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At least 775 records · Page 43Linked to original sources
PubMed1998

Amended economic impact analysis of final rule requiring use of labeling on natural rubber containing devices--FDA. Final rule; amended economic analysis statement.

The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997, final rule, FDA published in the Federal Register of June 1, 1998, an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it prepared under the Regulatory Flexibility Act (RFA), as amended by the small Business Regulatory Enforcement and Fairness Act (SBREFA). After considering comments submitted in response to the June 1, 1998, amended economic analysis statement, FDA is issuing the amended final economic impact statement, including an amended final regulatory flexibility analysis.

Dermatitis, Contact↗
PubMed1998

Natural rubber-containing medical devices; user labeling; cold seal adhesives partial stay--FDA. Final rule.

The final rule for user labeling requirements for natural rubber-containing medical devices, 21 CFR 801-437, was published on September 30, 1997, and becomes effective on September 30, 1998. The Food and Drug Administration (FDA) is adding a note to that rule to stay, for 270 days from the effective date, paragraphs (f) and (g) as those final rule requirements relate to device packaging that uses "cold seal" adhesives. Labeling changes required by other paragraphs of this final rule must be incorporated in the labeling of devices distributed after September 30, 1998, even if the devices are packaged in "cold seal" packages. Device packaging that uses natural rubber only on adhesives contained in the flaps of device packaging is not considered subject to the rule. Manufacturers of devices packaged with "cold seal" adhesives may, if necessary, submit a petition for an extension of the 270-day stay.

Dermatitis, Contact↗
PubMedDate not supplied

Rubber dam--the easy way.

Rubber dam use can only enhance a dental procedure by allowing better access, visibility, and dry field isolation. The reasons offered by many dentists for not using the dam can be overcome by additional training and clinical use. Suggestions are given that have made rubber dam use routine for the author and have facilitated much improved dentistry.

Dental Restoration, Permanent↗
PubMedDate not supplied

Management of dermatitis in the rubber manufacturing industry.

Dermatitis in the rubber industry has diminished markedly in this century, but the problem still is the second most common occupational disease. Contributing agents include natural rubber, as latex concentrate or dry crumb, as well as the various additives used for conditioning. Primary, secondary, and tertiary prevention all have roles in reduction of incidence and severity of impairment. The choice of gloves and skin care methods must be based on a consideration of the efficacy of the materials and the environment in which they will be used. Careful attention to diagnosis yields benefits in treatment course and impairment reduction. Teamwork by occupational physicians, nurses, industrial hygienists, employees, and management is required.

Dermatitis, Contact↗
PubMed2000

Trends in exposure to inhalable particulate and dermal contamination in the rubber manufacturing industry: effectiveness of control measures implemented over a nine-year period.

Exposure to inhalable particulates and dermal exposure to cyclohexane soluble matter (CSM) were evaluated in seven rubber manufacturing companies in 1988 and 1997. The identified exposure trends were used to study the effectiveness of control measures implemented over a nine-year period. Sampling and analytical methodologies were identical in both surveys. Inhalable particulate exposure was measured with a PAS6 sampling head. Dermal exposure was assessed by means of a dermal pad sampler worn at the lower wrist of the hand of preference. Changes in working organization and control measures taken after 1988 were identified based on discussions with management representatives and two walk-through surveys performed in 1994 and 1997. Exposure data were aggregated for comparison between years both at company and production function level. The mixed effect statistical procedure was used to evaluate the influence of control measures and seniority on current exposure levels. Comparison of the exposure levels between 1988 and 1997 revealed a reduction rate of 5.7 and 6.7% per year for inhalable particulate and dermal exposure, respectively. Companies and production functions with the highest exposure levels in 1988 and workers with seniority (more experience) showed a steeper decline in exposure levels. Fifty-seven control measures, mostly designed to control the levels of inhalable exposure were identified. Elimination of sources significantly reduced the inhalable particulate and dermal exposure by two-thirds of the level of 1988. Reduction of emission did not show a significant overall decrease in exposure concentrations. Control measures designed to control the levels of contaminants showed a significant reduction for both inhalable and dermal exposure, respectively 34 and 49% of the exposure level of 1988. These results indicate that efforts taken to improve work conditions in the rubber manufacturing industry in The Netherlands over this decade have been successful in reducing both inhalable particulate and dermal contamination.

