Track topics on Twitter Track topics that are important to you
The purpose of this study is to test whether bar coded surgical sponges can significantly increase the safety of operations, specifically by (1) reducing discrepancies and miscounts, (2) reducing total staff time spent on sponge counting, and (3) reducing disruptions to the operating room as a system. Also, the study aims to further characterize the limitations of the current surgical sponge counting protocol.
Prior work by Dr. Gawande showed that the incidence of a retained foreign body is between 1 in 9000 and 1 in 19000 inpatient operations, or at least once a year for a hospital of any size. Leaving foreign objects in body cavities after surgery can lead to infection, bowel obstruction and in some cases, death. The current approach to preventing this problem is based on adherence to a counting protocol to check the number of instruments and sponges at the beginning and end of the case. The problem of retained foreign body is often attributed to error in the counting process—for example in the case of a retained object, count totals at the beginning and end of the case can be erroneous if an item was not initially counted, or if an item was "double- counted" at the end of a case. In addition to this potential for incorrect counts, the counting protocols can lead to disruptions in case flow and inefficiencies.
In an observational study of surgical performance, which brought human factors experts into Brigham and Women's Hospital operating rooms to examine 10 complex cases, counting protocols for tracking instruments and sponges in particular played a surprisingly negative role on team performance. After the incision was made, nurses devoted an average of 35 minutes to the counting protocols. This represented 14.5% of the operative time. During this time, the investigators were able to document substantial negative effects on surgical work while the nurses were involved in the counting protocol. Furthermore, a counting discrepancy was observed to occur in two-thirds of the cases with a total of 17 discrepancies in 9 cases. As a result, in several patients, progress of a still-incomplete operation had to be substantially delayed or suspended while the nurses attempted to reconcile inconsistencies.
Based on these 2 studies, we conducted a rigorous search and innovation process, generating five possible technologies to detect when instruments or sponges are left behind. Discussions with engineers and a focus group of operating room nurses identified two of these technologies as most feasible for adoption: (1) bar-coded sponges; and (2) a computer vision system for tracking instruments.
SurgiCount Medical, which has subsequently joined Patient Safety Technologies, both of Los Angeles, has designed the Safety-sponge System, which utilizes bar-coded sponges and is now available for testing. The 4" x 4" X-ray detectable gauze sponges and 18" x 18" X-Ray detectable laparotomy pads are manufactured in the same fashion as sponges currently used today. They contain the X-ray detectable strip that can identify a retained sponge on a plain X-ray. A unique bar code (data matrix code) has been securely affixed to each sponge. The datamatrix code with ECC200 error correction allows for accuracy up to 1 error in 10.5 million (worst case), 1 in 612.9 million (best case). FDA 510K exemption status for the bar coded sponge has already been secured by the manufacturer. The bar code detector (sponge counter) has been designed as a small handheld computer with a touchscreen display.
Before introducing new technology into a healthcare system, it is important to study the effect that technology will have on the system. This includes both whether the new technology has the desired effect, but also whether there are any unintended negative effects. Our pre-clinical simulations suggest that the Safety-Sponge System has the potential to improve safety and efficiency in the operating room and other hospitals are moving ahead with purchase of the system. However we argue that the benefit must be proven in a randomized trial comparing it to the traditional counting protocol.
If our hypothesis is correct, this technology could revolutionize the counting procedures and improve both safety and efficiency in the operating room. This could decrease the risk of retained foreign bodies for patients. In addition, it could decrease the workload for the nursing staff in the operating room, leading to improvements in their working conditions and the overall safety of the system.
Comparisons: patients will be randomized to one of two equal groups: usual counting protocol versus bar-code technology assisted counting.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Bar coded sponge and scanner
Brigham and Women's Hospital
Brigham and Women's Hospital
Published on BioPortfolio: 2014-07-23T21:46:24-0400
Are we able to use the EPO staining technique using the sponge ?
The purpose of this study is to determine the safety and efficacy of the Collatamp G topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care...
The purpose of the study is to show that Fibrocaps plus gelatin sponge is better than gelatin sponge alone in stopping mild to moderate bleeding in children having surgery
Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg posi...
This study will compare the incidence of post-op infection after sinus surgery using conventional post-op oral antibiotics to the incidence of infection after sinus surgery when a bio-reso...
A conductive graphene-melamine sponge prepared via microwave irradiation is reported in this paper. Graphene oxide supported on melamine sponge was pre-reduced firstly at 100 °C and then further redu...
Sponges are sessile benthic filter-feeding animals, which harbor numerous microorganisms. The enormous diversity and abundance of sponge associated bacteria envisages sponges as hot spots of microbial...
To assess intrascanner repeatability and cross-scanner comparability for diffusion tensor imaging (DTI) metrics in a multicenter clinical trial.
Layered double hydroxides (LDHs) are very promising adsorbents for the removal of anionic pollutants from water. However, the low adsorption efficiency and recycling difficulty of conventional LDH pow...
A joint and integrated analysis of multi-site diffusion MRI (dMRI) datasets can dramatically increase the statistical power of neuroimaging studies and enable comparative studies pertaining to several...
An imaging technique that combines a POSITRON-EMISSION TOMOGRAPHY (PET) scanner and a CT X RAY scanner. This establishes a precise anatomic localization in the same session.
Sterile, gelatin-base surgical sponge applied topically as an adjunct to hemostasis when the control of bleeding by conventional procedures is ineffective to reduce capillary ooze or is impractical. (From AMA Drug Evaluations Annual, 1994, p797)
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
A non-invasive method that uses a CT scanner for capturing images of blood vessels and tissues. A CONTRAST MATERIAL is injected, which helps produce detailed images that aid in diagnosing VASCULAR DISEASES.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...