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The harsh realities

THE practical reasons why the expertise and presence of company representatives are required by surgical teams are easy to explain. For example:

  • Technological advances
  • The expectations of the clinical team for training and ongoing support from the CR
  • The latest ISOs, which place responsibility on the medical devices industry to risk manage the life cycle of product and to train medical staff on its use to gain maximum benefit for the patient

However, because the hospital has full responsibility for the patient, it is legally liable in the event of any adverse events.

That means there is a requirement for official recognition of the role of the company representative as that of a relevant competent professional, supporting best practice for the patient.

Patient with relative in hospital corridor, Golden Jubilee National Hospital, Glasgow, Clydebank, United Kingdom

Concerns over the dangers presented to hospitals are being voiced by managements, surgical teams and company representatives themselves.

Don’t forget, even the mere presence of a product specialist in an operating theatre can present adequate grounds for legal proceedings being taken against hospitals.

While such liability can generally be avoided altogether with an appropriate patient consent, it is important to understand under what circumstances a consent is either advisable or required.

Applicable local law should always be consulted to determine if there are any regulations prohibiting a representative’s presence. Even if the local law is silent, the company representative should be familiar with the policies of the hospital or clinic at which the treatment will occur.

With an HC Skills International qualification, medical device, pharmaceutical and other related company representatives who are required to be present in clinical areas in order to provide technical support become able to formally demonstrate their professional competence and justify their presence, eliminating legal risks to their employers and to hospital managements and thereby ensuring that patient safety remains paramount.