Abstract:Progress in science and technology in the health services has led to the development of methods of regenerating and replacing solid organs, tissues and cells, using human body components to create medical products of human origin intended for clinical use. In the activities in which products of human origin are used, however, from the point of donation and harvesting to the subsequent care of the recipient, medical products of human origin are exposed to the risk of specific complications related to the transm… Show more
“…These concerns have established the need for carefully considered policy and regulatory oversight on the quality and safety of transplants and derived products (Martin, 2017). Risk mitigating measures include general and MPHO‐specific donor selection criteria, controlled processing environments, product quality and safety assurance, traceability of implants and follow‐up on outcomes (Ashford & Delgado, 2017; Gkioka et al, 2018; Noël & Martin, 2015).…”
This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first‐choice supplement to a mother's own milk both within and beyond preterm, low‐birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO‐inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth.
“…These concerns have established the need for carefully considered policy and regulatory oversight on the quality and safety of transplants and derived products (Martin, 2017). Risk mitigating measures include general and MPHO‐specific donor selection criteria, controlled processing environments, product quality and safety assurance, traceability of implants and follow‐up on outcomes (Ashford & Delgado, 2017; Gkioka et al, 2018; Noël & Martin, 2015).…”
This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first‐choice supplement to a mother's own milk both within and beyond preterm, low‐birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO‐inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth.
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