RESUMEN
The microbiological tests on breast milk performed when samples of pasteurized breast milk are added to hospital milk banks are covered by French regulations dating from December 3rd 2007. They involve counts of the aerobic total flora and of Staphylococcus aureus in a sample of milk before pasteurization, and culture after pasteurization to check that the treated milk is sterile. The regulations specify the nature of the agar plates to be used, together with the conditions for plating and incubation, but they lack detail in other areas. We developed a quality assurance system, modified our process to meet the statutory requirements, prepared for COFRAC certification of the laboratory for this parameter, and proposed solutions to overcome the inadequacies of the regulations. The modifications of the process associated with the quality approach led to a successful initial certification visit. However, the preparation for this certification highlighted other inadequacies of the regulations that might affect the final results obtained for total flora and S. aureus counts. We think that the text should be modified to overcome these problems and to ensure high-quality counting such that those running hospital milk banks can have confidence in the laboratory results they receive.
Asunto(s)
Técnicas Microbiológicas , Bancos de Leche Humana/normas , Leche Humana/microbiología , Acreditación , Adulto , Femenino , Unidades Hospitalarias/legislación & jurisprudencia , Unidades Hospitalarias/normas , Humanos , Recién Nacido , Legislación Médica , Técnicas Microbiológicas/métodos , Técnicas Microbiológicas/normas , Bancos de Leche Humana/legislación & jurisprudencia , Pasteurización/legislación & jurisprudencia , Pasteurización/normas , Control de CalidadRESUMEN
BACKGROUND: Milk safety is an important concern in neonatal units and human milk banks. Therefore, evidence-based recommendations regarding raw milk handling and storage are needed to safely promote supplying hospitalized infants with their mother's own milk. OBJECTIVES: To evaluate raw human milk storage methods according to Brazilian milk management regulations by investigating the effects of refrigeration (5°C) for 12 hours and freezing (-20°C) for 15 days on the acidity and energy content in a large number of raw milk samples. METHODS: Expressed milk samples from 100 distinct donors were collected in glass bottles. Each sample was separated into 3 equal portions that were analyzed at room temperature and after either 12 hours of refrigeration or 15 days of freezing. Milk acidity and energy content were determined by Dornic titration and creamatocrit technique, respectively. RESULTS: All samples showed Dornic acidity values within the established acceptable limit (≤ 8°D), as required by Brazilian regulations. In addition, energy content did not significantly differ among fresh, refrigerated and frozen milk samples (median of ~50 kcal/100 mL for each). CONCLUSION: Most samples tested (> 80%) were considered top quality milk (< 4°D) based on acidity values, and milk energy content was preserved after storage. We conclude that the storage methods required by Brazilian regulations are suitable to ensure milk safety and energy content of stored milk when supplied to neonates.
Asunto(s)
Criopreservación , Regulación Gubernamental , Unidades de Cuidado Intensivo Neonatal , Bancos de Leche Humana/legislación & jurisprudencia , Leche Humana/química , Refrigeración , Manejo de Especímenes/métodos , Adulto , Brasil , Extracción de Leche Materna , Humanos , Recién Nacido , Bancos de Leche Humana/normas , Manejo de Especímenes/normasRESUMEN
No disponible
Asunto(s)
Niño , Femenino , Humanos , Lactante , Masculino , Bancos de Leche Humana/organización & administración , Bancos de Leche Humana/normas , Bancos de Leche Humana , Investigación/tendencias , Lactancia Materna/métodos , Lactancia Materna/tendencias , Bancos de Leche Humana/legislación & jurisprudencia , Bancos de Leche Humana/provisión & distribución , Bancos de Leche Humana/tendencias , Promoción de la Salud/organización & administración , Promoción de la Salud/normas , Promoción de la SaludRESUMEN
INTRODUCTION: In France, human milk banks pasteurize milk for the mother's own hospitalized baby (personalized milk) and for donation. There is specific legislation regulating the activity of human milk banks with bacterial screening of donor milk before and after pasteurization. Milk should be tested for Staphylococcus aureus and total aerobic flora. Any sample of milk positive for aerobic flora and/or S. aureus before and/or after pasteurization should be discarded. The real pathogenicity of the total aerobic flora is actually debated as well as the usefulness of systematic postpasteurization screening. The aim of this study was to quantify milk losses related to prepasteurization contamination by total aerobic flora in a regional milk bank, to identify losses due to contamination with S. aureus or aerobic flora, and to analyze differences between centers. METHODS: This was a prospective observational study conducted in the regional human milk bank of the Nord-Pas-de-Calais area in France. Data were collected from six major centers providing 80% of the milk collected between June 2011 and June 2012. Variables were the volumes of personalized milk collected by each center, volumes of contaminated milk, and the type of bacteria identified. RESULTS: During the study period, the regional human milk bank treated 4715 L (liters) of personalized milk and 508 L (10.8%) were discarded due to bacteriological screening. Among these 508 L, 43% were discarded because of a prepasteurization contamination with aerobic flora, 55% because of a prepasteurization contamination with S. aureus, and 2% because of other pathogenic bacteria. Postpasteurization tests were positive in 25 samples (0.5%). Only five of these 25 samples were positive before pasteurization and in all cases with S. aureus. A total of 218 L were destroyed because of prepasteurization contamination with total aerobic flora, while the postpasteurization culture was sterile. There was a great difference between centers in the percentage of discarded milk and the type of contamination. The percentage of discarded milk varied from 4 to 16% (P<0.001) and the percentage of prepasteurization positive samples with aerobic flora from 0 to 70% (P<0.001). Costing 80 /L in France, this represented an economic loss of 17,440. CONCLUSION: A significant volume of milk is discarded because of contamination with total aerobic flora found only in prepasteurization tests. Reassessment of the French regulations with regard to microbiological safety could save human milk to cover the needs of a larger group of preterm babies.
