC’s specialty cleaners are registered with NSF as A1 cleaners and can be validated in FDA processes.

  2. Hassled By Hose Assembly? P-80® Lubricants Can Help!

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    Rubber hoses are everywhere! Have you ever stopped to consider how many everyday items have hoses? Cars, trucks, buses, planes, boats, motorcycles, construction equipment, appliances, pumps, and medical equipment all contain hoses.

    So, what exactly is a hose? Hoses are flexible hollow tubes that transport fluids, or gases, from one location to another. It’s easy to see how hoses are an integral part of all of the items mentioned above. Hoses allow gas to travel from the fuel tank of your car to the engine, water to move from the water line in your home to the dispenser on your refrigerator, and medicine to flow through an IV unit.

    Most hoses are attached to other parts of an assembly by some type of connector, usually referred to as a coupling or a fitting. Hose fittings are typically made of metal or plastic. Anyone who has ever worked with rubber parts knows they can be difficult to assemble. Trying to install, remove or manipulate tight fitting rubber components can be a real challenge.

    Since hoses are so vital, it’s important to make sure they are assembled properly to avoid problems later on. Parts that are improperly aligned or installed may result in performance or safety issues. Hoses and couplings are designed with a tight fit so they stay together after assembly to function properly and avoid leakage. The insertion force needed to complete the assembly can be extreme, sometimes causing worker injury.

    So, how do you make hose assembly easier? P-80® temporary assembly lubricants can help! P-80 temporary rubber assembly lubricants significantly reduce friction to help rubber parts slide easily into place. P-80 lubricants are water-based, and do not contain alcohol or petroleum distillates so they will not cause rubber to dry out, swell or harden. P-80 does not contain silicon or other persistent ingredients, so once dry you have a tight fitting part.

    What are the advantages of using P-80 lubricants?
    • Reduce the force required for installation
    • Increase production rates
    • Reduce part breakage, leaks and rejects
    • Allow for closer fitting part design
    • Reduce risk of musculoskeletal and slippage related injuries

    What if my hoses undergo pressure testing immediately after assembly? P-80 lubricants provide temporary lubrication, once dry the lubrication ceases and parts stay in place. International Products Corporation (IPC) recommends using P-80® Grip-It for hose assemblies that are pressure tested or drop tested immediately after assembly. P-80 Grip-It provides the lubricity needed to complete your assembly and then dries quickly to allow the natural tight fit of rubber to return. When dry, P-80 Grip-it leaves a tacky finish to help parts stay in place, making it an excellent choice for use on pressure-tested hoses. Download our case study detailing how one major appliance manufacturer benefited from using P-80® Grip-It for dishwasher hose assembly to reduce drop test failures.

    In addition to Grip-It, P-80 is available in five additional water-based formulas, including two that are approved for use in incidental food contact applications. P-80 lubricants offer superior lubrication and are compatible with a variety of surfaces. They are environmentally friendly, most are biodegradable.

    Make hose assembly easier with P-80! Contact IPC’s technical team to help you find the best solution for your assembly needs.

Detergent Selection Guide

= Used ; = Preferred
SOILS Micro-90® Micro® Green Clean Micro® A07 Surface-Cleanse/930® LF2100® Zymit® Low-Foam Zymit® Pro
Biological soils: Blood, Feces, Mucous, Sebum, Sweat, Urine
Dyes, Inks
Eggs, Butter, Fruit Stains
Flavor, Fragrances
Insoluble Salts
Shop Dusts, Soldering Flux
Titanium Dioxides