COVID-19 has disrupted supply chains across the globe, highlighting the vulnerabilities in the current linear manufacturing paradigm of take, make and waste. During this pandemic, perhaps no shortage has been as acute as the one of Personal Protective Equipment (PPE) for frontline health workers. The health care providers across hospitals need industrial grade N95 respirators to protect themselves while treating COVID patients. Since 80% of PPE, including N95 respirators, are manufactured in China, the geopolitical issues between the US and China compounded the shortage of N95 masks.
To address shortages driven by the COVID-19 pandemic, the CDCP and the FDA issued emergency use authorization (EUA) to a few companies for the sterilization of N95 masks. FDA granted Stryker an EUA to decontaminate N95 respirators using its Sterizone VP4 sterilizer, allowing two decontamination cycles per mask. The FDA later revised this EUA to exclude filtering face-piece respirators (FFRs) respirators and Non-National Institutes of Occupational Safety and Health (NIOSH) respirators manufactured in China. The Sterizone VP4 is a low-temperature sterilization unit that is easy to operate and can process mix and match loads of metal and non-metal reusable medical devices capability of up to 75lbs, with a touch of a button.
In addition to sustainably solving the N95 shortages, Stryker Sustainability Solutions is a leading provider of reprocessing and remanufacturing services of single-use medical devices. Reprocessing of single-use medical devices (SUDs) is the practice of inspecting, cleaning, function testing, sterilizing and packaging so that they can be clinically and safely used again. The global reprocessed medical devices market value was $1.3 billion in 2018 and estimated to hit over $3 Billion by 2025, growing at 15% CAGR. The complexity of geopolitical issues and supply chain volatility will continue to hasten the growth of reprocessed device industry, spurring both innovation and near shoring. This is tightly-regulated industry where quality and safety are major concerns. The stringent regulations have already positively impacted adoption as the quality is tightly monitored on reprocessed devices.
Stryker’s triple-bottom approach around reprocessed devices is helping customers save money, enabling them to reinvest in patient care. It also diverts waste from landfills and reduces GHG emissions, setting an example for the medical devices industry. We give kudos to Stryker for their sustainability initiatives and protecting frontline medical workers!