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PubMed1992

Moderate heat treatment of bone allografts. Experimental results of osteointegration.

The use of bone allografts is often essential in orthopedic surgery. Strict donor screening, including HIV testing 3 months postoperatively, is mandatory before a transplant may be used. Yet these measures do not definitely rule out the possibility of HIV transmission, as there is a window period before infection is revealed by blood testing. Accordingly, there is a need for virus inactivation methods that can be used on bone allografts. As radiation treatment and chemical methods have a number of disadvantages, we chose a moderate heat treatment of 65 degrees C for a series of animal experiments. In 12 rabbit femoral condyles, moderate-heat-treated bone allografts were implanted into 6-mm drill holes. Twelve normal allografts and 12 empty drill holes served as controls. Radiologic and histological evaluation up to 12 weeks postoperatively revealed slow spontaneous bone remodeling from the rim to the center of the empty cavities. Normal deep frozen allografts were quickly intergrated after a short period of osteoclast reaction around the transplant, with occasional bone bridges between host and allograft. The examination of heat-treated allografts showed no differences to the controls, including morphologic aspects and the time course of osteointegration. Five zones of bone repair and osteointegration were distinguished. We conclude that thermal treatment of bone allografts has adverse effects on osteointegration in the rabbit femoral condyle. Thus, it may contribute to improving safety in human bone transplantation.

Animals↗
PubMed2005

A prospective comparison of the selective observation and routine exploration methods for penetrating abdominal stab wounds with organ or omentum evisceration.

BACKGROUND: Both routine laparotomy and selective observation methods have been used in the treatment of penetrating abdominal stab wounds with organ or omentum evisceration. There still are some conflicts about these treatment methods. METHODS: Between 1998 and 2003, 61 patients treated in the authors' emergency clinic because of penetrating abdominal stab wounds with organ or omentum evisceration were evaluated prospectively. Excepting those with absolute indications for mandatory laparotomy, these patients were treated by either routine laparotomy or selective observation methods. Their prognosis, rates of unnecessary laparotomy, length of hospital stay, and complications were compared using Fisher's exact test and Student's t test. RESULTS: Nine patients underwent mandatory laparotomy and were therefore excluded from the study. The overall incidence of the patients who had no significant abdominal pathology was 54.1% (33/61). The overall incidence of significant injuries among the asymptomatic patients was 36.5% (19/52). Routine laparotomy was performed for 21 patients, who experienced unnecessary laparotomy and complication rates of 33.33% and 19%, respectively. The mean length of hospital stay in this group was 137.38 +/- 53.25 hours. Of 31 patients, 24 who had been treated by selective observation methods were discharged without laparotomy. The unnecessary laparotomy and complication rates for this group were 6.45% (28.6% for the patients treated surgically) and 3.2%, respectively, whereas the mean length of hospital stay for this group was 81.22 +/- 42.46 hours. There were statistically significant differences in terms of unnecessary laparotomy rates and mean lengths of hospital stay, but no difference in terms of complication rates. CONCLUSION: The selective observation method is safe and superior to routine laparotomy for the treatment of penetrating abdominal stab wounds with omentum evisceration.

Abdominal Injuries↗
PubMed1995

Control of Salmonella enteritidis in Sweden.

The Swedish control of Salmonella, with special reference to Salmonella enteritidis, in poultry is described. The control is directed at all serotypes of Salmonella and imported grandparent chickens are controlled, which is considered to be the main reason why Sweden so far is not found to be involved in the worldwide spread of different phagetypes of S. enteritidis. However, this spread has initiated a more stringent control of Salmonella in layers as earlier existed in broilers. Since 1990, 90% of the layer flocks are voluntarily tested for Salmonella before slaughter by bacteriological examination of pooled faecal samples. If S. enteritidis is isolated the flock is destroyed. This test, and in addition two similar tests during the production are mandatory as of January 1st, 1994. The voluntary Salmonella control programme has also been extended to all of the layer parents and hatcheries since 1991. Only heat-treated feed is given to all layer chickens during the rearing period and its use is becoming gradually more common also during the production period. Since 1987, four layer flocks have been found to be infected by S. enteritidis phagetype 4 and one flock with phagetype 6. During 1970-1984, 90% of all flocks of broilers were voluntarily tested bacteriologically for Salmonella before slaughter, and since 1984 such a control is mandatory to all flocks. As a result of this and other controls, S. enteritidis has not been isolated from broilers since 1972. Based on a governmental regulation from 1961, introduced as a result of a large Salmonella epidemic in 1953, Sweden runs an active, official control of Salmonella (Wierup et al., 1992).(ABSTRACT TRUNCATED AT 250 WORDS)

