General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device. Final order.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify the needle destruction device, renaming the device to "sharps needle destruction device, a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device. This order reclassifies these types of devices from class III to class II and will reduce regulatory burdens on industry because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.

Medical devices; general hospital and personal use devices; classification of the intravascular administration set, automated air removal system. Final order.

The Food and Drug Administration (FDA) is classifying the intravascular administration set, automated air removal system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravascular administration set, automated air removal system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

[The proposed principles by GHTF of the classification and assessment for in vitro diagnostic (IVD) medical devices].

The IVD (In Vitro Diagnostic)Medical Devices are various and develop rapidly. This paper introduces briefly the principles of classification and conformity assessment for IVD medical that proposed by GHTF (Global Harmonization Task Force).

Entropy as a measure of diversity in an inventory of medical devices.

Quantitative techniques for the measurement of species diversity have been developed in ecological studies. One such technique, based on an entropy measurement, has been applied to the assessment of medical device diversity in large inventories of medical equipment. Using this technique it is possible to identify trends which are not apparent from simple considerations of the total number of devices, or the number of device types. Objective measurements of this type can be used to monitor the progress of planned equipment replacement programmes.

[Level of attention of the classified supplies as Z in the hospital universitário from USP]. / Nível de atendimento dos materials classificados como críticos no Hospital Universitário da USP.

The lack of the consumption materials in hospital units is a faced difficulty for health professionals. Some tools of the supplies' management are being incorporated with the purpose to minimize these lacks, between them the XYZ materials classification which is based on the operational importance of supplies. It allows fixing levels of attendance (LA) and levels' lacks (LL) to different supplies. The objectives of this study was to raise the number of non-observed requests of the Z's supplies, to calculate LA and LL of the 20 supplies that were more non-observed and to know were the possible causes that had led to these lacks. The sample of 747 non-observed requests had shown that of 572, 39.7% had presented some lack. The delay in the delivery for the supplier was the most representative cause with 39%. The LAs had varied from 92.11% to 27.08% and, the LLs from 7.89% to 72.92%.

Using HFMEA to assess potential for patient harm from tubing misconnections.

BACKGROUND: Reported cases of tubing misconnections and other tubing errors prompted Columbus Children's Hospital to study their potential for harm in its patient population. A Health Failure Mode and Effects Analysis (HFMEA) was conducted in October 2004 to determine the risks inherent in the use and labeling of various enteral, parenteral, and other tubing types in patient care and the potential for patient harm. METHODS: An assessment of the practice culture revealed considerable variability among nurses and respiratory therapists within and between units. Work on an HFMEA culminated in recommendations of risk reduction strategies. These included standardizing the process of labeling of tubing throughout the organization, developing an online pictorial catalog to list available tubing supplies with all aliases used by staff, and conducting an inventory of all supplies to identify products that need to be purchased or discontinued. Three groups are working on implementing each of the recommendations. RESULTS: Most of the results already realized occurred in labeling of tubing. The pediatric intensive care unit labels all tubing with infused medications 85% of the time; tubings inserted during surgery or in interventional radiology are labeled 53% and 93% of the time. Pocket-size cards with printed labels were tested in three units. DISCUSSION: This proactive risk assessment project has identified failure modes and possible causes and solutions; several recommendations have been implemented. No tubing misconnections have been reported.

Radio frequency identification applications in hospital environments.

Radio frequency identification (RFID) technology has recently begun to receive increased interest from practitioners and academicians. This interest is driven by mandates from major retailers such as Wal-Mart, Target and Metro Group, and the United States Department of Defense, in order to increase the efficiency and visibility of material and information flows in the supply chain. However, supply chain managers do not have a monopoly on the deployment of RFID. In this article, the authors discuss the potential benefits, the areas of applications, the implementation challenges, and the corresponding strategies of RFID in hospital environments.

Managing hospital supplies: process reengineering at Gujarat Cancer Research Institute, India.

PURPOSE: Aims to give an overview of the re-engineering of processes and structures at Gujarat Cancer Research Institute (GCRI), Ahmedabad. DESIGN/METHODOLOGY/APPROACH: A general review of the design, development and implementation of reengineered systems in order to address concerns about the existing systems. Findings GCRI is a comprehensive cancer care center with 550 beds and well equipped with modern diagnostic and treatment facilities. It serves about 200,000 outpatients and 16,000 inpatients annually. The approach to a better management of hospital supplies led to the design, development, and implementation of an IT-based reengineered and integrated purchase and inventory management system. The new system has given GCRI a saving of about 8 percent of its annual costs of purchases, and improved the availability of materials to the user departments. ORIGINALITY/VALUE: Shows that the savings obtained are used not only for buying more hospital supplies, but also to buy better quality of hospital supplies, and thereby satisfactorily address the GCRI responsibility towards meeting its social obligations for cancer care.

Asset tracking systems.

Asset tracking systems are used in healthcare to find objects--medical devices and other hospital equipment--and to record the physical location of those objects over time. Interest in asset tracking is growing daily, but the technology is still evolving, and so far very few systems have been implemented in hospitals. This situation is likely to change over the next few years, at which point many hospitals will be faced with choosing a system. We evaluated four asset tracking systems from four suppliers: Agility Healthcare Solutions, Ekahau, Radianse, and Versus Technology. We judged the systems' performance for two "levels" of asset tracking. The first level is basic locating--simply determining where in the facility an item can be found. This may be done because the equipment needs routine inspection and preventive maintenance or because it is required for recall purposes; or the equipment may be needed, often urgently, for clinical use. The second level, which is much more involved, is inventory optimization and workflow improvement. This entails analyzing asset utilization based on historical location data to improve the use, distribution, and processing of equipment. None of the evaluated products is ideal for all uses--each has strengths and weaknesses. In many cases, hospitals will have to select a product based on their specific needs. For example, they may need to choose between a supplier whose system is easy to install and a supplier whose tags have a long battery operating life.

