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Personal protective equipment (ppe)
About Surgical Mask
A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are not to be shared and maybe labeled as surgical, isolation, dental, or medical procedure masks. They may come with or without a face shield. These are often referred to as face masks, although not all face masks are regulated as surgical masks.
Surgical masks are made in different thicknesses and with different abilities to protect you from contact with liquids. These properties may also affect how easily you can breathe through the face mask and how well the surgical mask protects you.
If worn properly, a surgical mask is meant to help block large-particle droplets, splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others.
While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.
Surgical masks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the face mask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag, and put it in the trash. Wash your hands after handling the used mask.
About N95/KN95 Mask
An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.
The similarities between surgical masks and surgical N95s are:
They are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency), flammability, and biocompatibility.
They should not be shared or reused.
About medical gloves
Medical gloves are examples of personal protective equipment that are used to protect the wearer and/or the patient from the spread of infection or illness during medical procedures and examinations. Medical gloves are one part of an infection-control strategy.
Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). These gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification. FDA reviews these devices to ensure that performance criteria such as leak resistance, tear-resistance, and biocompatibility are met.
What you should know before using medical gloves
Wash your hands before putting on sterile gloves.
Make sure your gloves fit properly for you to wear them comfortably during all patient care activities.
Some people are allergic to natural rubber latex used in some medical gloves. FDA requires manufacturers to identify on the package labeling the materials used to make the gloves. If you or your patient is allergic to natural rubber latex, you should choose gloves made from other synthetic materials (such as polyvinyl chloride (PVC), nitrile, or polyurethane).
Be aware that sharp objects can puncture medical gloves.
Always change your gloves if they rip or tear.
After removing gloves, wash your hands thoroughly with soap and water or alcohol-based hand rub.
Never reuse medical gloves.
Never wash or disinfect medical gloves.
Never share medical gloves with other users.
On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body's immune response, causing the tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications. For a detailed description of the risks that the FDA identified, please refer to the final rule.
About Medical Gowns
Gowns are examples of personal protective equipment used in health care settings. They are used to protect the wearer from the spread of infection or illness if the wearer comes in contact with potentially infectious liquid and solid material. They may also be used to help prevent the gown wearer from transferring microorganisms that could harm vulnerable patients, such as those with weakened immune systems. Gowns are one part of an overall infection-control strategy.
A few of the many terms that have been used to refer to gowns intended for use in health care settings include surgical gowns, isolation gowns, surgical isolation gowns, non-surgical gowns, procedural gowns, and operating room gowns.
In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate that the gown provides the newly defined levels of protection:
Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, a cover gown for visitors, or in a standard medical unit
Level 2: Low risk, to be used, for example, during the blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
Level 3: Moderate risk, to be used, for example, during the arterial blood draw, inserting an intravenous (IV) line, in the Emergency Room, or for trauma cases
Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
Regardless of how the product is named (that is, isolation gown, procedure gown, or cover gown), when choosing gowns, look for product labeling that describes an intended use with the desired level of protection based on the above risk levels. Product names are not standardized.
A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. As referenced in Figure 1: the critical zones include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow. Surgical gowns can be used for any risk level (Levels 1-4). All surgical gowns must be labeled as a surgical gown.
Standards for Gowns
Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown.
The performance of gowns is tested using consensus standards:
American Society for Testing and Materials (ASTM) F2407 is an umbrella document that describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
Below is a summary of the ASTM F2407 standard recognized by the FDA.
Tensile Strength: ASTM D5034, ASTM D1682
Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
Seam Strength: ASTM D751 (stretch woven or knit)
Lint Generation (ISO 9073 Part 10)
Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75
American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.
Sterility Information for Gowns
For a device sold sterile, the FDA recommends sponsors provide the following information as detailed in the final guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. This information may include:
Sterilization method that will be used.
A description of the method that will be used to validate the sterilization cycle, but not the validation data itself (for established sterilization methods).
Reference to a standard method (e.g., AAMI Radiation Standard) usually is sufficient for established sterilization methods with FDA-recognized standards.
The sterility assurance level (SAL) for the device which the firm intends to meet. A SAL of 10-6 is required for surgical drapes and surgical gowns which are to be used during surgical procedures.
A description of the packaging’s ability to maintain the device's sterility.
If sterilization involves ethylene oxide (EtO), the maximum levels of residues of ethylene oxide, ethylene chlorohydrin, and ethylene glycol which remain on the device. The levels should be consistent with the draft Federal Register Notice on EtO limits.
In the case of radiation sterilization, the radiation dose.
Biocompatibility Information for Gowns
Surgical gowns are devices that are considered a surface-contacting device with intact skin with a contact duration of ≤ 24 hours. The FDA recommends that cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation or intracutaneous reactivity (ISO 10993-10) is evaluated for a device. For more information about biocompatibility end point assessment, please refer to the final guidance document entitled, “Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".