Abattoirs↗
PubMed1999

Basic problems of serological laboratory diagnosis.

Serological laboratory diagnosis is inflicted with at least two kinds of basic problems. One type relates to the fact that the serological diagnosis of infectious diseases is double indirect: First, to diagnose an infectious disease, the identification of the microbial agent is sought that caused the disease. Second, to identify this infectious agent, the patient's immune response to potential agents is measured. So, the serological test is neither measuring directly disease nor the cause of the disease, but the patient's immune system. Another type of problem is based on the fact that each person's immune system is very individual. The exact physicochemical properties of antibodies are unique for each clone of antibodies. The way an individual's immune system sees an infectious agent depends not only on the genetic makeup of the person but also on the personal experience from former encounters with infectious agents. Both types of problems lead to complexities in selecting the appropriate test, in interpreting the results, and in standardizing serological tests. Therefore, a close collaboration of the laboratory with the clinic is mandatory to avoid erroneous conclusions from serological test results, which might lead to wrong decisions in patient care.

Clinical Laboratory Techniques↗
PubMed2002

The use and interpretation of in vitro data in regulatory toxicology: cosmetics, toiletries and household products.

There is currently a drive to eliminate animal testing for cosmetics, toiletries and household products; indeed, the European Union Cosmetics Directive aims to prohibit the use of experimental animals for the testing of finished cosmetic products after 2002. At present, national prohibitions are in place in the UK, Germany, Austria and the Netherlands, for the testing of finished cosmetic products and cosmetic ingredients. In the USA animal testing for certain types of finished products is mandatory. Against this background, the currently available regulatory in vitro tests comprise methods for eye irritation, skin corrosivity, genotoxicity, dermal penetration and photoirritation. The draft updates to the Organisation for Economic Co-operation and Development guidelines for eye and skin irritation advocate the use of in vitro or ex vivo methods prior to the commencement of animal studies. At present, testing for these endpoints cannot be completed in vitro, but potentially corrosive substances and products can be classified without the need for animal studies. Regulatory genotoxicity testing can be completed using only in vitro methods, provided that a clear negative outcome is obtained for each test. Data from dermal penetration studies may be used to refine risk assessments. Current developments in areas such as skin sensitisation and skin irritation promise that in the reasonably near future such information may be generated without the use of animals.

Animal Testing Alternatives↗
PubMed2003

Bioethical considerations in neonatal screening: Japanese experiences.

Since 1979, at least 13,000 affected babies have been identified with one of the tested diseases. The outcome for patients is generally favorable if adequate treatment is given. Recently, ethical issues have arisen concerning whether or not written informed consent should be required, under what conditions the residual blood spot may be used for research purposes other than that originally designed, and whether or not the test is cost-effective. Mandatory screening seems acceptable under certain conditions, but parental education and opportunity for refusal should be part of the system. Refusal should be documented only after an attempt has been made to persuade parents to consent. Informed consent is necessary if there is uncertainty about the test's benefit to the child. Parents should be informed of the potential research value of the samples and assured that research results will not be linked to any particular/individual newborn. If identified or coded blood spots are used for research, IRB review and approval by IRB must occur. The net health care benefit from screening for six disorders in Japan was 0.25 billion yen ($2.2 million) per 100,000 screened newborns compared to $3.2 million for PKU and CH in the US for 100,000 screened newborns.

Blood Specimen Collection↗
PubMed1975

Ill patient with unknown or hidden pregnancy.