Asunto(s)
Bacterias Aerobias/aislamiento & purificación , Contaminación de Alimentos , Bancos de Leche Humana/legislación & jurisprudencia , Leche Humana/microbiología , Bacterias Aerobias/patogenicidad , Carga Bacteriana , Femenino , Contaminación de Alimentos/legislación & jurisprudencia , Contaminación de Alimentos/prevención & control , Francia , Análisis de Peligros y Puntos de Control Críticos/métodos , Humanos , Lactante , Estudios Prospectivos , Staphylococcus aureus/aislamiento & purificación , Eliminación de Residuos LíquidosAsunto(s)
Comercio , Regulación Gubernamental , Leche Humana , Seguridad , Lactancia Materna , Comercio/economía , Comercio/legislación & jurisprudencia , Femenino , Humanos , Internet , Bancos de Leche Humana/economía , Bancos de Leche Humana/legislación & jurisprudencia , Rol Profesional , Riesgo , Estados UnidosRESUMEN
When Muslims thought of establishing milk banks, religious reservations were raised. These reservations were based on the concept that women's milk creates 'milk kinship' believed to impede marriage in Islamic Law. This type of kinship is, however, a distinctive phenomenon of Arab tradition and relatively unknown in Western cultures. This article is a pioneer study which fathoms out the contemporary discussions of Muslim scholars on this issue. The main focus here is a religious guideline (fatwa) issued in 1983, referred to in this article as 'one text', by the Egyptian scholar Yusuf al-Qaradawi who saw no religious problem in establishing or using these banks. After a number of introductory remarks on the 'Western' phenomenon of milk banks and the 'Islamic' phenomenon of 'milk kinship', this article analyses the fatwa of al-Qaradawi 'one text' and investigates the 'two contexts' in which this fatwa was discussed, namely, the context of the Muslim world and that of Muslim minorities living in the West. The first context led to rejecting the fatwa and refusing to introduce the milk banking system in the Muslim world. The second context led to accepting this system and thus allowing Muslims living in the West to donate and receive milk from these banks. Besides its relevance to specialists in the fields of Islamic studies, anthropology and medical ethics, this article will also be helpful to physicians and nurses who deal with patients of Islamic background.
Asunto(s)
Árabes , Incesto/etnología , Islamismo , Bancos de Leche Humana/ética , Religión y Medicina , Diversidad Cultural , Femenino , Humanos , Incesto/legislación & jurisprudencia , Recién Nacido , Recien Nacido Prematuro , Bancos de Leche Humana/legislación & jurisprudenciaRESUMEN
In France, the screening for human T-cell leukemia/ lymphoma virus type 1 and 2 (HTLV-1 and HTLV-2) during the donation of human milk has been carried out from 1992 with the application of the circular DGS 24 November 1992. The screening for antibodies against these viruses is regulated and done systematically during every donation of milk. Breast feeding being the main mode of transmission of the HTLV-1, the last ministerial decree of 25 August 2010 has made the screening test compulsory for the anonymous donation and for the personalized donation (of a mother for her own child) from all women including those affected by the infection. The milk delivered by milk banks is pasteurized (62.5 °C for 30 minutes) before freezing at -18 °C, which inactivates the pathogens. This double means of prevention of the transmission of the HTLV-1 paradoxically seems disproportionate in the absence of any precautionary measure in the case of direct breast-feeding and the use of mother's raw milk. Indeed, in most neonatal intensive care units in maternity hospitals, unpasteurized milk is administered to the neonates without any systematic preliminary testing of the serological HTLV-1 status of the mother. An increased sensitization of the community of the obstetricians, midwives and neonatologists by the Association of the Milk Banks of France (ADLF) and the Société de pathologie exotique could address the issue of screening for HTLV-1 in "donated" milk and breast-feeding.
