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Medical devices; exemption from premarket notification; class II devices; triiodothyronine test system. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Action of 1997 (FDAMA).

Clinical Chemistry Tests↗

Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from premarket notification barium enema retention catheters and tips with or without a bag. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Barium Sulfate↗

Notification of HIV carriers: possible effect on uptake of AIDS testing.

Passing of the AIDS Prevention Bill, which demands the notification of human immunodeficiency virus (HIV) carriers, seems imminent in Japan. Its effect on people's willingness to be tested for the HIV antibody was assessed among heterosexual subjects (students, office workers) and groups at high risk of the acquired immunodeficiency syndrome (AIDS) (prostitutes, homosexual males) by means of a questionnaire. More than 70% of the 811 students and the 509 workers replied that, if notification became mandatory, they would agree to be tested but 10% of the males and 17% of the females in these two groups would prefer testing at institutes not complying with the clause; all 198 prostitutes said they would be prepared to undergo testing but 35% of them would prefer to go to non-complying clinics; 45% (410) of the 902 homosexual males replied that they would refuse testing, and 65% of those who agreed to be tested (492) would prefer to go to non-complying clinics....

AIDS Serodiagnosis↗

Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Device Approval↗

Description of an HIV patient notification exercise in Essex involving a dental healthcare worker.

During 2000, one of the Consultants in Communicable Disease Control (CsCDC) for North Essex Health Authority was advised that a healthcare worker (HCW) in dentistry had recently been diagnosed as HIV positive. As a result of the HCW's history and taking account the Guidance on HIV infected healthcare workers of the United Kingdom Expert Advisory Group on AIDS, North and South Essex Health Authorities embarked on the largest patient notification exercise in the United Kingdom, to date. This involved an examination of 36,000 patient records and resulted in the identification of 5,929 exposed patients. Of these 5,929 patients, 3,825 contacted the health authority helpline and 3,096 were counselled and screened for evidence of HIV infection. All tests were negative. This was also the first patient notification exercise to use salivary samples for patient screening. The exercise cost in excess of 300,000 Pounds, ignoring the opportunity costs of staff having to devote time to the exercise.

Contact Tracing↗

Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Computer-Aided Design↗

Critical limits for emergency clinician notification at United States children's hospitals.

Critical results demand rapid patient evaluation, possibly followed by life-saving intervention. A national survey of children's hospitals determined the critical limits used for emergency notification of critical laboratory results. Mean low and high critical limits for children for the tests listed most frequently were as follows (millimoles per liter): glucose, 2.6 and 24.7; potassium, 2.8 and 6.4; calcium, 1.62 and 3.17; and sodium 121 and 156. For newborns, significantly different (P less than .01) critical limits were glucose, 1.8 and 18.2; and potassium, 7.8. Hematology mean critical limits for children included hemoglobin, 69 and 208 g/L; platelets, 53 and 916 x 10(9)/L; hematocrit, 0.20 and 0.62 L/L; and white blood cell counts, 2.1 and 42.9 x 10(9)/L. Critical limits for pH were 7.21 and 7.59; for PCO2, 21 and 66 mm Hg; and for PO2, 45 and 124 mm Hg. Important qualitative critical results included blasts on the blood smear and abnormal cerebrospinal fluid findings. In comparison with other medical centers, children's hospitals maintained tighter critical limits for surveillance of renal function, hemostasis dysfunction, and newborn hypokalemia. Use of these results to eliminate outliers can help reduce unnecessary statim notification and improve resource utilization for the acute diagnosis and treatment of critically ill newborns and children.

Chemistry, Clinical↗

AIDS contact notification: initial program results in New Jersey.

As part of an 1988-89 evaluation of New Jersey's newly established HIV Notification Assistance Program (NAP), data were collected concerning number of HIV+ persons providing contact names; contact characteristics; reactions to NAP of HIV counselors, their clients, and of notified contacts; and program costs. There was initial resistance to the program both from HIV counselors and their clients. By mid-1989, acceptance of the program by referring HIV counselors had increased. The proportion of HIV+ clients who referred contacts was still low, but had increased to 10%. 160 contacts were notified: 72% sexual contacts and 28% needle sharing contacts, 59% male and 41% female, 58% black, 29% white, 13% Hispanic. 67% considered themselves at moderate or high risk for HIV; 31% stated that they had already been tested for HIV, with 7% having tested positive. Cost per notified contact was $2,260; cost per contact not previously tested HIV+ and unaware of risk was $3,014. Findings suggest that persuading counselors at HIV counseling and testing sites of the program's value is a key prerequisite for success, in situations where notification is carried out by a separate agency. Once the program has been in place for a time and has established credibility, the opportunity exists for initial resistance to be overcome.

