Medical Products FAQs
My product from DeRoyal appears yellowed. What causes this discoloration?
Typically, this discoloration is on the packaging only and not the actual product. This phenomenon is referred to as “Phenolic Yellowing”. There are several potential causes for this phenomenon, but the primary cause for the package discoloration is a reaction between the antioxidant used to make the plastic package and some other catalyst -- most likely of which are the processes and byproducts of the Ethyl Oxide sterilization gases.
Allow DeRoyal to assure you that this discoloration in no way compromises the performance, the packaging, or the sterility of the product -- as long as the packaging is in tact, neither the product nor its sterility is compromised.
For a more detailed explanation of this issue, please see our Phenolic Yellowing Statement (PDF).
Why is there not a Safety Data Sheet (SDS) included for certain DeRoyal products?
Many products manufactured and marketed by DeRoyal are considered to be “articles” as specified by the Hazard Communication Standard and are exempt from requirements of the Standard according to the Occupational Safety and Health Administration (OSHA). Many of the products that DeRoyal manufactures are produced from raw materials that are fluids or particles. However, once these raw materials are formed into a whole unit, the material cannot be spilled, consumed, ingested, inhaled, or absorbed. DeRoyal’s products that are manufactured or fabricated into an “article” typically are whole units that do not and cannot pose a risk in that they cannot be ingested, inhaled, or absorbed into the body through the skin, eyes, or mucous membranes under normal conditions of use. As such, these products are exempt from the SDS requirements.
For a more detailed explanation of this issue, please see our SDS Requirements Statement (PDF).
What is meant by the term “Not Made with Natural Rubber Latex” on DeRoyal product labels and literature?
The intent of the statement ‘Not Made with Natural Rubber Latex’ as used on DeRoyal Industries, Inc. product labels and literature is to denote the device components from which it is manufactured and / or its packaging components do not contain natural rubber latex that may contact humans, or to the extent that a device component and / or packaging component may contain natural rubber latex, the portion(s) of the device and / or its packaging which contain natural rubber latex are not intended to contact or are not likely to contact the user or patient in the course of using the product in accordance with labeling or customary usage in the industry.
How can a package that allows the passage of air through its membrane still be sterile?
Sterilization is a procedure that serves the purpose of making objects free of live bacteria and any other microorganisms. DeRoyal uses a sterilization processes known as 100% EtO (Ethylene Oxide). The destruction of pathogens is achieved by diffusing effective concentrations of EtO gas into the innermost sections of the product in question.
The packages used for DeRoyal’s sterile products are a medical-grade, gas-permeable paper on one side and a plastic film on the other. The packages used to house the sterile product are, therefore, designed to accommodate the EtO sterilization procedure.
Known as a Permeable Packaging Configuration (Primary Sterile Barrier), the package must possess: (a) permeability to Ethylene Oxide gas, water vapor (moisture), and air, (b) impermeability to bacteria and other contaminants, and (c) resistance to pressure and temperature fluctuations.
The package itself acts as a barrier (filter) that blocks any harmful microorganisms from entering the product. Viruses and bacteria are very small (30 to 450nm and 1250nm respectively); however, they are mammoth when compared to the molecule of oxygen (0.28nm), nitrogen (0.30nm), and ethylene oxide (0.94nm). The pores of the package (filter) are much smaller (1.03nm) than the size of bacteria or viruses but bigger than that of an oxygen, nitrogen, and ethylene oxide molecules. Therefore, the smaller particles (oxygen, nitrogen, & ethylene oxide) can go through but the bigger ones (bacteria and viruses) cannot pass through; thus, the package remains sterile despite the passage of air through it.
For a more detailed explanation of this issue, please see our Sterile Breathable Package Statement (PDF).