Many pregnancies are inadvertently interrupted because diagnostic and therapeutic procedures that are potentially teratogenic are unwittingly instituted. To prevent this ever-present possibility, it is essential that the family physician as well as the hospital's admitting physician know for certain whether a patient in her childbearing years is pregnant. The simple direct question "Are you pregnant?" unfortunately does not always elicit a reliable answer. The patient may not know that she is pregnant, a common occurrence in early pregnancy, or for any of a number of reasons she may choose to conceal her pregnancy. A pregnancy test thus becomes an important diagnostic tool in the armamentarium of every conscientious physician. It should be given routinely to all women of childbearing age before instituting extensive diagnostic x-ray studies, radiation therapy, or chemotherapy that may be contraindicated in pregnancy. Because most contraindicated procedures are performed in a hospital, it is suggested that a pregnancy test on urine be made mandatory on a woman's admission to a hospital.

Adult↗
PubMed1994

Postoperative recurrent ulcer.

Figure 2 summarizes my evaluation of most patients with postoperative recurrent ulcers. First, serum gastrin and calcium levels should be determined in all patients. At the initial endoscopy, any silk sutures should be removed, and gastric ulcers biopsied. The presence of gastric ulcers or evidence of delayed gastric emptying should influence the surgical procedure. Ideally, a Congo red test should be performed at the initial endoscopy. The only caveat is that excessive sedation may invalidate the test results. If the initial diagnostic endoscopy does not include a Congo red test and serum gastrin and calcium levels are normal, it is reasonable to proceed with medical management without vagotomy testing. I believe that if medical management fails and operative treatment is planned, all patients should undergo vagotomy testing. If the Congo red test is definitively positive, sham feeding is not necessary. On the other hand, if the Congo red test suggests hyposecretion, I believe that sham feeding is mandatory prior to proceeding with operation. Conversely, sham feeding tests may be falsely negative in postoperative patients. Therefore, many of our patients undergo both Congo red testing and sham feeding prior to reoperation. Finally, if delayed gastric emptying is believed to be part of the clinical syndrome, a radionuclide scan should be performed to assess gastric emptying. It can be either a solid-meal study or an acetanilidoiminodiacetic acid scan, which measures bile reflux as well as determines emptying of bile from the fasted stomach (see introductory article in this issue).

Humans↗
PubMed1997

Preoperative pregnancy testing: a survey of current practice.

STUDY OBJECTIVE: To examine contemporary practices and opinions regarding preoperative testing requirements, with special emphasis on perioperative pregnancy recognition and consequences thereof. DESIGN AND SETTING: Anonymous questionnaire survey distributed to 300 (almost exclusively American) physicians attending the 1996 Society of Obstetric Anesthesia and Perinatology meeting. MEASUREMENTS AND MAIN RESULTS: Responses from 169 anesthesiologists indicated that approximately one-third mandated pregnancy testing via departmental policy. More anesthesiologists (p = 0.02) mandated routine pregnancy testing of all elective (30%) versus all emergency (17%) surgical patients. Sixty-six percent versus 20% percent, respectively, would require rather than simply offer pregnancy testing when history indicated possible pregnancy; 20% and 15%, respectively, of those surveyed indicated elective surgery would be canceled by the anesthesiologist if the patient were pregnant or refused testing (p = NS). Although 98% of respondents recognized a legal requirement to report child abuse, and 82% believed pregnancy in a juvenile (i.e., the child's age is under local legal defined age for consent to sex) by definition constituted child abuse, fewer than 4% would report this information to the police, even if the impregnating male were known to be an adult. CONCLUSIONS: The desire to identify pregnancy using patient history was most prevalent among anesthesiologists, with less than one third using mandatory, departmentally imposed screening programs. Positive test results in minors are shared primarily with surgeons and patients, occasionally with parents and social services, but rarely with police, although a positive test almost universally signified child abuse, and mandatory reporting laws were acknowledged by anesthesiologists surveyed.

Adolescent↗
PubMed2003

Antimicrobial susceptibility and synergistic activity of meropenem against Gram-negative non-fermentative bacteria isolated from cystic fibrosis patients.

