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Use of a (proposed) standard protocol to validate Terumo TSCD-II connections between dissimilar blood bag tubing.

BACKGROUND AND OBJECTIVES: ISO standards for blood bags do not adequately define and control the dimensions of blood bag transfer tubing. This lack of standardization presents potential difficulties when making sterile connections between the wide range of tubing that has evolved in the absence of such standards. We aim to validate the suitability of the TSCD-II and provide a minimum standard for assessing the suitability of sterile connections (welds) between dissimilar tubing. MATERIALS AND METHODS: The Terumo TSCD-II was used in this study to connect by hermetic welding seven tubing types with a wide range of dimensions from five suppliers. Thirty sterile connections were made between each combination split between dry/dry, wet/wet and dry/wet connections. Welds were assessed for visual defects, by tensile stress test (TST) and pressure tests. RESULTS: All welds passed visual inspection and pressure tests. All welds had a minimum tensile strength of greater than 40 N and mean of greater than 45 N. CONCLUSION: Successful connections have been made between dissimilar tube types and this work does not support the requirement for 'tight' tubing dimensional specifications. We have recommended to the ISO Technical Committee 76 Work Group 1 that ISO 3826-1 be revised and should include a minimum standard validation protocol for joining dissimilar tubing.

Blood Component Transfusion↗

[Activity of ISO/TC212, clinical laboratory testing and in vitro diagnostic test systems].

ISO is the International Organization for Standardization, which is a worldwide federation of national standards bodies from 130 countries, one from each country. ISO is a non-governmental organization established in 1947. ISO/TC212, Clinical laboratory testing and in vitro diagnostic test systems was newly established in 1995, consisting of 86 P-members and 12 O-members. ISO/TC212 secretariat is the American National Standards Institute, and NCCLS carries out its secretarial activity. On behalf of the Japanese Industrial Standards Committee (JISC), the Japanese Committee for Clinical Laboratory Standards (JCCLS) serves as the secretariat for the ISO/TC212 National Technical Advisory Group. Three working groups are in the process of preparing the Draft International Standards (DIS) among 9 work items. The next plenary session of ISO/TC212 will be held on May 19-21, 1999 in Tokyo, Japan.

Clinical Laboratory Techniques↗

Resistance in long-term cancer support groups.

This article describes the common resistance patterns that occur in ongoing cancer support groups. These resistances, which can often go unrecognized, are a normal part of group development and group life in such groups, rather than the result of a few "problem" group members. The thesis of this article posits that the identification and working through of these resistances creates openings to deeper engagement among members and to overall greater group cohesion. Technical guidelines are offered for working with these resistances in the group-as-a-whole, in members, and also in the therapist.

Attitude↗

A potential blood substitute from carboxylic dextran and oxyhemoglobin. III. Evaluations by perfusion of normal and ischemic guinea-pig heart.

Hemodynamic parameters of six groups of guinea-pig hearts were studied by the working heart technic of Neely. Three groups were respectively perfused with: Krebs-Henseleit, purified native hemoglobin 1gm/dl and hemoglobin conjugated to dextran benzene tetracarboxylate 1 gm/dl. Three other groups were perfused under the same conditions except that after 30 mn of perfusion, 10 mn of total ischemia were produced followed by 30 mn of reperfusion with the previous solutions. All solutions contained 10 g/l of BSA. Hearts perfused with Hb solutions without ischemia or after ischemia show better parameters than with Krebs-Henseleit. These observations suggest that contrary to previously published results, purified Hb and more, dextran-BTC-Hb appear to be perfusable and are less deleterious for heart than saline without hemoglobin.

Animals↗

[Filtration of platelet concentrates. Technical aspects, quantitative results. Group PSL].

This work summarizes a multicentric study (20 Blood Transfusion Centers) concerning the use of different filters applied to platelet collection. The results are good with the different filters and platelets concentrates evaluation. Nevertheless, we have seen a great heterogeneity of platelet concentrates. This characteristic could explain the variability in filter performances. Maybe we have to adapt some type of filter with specific platelet concentrates. In conclusion, it is important to continue the evaluation of new platelet concentrate filters, in order to increase the performances and the filtration quality. Clinical trials seem to be useful in the future to appreciate the effects of filtered platelets on alloimmunization and CMV transmission.

Blood Platelets↗

Concept of ergonomic and systematic work design for disabled workers.

Ergonomic work-place design for disabled persons contains the selection of work-places appropriate for disabled, work-place design and work instruction and training. In order to support industry and administration in their activities of designing work-places for disabled workers a taxonomy of technical aids is presented taking into account the information most essential for practitioners. This classification is in accordance with the postulate of the ISO emphasizing the necessity for a classification of aids containing technical work aids as a main group. Therefore the classification system proposed should be considered as a frame work for a general taxonomy of technical aids at all.

