Six critical questions

Medical device companies: can you answer yes to these six questions?

  1. IS your representative, when supporting company products, qualified to a verifiable standard that allows them to work in an operating theatre?
  2. IS the representative able to function professionally, without compromising the safety of that clinical environment?
  3. CAN you say with certainty that your employee’s actions will not endanger the safety of the patient in that environment?
  4. CAN you guarantee that, within that environment, your employee’s conduct will not compromise the medical professionals’ standards concerning clinical practice, ethics, legal protection and doctor-patient confidentiality?
  5. ARE you aware of the potential ramifications of not being able to meet these obligations?
  6. ARE you aware you have to comply with all of the above?


In our experience, many medical device companies would not be able to respond positively to all six questions. That amounts to a big negative – and it needs to be addressed.

The HCS qualification programme is THE essential, recognised solution for those employed in the healthcare industry who work in clinical areas alongside medical professionals.

Our externally validated courses and qualifications address the fact that ALL personnel present in operating theatres have a legal duty of care to patients.

When all those in theatre can demonstrate the definitive competence that permits them to be there, it means that:

  1. The duty of care to patients is not compromised
  2. The professional and legal standing of the medical professionals is not compromised
  3. Hospital managements can, in the event of litigation, be confident of demonstrating that best practice is a keystone policy, by virtue of accredited and ongoing training
  4. The legal and reputational position of the healthcare employee as well as that of the employer is safe
  5. The healthcare employee is equipped with the specific skills and knowledge to demonstrate competence in clinical areas and their role is defined within the clinical team

Developing and reviewing a comprehensive competence framework of occupational standards for the international healthcare sector is being driven within different countries by agendas for change, learning strategies and skills frameworks.

That is because it is widely accepted that theories of legal liability can generally be placed into two main categories:

  • Claims based on the representative’s mere presence in the operating theatre
  • Claims based on the actions or omissions of the product specialist

The professional awards offered by HCS and accredited by internationally recognised education services provider EduQual form the recognised occupational perioperative standard which sets the competencies for the entire medical device industry.

It justifies and legitimises the product specialist’s role role and identifies that they are not in the clinical setting as a sales person but as an expert who is able to impart practical knowledge in a professional manner, sometimes under difficult circumstances and at critical times.

Thus, the emphasis is placed on the highest professional standards that are robust enough to withstand scrutiny, whether clinical, ethical or legal.