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Medical device course goes live

A CUSTOMISED training programme developed by HC Skills International for the industry body representing the interests of companies providing anaesthetic and respiratory device support to clinicians will be presented for the first time tomorrow.

The hospital Theatre Access programme is being delivered at Addenbrooke’s Hospital in Cambridge for members of Barema who are required to be present in operating theatres, intensive care units and other clinical departments to provide technical support for staff using equipment developed by medical technology firms.

HC Skills, who have led training and qualification access programmes for more than 7,000 industry professionals, announced the key tie-up with Barema in August.

The company will ally their unmatched experience and professionalism with Barema’s position as the United Kingdom’s premier organisation promoting the highest standards in the development of and promotion of medical devices and technology in the anaesthetic and respiratory field.

Diane Irvine, CEO of HC Skills, who are based at the Golden Jubilee National Hospital in Clydebank, near Glasgow, said: “In today’s environment, there is an increased appetite for compliance. Standards of company training in the medtech industry are high, and need to remain high – which is where we come in.”

Achievement of this new qualification will ensure that:

  • THE duty of care to patients is not compromised.
  • SPECIFIC knowledge and understanding has been acquired to demonstrate competence in clinical areas.
  • THE legal and reputational position of the individual as well as that of the employer is safe.
  • THE legal position of the hospital has not been jeopardised.

A spokesman for Barema said: “There is a host of courses available to our members – however, the one we have committed to with HC Skills will see medical device company reps trained and qualified to a level we can support.

“It will be tailored to the anaesthetic and respiratory sector and it is hoped that, later this year, it will receive the approval of the Association of Anaesthetists of Great Britain and Ireland, as it supports best practice.”

Under the prevailing legal conditions in the United Kingdom, no law is broken when medical device company representatives are present in hospital clinical areas.

However, those individuals are required to know and understand the protocols which apply in clinical areas, including those pertaining to patient safety, inoculations, background checks, drug tests, infection control, data protection and other relevant factors.

Yet there is no standardisation among hospitals health boards and trusts of what they require in terms of formal qualifications from external representatives, which creates confusion and disorganisation between hospitals and companies.

This is a key problem, because external employees who are required to be present in clinical areas present an unquantifiable legal risk to themselves, their employers and the hospital.

There are significant risks inherent in the presence in clinical areas of medical devices company representatives, who are a non-contracted third parties able only to justify their role in a practical sense – not in legal or professional terms.

Recognised qualifications reduce or eliminate legal risks to hospital managements and to the medical device company – plus they legitimise the product specialist’s extended role