Sanitizing and Disinfecting Wipes
Wipes are roughly divided into two categories:
Sanitizing Wipes - are usually referring to wipes intended for a therapeutic purpose, such as killing germs on the skin, or treating acne, diaper rash, or other skin conditions, are drugs under the law. Drugs must meet requirements for FDA approval for safety and effectiveness before they go on the market. Drugs are regulated by FDA’s Center for Drug Evaluation and Research. We commonly use wipes with a 75% or greater alcohol content with a trusted Safety Data sheet for this purpose.
Disinfecting Wipes - are usually referring to wipes intended to control germs on inanimate surfaces (disinfect or sanitize) and wipes containing insect repellents are regulated by the Environmental Protection Agency. List N specifically mentions products for use against Covid-19, and when possible it is advisable to stick to these products. However, If you can’t find a product on this list to use against SARS-CoV-2, look at a different product's label to confirm it has an EPA registration number and that human coronavirus is listed as a target pathogen.
Finally, wipes intended for cleansing objects in our homes, at work, the gym, and in public places are regulated by the Consumer Product Safety Commission
EPA - LIST N (disinfectants for use against Covid-19)
Thermal Imaging Systems
Thermal imaging systems, may be used to measure surface skin temperature. These systems include an infrared thermal camera and may have a temperature reference source. When used correctly, thermal imaging systems generally have been shown to accurately measure someone’s surface skin temperature without being physically close to the person being evaluated. Thermal imaging systems offer certain benefits in that other methods need a closer proximity or contact to measure temperature (for example, non-contact infrared thermometers or oral thermometers). Thermal imaging system may measure surface skin temperature faster than the typical forehead or oral (mouth) thermometer that requires a close distance or physical contact with the person being evaluated.. Scientific studies show that, when used correctly, thermal imaging systems generally measure surface skin temperature accurately. We offer a broad range of thermal imaging systems from individual systems (measuring one person at a time) with face recognition, systems without face recognition and crowd scanners measuring many people at a time.
Telethermographic systems may be marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications. Because they are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, when marketed for these non-medical applications, FDA device marketing authorization is not required, and all the other medical device requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products.
FDA: Thermal Imaging Systems (Infrared Thermographic Systems / Thermal Imaging Cameras)
N95 - NIOSH - GUIDANCE
The N95 NIOSH (National Institute for Occupational Safety and Health) certified respirators have been the gold standard of respiratory protection. The American multinational conglomorate 3M holds the lion share of the market and has been the gold standard for medical and occupational healthcare and safety. The two most common models are the 8210 and the 1860, both of a similar construction and design with the latter being the gold standard surgical mask due to its extensive blood splash testing. The 8210, originally designed as a worker’s safety mask, can also be used in healthcare settings when additional precautions (including first and foremost a face shield) are used.
The Covid-19 crisis has created massive demand for and shortages of the 3M N95 masks leading to a large black market, with price gauging and fraud. This has led to a large demand for any NIOSH N95 products (by being the only N95 products tested by a US recognized authority). The CDC publishes a list of all approved NIOSH respirators online (see link below). However, this list is often dated: some of the models listed are no longer in production; many of the models there are fraudulently counterfeited. The CDC also publishes a very relevant (yet hardly comprehensive) list of counterfeit respirators.
CDC NIOSH approved N95 CDC Counterfeit Respirators
There are several Chinese manufacturers on the CDC NIOSH list. Unfortunately, all of the have raised their prices manyfold in response to the crisis. 3M products are only sold through authorized dealers and 3M has been outspoken against any price gauging by publicly releasing their price list:
3M Fraudulent Activity, Price Gouging, and Counterfeit Products (revised April 8th)
GPD Health is committed to providing solutions for all ppe products and to not in any way be involved in a price gauged market. We help our clients put in orders via authorized distributors and offer non-3M NIOSH products only directly from the manufacturer when the prices are within tolerated levels. We will continue to update our clients and our readers with up to date news and developments.
