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Biomedical subjects

N Kralj

Publications and source records attributed to N Kralj.

8 recordsLinked to original sources

[Biomaterial regulation (biostoffverordnung) - aspects of the practical conversion].

German Biomaterial regulation (Biostoffverordnung) applies for activities with biological materials (BM). The purpose of this regulation is protection of employees working with BM. BM are micro organisms, inclusively genetically changed micro organisms, cell cultures and human pathogene endoparasits, which cause infections, sensitizing or toxic effects on humans. This regulation describes the necessary organizational, safety-relevant, personally and hygiene measures for the prevention of the diseases and damages caused by BA.

Biological Products↗

[Needle stick injuries in health care - frequency, causes und preventive strategies].

Healthcare workers (HCW) are at risk for infections with blood-borne pathogens - especially hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) - resulting from occupational blood-exposure trough injuries with sharp instruments and needle sticks. Results of a study on the epidemiology of needle stick injuries (NSI) among HCW in two German hospitals indicate that 500,000 NSI occur annually in Germany. Most of these injuries occur during disposal of used syringes and "recapping". Administration of the post-exposure prophylaxis is recommended for HCW who are occupationally exposed to HBV (vaccine/immunoglobulin) and HIV (antiretroviral drugs) i.e. the immediately reporting of blood exposure is very important. Comprehensive programmes to prevent NSI - e.g. avoiding of recapping, use of disposal containers, surgical gloves and in particular safety devices - minimize a high cost of NSI due to the administration of PEP, developing of chronic hepatitis, cirrhosis and liver cancer.

Blood-Borne Pathogens↗

[Current hepatitis B epidemiology in Germany].

Hepatitis B (HB) is the most common occupational hazard for health care workers. On the other hand 90% of the notified HB cases in Germany are observed among the general population (including other high-risk groups like i.v. drug abusers etc.). About 350 million persons all over the world are carriers of the hepatitis B virus (HBV). The availability of effective HB vaccines since 1982 made a control of HB possible. In this communication we report on epidemiological changes due to hepatitis B vaccination in a large university hospital in Germany. Health care workers and non-health care workers occupied at Freiburg university hospital were tested for HBV markers in 1984/85 (n = 4218), 1989/90 (n = 4081) and 1994/95 (n = 4022) during routine occupational health check-ups. Vaccinations were performed using a plasma-derived vaccine (1984/85) or a vaccine obtained by genetic engineering, respectively (1989/90, 1994/95). In 1984/85 prevalence of anti-HBs/HBc in German health care workers (12.4%) was 2.5 times higher than the one in non-health care workers (4.9%), in 1994/95 anti-HBs/HBc prevalence in both groups (4.4 vs. 4.5%) was comparable. On the other hand HBV carriage in persons occupied in professions without blood contact increased from 1984/85 (0.5%) to 1994/95 (1.1%). Therefore, the number of HBV carriers (ca. 1.1 millions) in Germany can be roughly estimated. Our data indicate a high degree of effectiveness of hepatitis B vaccines. Vaccination programme for the general population in accordance with German (STIKO) and WHO recommendations are necessary for the control of HBV infection.

Carrier State↗

[Non- and low-response after preventive hepatitis B vaccination].

20 years after the introduction of the hepatitis-B vaccine the question still remains unsolved as to how the 2 to 5 per cent of the vaccinees who, after basic immunisation, respond with no anti-HBs levels (0-10 IU/l nonresponder, NR) or low levels (11-99 IU/l low-responder, LR) should be boostered to acquire sufficient and long-lasting protective anti-HBs levels. In a retrospective analysis of booster results we found in 75 NR and LR that the probability for long-lasting protection is very low for NR, but better for LR (60%). In a second part of this publication, the efficacy of intradermal and intramuscular hepatitis-B boosters was examined by retrospective analysis of booster results among 26 NR and LR. A slight advantage of the intradermal application was found concerning post-booster anti-HBs increase and the maximal HBs values reached. Long-lasting protective anti-HBs values could not be established for either way of application. Finally, a survey of the literature summing up true results of intradermal hepatitis-B basic immunisations with reduced doses (mostly 2 micrograms), shows that whereas the seroconversion rates achieved by this method are almost compatible with those after regular basic vaccination, the GMT values were far lower than those after regular basic vaccination. Prospective and randomised studies are needed to show which kind of booster is most efficient for nonresponders and low-responders.

Adult↗

[Surgical gloves--how well do the protect against infections?].

Health care workers (HCW) in surgery are at high risk for bloodborne infections (BBI) e.g. by hepatitis-B(HB)-, hepatitis-C(HC)- and HI-virus. On the other hand, infectious medical staff can cause nosocomial BBI in patients, too. Intact gloves provide an efficient barrier against BBI but glove perforations are common during several surgical procedures. A review of studies on glove perforations during different surgical operations was carried out with special regard to user, number and location of perforations, duration and kind of operation. We compared the results with the frequency of glove perforation during operations in 1938 single used gloves. They were collected after different surgical procedures in a department for general surgery and tested for perforation by 1-liter-water-filling method according to DIN 455/1. The product used during the period of this investigation was Sempermed sterile latex surgical glove. Most perforations were found on the index finger and thumb of the non-dominant hand. Duration of operation, role of the user (primary surgeon) and kind of operation are predictors for the incidence of glove perforations. Double gloving, endoscopic and no-touch techniques decrease the possibility of blood contact during operation. Indicator systems are useful for detection of the loss of glove integrity. Due to the high perforation rate found in this study glove change as a routine during surgical procedures should be discussed (e.g. every 30 minutes).

Blood-Borne Pathogens↗

[Efficacy of hepatitis B preventive vaccination].

Health care workers are at increased hepatitis B risk. In the course of a study with 5035 persons occupied at the Freiburg university hospital, efficacy of hepatitis B vaccination and duration of protection were investigated. Estimations of post-vaccination-anti Hbs showed that women, younger persons, persons with a body mass index < 25 and non-smokers had higher anti Hbs concentrations than men, elderly persons overweight persons and smokers. 2% of female and 1.5% of male vaccinees did not develop anti Hbs and 4.8% and 7.1%, respectively were low responders (anti Hbs < 100 < 10 IU/l). Estimations of vaccination efficacy revealed that even 10 years after basic immunisation at least 50% of all vaccinees should have anti Hbs concentrations > 100 IU/l. The results of the study show that vaccination of children in accordance with German and WHO recommendations will afford full protection (anti Hbs > 10 IU/l) in at least 99% of all cases.

Adult↗