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Safety Gloves for Protection of Health Care Professionals

Periodic Reporting for period 2 - SafeGlov (Safety Gloves for Protection of Health Care Professionals)

Reporting period: 2020-12-01 to 2021-11-30

Needlestick, cut or syringe puncture-based injuries have potentially severe consequences for personnel in healthcare, not only in a pandemic. In addition to direct injuries, the protection is lost for gloves upon perforation. Perforated gloves do not provide any barrier against potentially infectious contact, leaving health care professionals vulnerable to contaminated body fluids, potentially carrying blood-borne diseases including hepatitis B/C and HIV. The prevalence of such incidence is high, amounting to millions of cases each year officially reported in the EU. The cost associated with such incidents is a major societal burden on Europe’s communal healthcare systems. This provides significant financial pressure for healthcare systems to adopt new innovations addressing the increased need for safety.

As a world debut, Smarterials integrates a double-layer into a single glove, which is innovative in terms of simplification, comfort and safety. The Two-in-One gloves integrate a sandwich layer to provide multi-barrier protection and an indicator, warning the user in case of breach. Gloves from these new materials provide unrivalled donning and wearing comfort. At the same time, production and use are more resource efficient and can be made cheaper compared to existing double gloving systems. The patent- pending invention builds on large-scale available substances of tailor-made material components.
Smarterials has been actively proceeding on the technical, regulatory and commercial side, even if impaired by the coronavirus pandemic. To cope with the impact of the pandemic and the problems with international travel, Smarterials employs a Malaysian consultant – who spent several weeks in the Berlin labs – and started a cooperation with a Malaysian University to support the development activities in Asia. A product management plan covers the implementation stages from conception, feasibility, development, quality, launch to delivery of the product. On the commercial side, Smarterials is in close contact with suppliers, various producers and distributors of surgical gloves to finalize the commercialization activities, actively working remotely with Asian producers to scale-up the production of Two-in-One (TiO) gloves.

The development was driven by a spec sheet mapping the market demand. On the technical side, Smarterials made a huge step towards the final product: the materials, more precisely Smarterials’ suspension, has been fine-tuned and scaled-up in three subsequent snapshots. A robotic dip-coating system was built to adapt the technology for high-frequency lab production and detailing the dipping process parameters of the manufacturing process, i. e. times and temperatures for industrial steps carried out during manufacturing, facilitating the step to the pilot and subsequent production lines. This activity was also identified as an additional business area, since requests from other companies for the robotic setup have been received.

Among others, the laboratory environment for testing and ensuring the quality of the R&D activities covers tests of the perforation indicator and needle puncture testing as well as properties and safety of the product. On the regulatory side, Smarterials’ interdisciplinary team is constantly managing and assessing the actual results, costs and planning via a documenting communication and within its design reviews. Smarterials is also setting a quality management system (QMS) in accordance with EN ISO 13485:2016.
Society is highly dependent on a functioning health care system. In the Covid19-pandemic the socio-economic relevance and impact of quality personal protective equipment (PPE) became obvious. With stocks low, hospitals and public bodies bought every PPE product available, sometimes even uncertified products. In 2021 the situation around PPE relaxed. In result, competitive market conditions returned, and quality products regained strong positions on the market. In fact, a competition around quality products and technologies is likely to start.

Smarterials develops a product to literally add an extra layer of safety for healthcare professionals, protecting those from blood and body fluid contamination as well as chemotherapeutics and similar pharmaceuticals. The objectives of the SME Instrument Ph II project are to realize Smarterials’ next big milestones: transfer of Two-in-One gloves onto production lines, certify the product as a medical device class IIa to finally launch the product in early 2023. Our gloves are one element to increase the safety of health care personal during work, keep health care workers healthy themselves and thereby protect the integrity of the health care systems. In addition, the Two-in-One gloves will replace the need to wear two gloves, thereby substantially reducing the amount of waste from disposable medical products