SGS, the world’s leading provider of testing and certification services, looks at the changes that have been introduced during the COVID-19 pandemic to ensure frontline health care professionals receive safe personal protective equipment (PPE).
Responding to the pandemic has meant governments all over the world have suddenly started ordering medical PPE at unprecedented rates. This has created market conditions that allow counterfeit, poor-quality, out-of-date and unsafe products to easy enter the supply chain.
To speed up the supply of medical PPE, governments have also tried variety of alternative approaches. In the US, the US FDA introduced ‘conservation strategies’ that allow the use of expired PPE and the reuse of single-use PPE. It has also relaxed some medical PPE requirements through enforcement policies and Emergency Use Authorizations. These are intended to increase the availability of medical PPE by clarifying the policies that the FDA intends to apply (and those it will not) for medical PPE items such as gowns, gloves, masks, and respirators.
The Europe Commission has urged Notified Bodies to prioritize new medical PPE when conducting conformity assessments against Regulation (EU) 2016/425. To create greater flexibility, it has also authorized Member States to buy PPE that are not CE marked but which can demonstrate an adequate level of health and safety efficacy. Market surveillance authorities have also been instructed to focus on PPE compliance.
Europe defines medical PPE as either ‘medical device’ or ‘PPE’. The classification then defines which legislation is enforced:
• PPE – Regulation (EU) 2016/425
• Medical device – Medical Device Directive 93/42/EEC (MDD) to be replaced by the Medical Device Regulation 2017/745 (now delayed until May 2021)
These establish a risk-based classification system that considers the intended use hazard – greater risk equals higher class/category.
In terms of PPE, the classification can broadly be broken down into:
• PPE items – disposable and re-usable face masks ensuring protection against particulate hazards, disposable and re-usable coveralls, gloves, and eyewear protection, which are used for prevention and protection against harmful biological agents such as viruses
• Medical PPE – surgical masks, examination gloves and some types of gowns
Medical PPE items are classified by the US FDA using a risk-based approach that depends on intend use setting and hazard mitigation. Generally, PPE items that are intended to have a lower risk mitigation and/or are intended for lower risk settings are deemed to be Class l medical devices. Medical PPE intended for higher risk scenarios – e.g. surgical masks, surgical gowns, and surgical respirators – are classified as Class II medical devices and have a greater regulatory burden.
Surgical masks, as Class ll medical devices, must demonstrate to the FDA, through design and/or testing, that they can mitigate certain risk hazards associated with surgical settings. The FDA-recognized consensus standard for surgical masks, ASTM F2100 – Standard Specification for Performance of Materials Used in Medical Face Masks, contains testing and requirements for the materials used in the construction of these medical face masks.
Evaluations and methods within ASTM F2100 include:
• Submicron Particle Filtration Efficiency (PFE) – ASTM F2299
• Bacteria Filtration Efficiency (BFE) – ASTM F2101
• Blood/Fluid Penetration Resistance – ASTM F1862
• Breathability/Air Flow Resistance – EN 14683 Annex C
• Flammability Resistance – 16 CFR 1610
Surgical N95 respirators, which are N95 respirator face masks cleared for use in healthcare settings, must meet the typical FDA requirements of a surgical mask as well as those requirements for a respirator approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR Part 84. This requires the completion of a variety of performance tests, detailed in Subpart K of 42 CFR Part 84, as well as the submission of drawings, packaging, labels, user instructions, a product quality plan, and a quality assurance manual for its manufacturing facility. Approved products are added to NIOSH’s online Certified Equipment List.
Manufacturers and suppliers of medical PPE are advised to ensure their products conform to the correct standards for their market to ensure the products used by frontline health care staff are compliant, safe and effective.
SGS Medical PPE Services
SGS offers a comprehensive range of services to help manufacturers and suppliers of medical PPE successfully access target markets around the world. Utilizing our global network of testing facilities and experts, we offer a one-stop shop for all PPE testing and certification requirements. Learn more about SGS’s Medical PPE Services. [https://www.sgs.com/en/consumer-goods-retail/softlines-and-accessories/personal-protective-equipment-ppe/ppe-medical-gloves-gowns-and-masks]
For more information, please contact:
Senior Technical Manager – Hardlines
SGS Consumer and Retail
Email: crs.media ( @ ) sgs dot com
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.