Persons with Disabilities↗

Current status of research on biophysical effects of ultrasound.

This overview of bioeffects of ultrasound presents some key aspects of selected papers dealing with biophysical end-points. Its purpose is to establish a basis for exposure and dosimetric standards for medical ultrasonic equipment. It is intended to provide essential background resource material for the medical/scientific community, and more specifically for scientific working groups. This document was prepared by members of the Safety Committee of the World Federation for Ultrasound in Medicine and Biology. It was produced as a resource document in response to a request for information by Working Group 12 (Ultrasound exposure parameters) of the International Electrotechnical Commission Technical Committee 87, Ultrasonics. IEC TC 87, WG12 is the working group responsible for generating international standards for the classification of equipment by its acoustic fields based on safety thresholds. Our paper is intended to update and supplement information on the thermal mechanism provided in the publication, "WFUMB Symposium on Safety and Standardisation in Medical Ultrasound: Issues and Recommendations Regarding Thermal Mechanisms for Biological Effects of Ultrasound" (WFUMB 1992). It also provides an overview of trends in research into nonthermal mechanisms as a preliminary to the next WFUMB Symposium on Safety of Medical Ultrasound when this subject will be examined in detail by a select group of international experts. The WFUMB-sponsored workshop will take place in Utsunomiya, Japan during 11-15th July, 1994. The purpose of the meeting is to evaluate the scientific literature and to formulate internationally accepted recommendations on the safe use of diagnostic ultrasound that may be endorsed as official policy of the WFUMB. It should be noted that the current publication is not intended for review or endorsement as an official WFUMB document. It is produced as a scientific paper by individuals who are members of the WFUMB Safety Committee, and it therefore represents the opinions of the authors. Nevertheless, during the preparation of this document, contributions were received from members of the International Electrotechnical Commission Technical Committee 87 as well as many other individual experts, and the authors sincerely acknowledge their support.

Air↗

Split liver is an effective tool to transplant paediatric patients.

Transplantation activity is dependent upon organ procurement; although great efforts are made to enlarge the cadaver donors' pool, it still remains far too small to meet the recipients' need. Waiting time is a particular problem for paediatric patients, and mortality on the waiting list for liver transplantation is very high. The number of paediatric donors is far too small to satisfy the request. To enlarge the liver pool, the split-liver procedure was introduced in several Transplant Centers. In November 1997, the North Italy Transplant program (NITp) Working Group for Liver Transplantation decided to start an official Split-liver Program. A protocol was therefore defined and criteria for donor's and recipient's eligibility were established to minimize the risk. The Working Group also standardized the technical procedure and defined collaboration between centers. Out of 410 cadaver liver donors used in the NITp, from 1 November 1997 until 31 May 1999, 49 patients (37 males and 12 females) were chosen for the split-liver procedure. Mean age was 29.9 +/- 17.5 years. Mean ICU stay of the donors was considerably short (2.5 +/- 2.1 days), and the other conditions foreseen for donor eligibility were met. In all cases (except two) an "in situ" technique was performed. Forty-nine adult recipients and 43 children were transplanted by the split-liver technique in our Transplant Centers. One right lobe and five left liver lobes were sent to Transplant Centers outside the NITp. Adult recipient age ranged from 18 to 60 years (mean 46.4 +/- 11.7 years), and the paediatric one from 2 to 144 months (mean 24.8). Mean patient follow-up was 8.3 +/- 5.5 months. In the paediatric group, the graft was successful in 34 cases (79%), five patients (10.2%) died and four (9.3%) were re-transplanted. In the adult group, graft survival was 67.3%, 11 (22%) patients died and 5 (10%) were re-transplanted. On 1 November 1997, 30 paediatric patients were on the liver waiting list. In the preceding 19 months, 52 patients were newly enrolled, and 36 transplants were performed. The mean waiting time of paediatric patients was 259 days (range 1-919 says). From 1 November 1997 to 31 May 1999, 61 paediatric patients were newly enrolled. In this period 70 patients were transplanted. The mean waiting time was 185 days (1-1010 days). At present, the liver waiting list includes eight paediatric patients. Split-liver transplantation is a successful procedure, effective in reducing waiting time for paediatric patients. It should be established if this may be a tool to enlarge the organ pool also for adult liver transplantation.

Adolescent↗

The European standard for sun-protective clothing: EN 13758.