Air Pollutants, Occupational↗
PubMed2000

Identification of dermal exposure pathways in the rubber manufacturing industry.

Current existing dermal exposure assessment strategies are predominantly based on regulatory protocols. In order to develop effective and efficient strategies more data driven approaches are needed. In a recently developed conceptual model for dermal exposure, compartments, barriers and mass transport processes relevant for dermal exposure were described. We systematically applied this conceptual model to the rubber manufacturing industry to assess dermal exposure to cyclohexane soluble matter (CSM) and used quantitative data to design an exposure assessment strategy. Identification of the spatial distribution of the dermal contamination showed high CSM surface concentrations for the upper body. Moreover, because of the high correlation between dermal exposure at the wrist and calculated total body exposure (r=0.89, P<0.01) an exposure assessment strategy based on only one pad sampler was employed to estimate CSM surface concentrations in the skin contaminant layer. Qualitative and quantitative evaluation of the relevant compartments and related mass transport processes demonstrated the importance of deposition of airborne contaminants and direct transfer of contaminants from sources and surfaces to the skin contaminant layer. Interestingly, the importance of the different exposure pathways varied considerably between production functions. The use of a model driven exposure assessment strategy in the rubber manufacturing industry revealed relevant skin regions, compartments and mass transport processes and enabled development of an effective and efficient strategy for dermal exposure assessment and hazard control in this particular occupational setting.

Bias↗
PubMedDate not supplied

[Effects of working conditions in the production of synthetic rubber on workers' health].

Examination of 325 Kazan workers engaged in the production of synthetic rubber revealed a high (35.6%) prevalence of thyroid pathology. Patients with thyroid disease and apparently healthy workers manufacturing synthetic rubber were found to have lower levels of T3, T4, and zinc and higher levels of thyroglobulin antibodies and chromium in the serum than in apparently healthy individuals not contacting with noxious agents. The magnitude of increases in the workers' serum concentration of chromium was related to the length of service. The changes were more pronounced in patients with thyroid disease. Correlation analysis revealed that there were direct relationships between the serum levels of T3, T4, and zinc in all groups. There was an inverse correlation between the levels of T4 and the length of service in noxious production in the workers with thyroid disease.

Adult↗
PubMed2001

[Health risk among workers employed in rubber footwear plant].

The aim of the study was to assess the health risk of workers performing specific jobs in the process of the rubber footwear production by defining the cause and length of temporary work disability, as well as mortality causes and level. The analysis was carried out in the groups of workers performing the following jobs: mixing, mill operation, pressing and vulcanizing (A); semi-product preparation and calendaring (B); finishing and sorting (C); production of polyvinyl chloride footwear (D); and auxiliary works (E). The sickness absence study covered all workers (208 men and 315 women) employed in a large rubber footwear company and performing all above-listed jobs in 1995. Standardized sick days ratio was used to analyze the risk of temporary work disability. Mortality rate was estimated on the basis of the results of the cohort study performed in the same company among workers who had worked at least three months during the years 1945-1985. The follow-up continued until 31 December 1997. The present study included sub-cohorts composed of 5628 men and 7197 women, performing jobs listed above. The results of both studies indicated the enhanced risk of cardiovascular diseases among workers employed in the basic phases of the production process. The increased risk of the diseases of the digestive system was observed in men and women employed in: finishing, sorting and packing of the products (group C); in men involved in mixing, pressing and vulcanizing (group A); and in women engaged in auxiliary works (group E). In addition, the enhanced risk of sickness absence due to the diseases of the respiratory, digestive, or genitourinary systems was related to the enhanced risk of death from malignant neoplasms in a given site. The analysis showed that the temporary work disability may be regarded as a parameter useful in early assessment of health effects of the work environmental hazards.

Absenteeism↗
PubMed2002

A new fluoride-releasing rubber cup for professional oral hygiene.