Millions of Counterfeit Masks Reaching Healthcare workers (5/13/2020)
KN95 Guidance
KN95 is the equivalent international standard for N95. These respirators were never used by the US, and hence never passed the NIOSH (The National Institute for Occupational Safety and Health) tests. In response to the respirator shortage surrounding COVID-19 the FDA in an EUA allowed the import of KN95 masks, when meeting various criteria (described in the link below). This resulted in a large number of KN95’s being allowed into the US. Unfortunately, many of these previously allowed KN95 respirators proved to be unreliable and unsafe. The FDA therefore revised its guidance removing many KN95s from the list of approved Non-NIOSH masks for import. There has been retesting of many models and a gradual expansion of approved Non-Niosh respirators. In fact, there currently is an oversupply of foreign KN95 masks on the ground in the US (often selling at below cost). We recommend extreme care be used in selecting a foreign KN95, particularly for medical use. We also recommend sampling any model prior to order since there are marked differences in size and fit.
Updated
FDA Guidance on Non-Niosh Respirators
FDA Approved Non-Niosh Respirators (updated June 19th)
Useful NIOSH-Style test results for many KN95 models (updated June 19th)
Some background on the (currently) authorized Chinese KN95 manufacturers
Surgical Gowns
Surgical gowns are tiered by the extent of protection and the corresponding environments where they should be worn. AAMI (The Association for the Advancement of Medical Instrumentation) and specifically, ANSI (American National Standards Institute)/AAMI PB70:2012 set forth the classification system (Levels 1-4), based on liquid barrier performance using standardized test methods. The U.S. Food and Drug Administration (FDA) has adopted ANSI/ AAMI PB70:2012 as the standard by which all surgical gown manufacturers must abide. Surgical gowns are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. For a device sold sterile, the FDA recommends sponsors provide the following information as detailed in the final guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Given the extreme shortage in gowns, they too have been the subject of much price gauging and fraud. There are no shortcuts in the diligence required to verify the manufacturer and the logistical supply chain up until delivery.
IR Thermometer Guidance
Infrared thermometers allow for a (virtually) contactless reading of temperature. Given that fever is a common symptom associated with the Coronavirus, routine temperature checks are advised. As a electronic medical device, the quality varies significantly. We recommend using an IR thermometer from a reputable manufacturer, and when importing to the USA, only use manufacturers that have successfully exported their products with all requisite regulatory and customs forms.
FDA Covid-19 Enforcement Policy
Tariff Exclusions and Exemptions - (sections 63-66)
Pulse Oximeter Guidance
Pulse oximeters have great potential in the early detection of severe Coronavirus. We now know that for many patients the virus will gradually constrict the volume of the lungs without filling them with fluid. Patients will then naturally increase their breathing and heart rates without becoming short of breath. This process can get worse until the lung capacity is so diminished and the body is so weakened that the patients can no longer breath freely. Patients thus end up in the ER with blood oxygen levels that are not consistent with consciousness. The body becomes so weak that it can no longer resist bacteria from entering the lungs causing patients to end up with pneumonia and on ventilators which have very high mortality rates. This can all often be prevented with a simply pulse oximeter that will alert people of a drop in blood oxygen levels BEFORE there is severe distress, allowing them to seek preventative early treatment well before it is too late. We strongly recommend that everyone make pulse oximeter readings part of their daily routine.
Quality does vary. We strongly recommend only using pulse oximeters that take fingertip readings and that are FDA approved (as apposed to “cleared”) with 510(K) notification. Pulse oximeters built into smart watches and bracelets cannot be considered sufficiently reliable for medical settings.
Antigen and Antibody Testing
Rapid test kits in general and those testing for antibodies in particular offer important information for the gradual relaxation of social distancing measures. The holy grail is a test that can be done at home (much like a home pregnancy test), or, at minimum, a test that can be done in a CLIA (Clinical Laboratory Improvement Act) waved facility. These are tests that don’t require complex lab personnel and equipment. Unfortunately many rapid antibody test kits have been released with very limited efficacy. The FDA has granted EUA (emergency use authorization) to several antibody tests; however they are all require testing of serum or plasma in a complex lab. GPD Health only supplies tests with EUA, and eagerly await the first reliable test that can be broadly distributed to the public via non-complex testing facilities. Note that even testing done at a lab and with a blood test should have FDA EUA under Policy C (see “FDA Testing “Guidance” linked below). Please contact us for further information.
John’s Hopkins Serology-Based Testing - Global Progress Tracker