1. Salcido, Richard MD

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Wound care professionals focus on providing quality care for their patients and working within the healthcare management systems. We trust that our wound products are safe and efficacious, but what is the process that safeguards the quality of products approved and monitored by the Food and Drug Administration (FDA)?

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To maintain quality oversight and consumer protections, the FDA has robust quality management oversight programs. As practitioners and taxpayers, we have access to the internal documentation of any FDA-approved product.1


In developing professional core competencies and as part of an ongoing interest in quality management research, I am conducting onsite visits to several wound care-related companies to learn about their FDA-mandated quality management systems-the topic of a future research manuscript. We not only strive to learn from each other, but we also can certainly learn more about quality management systems from our wound product manufacturers and the complex, but useful, interrelated health systems processes.2


The 4 pillars of quality management systems are based on answering the following questions: (1) How do wound care manufacturers utilize and communicate quality principles? (2) How are relationships used to reinforce and support quality principles? (3) What structures or systems encourage quality efforts? (4) How are data used to drive improvement?


Wound care products are categorized by the FDA, depending on their specific design and intended use.3 Medical devices and disinfectants in the FDA regulatory categorical system must adhere to the requirements set by the FDA for safety, marketing, and usage under the "Quality Systems Regulation" (QSR) FDA CFR 820 Federal Regulations.1


Wound care product quality management systems are rooted in the FDA requirement. For a given manufacturer, it is the company's leadership, mission, and values that drive the quality system (QS) implementation policies and procedures. The leadership for the company's QS is nested in the chief executive officer (CEO) and the director of quality assurance and regulatory affairs.3 The CEO has primary responsibility for leading the Organizational Quality System (OQS) but delegates authority to lead and manage the system to the director of quality assurance (DQA). The board has oversight through the CEO. The OQS requirement is coupled with the organization's core mission, which is customer driven and organized around highly competent managers, engineers, suppliers, and industry relationships.


Both the FDA's QSR and the OQS regulation require that internal policies and procedures are established and followed. The QS provides a checklist that demonstrates a linkage with the FDA's QSR. And, CFR 820 includes, but is not limited to, documentation controls and records, management responsibility, personnel, supply-chain elements distribution, and installing and servicing of equipment or products. Quality system management systems include statistical techniques, production and process controls, documentation of nonconforming products and compliant files, and demonstrating compliance with the essentials in FDA accreditation and approval programs.


Wound care product manufacturers are required to have internal control systems to track all QS-related documents, which hold the CEO and the DQA accountable for managing the process, including the outcomes and reporting mechanisms throughout the organization and to its stakeholders, organizational board, shareholders, regulators, and finally to the FDA. The quality policy helps ensure the provision of safe and effective products and services by continuous quality improvement, meeting and exceeding the quality and regulatory requirements, and adherence to the established quality management protocols. The risk management program is embedded in the OQS and focuses on design and development, supplier management and auditing, inspection, and auditing protocols.


Quality planning processes are predicated on the "learning organization model,"4 as reflected by the changing needs of the internal and external stakeholders, and they include ongoing maintenance of the developed quality plan, with established frequent and regular updates, including quarterly and annual updates. In addition, they must maintain corrective and preventive action plan, which is a response to any adverse event, sentinel event, or reportable ethical laps.


Systems-based healthcare requires practitioners to understand systems integral to patient care beyond the bedside or point of service. Learning about theses interrelated systems allows us to provide better care, safe products, and evidence-based medicine.


Richard "Sal" Salcido, MD

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1. US Food and Drug Administration. CFR-Code of Federal Regulations Title 21. Last accessed May 24, 2012. [Context Link]


2. Salcido R. Research partnerships: academia, industry, patients, and clinicians. Adv Wound Care 1999; 12: 231-2. [Context Link]


3. PuriCore. Last accessed May 24, 2012. [Context Link]


4. Senge PM. The Fifth Discipline: The Art and Practice of the Learning Organization. Performance Instruction. New York: Doubleday/Currency; 2006: 445. [Context Link]