Rubber cups in combination with prophylaxis pastes are commonly used for supragingival professional tooth cleaning. This procedure requires frequent interruption in order to collect fresh paste. Moreover, the paste-saliva slurry blurs the visibility, which implies intermittent rinsing to look for residual discolorations. Hawe Neos Dental (Bioggio, Switzerland) has developed a new prophylaxis cup aimed at cleaning and smoothing the tooth surfaces, while simultaneously fluoridating the enamel without a prophylaxis paste. This new prophylaxis cup was tested with respect to cleaning efficiency, resulting surface roughness, abrasivity, and the promotion of fluoride uptake into enamel. After 15 seconds of use, the new cup showed a cleaning efficiency which was 20 to 30% higher than that of a conventional rubber cup (p < 0.01) used with the prophylaxis pastes Nupro coarse or Hawe cleanic (78% vs. 57 and 49%). The fluoride cup had a smoothing effect on the enamel surface comparable to that effected by the two prophylaxis pastes. The abrasivity on enamel was lowest with the new cup. On dentin, abrasivity was comparable to Nupro coarse, but higher than with Hawe cleanic. The fluoride cup also produced a higher amount of KOH-soluble fluoride on the enamel surface when compared to Hawe cleanic. With respect to the structurally bound fluoride, no difference was found. The newly developed fluoride releasing Hawe Neos cup represents an effective alternative to conventional procedures for supragingival professional tooth cleaning on enamel.

Acidulated Phosphate Fluoride↗
PubMed2003

Effectiveness of rubber band ligation in haemorrhoids and factors related to relapse.

PURPOSE: to assess the effectiveness of ambulatory rubber band ligation (RBL) in the treatment of symptomatic internal haemorrhoids and to identify factors related to relapse. PATIENTS AND METHODS: prospective study of 232 patients treated with rubber band ligation for symptomatic haemorrhoids (grade I-III or grade IV with severe contraindication for surgery) from November 1996 to November 2000 at the outpatient clinic. Ligation was performed with a Stille AB (Comedic) ligator and suction pump, placing 1-3 bands per session and with up to three sessions per patient. Effectiveness of treatment was defined as the absence of symptoms and was confirmed by anoscopy by checking the residual scar after the cushions' detachment. Categorical variables were compared using the shi-squared test, whereas Student's t-test was used for continuous variables. Logistic regression was employed to identify clinical factors related to relapse. RESULTS: a total of 331 bands were placed during 235 sessions in the 163 patients who completed follow-up (70%). Mean age was 45.6 years, with males accounting for 64.4%. Most patients (86.5%) had grade II or grade III haemorrhoids. Overall morbidity was 6%. The most frequent complications were rectal tenesmus (11%), slight or mild anal pain (7.4%), dysuria (4.3%) and transient anal bleeding (3.7%). The treatment was effective in 86% of patients after a mean follow-up of 32 months. Efficacy was high for grades I and II (100% and 97.4% ) but decreased for grade III (69.8%; p<0.001) and grade IV (0%; p<0.001). Most relapses occurred within the first 24 months (87%) and were not significantly related to age, gender, duration of symptoms, itching, bleeding, pain, tenesmus or bowel habit, but were significantly related to the presence of prolapse and its grade (p<0.001), and to the involvement of left posterior, right lateral and anterior pedicles (p<0.05). CONCLUSIONS: ambulatory RBL is a safe and effective treatment for grade I, II and III symptomatic haemorrhoids, and is associated with low morbidity. Recurrence is uncommon and occurs mainly within the first 24 months, being related to the presence and grade of prolapse as well as to its location, but bears little relation to the rest of factors analysed.

Adolescent↗
PubMed1992

[The cancer morbidity of workers in rubber manufacture].

The report discusses the results of the first study of cancer morbidity undertaken in the former USSR in a cohort of rubber workers versus length of service. Certain groups of occupations revealed high risk for malignant tumors of the oral cavity, throat, stomach, pancreas, large and rectal colon, lung, brain, lymphatic and hemopoietic tissue. Relatively high risk of tumors of the larynx, gallbladder, biliary tracts, ovary and vulva was found in females working under hazardous conditions. Agreement of the results with those reported aboard points to elevated risk of cancer in domestic rubber production, too.

Adult↗
PubMed1963

FIELD TESTS OF RUBBER DISC FLOW-REGULATORS ON COMPRESSION SPRAYERS.

