ONE OF THE areas of dentistry where patient safety is potentially at risk is in the use of acellular bone or skin products – products derived from human tissue.
Since April last year all suppliers of such products must hold a licence from the Human Tissue Authority (HTA) and last November the HTA reiterated that by calling on dentists and oral surgeons to ensure they are using products from licensed suppliers.
The rules ensure that material which comes from human donors is tested for diseases such as HIV, hepatitis B and hepatitis C before use, and that any products derived from human tissues or cells that may pose a potential health risk can easily be recalled.
The rules apply to all acellular products used for patient treatment, including products derived from human skin used to promote wound healing after injury, or products derived from human bone which may be used in dental or orthopaedic surgery.
The HTA’s statement was aimed at dentists and oral surgeons in particular, as they may not have high awareness of the regulation, to ensure they only obtain supplies of acellular products from HTA-licensed establishments.
Dr Sandy Mather, director of regulation at the HTA, said: “Earlier this year we reviewed the risks to patients from bone and skin products following a number of cases where patient safety had been put at risk in Europe. The new regulation was announced in February 2009, with a licence application deadline of 6 April 2009. Nine months after announcing the new regulation, we expect all suppliers of acellular products in the UK to hold an HTA licence: it is unlawful to operate without one. The rules put patient safety first and we would urge dentists and oral surgeons to ensure, if they are purchasing acellular products from UK suppliers, that the supplier holds an HTA licence.”
She continued, “The HTA has provided advice and guidance to those distributing acellular products, including a dedicated training day, online information and answering many phone and email enquiries. We have also widely communicated the requirements through professional bodies, the media and directly to acellular suppliers.”
She added that dentists and oral surgeons that have any questions or are aware of suppliers working outside the regulatory framework, they should contact the HTA. “Where the HTA has evidence that a supplier is acting without an HTA licence, we will take proportionate action.”