Clothing is considered one of the most important tools for sun protection. Contrary to popular opinion, however, some summer fabrics provide insufficient ultraviolet (UV) protection. The European Committee for Standardization (CEN), has developed a new standard on requirements for test methods and labelling of sun-protective garments. This document has now been completed and is published. Within CEN, a working group, CEN/TC 248 WG14 'UV protective clothing', was set up with the mission to produce standards on the UV-protective properties of textile materials. This working group started its activities in 1998 and included 30 experts (dermatologists, physicists, textile technologists, fabric manufacturers and retailers of apparel textiles) from 11 European member states. Within this working group, all medical, ethical, technical and economical aspects of standardization of UV-protective clothing were discussed on the basis of the expertise of each member and in consideration of the relevant literature in this field. Decisions were made in consensus. The first part of the standard (EN 13758-1) deals with all details of test methods (e.g. spectrophotometric measurements) for textile materials and part 2 (EN 13758-2) covers classification and marking of apparel textiles. UV-protective cloths for which compliance with this standard is claimed must fulfill all stringent instructions of testing, classification and marking, including a UV protection factor (UPF) larger than 40 (UPF 40+), average UVA transmission lower than 5%, and design requirements as specified in part 2 of the standard. A pictogram, which is marked with the number of the standard EN 13758-2 and the UPF of 40+, shall be attached to the garment if it is in compliance with the standard. The dermatology community should take cognizance of this new standard document. Garment manufacturers and retailers may now follow these official guidelines for testing and labelling of UV-protective summer clothes, and the sun-aware consumer can easily recognize garments that definitely provide sufficient UV protection.

European Union↗

Community-based participatory research in the California Health Interview Survey.

INTRODUCTION: The California Health Interview Survey, the largest state health survey in the United States, uses community-based participatory research principles to develop each cycle. Other large-scale health surveys rarely include participatory research approaches. Every 2 years, the California Health Interview Survey generates state and local population-based data on health insurance coverage, access to health care, chronic disease prevalence and management, health behaviors and disease prevention, and other health issues in California. The survey is used for policy and program development, advocacy, and research. METHODS: The development of the California Health Interview Survey involves more than 145 people from more than 60 state and local policymaking bodies, public health agencies, advocacy groups, research organizations, and health care organizations. They participate as volunteers in an advisory board, on technical advisory committees, and in work groups that interact with California Health Interview Survey research staff in an accountable advisory process that shapes survey topics, measures, and sample design and determines languages selected for translation. Survey results and data are provided to the communities involved in the survey. RESULTS: California Health Interview Survey data have been widely used by local, state, and national public health leaders, policymakers, advocates, and researchers to improve access to health insurance and health care services and to develop and target prevention programs for obesity and chronic illnesses. CONCLUSION: The California Health Interview Survey participatory research model has been an effective approach to planning and implementing a health survey and should be considered by developers of other large health surveys.

California↗

The prevention of back injuries in Swedish health care--a comparison between two models for action-oriented feedback. PROSA Study Group.

This paper considers two different models for action-oriented feedback designed to prevent back injuries in Swedish health care. Feedback was provided by physiotherapists/ergonomists from Occupational Health Services. The models tested were feedback to work groups, and feedback solely to supervisors. Both generated a considerable number of accident-prevention proposals. Proposals of supervisors were implemented to a greater extent. Supervisors tended to advocate training, while work groups were more concerned with improved technical aids. Otherwise, only minor differences were detected between the models in application. The active involvement promoted by feedback, in particular to work groups, was considerable.

Back Injuries↗

Minimal requirements in prostate cancer irradiation: a consensus document by the AIRO Lombardia Cooperative Group.

PURPOSE: With the aim of establishing clinical and technical criteria to homogenize radiotherapy practice, a working group of AIRO-Lombardia (Associazione Italiana di Radioterapia Oncologica--Gruppo regionale della Lombardia) has tried to define minimal requirements for radical and postoperative irradiation in prostate cancer. The document has been structured in such a way as to be also of interest to the urological and medical oncology communities. METHODS: The working group, composed of representatives of most of the regional radiotherapy departments in the Lombardy region, had monthly meetings during 1996 and 1997. The document on minimal requirements has been derived from the participants' combined experience and knowledge, from review of the literature, and from a 1995 regional survey on current practice of prostate irradiation. RESULTS: Minimal requirements for radical and postoperative irradiation of prostate cancer have been defined with respect to treatment strategies, pre-treatment diagnostic evaluation and staging, treatment prescription, preparation and execution, and quality assurance procedures. CONCLUSION: Standards of reference for minimal requirements in prostate cancer irradiation adapted to the regional structures and resources have been defined.

Humans↗

[The therapist in group psychotherapy].

Nowadays, group psychotherapy designates a broad range of procedures based on different theoretical frameworks, applied to several contexts. The purpose of this study is to understand the group therapist's role, delineating some strategies and necessary abilities for group psychotherapy practice. The authors emphasize the technical-scientific level in which the work with groups is developed and the influence of the therapist's personality on the participants. They conclude that, in order to preserve their role without loosing the specificity of his function due to his involvement in multiple patients' experiences, therapists must have a stable professional identity. Therefore, the therapists' preparation, based on a process of continuing formation, is a necessary condition to enable them to face peculiar situations that occur in the group context and also to assure the singular therapeutic potential of group psychotherapy.