AIDS Serodiagnosis↗

Ethical issues in administrative continuous improvement. Applying the concept of prior notification to the conduct of firm trials.

Consensus exists concerning the distinctions to be drawn between clinical practice and research. When the latter is undertaken, established regulations require that protocols including plans for obtaining subjects' informed consent be submitted to Institutional Review Boards for approval. Less consensus or codification exists concerning evaluations conducted by managers in health care settings. The recent development of firm systems, in which randomized, controlled designs are employed to evaluate administrative interventions, provides a unique context in which to consider whether the subjects of administrative evaluations should be afforded protections granted subjects of clinical research. Accordingly, the history of firm trials from an ethical perspective is reviewed. At the University of Washington, participants of such studies are informed through the process of prior notification, an adaptation of procedures employed widely to inform patients that records or specimens may be used in epidemiologic or biomedical research. Prior notification appears to be a useful refinement of the firm system methodology, one that may have application to managerial manipulations in other arenas.

Behavioral Research↗

[Evaluation of sick leave notification II--a certificate for more than eight weeks sick leave. From the project Evaluation of follow-up of long-term sick leave patients].

An increase in sick leave has been registered by both the National Insurance Administration and by the Confederation of Norwegian Business and Industry. In 1988, expenditure on sick leave was NOK 20.7 billion. The same year the National Insurance Institution found that the average length of each sick leave was 49 days. An arrangement for notification of sick leave was enforced in order to strengthen follow up of persons in receipt of sick pay who had been off work for more than eight weeks. Our survey in Skedsmo shows that this arrangement is not commonly known among the public. In view of the increasing public consciousness about national insurance in general, the doctors who are required to submit notification of sick leave are of the opinion that this arrangement is a useful venture. It is difficult to conclude, however, that this arrangement has been of any benefit to the individual patient. The national insurance office has registered a decrease in expenditure on sick leave, but the work load of officials in the administration has increased.

Absenteeism↗

Notification of HIV carriers: possible effect on uptake of AIDS testing.

Passing of the AIDS Prevention Bill, which demands the notification of human immunodeficiency virus (HIV) carriers, seems imminent in Japan. Its effect on people's willingness to be tested for the HIV antibody was assessed among heterosexual subjects (students, office workers) and groups at high risk of the acquired immunodeficiency syndrome (AIDS) (prostitutes, homosexual males) by means of a questionnaire. More than 70% of the 811 students and 509 workers replied that, if notification became mandatory, they would agree to be tested but 10% of the males and 17% of the females in these two groups would prefer testing at institutes not complying with the clause; all 198 prostitutes said that they would be prepared to undergo testing but 35% of them would prefer to go to non-complying clinics; 45% (410) of 902 homosexual males replied that they would refuse testing, and 65% of those who would agree to be tested (492) would prefer to go to non-complying clinics. These findings strongly suggest that when the bill is passed the greater the self-perceived risk of HIV infection the poorer will be the uptake of AIDS testing. Hence the bill would be counterproductive in the surveillance of potential HIV carriers.

Acquired Immunodeficiency Syndrome↗

Risk for bladder cancer. Psychological impact of notification.

Informing persons that they have been exposed to a carcinogenic chemical (beta-naphthylamine) may adversely affect these persons and their families. The purpose of this study was to identify and assess the psychological impact of a bladder cancer notification and screening program on persons at risk and their families. Approximately 140 subjects were randomly selected from 850 workers exposed to beta-naphthylamine. The Family APGAR, Impact of Event Scale, and Improved Readability Form of the Minnesota Multiphasic Personality Inventory were administered within four weeks of the initial medical screening and readministered six months later. Results show no evidence of disruption to families or substantive psychopathology among these persons. While the actual acquisition of cancer is undoubtedly a psychological trauma, mere notification of risk may not be traumatic in every situation.

2-Naphthylamine↗

The notification of infectious diseases in England and Wales.

For nearly a hundred years, it has been a statutory requirement for doctors to notify a Proper Officer of the local authority (now, usually, the Consultant in Communicable Disease Control) of cases of certain infectious diseases. This prompts local investigation and appropriate action to control the disease. These data are also used for the analysis of local and national trends. This article describes how the notification system has evolved, its legal basis, and some of its strengths and weaknesses, and suggests how improvements could be achieved. Trends in notification data are presented for several diseases and compared with data derived from other sources.

