Q1. How do manufacturers ensure personal protective equipment (PPE) is safe and effective?
A1. To help ensure medical devices, including PPE are safe and effective, the FDA has established Quality Systems Regulations and Good Manufacturing Practices. Manufacturers are expected to use these regulations and practices to maintain consistent product quality and to guide performance testing to make sure that their products conform to recognized consensus standards. For PPE, these standards may include for fluid resistance, leak protection, filtering capacity, or resistance to tears and snags. When these regulations and practices are followed, they provide reasonable assurance that the device is safe and effective.
FDA has also issued device-specific guidance for some products so that manufacturers understand the Agency’s expectations. Search for FDA Guidance Documents
Q2. Will personal protective equipment protect against a specific disease?
A2.PPE are designed to create a non-disease specific barrier to penetration of substances, solid, liquid, or airborne particles. In general, neither FDA nor the manufacturer can provide assurances that PPE will protect you against a specific disease. The data that FDA uses for the evaluation and clearance of PPE rarely includes performance evaluation or testing against specific viruses, such as Ebola or flu. If performance data has met FDA requirements and demonstrate protection against a specific disease, the product labeling will state the claim for protection against a specific virus or bacteria.
When there is an outbreak that affects the broad population, The Centers for Disease Control and Prevention (CDC), is responsible for making specific recommendations for infection control measures in different circumstances and settings. For example, the CDC has provided the following recommendations:
Q3. Should caregivers use PPE to help protect against infection when caring for a sick person at home?
A3.In some circumstances, a health care provider may recommend that caregivers use PPE when caring for a sick person at home. It is important to know that the use of PPE alone will not fully protect you from acquiring an infection or passing an infection to another person. Other infection control practices, such as hand-washing, using alcohol-based hand sanitizers, isolation of patients and using properly covering cough and sneezes, are also important steps to minimize your risk of infection.
Additionally, please be aware of proper removal and disposal procedures. Even if PPE successfully protects you while it is worn, improper removal and disposal of contaminated PPEs can expose the wearer and other people to infection.
Q4. Where can I buy PPE?
A4. Most types of PPE are available without a prescription. Pharmacies, medical supply stores, and Internet medical supply retailers sell PPE.
For more information about buying medical products on the Internet, see FDA’s website on Protecting Yourself.
Q5. Can I reuse PPE?
A5. In general, most PPE is designed to be used only one time and by one person prior to disposal. There are a few exceptions, for example some types of elastomeric respirator masks and protective eyewear such as goggles may be reused if the user follows decontamination methods in the product labeling.
If PPE is exposed to infectious materials during use (e.g., body fluids from an infected person) the PPE is considered contaminated and the wearer should remove it promptly, using proper removal and disposal procedures. Please be aware that even if a PPE successfully protects you while it is being worn, improper removal and disposal of contaminated PPEs can expose the wearer and other people to infectious agents.
Q6. Can I wash disposable PPE?
A6. No. Disposable PPE is designed to be used only one time and by one person; it cannot be washed. Washing PPE changes its protective or barrier capabilities, and it may no longer be effective.
Q7. Can I share PPE with other users?
A7. In general, most PPE cleared by the FDA is intended to be used only one time and by one person. Sharing PPE is not advised. The protective capabilities of single use PPE cannot be assured when it is reused by the same person or used by more than one person. Sharing PPE that is intended for single use may expose another person to infectious materials. PPE should be removed promptly after use and disposed of properly.
Q8: Does every piece of PPE provide the same level of protection?
A8: PPE is designed to be used with other infection control practices such as hand-washing, using alcohol-based hand sanitizers and covering coughs and sneezes to minimize the spread of infection from one person to another.
Wearers of PPE can determine what protective level a PPE is rated for by the standards to which it has been tested.
CDC's National Institute for Occupational Safety and Health (NIOSH) maintains a database called NIOSH Personal Protective Equipment Information (PPE-Info) that includes most of the current PPE standards in more detail.
Q9: If I experience a problem with my PPE, what should I do?
A9: If you suspect or experience a problem with your PPE, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program and notify the manufacturer.
Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.