Humans↗

The essence of leadership: facing the challenge of being the new manager.

To meet the challenge of today's work environment, the leader of a professional, technically skilled, and highly diverse work "group must be an enabler of people, a facilitator of groups, as well as know how to be an effective group member" (Blanchard et al, The One Minute Manager Builds High Performance Teams, New York, NY, William Morrow, 1990). To accomplish this the leader must participate as a member of the work group as well as identify areas of needed management support and direction. Creating the climate that allows professional work teams to develop and mature is both challenging and rewarding. Fully mature, high-performance teams require minimal direction from the leader. At this stage empowerment is reached: the leader lets go so that the team can get going.

Humans↗

Confronting and eradicating an epidemic of bacteraemia.

Obtaining vascular access by catheterisation is a good option, especially in patients with vascular system fragility. In the authors' department, there was an increase in Gram Negative Bacillus (GNB) infection in patients with long term catheters (LTC). An objective was set to design an action plan and a new working methodology in order to eradicate the infection and the cause. Three periods were established in the prospective follow-up of LTC patients: the pre-epidemic period (01/94 to 03/99), with a bacteraemia every 144 days per patient, the epidemic period (04/99 to 12/00) with a bacteraemia every ten days per patient, and the post-epidemic period (01/01 to 04/02). A multidisciplinary working group was established, which produced action plans for nursing and technical staff. The working methodology of the service was studied and analysed by means of a review. The deionised water cultures at the entrance to the haemodialysis ward were negative. The dialysis and connector cultures were positive for GNB, confirming that they were of the same genetic origin. An evaluation of the periods was carried out, studying the working methodology, to which no changes were made between the pre-epidemic and epidemic period. In the post-epidemic period, a number of changes were made to the care dynamic, with no other bacteraemia arising to date. Adapting and improving protocols is a good indicator of quality. The role of nursing staff is vital in prevention of GNB.

Bacteremia↗

[Data on predicting the status of body functions of the engineering and technical personnel in the mines].

Reliability of mine foremen influences greatly the group microclimate, productivity and safety of work in mines. Engineering and technical personnel with high level of professional reliability shows the best parameters of psychophysiologic status. Criteria are worked out to score the most informative psychophysiologic functions in mine foremen during the preliminary and regular check-ups of such personnel.

Administrative Personnel↗

Geographical focus. Proteomics initiatives in Spain: ProteoRed.

The Spanish National Network of Proteomic Facilities--ProteoRed has been created as an initiative for the coordination, integration and development of the proteomics facilities and laboratories distributed throughout Spain. ProteoRed's main objective is to give support to the scientific community allowing them wide access to emerging proteomics technologies and thus encouraging the science of proteomics. In addition, standardization of protocols and robustness of workflows are addressed by multi-centric laboratory activities. Educational, training and dissemination issues are part of the core activities of ProteoRed. To reach these objectives, specific activities have been developed through six working groups (WG1-WG6) covering functional, technical, educational and scientific aspects of proteomics.

Computational Biology↗

Unscheduled DNA synthesis tests. A report of the U.S. Environmental Protection Agency Gene-Tox Program.

The utility of unscheduled DNA synthesis (UDS) testing for screening potentially hazardous chemicals was evaluated using the published papers and technical reports available to the UDS Work Group. A total of 244 documents were reviewed. Based on criteria defined in advance for evaluation of the results, 169 were rejected. From the 75 documents accepted, results were reviewed for 136 chemicals tested using autoradiographic approaches and for 147 chemicals tested using liquid scintillation counting (LSC) procedures; 38 chemicals were tested by both approaches to measure UDS. Since there were no documents available that provided detailed recommendations of UDS screening protocols or criteria for evaluating the results, the UDS Work Group presents suggested protocols and evaluation criteria suitable for measuring and evaluating UDS by autoradiography in primary rat hepatocytes and diploid human fibroblasts and by the LSC approach in diploid human fibroblasts. UDS detection is an appropriate system for inclusion in carcinogenicity and mutagenicity testing programs, because it measures the repair of DNA damage induced by many classes of chemicals over the entire mammalian genome. However, for this system to be utilized effectively, appropriate metabolic activation systems for autoradiographic measurements of UDS in human diploid fibroblasts must be developed, the nature of hepatocyte-to-hepatocyte variability in UDS responses must be determined, and the three suggested protocols must be thoroughly evaluated by using them to test a large number of coded chemicals of known in vivo mutagenicity and carcinogenicity.

Animals↗