COVID-19 Pandemic Fuels Many of ECRI ’ s Annual List of Top Healthcare Hazards
By Kelly M . Pyrek
The delivery of healthcare , as well as the safe use of medical technology , requires identifying possible sources of danger and taking steps to minimize the likelihood that adverse events will occur , emphasizes the non-profit safety-focused organization ECRI . Helping healthcare professionals manage those risks is the Top 10 Health Technology Hazards list , produced annually by ECRI ’ s device evaluation group and designed to identify the potential sources of danger that ECRI experts believe warrant the greatest attention .
The No 1 issue on the 2021 ECRI list is the complexity of managing medical devices with COVID-19 emergency use authorization ( EUA ). According to the Food and Drug Administration ( FDA ), the EUA authority allows FDA to help strengthen the nation ’ s public health protections against chemical , biological , radiological , nuclear ( CBRN ) threats by facilitating the availability and use of medical countermeasures ( MCMs ) needed during public health emergencies . As we have seen , to meet the unprecedented need for medical equipment and supplies during the COVID-19 pandemic , the FDA temporarily authorized the use of hundreds of medical devices that had not previously been approved for use . The FDA can designate previously unapproved products — or new uses for previously approved products — as acceptable for use during an emergency .
In addition to COVID-19 tests , the FDA has issued EUAs for other devices , such as ventilators , respirators , face shields , and decontamination systems to treat COVID-19 patients and to protect healthcare workers . The ECRI hazards report ( 2021 ) emphasizes that two factors must be considered when using EUA devices : “ First , these devices are authorized only for the duration of the pertinent EUA . When the health emergency ends or FDA revokes an EUA — which can happen at any time — EUA devices revert to unapproved status . At that time , the legal protections that support the use of EUA devices on new patients are terminated . Second , EUA devices may not be as safe or effective as devices that have been through FDA ’ s normal clearance process . FDA can issue an EUA if it determines that the device may be effective for the specified use , and if it judges that the benefits of the product outweigh the known and potential risks of the product . But this is a lower standard for checking safety and effectiveness than FDA uses for its normal process . Thus , EUA device users must be mindful of the potential for problems .”
As the ECRI hazards report ( 2021 ) points out , “ Healthcare facilities that use EUA devices face a complex challenge : They must manage inventories of EUA devices and their documentation , monitor each device ’ s status daily to determine whether the EUA remains active and unchanged , and determine what to do with these devices once the EUA ends .”
“ By making this topic our No . 1 hazard for 2021 , we hope to alert healthcare facilities to the complexity of this issue and the importance of developing processes for EUA device management ,” says Amanda Sivek , PhD , principal project engineer at ECRI .
Besides medical devices , Sivek says that items of personal protective equipment ( PPE ) are included in ECRI ’ s guidance about EUA-covered items . “ ECRI is concerned about healthcare facility management of medical devices and equipment , including PPE like non- NIOSH-approved respirators that have been authorized for use during the COVID-19 public health emergency ,” Sivek says . “ N95 respirators are U . S . NIOSH-approved and not subject to EUA . However , FDA authorized the use of specific decontamination devices for N95 respirators that are included in this hazard .”
Also , these items of PPE create similar translational science challenges as EUA-covered medical devices do , says Sivek , who adds , “ EUA devices have a unique complication due to their temporary authorization for use . When the COVID-19 public health emergency ends , or FDA revokes a EUA — which can happen at any time — EUA devices revert to unapproved status . At that time , the legal protections that support the use of EUA devices on new patients are terminated .”
Seen as a strategy to combat domestic production shortfalls , importing critical medical devices and products -- such as ventilators or hand sanitizer -- presents unique hazards and is No . 4 on the ECRI hazards list . For example , in late January the FDA placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U . S . until it is able to review the products ’ safety . As the FDA
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As we have seen , to meet the unprecedented need for medical equipment and supplies during the COVID-19 pandemic , the FDA temporarily authorized the use of hundreds of medical devices that had not previously been approved for use .