[ABC supplies classification: a managment tool of costs in nursing]. / Classificação ABC dos materiais: uma ferramenta gerencial de custos em enfermagem.

The implementation of costs management systems has been extremely helpful to healthcare area owing to their efficacy in cutting expenditures as well as improving service quality. The ABC classification is an applied strategy to stocktaking and control. The research, which consists of an exploratory/descriptive quantitative analysis, has been carried out in order to identify, in a year time period, the demand for supplies at Universidade de Sao Paulo's Hospital. Of 1938 classified materials, 67 itens had been classified that they correspond to the materials with bigger costs for the hospital. 31.3% of these A-Class supplies catalogued items are the nursing materials, more used for the nursing team.

Actual and estimated costs of disposable materials used during surgical procedures.

It is difficult to estimate precisely the costs of disposable materials used during surgical operations. To evaluate the actual costs of disposable materials, we calculated the actual costs of disposable materials used in 59 operations by taking account of costs of all disposable materials used for each operation. The costs of the disposable materials varied significantly from operation to operation (US$ 38-4230 per operation), and the median [25-percentile and 75-percentile] of the sum total of disposable material costs of a single operation was found to be US$ 686 [205 and 993]. Multiple regression analysis with a stepwise regression method showed that costs of disposable materials significantly correlated only with operation time (p<0.001). Based on the results, we propose a simple method for estimating costs of disposable materials by measuring operation time, and we found that the method gives reliable results. Since costs of disposable materials used during surgical operations are considerable, precise estimation of the costs is essential for hospital cost accounting. Our method should be useful for planning hospital administration strategies.

Technology. Behind the hype.

Having proven successful in retail, military and other industries, radio frequency identification is making its way into health care. But can the technology live up to the bold claims?

North American neonatal extracorporeal membrane oxygenation (ECMO) devices: 2002 survey results.

In mid 2002, surveys of active extracorporeal membrane oxygenation (ECMO) centers in the United States and Canada were conducted via E-mail regarding neonatal equipment and personnel. Seventy-four out of 99 (75%) North American ECMO centers listed in the Extracorporeal Life Support Organization (ELSO) directory responded to the survey. Of the responding centers, 95% use roller pumps, and the remaining 5% use centrifugal pumps. Silicone membrane oxygenators were used by 97% of the respondents, while 3% used hollow fiber oxygenators. Of the silicone membrane oxygenator users, 82% used the Medtronic ECMOtherm heat exchanger, 15% used a Gish heat exchanger, and 3% used the Dideco D720 heat exchanger. Sixty-one percent of the responding centers used some form of in-line blood gas monitoring. Five percent of the centers used a bubble trap in the arterial line, and 12% used an arterial line filter. A bladder was used by 92% of the centers, and 29% used a mechanical bladder box for servo regulation, the remaining 71% used pressure servo regulation. An air bubble detector was used by 65% of the responding centers, although 81% had the device available. Heparin coating was used by 5% of the centers on all their neonatal ECMO patients. The average low range ACT was 183 seconds, and the average high range ACT was 216 seconds. At 49% of the responding centers, perfusionists were involved with the ECMO program, registered nurses were involved at 84% of the centers, and respiratory therapists were involved at 61% of the centers, perfusion assistants were involved at one center (1%), and biomedical engineers were involved at one of the centers. When compared to a 1990 survey, a shift away from using bladder boxes and toward using air bubble detectors is apparent. But other than those two shifts, ECMO is done in much the same manner as it was done 12 years ago.

Medical devices; various proposed rules for device classification; withdrawal of proposed rules. Food and Drug Administration. Withdrawal of proposed rules.

The Food and Drug Administration (FDA) is withdrawing various proposed rules related to classification of general hospital and personal use devices, anesthesiology devices, and immunology and microbiology devices to eliminate unnecessary regulations.

Can a hospital be like a supermarket? Better data will provide cost controls, efficiencies, and income streams.

Electronic bar coding, scanning, and the data generated are an inevitable part of a health care provider's future. Initially, it will probably be implemented in hospitals, where the diversity of products and scrutiny to reduce costs are greatest. Many lessons can be learned from the introduction of electronic scanning in the grocery or supermarket industry. The transformation to scanning in the grocery industry met with initial resistance and problems, but generated creative solutions, best practices, and a rich database.

Technology. Beyond bar codes.

Just as the Food and Drug Administration orders the use of bar codes on most prescription drugs and blood products meant for transfusion, there is a push for an even more potent technology--radio frequency identification.

Coding of contract status aids in cost control.

Repeat purchases of stocked and nonstocked items account form the largest expenditures in any given hospital. The purchase orders for these items are often rushed through the system, for they are both repetitive and routine. Little consideration is given to whether the items are under a purchasing contract or that the vendor abides by the contracted price. In this article, the author describes a coding system that indicates both usage volumes and contract status. This system can be readily implemented and used to flag high usage items for contracting as well as ensure that the hospital enjoys maximum benefit from existing contracts. This same easy-to-interpret system can be utilized by all hospital users to assist in alternative product selection for cost control.