As certain medtech companies continue ramping up production of devices and components to fight the coronavirus, the FDA’s Center for Devices and Radiological Health (CDRH) on Sunday announced several tips to help protect medtech manufacturing employees from contracting COVID-19.
In addition to frequent and thorough hand-washing, maintaining social distancing and avoiding face-touching, the agency urged companies to adopt policies and procedures for identifying and isolating sick people as well as for employees to use to report illness.
CDRH also recommended regular cleaning and provided a list of EPA-approved disinfectants to use against the coronavirus. And it urged restricting the number of workers entering isolation or “clean” areas.
Here are some more specific recommendations:
- 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 said it is continuing to take steps to help increase the availability of personal protective equipment for medical uses. More information on the CDRH safety recommendations may be found here.