The FDA Considers How Best to Weather Risks in the Medical Device Supply Chain
While the Security Exchange Commission and international regulatory bodies, such as the Organization for Economic Cooperative Development (OECD), have been uncharacteristic drivers of upstream supply chain compliance issues affecting the sourcing of medical device materials, public health regulatory agencies are deliberating over downstream concerns of “critical” medical device product shortages. On April 11, 2013, the U.S. Food and Drug Administration (“FDA”) convened an advisory board committee during which the agency presented their concerns over the impact of extreme weather conditions and natural disasters have had on medical devices. Impactful incidents include: power and network outages; flooding; extreme hot or cold temperatures; high or very low humidity; dust storms and fires; water supply contamination; and transportation interruptions. The effects of any of these incidents can lead to devastating public health outcomes. For example, when the raw materials or components cannot be obtained by medical device manufacturers, there potentially may be a shortage of essential medical devices commercially available. Medical devices encompass a large breadth in terms of variety, applications, and uses. As recently as in 2011, less than 10% of medical devices in the U.S. were the product of a sole manufacturer. Increased globalization of the supply chain and reliance on sub-sourced components and raw materials translate into an increasing need to understand the nuances of supply chain positions and upstream sourcing. The significance of extreme weather conditions’ impact on the medical device supply chain may be more broadly linked to the quality of supplier management.
Members of the Advisory Board committee, including industry, had varying perceptions regarding the predominant drivers of product malfunctions and shortages and how to remedy their occurrences. At the April 11th meeting, a panelist representing industry posited that the issue may be broader than the affects of extreme weather and natural disasters and that there is a difference today in the complexity of the supply chain than when the quality systems regulations were initially drafted 20 years ago. Ultimately, the consensus of the board alluded to a need to reinforce the quality built into managing suppliers and their ability to deliver conforming parts and components.
As background, in the U.S. and the EU, finished device manufacturers have a legal responsibility for the products and services they obtain from outsourced vendors and suppliers. In the EU, conformance with a harmonized standard, ISO 13485:2003, requires a manufacturer to identify its outsourced processes and the controls applied to them. In the U.S., the Quality Systems Regulations under 21 CFR § 820 require finished device manufacturers to bear overall responsibility for the safety and effectiveness of a finished device. Although the FDA’s inspection authority only extends to manufacturers of finished devices, under 21 CFR § 820.50, such manufacturers are expected to assess and evaluate suppliers to ensure their processes and products meet quality standards. To that end, manufacturers must maintain and follow a documented evaluation method to select and assess suppliers.
The FDA is signaling its expectations that manufacturers maintain better control of their supply sourcing through increased enforcement efforts. For example, at the close of 2012, more post-inspection warning letters citing supplier control (820.50) violations were issued than in 2009, 2010, and 2011 combined, and that 2012 count was nearly matched in the first quarter of 2013. The FDA considers products that do not conform to the QSRs to be adulterated within the meaning of the Food, Drug and Cosmetic Act and subject to removal from the market. In the current age of information and big data, the threshold standard for what information to obtain and how to manage it has evolved from the paper and pen checklist a manufacturer might rely on from its supplier. To ensure compliance, prudent manufacturers should employ logistical tools for robust data obtainment and analysis to assess and monitor their suppliers. The Advisory Board and the FDA will likely revisit this issue in a guidance document addressing its present-day interpretation of supplier controls.