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Our strategic approach is based on right-touch regulation. This means being clear on the risks we are regulating, being proportionate and targeted in regulating those risks, taking into account the role of professional bodies and other regulators, and using the minimum necessary direct...
In 2017 the HTA undertook a fundamental evaluation of the extent to which our strategic approach protects public and professional confidence in the proper use, and quality and safety of, human tissues, cells and organs.
The HTA is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care, established by the Human Tissue Act 2004.
The majority of licensed establishments in the Anatomy sector reported that they have good quality management and governance systems in place. 36 establishments reported that they regularly undertake traceability audits.
In the previous round of compliance updates, 14 establishments indicated they used fresh frozen material. In the 2017 update, this number increased to 19.
We found that there is a range of ‘relevant material’ being stored and used across Anatomy establishments (Figure 5). The most common specimens are:
Seven of the 37 (14%) Anatomy establishments do not undertake any preservation on site. We found that a range of methods are undertaken at the remaining 30 establishments, with most establishments utilising several different methods for preserving bodies and tissue (Figure 4).
The compliance data shows that Anatomy establishments can vary quite widely in the number of donated bodies they receive each year (Figure 3). For example:
In addition to storing material for anatomical examination, education, and training, 15 (41%) of establishments reported that they store relevant material for research studies ‘in connection with disorders, or the functioning of the human body’, another ‘scheduled purpose’ under the Human Tissue...