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In the medical device industry, patient safety and regulatory compliance are non-negotiable. One critical step in ensuring both is understanding which chemical substances may be released from a device during storage, handling, or clinical use. This is where Extractables and Leachables (E&L) testing comes in — a process governed by ISO 10993-18, the international standard for the chemical characterisation of medical device materials.

Why does Over-Extraction Mislead Results? ISO 10993-18 defines the framework for chemical characterisation of medical devices. The intention is clear: to protect patients by identifying…

Introduction Choosing the right biocompatibility standard is critical for regulatory success. ISO 10993 and ISO 18562 both assess medical device safety. But they apply to different risk pathways. Understanding their scope helps manufacturers design compliant devices, satisfy regulators, and…

This article explores cytotoxicity testing, a critical step in assessing the biocompatibility of medical devices. It explains how cytotoxicity studies are conducted using in vitro methods to evaluate whether materials used in a device cause cell damage or death.

Introduction For over three quarters of my life, biological evaluation meant absolutely nothing to me. But in this last quarter of my…

What does ATP stand for? ‘Mitochondria is the powerhouse of a cell’ is a phrase that should be engrained from many science lessons in school, but what exactly gives the mitochondria its power-like abilities? The answer is an intracellular small…

Understanding BS EN ISO 22441:2022 – The Standard Behind VHP Sterilisation  BS EN ISO 22441:2022 sets the global framework for validating low temperature hydrogen peroxide sterilisation processes, ensuring both safety and repeatability for medical device manufacturers.

How Can Medical Device Manufacturers Validate Sterilisation? In the world of medical devices, the term “sterile” represents a crucial claim: that a medical device is free from viable microorganisms. This guarantee is essential for ensuring patient safety during critical…

Real-World Challenges in Reprocessing Imagine a crucial step in patient safety being overlooked. That’s often the reality for sterile processing departments (SPD). Without proper inclusion and clear communication, the risk of improper reprocessing skyrockets, putting patients in harm’s way…

Medical Device Cleaning Procedures Cleaning procedures are critical for medical devices as they reduce the risk of infection when being handled between uses. For this reason, cleaning procedures…

Highly Accelerated Life Testing HALT HALT, or Highly Accelerated Life Testing was a term coined by Gregg K. Hobbs in 1988, describing an aggressive methodology of stress testing. It was intended to rapidly discover flaws in a device or part…

The Increasing Demand for Chemical Disinfectants It is no surprise that since the COVID-19 pandemic, there has been a surge in the disinfectant market, as manufacturers produced more and more in order to meet the increasing demand. However, this increase…

Medical Devices: Are they compatible with IPC? As a medical device manufacturer, your products contribute towards the treatment, care and recovery of millions of people around the world. But while they are designed to function reliably, many medical devices are…

What Is Quality Testing in Medical Devices and Why Does it Matter?  When people think of medical devices, they often picture the final product – sleek, sterile, and ready for use. But behind every safe and effective…

Introduction  In the ongoing battle against infections, surface material compatibility often goes unnoticed, yet it significantly impacts both patient and healthcare provider safety. …

What do air purification and disinfection systems do? Air purification and disinfection systems are being designed to effectively clean the air in the environment and reduce or inactivate harmful populations of airborne pathogenic microorganisms, aiming to provide significant assistance in…

What classification of medical device is my disinfectant? Annex VIII of the EU 2017/745 Medical Device Regulation (MDR) outlines the classification rules for medical devices. Application of these classification rules should be determined by the intended use of the device.

The importance of the EN 17272 test Healthcare-associated infections (HCAIs) are one of the biggest threats to the healthcare system. These infections are usually acquired after hospitalisation and manifest 48 hours after admission to the hospital. These infections are…

Disinfection systems utilising ultraviolet C (UV-C) irradiation are becoming more and more common, but this increased usage can lead to an increased risk of harmful exposure to UV-C radiation. UV-C exposure can lead to some unpleasant health issues, particularly in…

What is a total viable count? Total viable count (TVC) is a measurement that estimates the total amount of living microorganisms in a sample, this includes bacteria, yeast or mould species. TVC counts are usually regarded as ‘non-selective’ as the…

Laboratory Training Course for Medical Device Manufacturers We have been listening to our client feedback, and in response to market need, Lorit Consultancy and Test Labs have co-developed a laboratory training course specifically designed for medical device manufacturers. This course…

Medical Devices: Are they compatible with IPC? As a medical device manufacturer, your products contribute towards the treatment, care and recovery of millions of people around the world. But while they are designed to function reliably, many medical devices are…

What is Good Laboratory Practice? Good Laboratory Practice (GLP) refers to a set of principles designed to be implemented within a testing facilities quality management system. These principles define the processes and conditions under which non-clinical health and environmental safety…

What is IEC 60601-1? First published in 1977 by the International Electrotechnical Commission, IEC 60601-1 General requirements for basic safety and essential performance is the general standard of the 60601 series and gives requirements that must be met throughout the…

Why Does Electrical Safety Matter in Medical Technology? Electrical safety is of the utmost importance in medical technology because medical devices, which range from simple diagnostic tools to complex life support systems, interact directly with patients and medical personnel. One…