• What?

The BTEC Professional Hospital /Theatre Access Award is the national recognised occupational peri-operative standard which sets out the competencies for the medical device industry.

Developing and reviewing a comprehensive competence framework of occupational standards for the healthcare sector is currently being driven by The "Agenda for Change",The "NHS Lifelong Learning Strategy", The "National Skills Framework" (knowledge and skills framework) and "Clinical Governance"

• Why?

Whether you work in industry, the NHS or the independent sector, all personnel have a legal duty of care to patients. Ensuring patients receive competent care is managed under the umbrella of Risk Management, which is integral to the Clinical Governance agenda and the Healthcare plans of the UK Departments of Health.

Hospital staff are not the only people present in clinical areas. Medical device companies and their representatives are routinely present in clinical areas educating staff on new techniques and supporting them in the use of their products. These "visitors" have the same obligations as hospital staff in terms of the requirement to comply with the National Competency Framework.

The reality of a recognised national training standard which validates the competence of the device representative to 'work' in areas of clinical care is a major step towards establishing professional accountability.

• Key Points

Department of Health rules - covering management regulations, code of practice and confidentiality and the necessity to adhere to the Data Protection Act - are clear.

However, the presence in any clinical area of someone untrained in hospital policies and with no contractual link to the hospital presents an unquantifiable risk for both hospital management AND the company employing them.

In certain circumstances, pharmaceutical and medical device companies and their representatives could be leaving themselves open to civil litigation by patients and/or health trusts.

Remember, the externally validated BTEC professional qualification gives the company representative the specific skills and knowledge to demonstrate competence in clinical areas. It also defines their role in the clinical team.

The reality of a recognised national training standard which validates the competence of the device representative to 'work' in areas of clinical care is a major step towards establishing professional accountability.