Communicable Disease Control↗

Syphilis in San Diego County 1983-1992: crack cocaine, prostitution, and the limitations of partner notification.

BACKGROUND AND OBJECTIVES: Recent epidemics of syphilis have been associated with crack cocaine use and anonymous sex for drugs, suggesting a potential limitation of sex partner notification as a disease control strategy. To assess these factors in an inner city epidemic of syphilis in San Diego County, California, we performed a descriptive epidemiologic analysis. STUDY DESIGN: Descriptive epidemiologic data were obtained from case investigation reports of primary and secondary syphilis. RESULTS: In the middle and late phases of the epidemic (1990-1992), the incidence of syphilis in the inner city area was more than six times that in remainder of the county. Illegal drug use was reported by 30% of patients. Drug use, especially crack cocaine, was related to prostitution. The estimated total number of sex partners per patient ratio was 4.2, whereas the named sex partners per patient ratio was only 1.5. Twenty-two percent of patients did not report any named partners. Overall, only 26% of the estimated total number of sex partners received treatment. CONCLUSIONS: Expanding partner notification to include more high-risk persons identified through social networks and increasing screening among high-risk populations may improve control of inner city drug/prostitution-related syphilis epidemics.

California↗

Comparison of partner notification at anonymous and confidential HIV test sites in Colorado.

We compared health department-initiated partner notification at a single anonymous human immunodeficiency virus (HIV) test site in Denver to 13 confidential HIV test sites throughout Colorado over an 18-month period. The average number of named, notified, and counseled in-state partners was from 30 to 50% greater among confidential site index cases than anonymous site index cases, and the seropositivity rate in newly tested partners of confidential site index cases was more than twice the rate in partners of anonymous test site index cases. When analyses were restricted to gay/bisexual male index cases, the results were the same as for the total group. We recommend that state and local health departments collect data to evaluate and improve the delivery of partner notification services.

AIDS Serodiagnosis↗

A survey of public health partner notification for sexually transmitted diseases in Canada.

OBJECTIVE: To describe the range of practice for sexually transmitted disease (STD) contact tracing/partner notification (PN) by public health agencies in Canada. METHODS: A two-level mailed survey, using two different questionnaires, was conducted from Aug. 1991 to Feb. 1992, directed to: 1) provincial and territorial epidemiologists/directors of STD control, asking about program organization; and 2) 154 local health units/provincially run PN programs, asking about practice patterns of STD partner notification. CONCLUSIONS: In Canada, STD PN by public health agencies is routinely practised in most provinces. PN efforts vary by the STD; less PN effort goes to chlamydia despite a high burden of illness; HIV PN is frequently perceived to be within the responsibility of the physician. For STDs with higher PN effort, the preferred method is provider referral. Targeting is seldom utilized, and there are little available data at a local level monitoring even process measures of effectiveness.

Canada↗

Individual counseling of patients with sexually transmitted diseases. A way to improve partner notification in a Zambian setting?

BACKGROUND: Sexually transmitted diseases (STD) are a major health problem in Zambia. Partner notification, which is a recommended strategy to decrease STD, must be improved. GOAL: To assess whether individual counseling of patients with STD, combined with contact slip(s), had any impact on the proportion of sex partners traced in an urban setting in Zambia. STUDY DESIGN: A randomized trial comprised of 94 women and 302 men with STD. RESULTS: Women and men in the intervention group informed more partners than did those in the control group. In the intervention group, 1.8 partners per man was treated compared to 1.2 in the control group (P < 0.001). There was no difference between the two groups of women. There was a gradual decline from numbers of partners informed to numbers of partners treated according to the patient to number of contact slips filed. CONCLUSIONS: Individual counseling of men with STD improved partner notification.

Adolescent↗

[Adverse drug reactions and a program of voluntary notification: an opinion survey of primary care physicians].

OBJECTIVES: To discover the view of primary care doctors on aspects of the safety of medicines, their knowledge of the programme of automatic notification of negative side-effects of medicines (NSEM), their opinion of the programme and factors affecting low notification. DESIGN: A survey of views. SETTING: Madrid's Health Area 1. PARTICIPANTS: General practitioners and paediatricians (n = 417). MEASUREMENTS AND RESULTS: 281 doctors (67.4%) replied. 88.4% (48 + 40.4%) said they included questions on possible side-effects in the case history interview (always or almost always). 58.2% suspected at least one negative side-effect each month. CONCLUSIONS: Doctors are very interested in detecting and identifying the NSEM of their patients, and therefore believe that a centralised system to record NSEM should be set up.

Adult↗