ECRI is concerned about healthcare facility management of medical devices and equipment , including PPE like non-NIOSHapproved respirators that have been authorized for use during the COVID-19 public health emergency .” explained , “ Over the course of the ongoing pandemic , the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol ( also known as ethyl alcohol ) but tested positive for methanol contamination . Methanol , or wood alcohol , is a substance that can be toxic when absorbed through the skin and life-threatening when ingested . Methanol is not an acceptable ingredient in hand sanitizer or other drugs .” FDA says it is considering any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U . S . current good manufacturing practice requirements .
This marks the first time the FDA has issued a countrywide import alert for any category of drug product . The FDA ’ s analyses of alcohol-based hand sanitizers imported from Mexico found 84 percent of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA ’ s regulations . More than half of the samples were found to contain toxic ingredients , including methanol and / or 1-propanol , at dangerous levels . The agency has posted and regularly updates a list of hand sanitizer products that consumers should not use , which include those that FDA has found to contain methanol and / or 1-propanol . In most cases , methanol does not appear as an ingredient on the product label .
Noting these kinds of importing-related dangers , the ECRI hazards report ( 2021 ) notes that N95-style masks may fail to protect healthcare personnel from infectious respiratory diseases , and that some imported N95-style masks do not offer the level of protection claimed : “ Not every healthcare worker requires the level of protection afforded by a NIOSH-certified N95 respirator . But for individuals at high risk of being exposed to aerosols from COVID-19 patients , a mask that provides reliable , N95-level respiratory protection is essential … Of particular concern are KN95 masks imported from China .”
N95 filtering facepiece respirators are certified by the U . S . National Institute for Occupational Safety and Health ( NIOSH ) as being able to block at least 95 percent of airborne particles under specified test conditions . As the ECRI hazards report ( 2021 ) notes , “ Although KN95s have not been certified by NIOSH , they are marketed as meeting the requirements of a Chinese standard that aligns with NIOSH ’ s N95 mask requirements . However , ECRI testing through December 2020 found that , of the imported non-NIOSH-certified respirator alternatives tested , more than 60 percent failed to filter airborne particles as well as claimed . Use of less-effective respirators , especially for aerosol-generating procedures , may increase staff and patient exposure to infectious respiratory diseases . Organizations considering the use of non- NIOSH-certified respirators should verify that the models have been properly tested before they are put into use during the treatment of COVID-19 patients . If you ’ ve acquired respirators that fail to meet the N95 standard , consider using them for nonsurgical , no-splash procedures in which surgical or procedure masks are currently used .”
Sivek observes that “ U . S . CDC and ECRI considers the use of all imported , EUA personal protective equipment as a last resort when normal supplies of PPE are critically low or have run out .” She says that before using EUA PPE , healthcare organizations should review the following resources :
VIEW EUA PPE RESOURCES
ECRI ’ s # 4 hazard for 2021 , Imported N95-Style Masks May Fail to Protect Healthcare Workers from Infectious Respiratory Diseases , available to members
— Amanda Sivek , PhD
CDC ’ s current strategies for optimizing PPE supplies
ECRI ’ s strategies for addressing expected or known shortages of : eye protection , N95 respirators , powered air-purifying respirators , facemasks , isolation gowns , and gloves , which are available for free in our COVID-19 Resource Center
The No . 5 concern on ECRI ’ s hazards list – the use of consumer-grade items in the healthcare environment — could also be partially exacerbated by the COVID-19-related shortages of medical commodities , such as finger pulse oximeters , blood pressure cuffs , and glucose monitors . As the ECRI hazards report ( 2021 ) explains , “ Consumer-grade healthcare products can be useful to monitor a patient ’ s physiologic trends , but users should not rely on these products to make healthcare decisions . The measurements or other results from these products may not be sufficiently accurate or may be misleading … Patients and clinicians alike are increasingly interested in such products to provide some level of care when a traditional medical device is unavailable , inappropriate , inconvenient , or too expensive .”
The report continues , “ During the COVID-19 pandemic , for example , healthcare providers have considered using consumer-grade devices , even in the acute-care environment , as a means to reduce bedside visits ( thereby reducing exposure risks ) and to address medical device shortages and other resource limitations . However , most consumer-grade devices have not been through FDA ’ s medical device approval process . Thus , users cannot be sure that they are as accurate or reliable as products that have been