ISO 80369-7: Changing the Standard for Luer Connectors
ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors. Its publication in October 2016 capped a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical Committee’s desire to disrupt as little as possible surrounding the current practices with Luer connectors, ISO 80369-7 still makes many significant changes.
2024 Predictions for Medical Packaging
What medical packaging trends are most likely to garner attention in 2024? Packaging Digest explored this during a virtual roundtable with industry experts.
How alcohol could make renal denervation for hypertension faster and simpler
Ablative Solutions is developing the Peregrine renal denervation (RDN) system to treat hypertension. The company hopes to follow Recor Medical and Medtronic in winning FDA approval for the system.
What 1988 Event Impacted the Use of Luer Connectors?
By 1980, the luer connector had become standard in the United States for connecting catheters to plastic tubing, according to a detailed history of the luer that MD+DI published in 2012. In Europe, however, the Record (also known as Rekord) was most widely used.
FDA Encourages Vaporized Hydrogen Peroxide as Possible EtO Alternative
The U.S. Food and Drug Administration (FDA) announced that it considers vaporized hydrogen peroxide (VHP) to be an “established method of sterilization” for medical devices.
Exploring Cell Technology for Medical Applications
“Medical devices are used in various environments – in hospitals, doctor’s offices, in patient’s homes, and even in the patient. Ensuring safe use and reliable performance starts at the design phase — decisions made throughout the development process will ultimately impact the device’s overall safety, reliability, and performance.”
Key considerations for electromagnetic sensors for surgical navigation
This article details the advantages of EMN for surgical navigation and explores considerations for optimizing sensor performance, cost, and manufacturability.
MasterControl Study: FDA, CPSC Recalls Up 115% Since 2018
MasterControl , a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) showing that recalls have increased more than 115 percent since 2018.
Body Temperature Softens Needle on Insertion
A joint research team at KAIST developed an intravenous (IV) needle that softens upon insertion, minimizing risk of damage to blood vessels and tissues.