Asunto(s)
Infecciones por HTLV-I/prevención & control , Infecciones por HTLV-II/prevención & control , Virus Linfotrópico T Tipo 1 Humano/aislamiento & purificación , Virus Linfotrópico T Tipo 2 Humano/aislamiento & purificación , Tamizaje Masivo/legislación & jurisprudencia , Bancos de Leche Humana , Leche Humana/virología , Donantes de Tejidos , Adulto , Lactancia Materna , Criopreservación , Transmisión de Enfermedad Infecciosa/prevención & control , Femenino , Francia , Infecciones por HTLV-I/transmisión , Infecciones por HTLV-II/transmisión , Política de Salud , Calor , Humanos , Recién Nacido , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Bancos de Leche Humana/legislación & jurisprudencia , Bancos de Leche Humana/normas , Madres , Estudios Retrospectivos , Inactivación de VirusAsunto(s)
Bancos de Sangre , Bancos de Leche Humana , Preservación de Órganos , Salud Pública , Bancos de Esperma , Conservación de Tejido , Bancos de Sangre/economía , Bancos de Sangre/historia , Bancos de Sangre/legislación & jurisprudencia , Economía/historia , Economía/legislación & jurisprudencia , Historia del Siglo XX , Historia del Siglo XXI , Cuerpo Humano , Bancos de Leche Humana/economía , Bancos de Leche Humana/historia , Bancos de Leche Humana/legislación & jurisprudencia , Preservación de Órganos/economía , Preservación de Órganos/historia , Preservación de Órganos/psicología , Salud Pública/economía , Salud Pública/educación , Salud Pública/historia , Salud Pública/legislación & jurisprudencia , Cambio Social/historia , Bancos de Esperma/economía , Bancos de Esperma/historia , Bancos de Esperma/legislación & jurisprudencia , Conservación de Tejido/economía , Conservación de Tejido/historia , Estados Unidos/etnologíaAsunto(s)
Bancos de Leche Humana/legislación & jurisprudencia , Bancos de Leche Humana/normas , Guías de Práctica Clínica como Asunto , Técnicas Bacteriológicas/normas , Desinfección/métodos , Desinfección/normas , Selección de Donante/métodos , Humanos , Bancos de Leche Humana/provisión & distribución , Leche Humana/microbiología , Leche Humana/fisiología , Control de Calidad , Manejo de Especímenes/métodos , Manejo de Especímenes/normas , Donantes de Tejidos/provisión & distribuciónRESUMEN
Incluye las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada centro, incluidos el equipo y recurso humano y técnico. El documento describe los requisitos, organización y creación de bancos de leche, así como el perfil y atribuciones de quien lo dirige. Incluye además la descripción y atribuciones del equipo técnico. Hace referencia a la creación de comités de lactancia materna, especialmente aplicables a hospitales públicos. El artículo 14 enumera y describe los requisitos para la autorización de bancos de leche en entidades privadas. En relación a las donantes, describe los requisitos y características de deberán llenar para serlo, así como quiénes y sus circunstancias, los beneficiarios de dichas donaciones.
Asunto(s)
Humanos , Femenino , Lactancia Materna/métodos , Bancos de Leche Humana/legislación & jurisprudencia , Bancos de Leche Humana/organización & administración , Nutrición del Lactante/economía , Guatemala , Lactante , Concesión de Licencias/legislación & jurisprudencia , Concesión de Licencias/normas , Leche HumanaRESUMEN
The PREM Bank has been providing pasteurised donor human milk (PDHM) to very preterm for the past 3 years. It is the first human milk bank (HMB) to operate in Australia in over 20 years. Our community has rapidly embraced the concept of human milk banking, with both donations and demand for PDHM exceeding expectations. Providing PDHM in 'exceptional circumstances' where a mothers' own milk is unavailable is supported by the WHO and UNICEF. We submit that neonatal intensive care is an exceptional circumstance. Although evidence supporting PDHM use from randomised control trial (RCT) is limited, the latest systematic reviews suggest a lower risk of necrotising enterocolitis with PDHM as opposed to artificial formula. Study design and ethical issues may limit future evidence from RCT. We therefore support the ongoing use of PDHM in neonatal care, where provided by an appropriately managed HMB. Internationally many HMBs operate unregulated, and this is also the case in Australia. To ensure safety the PREM Bank has committed to meet the appropriate standards recommended in the Code of Good Manufacturing Practices (Blood and Tissues) in Australia and models risk management during processing on Codex HACCP (Hazard Analysis Critical Control Point) requirements. There is scope to continually re-evaluate the screening of donors and quality standards recommended during HMB. This will be most effective if strong networks of HMBs are developed with regional reference laboratories to encourage compliance with safety guidelines. HMB networks will facilitate collection of evidence for refining HMB practice and improving outcomes for preterm and sick infants.