RESUMEN
INTRODUCTION: Single-use medical devices used in surgery can create environmental waste and increased costs. Reprocessed medical devices may reduce cost and environmental impact. This study investigated the reprocessing capabilities of newly FDA-approved devices in surgery. METHODS: Devices were identified using the publicly-available FDA Releasable 510(k) Database from 2018 to 2023 using the instrument product codes for laparoscope, general, and plastic surgery (GCJ); and electrosurgical (GEI) devices. GCJ and GEI devices were categorized based on usage, and the number of devices (total, single, and reprocessed) were extracted. Costs were obtained from public websites. RESULTS: There were 658,510(k) applications for surgical devices, representing 3.8 % (658/16723) of total applications. Reprocessing capabilities existed for 29 % of GCJ devices and 14 % of GEI devices. Among GCJ devices, 5 (56 %) laparoscopy and 16 (38 %) camera devices had reprocessing capabilities. For GEI devices, 7 (50 %) laparoscopic and 5 (50 %) cable devices had reprocessing capabilities. Only one (6 %) tissue ablation device had reprocessing capabilities. The average cost of GCJ and GEI single-use devices ($11314; $8554, respectively) was less than reprocessed counterparts ($17206; $16134, respectively). CONCLUSION: Reprocessing capabilities for newly approved surgical devices are variable and overall limited. To enhance adoption of reprocessing in surgical practice, future efforts will likely be needed to expand the reprocessing potential of new surgical devices.
Asunto(s)
Equipo Reutilizado , Humanos , Equipo Reutilizado/normas , Estados Unidos , United States Food and Drug Administration , Aprobación de Recursos , Equipos Desechables/economíaRESUMEN
Several neglected tropical diseases (NTDs) are highly disfiguring, particularly those in resource-poor countries that lack access to basic surgery. There has been a push to integrate surgery into treatment programs for NTDs. In this article, we provide an overview of the major disfiguring NTDs and discuss the processes and barriers that impede access to reconstructive surgical treatments or their integration into health systems. Methods: A review of the literature was conducted using the online database PubMed, from 2008 to 2021 with the specific diseases listed as NTDs either on the World Health Organization or the PLoS Neglected Tropical Disease websites. Reference lists of identified articles and reviews were also searched, as were databases from the World Health Organization's Weekly Epidemiological Record. Result: Success in the surgical treatment and postoperative care of disfiguring NTDs would benefit from standardization and harmonization of surgical approaches and procedures. In some settings, reconstructive surgery should be used cautiously, emphasizing appropriate use of antibiotics, partnerships with global and local surgical teams, and local capacity building. Preventative hygiene approaches remain paramount in resource-poor areas. Conclusions: Surgery is a promising treatment for NTDs that result in disfigurement and disability. The expansion of local capacity building, with medical trips and surgical training of local health workers, together with the development of universal surgical protocols remain essential cornerstones for NTD reconstructive surgery. Antibiotics and drug management should comprise key first steps before turning to surgery.