By Linda Rouse O’Neill, Senior Vice President, Supply Chain Policy, Health Industry Distributors Association
When medical products are constrained or in short supply, offers from unknown sources fill inboxes across the supply chain. Navigating these offers is difficult, especially during times of crisis. During the COVID-19 pandemic, providers reported receiving incorrect product, poor quality items, or counterfeit items that failed to protect staff from disease risks.
Fortunately, medical products distributors were there to help. Distributors have experience vetting suppliers and can be a resource for providers who wish to perform due diligence. That is why HIDA recently launched a Supplier Checklist to help healthcare providers and public partners who also do not always have this type of expertise vet suppliers of healthcare products. The HIDA Supplier Checklist contains criteria and best practices to perform due diligence on prospective suppliers.
Key questions to ask include:
- Are you able to demonstrate proof agency regulatory compliance?
- Are you able/willing to host a site visit for potential commercial or public sector partner?
- How long have you or your source manufactured medical supplies?
- Can you provide information on inventory?
- Can you provide samples of products from multiple lots?
- Can you provide copies of customer invoices with specific products listed?
- Can you provide a copy of your quality manual?
- Can you provide the company’s W-9 and applicable business licenses in the states supplied?
- Can you provide documentation of financial health?
- Have you ever had to conduct a FDA recall? If so, for how long?
- When was your most recent FDA inspection? What was the result?
- Do you have an International Organization for Standardization (ISO) registration number?
The Supplier Checklist is a project of the HIDA Industrial Base Working Group. The Working Group collaborates with federal partners to provide industry perspectives on strategic and thoughtful approaches to increase domestic manufacturing capacity for critical medical products.
The checklist is one of many preparedness resources HIDA has created in partnership with other stakeholders.. HIDA provided subject matter expertise to ASPR TRACIE for the Disaster Available Supplies In Hospitals (DASH) tool. This is an interactive tool that helps hospital emergency planners and supply chain staff estimate supply needs during various public health scenarios. And in collaboration with ASPR, HIDA published a Preparedness Playbook to monitor the medical supply chain and coordinate production and distribution during a public health emergency.