Month: April 2020

In order to determine how widespread COVID-19 has become, medical laboratories and In Vitro Diagnostics (IVD) companies are in the midst of developing serological survey testing. This type of testing would be able to detect whether a person’s immune system has developed antibodies to counteract the SARS-CoV-2 virus. In turn, this could also give insight into the infection rates of entire populations.  Because of the delay from the time of infection to when the body begins developing antibodies, these tests...

In light of a shortage of drugs needed for COVID-19 ventilator patients, the Food and Drug Administration (FDA) is not taking action against compounding pharmacies that make copies of approved drugs, use bulk ingredients that are unapproved, or fail to meet manufacturing requirements for stability. The primary reason for relaxing these regulations is to make treatment options available to hospitals that can not obtain FDA-approved drugs. The new rules apply only to outsourcing facilities, and not to smaller compounders that...

The U.S. Food and Drug Administration took action just ten days after learning about new direct-to-consumer (DTC) testing schemes. Lab companies were selling COVID-19 tests straight to consumers who were promised that the samples they collected themselves would be tested at Clinical Laboratory Improvement Amendments (CLIA)-certified labs.  Although the at-home tests for COVID-19 would seem to be a good option to increase nation-wide testing, the problem lies with the collection of the sample by the consumer. Specimen quality concerns are...

The U.S. Drug Enforcement Administration (DEA) has issued three exceptions for registered hospitals and clinics in light of the COVID-19 pandemic. These exceptions will endure for the duration of the pandemic and include the following: DEA-registered hospitals and clinics are temporarily allowed to handle controlled substances at their satellite locations, provided that certain conditions are met. Distributors also have the flexibility to ship these substances directly to these set locations if the right conditions are met. Narcotic treatment programs are...

Patient satisfaction is driving medicare scoring. That means an increase in interest for technologies that are able to reduce - or completely remove -  pain from the patient experience. One such technology is Velano Vascular’s PIVO device. When blood is drawn with one of these devices, a small, flexible flow tube is pushed through an IV line and directly into the vein in order to collect the needed amount of blood - causing no pain to the patient.  According to...