CDRH recognizes the challenges medical device manufacturers face in their effort to ensure the safety and well-being of their manufacturing personnel.
CDRH recommends medical device manufacturers take the following steps to reduce the risk of exposure to SARS-CoV-2, the virus that causes COVID-19, among manufacturing personnel:
- Implement basic infection prevention measures. This includes, but is not limited to, promoting frequent and thorough hand washing with soap and water for at least 20 seconds, encouraging workers to stay home if sick, increasing physical distance between employees consistent with federal, state and local health authority recommendations, and reminding workers to avoid touching their eyes, nose, and mouth with unwashed hands.
- Implement policies and procedures for prompt identification and isolation of sick people. This includes, but is not limited to, encouraging employees to self-monitor for signs and symptoms of COVID-19 (e.g. fever, cough, shortness of breath), implementing policies and procedures for employees to report when they are sick, immediately isolating people who have developed signs and/or symptoms of COVID-19, and training workers to implement these policies.
- Regularly clean and disinfect surfaces, equipment, and other elements of the work environment. See EPA's list of disinfectants for use against SARS-CoV-2 virus.
- Where feasible, restrict the number of personnel entering isolation or "clean" areas.
- Protect workers in close contact with one another (i.e. within 6 feet). This may include the use of additional engineering controls (e.g. use of high-efficiency air filters, increased ventilation rates, use of physical barriers), administrative controls (e.g. minimizing contact among workers, reducing the number of employees at a facility at a time, training workers on infection prevention measures), safe work practices, and/or personal protective equipment (e.g. masks, gloves, goggles, shoe coverings, coveralls, gowns).
- Avoid face-to-face work area designs.
- Assess any manufacturing line and/or cleanroom modifications to ensure they provide adequate worker protections and do not adversely impact the employee's job function.
- Closely monitor cleanroom process controls such as air filtration, positive air pressure and movement of air to ensure proper function.
- Use validated cleaning processes within the cleanroom at defined intervals and frequency.
- Review the Occupational Safety and Health Administration (OSHA) document, OSHA: Guidance on Preparing Workplaces for COVID-19, and follow applicable OSHA standards and guidance, where appropriate.
The FDA continues to take steps to help increase the availability of personal protective equipment for medical uses (for example, through guidance documents regarding enforcement policies for personal protective equipment).