Disposable Medical PPE
The World Health Organization (WHO) has estimated that the global fight against COVID-19 requires over 89 million masks, 30 million gowns, 1.59 million goggles, and 76 million gloves, a month. Without this equipment, medical staff, patients, and other frontline groups are at risk.1 In Spain, it is reported that a severe lack of PPE has resulted in 12,000 health care professionals becoming infected and, in Italy, it is thought 61 doctors died because they lacked adequate protection.2
Beating a pandemic requires a global response. Governments all over the world have rapidly begun ordering PPE at unprecedented rates.3 The great disparity between need and availability has created a market that allows counterfeit, poor-quality, and out-of-date products to enter the supply chain.
There have been several high-profile cases of PPE supplies failing to match relevant safety standards. In the UK, a shipment of 400,000 gowns was rejected when they were found to be ‘useless’.4 In Holland, 600,000 face masks were recalled for poor quality.5 The issue happened in Australia and Finland, where some PPE was also found to have been marked with a use-by date of 2012.6
To expediate the supply of PPE, some Governments are trying alternative approaches. For example, the US Food and Drug Administration (FDA) has introduced ‘conservation strategies’, which include the use of expired PPE and the reuse of single-use PPE.7 It has also relaxed some medical PPE requirements through enforcement policies and Emergency Use Authorizations. Through these guidance the FDA seeks to increase the availability of medical PPE by clarifying the policies that FDA intends to apply (and those it will not) for medical PPE items such as gowns, gloves, masks, and respirators.
In Europe, the 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 can demonstrate adequate levels of health and safety efficacy but is not CE marked. To create an extra level of protection, it has also instructed market surveillance authorities to focus on non-compliant PPE.
Around the world, regulatory authorities have been forced to adopt temporary practices to increase the flow of PPE, without letting dangerous products reach the frontline.
In Europe, medical PPE is either a ‘medical device’ or a ‘PPE’ item. What classification is given to the product will affect which legislation it should conform to:
- PPE – Regulation (EU) 2016/425
- Medical devices – Medical Device Directive 93/42/EEC (MDD) to be replaced by the Medical Device Regulation 2017/745 (now delayed until May 2021)8
These establish a risk-based classification system that considers the intended use hazard, the greater the risk, the higher the 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
In the US, medical PPE are classified by a risked based approach depending on their intended use and setting. The FDA classifies non-surgical items, such as isolation gowns, general medical masks, and examination gloves, as Class l medical devices. These are regulated under 21 CFR 880.6250, and 513(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act.
Medical PPE for use in surgical settings, such as surgical masks, gowns, and respirators, are considered Class ll medical devices, and thus the FDA requires a higher level of regulation (21 CFR 878.4040).
Surgical masks, for example, are regulated under 21 CFR 878.4040 and must demonstrate to the FDA, through design or testing, that they mitigate certain hazards associated with surgical settings. FDA-recognized consensus standards have been developed for these areas and include:
- ASTM F2100 – performance of materials (overall standard for surgical masks)
- ASTM F2101 – bacterial filtration
- ASTM F2299 – particulate filtration
- ASTM F1862 – blood/fluid penetration
- EN 14683 Annex C – breathability
- 16 CFR 1601 – flammability
A surgical N95 respirator, an N95 that has been cleared for use in healthcare settings, must meet the typical FDA requirements of a surgical mask as well as being a respirator approved by the National Institute for Occupational Safety and Health (NIOSH) under 42 CFR Part 84.
NIOSH approval of a respirator entails the successful completion of performance tests, the submission of drawing, packaging, labels and user instructions, a product quality plan, and a quality assurance manual for its manufacturing facility. The performance test requirements can be found in Subpart K of 42 CFR Part 84. Once a product is approved, it must be added to NIOSH’s online Certified Equipment List.
The COVID-19 pandemic has put a considerable strain on PPE supply chains. This has allowed sub-standard products to flood onto the market, thereby endangering the health of frontline medical staff and keyworkers. In response, authorities around the world have loosened restrictions to improve the flow of safe and effective PPE to those people that need it.
Temporary regulatory changes have added greater complexity to a market that is already necessarily difficult to navigate. Manufacturers and suppliers are advised to partner with a third-party service provider that can support them in complying with their target market’s requirements.
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.
For further information on our range of services, please contact us direct:
Senior Technical Manager - Hardlines
SGS Consumer and Retail
2 ‘Health Care Kamikazes’: How Spain’s Workers Are Battling Coronavirus, Unprotected & Italy confirms 61 doctors have died after contracting coronavirus
3 France has ordered over 1 billion face masks, most from China: minister
4 Exclusive: PPE brought back from Turkey by the RAF found to be "useless"
5 Netherlands recalls 600,000 face masks from China due to low quality
6 Finland: Chinese face masks fail tests & Australia seizes faulty coronavirus protective equipment imported from China
7 Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers
8 Safeguards - Europe’s New Medical Device Regulation Delayed by One Year