PPE News Flash - Volume 7
Intertek PPE News
Swimming Aids (PPE) Total Quality Assurance Solutions
Swimming aids such as flotation devices help new swimmers keep afloat. Intertek offers comprehensive swimming aid testing and certification services to support manufacturers, distributors, and retailers with testing capabilities to verify swimming compliance according to the requirements of the applicable safety standard EN 13138-1.
Intertek Protective Eyewear TQA Solutions
From safety, ski and swimming goggles to face shields, Intertek offers comprehensive protective eyewear testing used in a variety of professions and recreational activities to protect against hazards including bodily fluids, and penetration and perforation injuries.
PPE Recall Cases & Safety Alerts
EU Safety Gate
In 2021, the EU’s safety gate rapid alarm system issued a total of 138 notifications for the product recalls of PPE filtering face masks (137 notifications) and disposable gloves (1 notification). Common failures attributed to these PPE categories were due to non-compliance with the EN 149 standard, poor filtration performance, and/or poor fit to the face. For 2022 Q1 (from 1st Jan 2022 until 31st Mar 2022) there are a total of 19 notifications all related to filtering mask. All of them have issues with poor filtration performance.
The recall cases demonstrate the importance of testing protective products to the correct standard and ensuring the product meets the standard performance requirements. The basis is established according to General Product Safety Directives 2001/95/EC (GPSD) and non-compliances are published on a weekly basis.
Regulatory Updates
UK: HSE Makes Personal Protective Equipment (PPE) at Work Regulations
The UK’s national workplace safety authority and regulator, the Health and Safety Executive (HSE), has amended its PPE standard, PPER 1992. The Personal Protective Equipment at Work Regulation, now PPER 2022, has come into force and extends to limb workers’ and employers’ duties regarding PPE. Within it, workers must have sufficient instruction and training on PPE use. The assessment measures (including engineering control) must ensure PPE is provided; compatible; maintained; correctly stored; and used properly.
US: FDA Publishes Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health
To mitigate shortages observed by the U.S. government, the FDA published materials outlining the actions and lessons learned thus far from COVID-19’s public health challenges. The fact sheet includes the current availability of medical devices and apparel with an estimated shortage timeline for each. Amongst the list are non-surgical isolation gowns, surgical masks, and latex and vinyl patient examination gloves. The defined shortage list is determined by the amended Federal Food, Drug, and Cosmetic Act (FD&C Act), adding section 506J which requires manufacturers to notify the FSA during a public health emergency of the permanent or temporary discontinuation of certain devices that may lead to disruptions of supplies in the U.S.
Canada: Personal Protective Equipment Survey
The Personal Protective Equipment Survey explores the evolution of the private sector’s demand and supply of PPE in January 2022. Notably, concerns about personal protective equipment shortages increased in January and nearly 1 in 10 (8.6%) businesses in the manufacturing, retail, and wholesale sectors were involved in the manufacturing or distribution of personal protective equipment.
Canada: The DM and CDS Issues a New COVID-19 Directive
The Department of National Defence (DM) and Chief of Defence Staff (CDS) have released the Directive on DND/CAF Operating and Reconstituting in a Persistent COVID-19 Environment, superseding the 2021 Posture, and reverting to some pre-pandemic conditions.
Intertek PPE Resources
On-Demand Webinar: Introduction to Safety PPE Testing and Certification
Do you need an introduction to our testing and certification capabilities? Intertek PPE experts present regulatory guidelines and safety standards for brands, buyers, and manufacturers. View this webinar to learn how we can assist you.
Brochure: Personal Protective Equipment
Read our newly released PPE brochure for the consumer products and retail industry. Learn about Intertek’s capabilities for providing Total Quality Assurance solutions for a broad spectrum of PPE products.
Guide: PPE Production: Understanding Product Categories and Testing Requirements
We developed this guide for manufacturers who not familiar with the complex production requirements, to help ensure you are producing quality and compliant products.