Blood gas analyzers measure gases dissolved in the blood, such as oxygen and carbon dioxide. Such information is vital when caring for patients with critical illnesses or respiratory infections, such as COVID-19.
Widespread testing is crucial for tracking the spread of COVID-19. As of April 19, the United States alone had performed almost 997 million tests for COVID-19 since the outbreak of the pandemic, the highest number of any country.
At the beginning of 2020, Hervé de Malliard, CEO of systems integrator MGA Technologies in Civrieux d’Azergues, France, observed the first signs of the COVID-19 crisis.
Validation causes more headaches for medical device manufacturers than almost any other stage of the production process. For companies certified to ISO 13485, validation is always a costly and time-consuming undertaking, regardless of whether a new process is being set up or an existing process is being transferred.
In May, the European Union’s sweeping new Medical Device Regulation (MDR) will take effect. (The law had been scheduled to go into effect last May, but was postponed due to the COVID-19 pandemic.)
Shukla Medical, a subsidiary of aerospace manufacturer S.S. White Technologies, designs and manufactures universal orthopedic implant removal tools such as the Xtract-All Spine Universal Spinal Implant Removal System. Their products are used by surgeons to preserve the patient's bone while removing old implants.
Much of the conversation around medical device cleanliness is about sanitation and sterilization. While both are important for eliminating potentially harmful microorganisms, medical devices also need to be cleaned prior to sterilization.
Flow and leak testing are required for any medical device that brings a substance to or from the body. Flow testing ensures that there are no blockages and the substance being delivered can make it through.
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