Foodborne illness, food inspection policy and restaurants in the U.S.

Objectives. The purpose of this paper is to conduct a literature review of research relating to foodborne illness, food inspection policy, and restaurants in the United States. Aim 1: To convey the public health importance of studying restaurant food inspection policies and suggest that more research is needed in this field, Aim 2: To conduct a systematic literature review of recent literature pertaining to this subject such that future researchers can understand the: (1) Public perception and expectations of restaurant food inspection policies; (2) Arguments in favor of a grade card policy; and, conversely; (3) Reasons why inspection policies may not work. ^ Data/methods. This paper utilizes a systematic review format to review articles relating to food inspections and restaurants in the U.S. Eight articles were reviewed. ^ Results. The resulting data from the literature provides no conclusive answer as to how, when, and in what method inspection policies should be carried out. The authors do, however, put forward varying solutions as to how to fix the problem of foodborne illness outbreaks in restaurants. These solutions include the implementation of grade cards in restaurants and, conversely, a complete overhaul of the inspection policy system.^ Discussion. The literature on foodborne disease, food inspection policy, and restaurants in the U.S. is limited and varied. But, from the research that is available, we can see that two schools of thought exist. The first of these calls for the implementation of a grade card system, while the second proposes a reassessment and possible overhaul of the food inspection policy system. It is still unclear which of these methods would best slow the increase in foodborne disease transmission in the U.S.^ Conclusion. In order to arrive at solutions to the problem of foodborne disease transmission as it relates to restaurants in this country, we may need to look at literature from other countries and, subsequently, begin incremental changes in the way inspection policies are developed and enforced.^

Effects of congressional modernization laws on public access to innovative medical device technologies

The Federal Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) play key roles in making Class III, medical devices available to the public, and they are required by law to meet statutory deadlines for applications under review. Historically, both agencies have failed to meet their respective statutory requirements. Since these failures affect patient access and may adversely impact public health, Congress has enacted several “modernization” laws. However, the effectiveness of these modernization laws has not been adequately studied or established for Class III medical devices. ^ The aim of this research study was, therefore, to analyze how these modernization laws may have affected public access to medical devices. Two questions were addressed: (1) How have the FDA modernization laws affected the time to approval for medical device premarket approval applications (PMAs)? (2) How has the CMS modernization law affected the time to approval for national coverage decisions (NCDs)? The data for this research study were collected from publicly available databases for the period January 1, 1995, through December 31, 2008. These dates were selected to ensure that a sufficient period of time was captured to measure pre- and post-modernization effects on time to approval. All records containing original PMAs were obtained from the FDA database, and all records containing NCDs were obtained from the CMS database. Source documents, including FDA premarket approval letters and CMS national coverage decision memoranda, were reviewed to obtain additional data not found in the search results. Analyses were conducted to determine the effects of the pre- and post-modernization laws on time to approval. Secondary analyses of FDA subcategories were conducted to uncover any causal factors that might explain differences in time to approval and to compare with the primary trends. The primary analysis showed that the FDA modernization laws of 1997 and 2002 initially reduced PMA time to approval; after the 2002 modernization law, the time to approval began increasing and continued to increase through December 2008. The non-combined, subcategory approval trends were similar to the primary analysis trends. The combined, subcategory analysis showed no clear trends with the exception of non-implantable devices, for which time to approval trended down after 1997. The CMS modernization law of 2003 reduced NCD time to approval, a trend that continued through December 2008. This study also showed that approximately 86% of PMA devices do not receive NCDs. ^ As a result of this research study, recommendations are offered to help resolve statutory non-compliance and access issues, as follows: (1) Authorities should examine underlying causal factors for the observed trends; (2) Process improvements should be made to better coordinate FDA and CMS activities to include sharing data, reducing duplication, and establishing clear criteria for “safe and effective” and “reasonable and necessary”; (3) A common identifier should be established to allow tracking and trending of applications between FDA and CMS databases; (4) Statutory requirements may need to be revised; and (5) An investigation should be undertaken to determine why NCDs are not issued for the majority of PMAs. Any process improvements should be made without creating additional safety risks and adversely impacting public health. Finally, additional studies are needed to fully characterize and better understand the trends identified in this research study.^