“Laws of Motion” PPE Surgical Gowns Should Not Be Used, FDA Warns

Surgical gowns and personal protective equipment (PPE) sold by the manufacturer “Laws of Motion” should not be used by healthcare personnel, according to a warning issued by federal health regulators, since the products may not provide adequate protection against infectious diseases, including COVID-19.

On August 28, the FDA issued a letter to health care providers, calling on them to stop using Laws of Motion PPE gowns, due to quality issues resulting in an inadequate level of fluid barrier protection.

The warning calls for health care facility risk managers, procurement staff and health care providers not to use surgical gowns sold as PPE from Laws of Motion until further notice, as the agency continues the investigation. Healthcare personnel should also check their current stock of PPE and identify the supplier or manufacturer of the PPE in the hospital inventory.

Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, respirators, or other equipment designed to protect the wearer from injury or the spread of infection or illness. It is intended to be worn by health care staff during procedures to protect the patient and healthcare provider from the transfer of microorganisms, body fluids, and particulate matter.

PPE is typically worn during surgery or invasive procedures, such as intubating a patient or administering nebulizer treatments for respiratory issues.

Recently, the need for PPE became even more necessary as the coronavirus pandemic has called for healthcare personnel to wear PPE on a consistent basis, even when conducting routine patient care, to help prevent the spread of the virus that causes COVID-19.

In March and April, healthcare providers around the world reported widespread shortages of PPE as they began treating high numbers of patients for COVID-19. While the shortage has largely subsided, PPE is a staple in the health care environment and effective PPE is necessary for every healthcare staff member during every shift to help prevent the spread of the coronavirus.

The FDA indicates healthcare staff should report any issues with quality or performance of the Laws of Motion gowns, including surgical gowns, to the FDA’s MedWatch Adverse Event Reporting program.