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Personal Protective Equipment and Influenza Outbreaks, including Bird Flu (Avian Influenza)
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Q. What is personal protective equipment?
A. Personal protective equipment is any type of specialized clothing, barrier product, or breathing (respiratory) device used to protect workers from serious injuries or illnesses while doing their jobs. PPE that is intended for use in preventing or treating diseases is subject to regulation by FDA under the device provisions of the Federal Food, Drug, and Cosmetic Act. This includes devices such as surgical gowns, gloves, masks and respirators that are intended to be used by healthcare workers. FDA evaluates the performance of such PPE before it may be marketed (cleared). FDA also makes sure the manufacturers follow good manufacturing practices and address complaints and adverse events associated with their products. Other PPE that is not intended for use in preventing or treating diseases, either by workers or by the general public, is not regulated by FDA. For more information, see FDA’s Role in Regulating PPE and other links on this website.
Q. How does personal protective equipment help prevent the spread of infection?
A. Personal protective equipment acts as a barrier between infectious materials and the skin, mouth, nose, or eyes (mucous membranes).
Proper use of FDA-cleared PPE by workers involved in patient care helps prevent the spread of infection because it
- helps protect wearers from infection or contamination from blood, body fluids, or respiratory secretions;
- reduces the chance that healthcare workers will infect or contaminate others; and
- reduces the chance of transmitting infections from one person to another.
Q. Will personal protective equipment cleared by FDA protect against bird flu (avian influenza)?
A. All personal protective equipment cleared by FDA must be able to block the passage of small particles the size of most infectious materials. FDA is not aware of any studies that specifically test PPE with any influenza virus, and no such data have been submitted to FDA by manufacturers. Thus neither FDA, nor a manufacturer, knows to what extent PPE will protect you against bird flu. Keep in mind that other infection control practices, such as hand-washing, isolating sick patients, and using appropriate coughing etiquette, are also important to minimize your risk of infection.
CDC (Centers for Disease Control and Prevention), not FDA, makes recommendations for infection control practices, including recommendations specific to influenza.
As part of its overall infection control recommendations, CDC recommends that healthcare workers wear the following personal protective equipment during the care of a patient with suspected or confirmed flu (influenza):
- surgical masks
- medical gloves
- surgical gowns
For more information about CDC’s recommendations for controlling the spread of the flu, see What You Should Know about the Flu.
Q. How do I know if personal protective equipment is cleared by FDA?
A. FDA’s  website lets you search for medical devices that FDA has cleared or approved, including personal protective equipment. Note that some of these products may not be available for purchase.
Q. Do you recommend using personal protective equipment to help protect against infection when caring for a sick person at home?
A. The use of PPE alone will not fully protect you from acquiring an infection. Other infection control practices, such as hand-washing, isolation of patients and coughing etiquette, are also important to minimize your risk of infection.
CDC (and not FDA) makes recommendations for infection control measures in different circumstances. These may include recommendations for use of PPE. For more information about CDC’s recommendations for controlling the spread of the flu, see What You Should Know about the Flu.
Q. If CDC recommends personal protective equipment, where can I buy it?
A. You can buy personal protective equipment from pharmacies, from medical suppliers, or from sources you find on the Internet.
For more information about buying medical products on the Internet, see FDA’s website on Buying Medicines and Medical Products Online.
Q. Do I need a prescription to buy personal protective equipment?
A. No, you do not need a prescription to buy personal protective equipment.
Q. What should I do if my personal protective equipment tears or rips?
A. If your gloves tear or rip, remove them carefully, wash your hands thoroughly with soap and water or alcohol-based hand rub, and put on new gloves. If your mask or gown rips, remove it carefully, change your clothes if they are soiled, and put on a new mask or gown.
If you think that your gloves, masks, or gowns are defective in some way, you should contact the manufacturer. We also encourage you to inform FDA through the FDA’s MedWatch program.
Q. How can I find a new supplier if my usual supplier is out of gloves, masks, or gowns?
A. FDA does not maintain lists of device retailers. However, FDA’s Device Listing Database contains lists of all medical devices that are cleared and are in commercial distribution, including personal protective equipment.
Q. Should medical offices keep an extra supply of masks, medical gloves, or gowns in reserve in case of a flu outbreak?
A. When deciding whether or not to keep personal protective equipment in reserve, you should consider
- your normal usage patterns;
- how those patterns might change in the event of a flu outbreak; and
- how difficult it would be for you to find supplies if your existing supplier could not deliver your supplies as quickly as usual.
Q. Can I reuse personal protective equipment?
A. Not usually. Almost all personal protective equipment is designed to be used one time for one patient. Dispose of the equipment carefully after each patient use or if the equipment becomes soiled.
The only type of personal protective equipment that can be reused is a surgical gown that is labeled as washable for multiple use.
Q. Can I wash disposable personal protective equipment?
A. No. You cannot wash disposable personal protective equipment. Washing medical gloves or disposable masks and gowns will destroy their barrier properties so that they will no longer help prevent infection. Dispose of the equipment carefully after each patient use or if the equipment becomes soiled.
The only type of personal protective equipment that can be washed is a surgical gown that is labeled as washable for multiple use.
Q. Can I disinfect disposable personal protective equipment?
A. No. There is no way to disinfect disposable personal protective equipment. Dispose of the equipment carefully after each patient use or if the equipment becomes soiled.
Q. Can I share personal protective equipment with other users?
A. No. You should not share personal protective equipment because used equipment will not provide an effective barrier against infection.
Q. If personal protective equipment is manufactured in an area affected by bird flu (avian influenza), is it safe to use?
A. Yes. Personal protective equipment is manufactured in a clean environment. Even if someone involved in the manufacturing of the equipment was sick, the flu virus does not survive very long outside of the body. People using the equipment days or weeks later would not be at risk of getting the flu from using the equipment.
Q. What should I do if I suspect that a company is making false, misleading or unauthorized claims about how well its product protects against flu?
A. FDA has not cleared any PPE for use specifically to help prevent (or treat) the flu and does not know of any studies that have tested PPE against influenza virus. If you are concerned about any product claims, you can report them to FDA in the following ways:
- Notify the CDRH Office of Compliance from 8 - 4:30 (Eastern Standard Time) at 240-276-0115.
- Notify the FDA District Office either where the company is located or where you live. Look up FDA District Office.
Updated May 9, 2006 |
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