In honor of International Women’s Day (IWD) on March 8, the American National Standards Institute (ANSI) proudly recognizes the efforts of women in proactive leadership roles who are committed to the COVID-19 recovery and response.
IWD is a time to celebrate women's achievements, and in light of the day, UN Women—the United Nations entity dedicated to gender equality and the empowerment of women—spotlights its 2021 theme: “Women in leadership: Achieving an equal future in a COVID-19 world.” Today, ANSI takes a closer look at the female management and leadership in support of Standards Alliance Phase 2, which addresses global coronavirus response and recovery and supports gender-based issues and inclusiveness.
Women United in Action in the Fight against COVID-19
Since the start of the COVID-19 pandemic, nations across the world have raced to increase production and access to medical devices to prevent and treat the deadly virus. In-demand resources include personal protective equipment, rapid diagnostic test kits, and ventilators. However, countries cannot safely deploy these products without a strong medical device regulatory framework and knowledge of emergency use authorization (EUA) procedures and rules.
Women in outreach, implementation, and leadership roles have helped support access to essential medical resources, as a part of their work with Standards Alliance Phase 2 (SA2). SA2 is a public-private partnership with the United States Agency for International Development (USAID), which, among other priorities, focuses on COVID-19 response and recovery. While USAID has committed more than $1 billion to help fight the virus pandemic around the world, women who are supporting and leading elements of the SA2 project are invaluable in the fight against the pandemic.
In particular, the SA2 COVID-19 Medical Device Regulatory Convergence project (MDRC) is focusing on reducing barriers to countries' importation of U.S. medical devices that aid in the fight against COVID-19. MDRC is a partnership between ANSI and USAID, and spearheaded by the Advanced Medical Technology Association (AdvaMed).
Steven Bipes, vice president of global strategy and analysis at AdvaMed notes, "AdvaMed supports ANSI’s recognition of the opportunity to expand programing to address gender-based issues such as representation in policy making and technical work, and gender responsive standards. Medical device standards have a broad impact across society and tend to have a foundation in STEM fields, which often include an underrepresentation of women. The expansion of the Standards Alliance through this project will pursue an inclusive approach to foster equality by working to ensure gender representation during events and in speaking roles."
A key component of the MDRC is the Inter-American Coalition for Regulatory Convergence, established to achieve medical device regulatory convergence and implement cross-sectoral good regulatory practices. The coalition's technical secretariat is led by the industry’s leading and highly experienced professionals who are also women from a diversity of national and ethnic backgrounds. This diverse team of women experts in the fields of medical technology, global strategy, technology, and regulatory affairs, and more is actively working with key government agencies and local private sector partners to identify how the industry can help ensure that providers and patients everywhere have access to the medical technologies they need to help diagnose and fight the coronavirus.
MDRC serves to increase the transparency and predictability of partner governments' regulatory ecosystems for medical devices, aligning them with international standards, and improving their overall National Quality Infrastructure.
Ultimately, the collaborative effort will enable the importation of testing kits; improve governments' acceptance of international standards for medical equipment; diminish regulatory barriers and impediments; and train various agencies and the private sector on documentation required for regulatory approval and the proper use of medical devices and testing equipment.
ANSI recognizes the 20+ women who lead efforts as part of the AdvaMed MDRC Core Team, the AdvaMed – MDRC Support team, the AdvaMed MDRC Steering Group (Global) & AdvaMed Global Harmonization Working Group, the AdvaMed MDRC Steering Group (Regional), women in leadership within ANSI, and others involved in the effort against COVID-19, in support of International Women's Day.
More about Standards Alliance Phase 2
The SA2 is a public-private partnership that promotes reciprocal trade with the U.S. by developing the capacity of partner countries in the areas of legal and regulatory framework, standards development, conformity assessment procedures, and private sector engagement to improve their understanding and application of standards and conformity assessment. Launched in 2019, the second phase of the project will last 5 years. SA2 builds on the past successes, lessons learned, and impact of the first phase of the Standards Alliance.
Read more about International Women's Day.
Access the related article: Standards Alliance Phase 2 Supports COVID-19 Response and Recovery