Personal Protective Equipment (PPE)
PPE is any protective garment or equipment designed to protect the wearer’s body from injury or infection. This can include protective clothing, helmets, goggles and dust masks.
One of my jobs at a hazardous waste facility in the United Kingdom was to order and stock the company PPE room. During this period, I became accustomed to the intricate differences between earplugs and earmuffs, hazmat suits colours (exposure limits depending on the chemical) as well as the difference between anti-static and steel-capped boots. I also trained to be a Respiratory Protective Equipment (RPE) fit tester. Subsequently, I trained colleagues on how to fit, don, doff and test half and full-face masks. Legally RPE must be both adequate and suitable to ensure protection to the wearer.
PPE regulations in the UK
The United Kingdom has defined laws about worker safety stemming from the Health and Safety at Work etc. Act of 1974. Work regulations about PPE were first published in 1992. The Health and Safety Executive (HSE) in the United Kingdom defines the terms adequate and suitable to mean the following: –
Adequate – It is right for the hazard and reduces exposure to the level required to protect the wearer’s health.
Suitable – It is right for the wearer, task and environment, such that the wearer can work freely and without additional risks due to the PPE.
All PPE must meet the relevant minimum British standards (BS EN) or international standards (BS EN ISO). Furthermore, CE marking is essential to ensure manufacturer responsibility, conformity with all the legal requirements to meet this standard. Additionally, the manufacturer is ensuring validity for that product to be sold throughout the European Economic Area (EEA). These Standards could potentially change, as the United Kingdom is under a transition period because of Brexit.
Due to recent shortages in PPE because of the Coronavirus, necessity has been the mother of invention. Initially, several companies answered the call to supply alcoholic hand sanitisers. With the supply chain in disarray 3D printing has had an immediate beneficial effect on manufacturing processes. 3D printed PPE covers the shortage
of supply. Therefore, assisting medical and social workers to carry out
their everyday tasks safer. Opensource PPE products for 3D printing is available on various websites. Below the face shield, mask and ventilator splitter shown are all examples of 3D printed PPE.
Precautions When 3D Printing PPE
3D printed materials are often more porous than typical medical device materials due to manufacturing methods. This could potentially allow 3D products to harbour microbes if they are not carefully sterilized.
The most frequently used methods of sterilisation include heat, radiation and chemical sterilisation. Any 3D printed device produced for healthcare needs must be able to withstand exposure to these techniques.
From experience, it is known that most 3D printed creations warp, melt or lose tensile strength when exposed to medical sterilisation. On a whole 3D printing sterile medical equipment is not conducive to mass-scale production.
Isinnova is a 3D printing company based in Brescia, Italy. They collaborated with physicist Massimo Temporelli (FabLab) and Chiari hospital in Lombardy region to produce replacement ventilator valves. In the first instance, they helped 10 Coronavirus patients. Additionally, the hospital received 100 more valves made via 3D printing. However, the manufacturers of the valves are refusing to share their blueprint for further production and could potentially sue for copyright breaches. Furthermore, critics have complained that the 3D valves were not tested for customary safety certifications. Because of the current circumstances and worldwide shortage of ventilators. I am sure if asked the patients would be grateful for Isinnova and Massimo’s ingenuity.
Bravissimi ragazzi, grazie tanto.