Bridging the gap

Anyone who is invited into hospitals or areas of clinical care in an advisory capacity is bound by the same legal and ethical obligations as those employed within the NHS (ref. NHS Code of Confidentiality (2003).

What does this mean? Does it mean you need a “Green Card”, like the one used in the USA that demonstrates that you have been granted authorisation to live and work there?

At the moment, ID cards that “demonstrate” that individuals are qualified to be present within hospital environments are not equal. This is because not all of them are underpinned by National Occupational Standards.

So what do the regulations that are currently in force mean?


It means that visitors in this context are defined as volunteers or external service providers i.e. contractors, pharmaceutical and medical devices company representatives.

It is the presence of someone untrained in hospital policies and with no contractual responsibility to the hospital that presents an unquantifiable risk for hospital management, as per the Department of Health: NHS Code of Practice, July 2003; Management Regulations,1999 and the Data Protection Act,1998.

Competence of healthcare company representatives needs to be ASSURED and not ASSUMED.

Hospital managers are responsible for all those present within their departments and all patients with whom they may have contact.

Theatres and other clinical areas are already classified as areas of high risk to patients and therefore any non-essential visitor may be assessed as an additional hazard in an already risk managed environment.

Historically, there has been a relative informality regarding the legitimate presence and competence of external service providers and medical device representatives in hospitals.

In the past, these “visitors” were normally closely supervised by senior nursing staff, whether on wards or in areas of higher patient dependency. Now, hospitals are using credentialing schemes to ask for evidence of the competence, inoculation and DBS/PVG status of company representatives.

To ASSURE the competence of company representatives, there is now a National Occupational Standard (NOS) for the industry that provides hospital managers with the evidence required to meet their own clinical standards of care.

With an externally validated professional qualification from a Government awarding body, hospital departmental managers will be ASSURED of the competence of healthcare company representatives to be present in their patient care areas.


Representatives from the medical devices and pharmaceutical industry are present in the operating theatre and other clinical areas on a regular basis, promoting and providing necessary technical support for their products.

Device representatives have a very thorough training on their products, application and ongoing maintenance but the legal implications of working within hospitals are often not addressed.

When external service providers are on hospital premises, their contractual and legal obligations are exactly the same as the hospital staff.

Company compliance with hospital standards relating to informed consent, patient confidentiality, infection control/decontamination and risk management regulations etc. must be regularly reviewed and updated to meet current standards.

As already stated, it is the presence of someone untrained in hospital policies that presents an unquantifiable risk for hospital management.

It would appear, that there is a gap in the implementation of the regulations, which allows company representatives to enter specialist clinical areas without externally validated, competence-based training that meets the legal requirements.


Currently we know that there are many and varied courses for company representatives working in the medical devices arena.

The introduction of a NOS within the medical devices industry closes the gap between the professional healthcare provider and the medical device representative.

The reality of a recognised NOS training standard which validates the competence of the device representative to be present in areas of clinical care is a major step towards establishing their professional accountability.

The Professional Theatre Access and Hospital Access qualifications from HC Skills have external educational validation from EduQual, one of the examining and awarding bodies in the UK and throughout the world.

The level of validation is Professional and set to demand reflective practice, analysis and application of knowledge in the specialist clinical environment.

The EduQual Professional Hospital and Theatre Access qualifications provide hospital managers with demonstrable evidence of the competence and legal compliance of non-clinical staff who have access to hospital areas where clinical care is delivered.

These qualifications are National Occupational Standards that support compliance by providing evidence of competence in the following key elements, thus ensuring patient/staff safety:

  • Informed consent
  • Patient confidentiality
  • Track, trace and audit
  • Infection control policies
  • Vicarious liability
  • Hospital regulations
  • Radiation safety
  • Laser safety
  • Manual Handling
  • Health & Safety at Work

Several of the leading medical device companies have adopted this National Occupational Standard and ensure their representatives qualify in the EduQual Professional Award in Access to the Operating Theatre.

Those medical device company representatives not requiring to access Theatres/Critical care areas undertake the Professional Award in Hospital Access.

Their representatives can now show hospital managers their externally validated evidence of competence to demonstrate, teach, support and promote their products, safely, in areas of clinical care.


We know that hospital managers have a responsibility for all non-clinical personnel who seek access to areas of patient care.

For the departmental manager, the EduQual Hospital and Theatre Access Qualifications means that they can confidently accept those trained representatives into their department knowing that a legally compliant, competent and professional individual will be supporting them.




Tel: +44 (0) 141 946 6482

Address: Healthcare Skills Training International Ltd
West of Scotland Science Park
Block 7, Kelvin Campus
Glasgow G20 0SP