An analysis of third-party regulatory audit systems for medical device safety.

摘要

Auditing the quality process used to manufacture medical products provides benefits for multiple stakeholders. Assurance that the manufacturing process follows acceptable standards of quality provides stakeholders with confidence that manufacturing-related risks and adverse events are minimized. When government provides this protection, the resources required to audit and assure regulatory compliance proves to be costly. Foreign governments have adopted private auditing systems in response to reduced government budgets and global markets' demands for uniform auditing systems.;The purpose of this exploratory, descriptive research study was to help government officials, public administrators and stakeholders become more effective decision makers, managers and participants by enhancing their knowledge of the implications of cost and accountability when privatizing regulatory audits for quality manufacturing of medical devices. The objectives of the study were: (1) to examine the costs and benefits of privatization with respect to efficiency and accountability, (2) to evaluate privatized models in use by other governments, and (3) to evaluate the use of third parties in conducting Food and Drug Administration (FDA) medical device inspections.;This study utilized a combination of qualitative and quantitative research methodologies and secondary data analysis. The information and data were collected from a critical review of the literature involving privatization of audits, in-depth interviews and discussions with representatives from the FDA and international governing bodies that audit medical device manufacturing quality, and various government documents.;This study concluded that with training and experience, third parties can conduct inspections comparable to the FDA with respect to detecting manufacturing deficiencies in an equivalent inspection time period. Findings also suggest that while production costs may not be significantly different, transaction costs associated with the need for continuous communication, training and monitoring may cancel savings realized or increase the cost of having third parties conduct inspections. The study also indicated that concerns about accountability when cost savings are the driving force for privatization could be reduced if government balances their control and production in the audit process.