As part of a WHO project for the evaluation of spraying equipment for use in malaria eradication campaigns, field trials were carried out in Northern Nigeria which confirmed the potential usefulness of rubber disc flow-regulators on compression sprayers. In these trials the operational characteristics of disc regulators were compared with those of mechanical regulators. Although the scale of the tests was too small to indicate the financial implications of the widespread use of disc regulators, some valid quantitative data were obtained on constancy of flow rate, liquid distribution, tendency to clog, and other factors. The greatest advantage of the rubber disc regulator for the field operator is its simplicity; it has, however, two disadvantages as compared with the mechanical regulator: it tends to clog more frequently with debris and it is rather easily lost when spraying apparatus is being cleaned.

Equipment and Supplies↗
PubMed2004

[Cellular immunity state assessed in bronchial and alveolar lavage for experimental animals exposed to the rubber dust].

Experiments on 21 rats helped to study influence of mechanical rubber dust on cellular immunity state in bronchial and alveolar lavage, efficiency of Ruvimine for prophylaxis. Findings are that mechanical rubber dust is strongly cytotoxic. Ruvimine administration during the whole experiment demonstrates therapeutic and prophylactic effect and normalizes local pulmonary phagocytosis.

Animals↗
PubMed2005

Death following rubber bullet wounds to the chest: case report.

The rubber bullet has been portrayed as a non-lethal weapon and has gained preference in riot-control over live ammunition. Despite the fact that it was designed to be safer than live ammunition, several cases of fatalities have been reported from its use. Most of these fatalities were because of abuse of the weapon in terms of range of fire and anatomical area of the body targeted. This is a case report of such a fatality following shotgun rubber bullet injury, including the circumstance surrounding this unusual occurrence, the autopsy findings and reports of the ballistic analysis. Four projectiles penetrated the right chest lodging in the right lung and injuring the right pulmonary artery, causing death. The mechanism of death in this case is rapid massive pulmonary haemorrhage.

Adult↗
PubMed2005

Handling protocol of posterior composites Rubber Dam.

Although it can never provide perfect isolation, rubber dam greatly facilitates adhesive procedures by keeping the operating field dry throughout operative procedures. Research has shown time and again that the modern dentin bonding agents cannot cope with blood- or saliva contamination. In spite of this very few dentists use rubber dam routinely. Once experienced in its use, it should not take up much more clinical time than 2 minutes.

Humans↗
PubMed2006

Optimization of RQRT-pCR protocols to measure beta-1,3-glucanase mRNA levels in infected tissues of rubber tree (Hevea brasiliensis).

RQRT-PCR technique was evaluated for its validity as an alternative to Northern blotting for quantification of plant gene expression in diseased tissues of Hevea. Reliable RT-PCR results could be obtained by co-amplification of housekeeping actin gene as the internal control along with the gene of interest. The product of interest was quantified relative to that of the internal control by measuring net intensity of bands. Expression levels of defense-related beta-1,3-glucanase gene was studied in the pathogen infected tissues of rubber. The beta-1,3-glucanase gene was found to be induced in infected leaf tissues and reached a peak at 48 h after inoculation. The beta-1,3-glucanase gene expression during pathogen infection was determined through Northern blot hybridization also, using 18S RNA as the internal control. RQRT-PCR and Northern hybridization showed almost similar results, thereby validating the use of this technique to study the gene expression in rubber.

Autoradiography↗
PubMed2003

Biomonitoring of genotoxic risks and haematological changes in workers in rubber industry.

Several substances used in rubber processing are known to be of genotoxins and haematotoxins. Such as benzene, phenols, amines amides, naphthalene and benzo(a)pyrene. Twenty-five exposed workers from a rubber factory were compared with twenty-five controls working as administrative staff in the same factory. An elevated level of urinary thioether (mercapturic acid derivatives) a significant elevation in the level of DNA SSB was found among exposed workers in comparison with control group (p < 0.01). A significant increase in the absolute numbers of peripheral leukocytes and in erthrocyte mean cell volume was observed among exposed workers in comparison with controls (p < 0.01), while a significant decrease in the percentage of lymphocytes and eosinophils was found among exposed workers in comparison with controls. However, the percentage of monocytes was not altered. The reported results have justified the use of genotoxic biomarkers in assessing levels of genotoxic exposure in human population groups and as a screening biomarkers in periodic medical examination as a protective measure.

Adult↗