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.

External patient temperature control in emergency centres, trauma centres, intensive care units and operating theatres: a multi-society literature review.

Here we review the available literature supporting the routine and timely use of external patient warming devices of all possible types during emergency department and peri-operative situations, including the role of best ambient temperature, and provides a best-practice statement on the need for such devices. It aims to present a guideline document endorsed by the major South African professional societies in the field of emergency and peri-operative care.

[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%.

Nível de atendimento dos materiais classificados como críticos no Hospital Universitário da USP / Level of attendance of the classified supplies as Z in the Hospital UNiversitário from USP / Nivel de la atención de las fuentes clasificadas como Z en el Hospital Universitário de la USP

A falta de materiais de consumo é uma dificuldade enfrentada pelos profissionais da saúde. Algumas ferramentas vêm sendo utilizadas para minimizar essas faltas, entre elas a classificação de materiais XYZ, baseada na importância operacional dos itens. Esta permite fixar Níveis de Atendimento (Nas) e Níveis da Falta (NFs) aos diferentes itens. Os objetivos desse estudo foram levantar o número de solicitações não atendidas dos materiais Z, calcular o NA e NF dos 20 materiais que mais faltaram e conhecer as causas dessas faltas. A amostra das 747 solicitações não atendidas mostrou que dos 572 materiais Z, 39,7% apresentaram falta. O atraso da entrega pelo fornecedor foi a causa mais representativa com 39%. Os NAs variaram de 92,11% a 27,08% e, os NFs de 7,89% a 72,92.

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 ofsupplies. 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 possiblecauses 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%.

La carencia de los materiales de la consumición en las unidades en el hospital es una dificultad para los profesionales de la salud. Algunas herramientas de la gerencia de los materiales han sido incorporadas con el propósito de reducir al mínimo éstos deficits, entre ellos la clasificación de los materiales XYZ que se basa en la importancia operacional de materiales. Permite el fijar de niveles de la atención (NA) y los niveles de carecencia (NF) a diversos materiales. Los objetivos de este estudio fueron levantar el número del cuidado no tomado de las peticiones de las fuentes del Z, calcular el NA y NF de las 20 fuentes que tenían carecido y saber las causas posibles que habían conducido a estas carecias. La muestra del cuidado no tomado de 747 peticiones había demostrado el de 572, el 39.7% había presentado una cierta carencia. Retrasa en la entrega para el surtidor era la mayoría de la causa representativa con el 39%. La NAS había variado a partir de la 92.11% hasta el 27.08% y, el NFS a partir de la 7.89% hasta el 72.92%.

[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.

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.