The objective of the present study was to evaluate the activity of meropenem (a beta-lactam carbapenem with good bactericidal potency and a very wide spectrum of activity) and of ticarcillin, ceftazidime ciprofloxacin, tobramycin, cefepime, which are the most commonly used antimicrobial agents for treatment of pulmonary infections associated with CF. The effect of these antibiotics was tested on 27 multiresistant strains isolated from 24 CF patients during 2000 and 2001. Furthermore, the in vitro synergistic effect of meropenem in association with the other antibiotics was evaluated. Ciprofloxacin, ticarcillin, meropenem and ceftazidime had the most activity and inhibited 66%, 37%, 36% and 33% of strains respectively. The addition of a second antibiotic to meropenem resulted in a synergistic effect on 5 (18.5%) isolates; on average 2.8 synergistic combinations where determined per strain. Of these 27 isolates, antagonism was observed in 3 (11%) strains (1 antagonistic combination per strain). Our study suggests that selecting effective double antibiotic therapy cannot be made empirically for CF patients infected with Gram-negative multiresistant bacilli. Therefore in vitro methods for testing double antibiotic combinations are mandatory.

Anti-Bacterial Agents↗
PubMed1989

Cytopathology: new legislative, regulatory, and proficiency testing requirements.

In 1988, a combination of efforts by the press, the Maryland General Assembly, the Department of Health and Mental Hygiene (DHMH), and an advisory panel of pathologists and cytotechnologists led to broader and stricter regulation of cytopathology laboratories in Maryland. A new law called for standards covering the maximum number of slides a cytotechnologist may examine, unsatisfactory specimens, slide and records retention, a limitation on the use of out-of-state laboratories by Maryland physicians, and a mandatory, state-run proficiency testing program. Maryland's proficiency testing program is modeled on that of New York State but incorporates improvements in diagnostic definitions, testing mechanisms, and retraining requirements.

Laboratories↗
PubMed1990

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--HHS. Notice.

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11986). A similar notice listing all currently certified laboratories will be published monthly, and updated to include laboratories which subsequently apply and complete the certification process. If any listed laboratory fails to maintain its certification, it will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.

Certification↗
PubMed1990

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--ADAMHA. Notice.

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11979, 11986). A similar notice listing all currently certified laboratories will be published during the first week of each month, and updated to include laboratories which subsequently apply and complete the certification process. If any listed laboratory's certification is totally suspended or revoked, the laboratory will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.

Certification↗
PubMed1991

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--ADAMHA. Notice.

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11979, 11986). A similar notice listing all currently certified laboratories will be published during the first week of each month, and updated to include laboratories which subsequently apply for and complete the certification process. If any listed laboratory's certification is totally suspended or revoked, the laboratory will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.

Certification↗
PubMed1990

Current list of laboratories which meet minimum standards to engage in urine drug testing for federal agencies--ADAMHA. Notice.

The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11986). Starting this month, a similar notice listing all currently certified laboratories will be published monthly, and updated to include laboratories which subsequently apply and complete the certification process. If any listed laboratory fails to maintain its certification, it will be omitted from updated lists until such time as it is restored to full certification under the Guidelines.

Government Agencies↗
PubMedDate not supplied

Sperm function assays and their predictive value for fertilization outcome in IVF therapy: a meta-analysis.

The prevalence of male infertility and the availability of new, highly successful therapeutic options make the testing of sperm functional competence mandatory. An objective, outcome-based examination of the validity of the currently available assays was performed based upon the results obtained from 2906 subjects evaluated in 34 prospectively designed, controlled studies. The aim was carried out through a meta-analytical approach that examined the predictive value of four categories of sperm functional assays: computer-aided sperm motion analysis (CASA); induced-acrosome reaction testing; sperm penetration assay (SPA); and sperm-zona pellucida binding assays for IVF outcome. Results demonstrated a high predictive power of the sperm-zona pellucida binding and the induced-acrosome reaction assays for fertilization outcome. On the other hand, the findings indicated a poor clinical value of the SPA as predictor of fertilization and a real need for standardization and further investigation of the potential clinical utility of CASA systems. This analysis points out to limitations of the current tests and the need for standardization of methodologies and provides objective evidence on which clinical management and future research can be based.

Acrosome Reaction↗