A healthcare client, based in New York City, was planning to open the first FDA-regulated commercial facility in the United States. This facility, called the ProMade PoC Center, was intended to create accessto patient-specific custom solutions for more complex procedures that are digitally designed pre-operatively for an ideal match with the patient’s anatomy. However, the client faced several challenges in ensuring that the facility was in compliance with all relevant federal, state, and local regulations.
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Lima HSS ProMad – First FDA-regulated 3D printing facility in the United States
Project name
Lima HSS ProMad
Location
USA, New York City
Duration
6 months
Client
6 months
Date of completion
March, 2021
Challenge:
Solution:
The healthcare client turned to Safety Excellence Group for help in addressing these challenges. Our team of experienced environmental, health, and safety consultants worked closely with the client to provide a comprehensive environmental assessment and a comprehensive HSE report that outlined all relevant federal, state, and local requirements. We also provided an industrial hygienist and a certifiedradiation equipment safety officer (CRESO) to review any radiation-emitting tool, as well as an environmental manager and two qualified principal consultants for the project. Our team also provided support in several other key areas, including:
- Coordinating with the local structure and stakeholders for HSE aspects, particularly those concerning the fire/explosion risk and emergency management in general
- Identifying and highlighting the potential risks and penalties of the local authority and the possible impact on the client’s business, including administrative sanctions, production stoppage, and criminal liability under Italian law
- Highlighting the obligations and tools necessary to protect the client and its management, including industrial waste management and potential other environmental impacts
- Verifying the regulatory aspects, identifying temporary storage areas and the correct methods of storing the waste, identifying local companies charged with disposal, and proposing related contracts and economic negotiations
- Supporting environmental permits and registration with the NYC and NY State authorities
- Developing and implementing HSE programs, as well as training programs for staff and management
- Providing project management of radiation registration via CRESO and delivering an electron beam melting (EBM) radiation registration report
Additionally, we provided support for the client’s compliance with NYC DEP sanitary discharge requirements and air registration and/or permits. This included meetings required to coordinate a path forward with the DEP, preparing a one-page summary of the EBM machine specs focused on emissions,performing air sampling per OSHA and NYC DEP requirements, and providing sampling of water to determine the eligibility of water discharge.
End Result:
Thanks to Safety Excellence Group’s expert support and guidance, the healthcare client was able to overcome the challenges it faced and open the ProMade PoC Center on March 24, 2021. The facility is the first FDA-regulated commercial facility of its kind in the United States and will create access to patient-specific custom solutions for more complex procedures that are digitally designed pre-operatively for an ideal match with the patient’s anatomy. The facility’s integration with the client’s world-leading academic medical center specialized in musculoskeletal health will further advance state-of-the-art solutions to the most complex orthopedic challenges. The facility will also offer design and manufacturing services to patients from other hospitals in the United States. The facility’s openingmarks the next stage of realizing the ultimate goal of the two organizations: to restore the emotion of motion by empowering surgeons to improve patient outcomes from joint replacement surgery. With Safety Excellence Group’s support, the client was able to successfully navigate the complex regulatorylandscape and achieve its vision of providing world-class healthcare solutions.