FDA Aware of Some Shortages of Personal Protective Equipment at Hospitals

Regulatory NewsRegulatory News | 27 February 2020 |  By 

The US Food and Drug Administration (FDA) told Focus on Thursday that it has heard of spot shortages of some medical devices, including personal protective equipment (PPE) used by hospitals to guard against the coronavirus (COVID-19). 
“However, FDA is currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC [Centers for Disease Control and Prevention] and other partners of increased ordering of a range of human medical products through distributors as some healthcare facilities in the U.S. are preparing for potential future need if the outbreak were to become more severe.  The FDA asks that hospitals report any device shortage concerns to the FDA,” the agency said in a statement to Focus.

Two US officials also told Reuters on Thursday that the administration may use the Defense Production Act to expand domestic production of protective masks and clothing to combat the coronavirus.

Meanwhile, FDA said it has contacted all 63 device manufacturers with 72 facilities in China that produce essential medical devices.

"We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the US market," FDA said in a statement.

The agency also warned that no law exists to require device manufacturers to notify FDA when they "become aware of a circumstance, including discontinuation of a product, that could lead to a potential shortage, and manufacturers are not required to respond when the FDA requests information about potential supply chain disruption. "
The CDC, meanwhile, recommends that health facilities should have policies and procedures describing a recommended sequence for safely putting on and taking off PPE, including gloves, gowns and respiratory and eye protection. The CDC also offers recommendations on what should be worn by individuals transporting patients who are confirmed with or under investigation for COVID-19 within a health facility.
According to industry group AdvaMed, the Chinese government also has identified certain protective equipment as essential to its emergency response, including medical protective clothing and masks, surgical masks, disposable medical caps and shoe covers, goggles, protective helmets, disposable isolation gowns, nitrile gloves, sterile gloves and non-contact infrared thermometers.
China is the world’s largest producer of medical protective masks, and production difficulties have had ripple effects across the region. In addition to the protective equipment shortages at hospitals, generic drugmakers are bracing for potential shortages next summer and FDA is tracking 20 specific drugs that could be affected.
The spot shortages of such devices and potential for other shortages come as WHO on Thursday confirmed more than 82,000 cases of COVID-19 and more than 2,800 deaths worldwide.
Meanwhile, President Donald Trump announced last night that Vice President Mike Pence has taken over as the leader of the US response to the coronavirus. The CDC also confirmed last night the first COVID-19 case with unknown origin.


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