Real World Dangers

Real-world dangers

AN alarming pattern of risk to patients is emerging, primarily as a result of the inappropriate management of medical device representatives entering operating theatres, says Debbie Lee, Lead Professional Officer for the UK’s Association for Perioperative Practice (formerly the National Association of Theatre Nurses).


“My main role is to provide a readily accessible service to some 8000 members by being available to answer any direct inquiries concerning clinical and professional issues.

“Many of my colleagues have reported that NHS organisations are failing to manage the risk as part of an effective clinical governance framework.

“As surgery and surgical techniques become more innovative and complex, medical device representatives are increasingly being requested to provide instruction, advice and support during the intra-operative phase and, therefore, be in attendance.

“NATN guidance is specific on this issue and recommends that “demonstrations of new technology should take place in a workshop or laboratory setting and perioperative staff should be familiar with the technology prior to direct patient use”.

“But this is clearly not happening in clinical practice, as the norm appears to be that medical representatives are allowed access to the operating theatre to demonstrate new devices directly on patients during the intra-operative phase.

“In one scenario, a new knee replacement system was introduced into the operating department. The operating surgeon and his team were not familiar with it and were reliant entirely on the expertise of the medical device representative present.

“Unfortunately, this expertise was not evident. The surgeon used the wrong cutting jig as a result of advice from the representative, and the patient had to undergo further reconstructive surgery to correct the error.

“Furthermore, the patient was put at risk by having to endure a longer than expected anaesthetic as well as requiring more extensive physiotherapy and rehabilitation post operatively at greater expense to the NHS.

“In another case, new equipment for electro-diathermy in laparoscopic surgery was requested by a surgeon. The company representative was allowed access to the department to provide assistance and promptly provided the wrong decontamination advice for the equipment.

“The individual also failed to provide an authorised decontamination certificate for the device.

“The consequence for the patient was a post-operative infection and being informed that a medical device which had not been sterilised appropriately was the cause.

“In a third scenario, a new hip replacement system was on trial.

“The medical device representative was allowed access to the operating department to provide training and instruction in the assembly and use of the equipment but failed to ensure the prosthesis required was correct.

“The patient was put at risk by having an extraordinarily long anaesthetic while the representative journeyed some 40 miles to another trust to acquire the needed prosthesis.”

Valuable safeguards

These scenarios are deeply concerning and are just the tip of the iceberg. NATN, therefore, echoes the concerns of HCS International.

Theatre managers should not permit representatives into their departments on the basis only of trust. Product specialists have to attain and be able to demonstrate evidence of a recognised level of competence to ensure any risk to patients is minimised.

The AfPP views the Theatre Skills Award as a valuable safeguard for its members. It provides theatre managers and staff with objective evidence of competence which means they can be more confident that they are managing risks effectively and working within the framework of clinical governance.”

The concerns described above are reinforced by anecdotal evidence provided to HC Skills International by product specialists.

Activities reported to us – that should set alarm bells ringing –  include:

  • Being compelled to act as theatre staff in the absence of hospital staff
  • Opening sterile packs of items not related to the CR’s product
  • Taking part in swab count and recording
  • Documenting information in patient medical records
  • Transfering information, contrary to data protection laws
  • Advising surgeons on operative procedure
  • Teaching surgeons with limited experience of certain techniques
  • Performing ultrasound scans
  • Assisting in cardiac pacing procedures

Two conclusions are to be drawn from this:

  1. Company representatives recognise the problem and are seeking a solution.
  2. Hospital staff are, by act or omission, failing to implement professional standards.

Don’t forget, the CR has a legitimate role in providing information and training to the clinical team, especially in light of the introduction of new technology and the need for ongoing management of high-tech equipment. In short, product expertise brought to the clinical team is essential.

With an HC Skills International qualification, medical device, pharmaceutical and other related company representatives become aware of the responsibilities implied by their presence, and surgical teams have a concise understanding of what can and cannot be expected of those individuals.

Furthermore, legal risks to hospital managements and employers (medical device companies) are reduced or eliminated and the safety of patients and their legal rights have been respected.

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