Postoperative Complications, Surgical Sponges, Surgical Instruments, Retained Surgical Tools — Incidence of Retained Surgical Devices and Treatment
Citation(s)
Berkowitz S, Marshall H, Charles A Retained intra-abdominal surgical instruments: time to use nascent technology? Am Surg. 2007 Nov;73(11):1083-5. Review.
Brooks J US Medicare will stop paying for preventable errors. CMAJ. 2007 Oct 9;177(8):841-2.
Hall MJ, Schwartzman A, Zhang J, Liu X Ambulatory Surgery Data From Hospitals and Ambulatory Surgery Centers: United States, 2010. Natl Health Stat Report. 2017 Feb;(102):1-15.
Hariharan D, Lobo DN Retained surgical sponges, needles and instruments. Ann R Coll Surg Engl. 2013 Mar;95(2):87-92. doi: 10.1308/003588413X13511609957218. Review.
Lauwers PR, Van Hee RH Intraperitoneal gossypibomas: the need to count sponges. World J Surg. 2000 May;24(5):521-7. Review.
Steelman VM, Shaw C, Shine L, Hardy-Fairbanks AJ Retained surgical sponges: a descriptive study of 319 occurrences and contributing factors from 2012 to 2017. Patient Saf Surg. 2018 Jun 29;12:20. doi: 10.1186/s13037-018-0166-0. eCollection 2018.
Wan W, Le T, Riskin L, Macario A Improving safety in the operating room: a systematic literature review of retained surgical sponges. Curr Opin Anaesthesiol. 2009 Apr;22(2):207-14. doi: 10.1097/ACO.0b013e328324f82d. Review.
Incidence of a Retained Surgical Device in Patients That Underwent Surgery
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
