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The need for safeguards

 

UNTIL the late 1980s, development in clinical/surgical technology and instrumentation had been incremental.

But the historical medical context was fundamentally changed with the advent of widespread computing and the development of sophisticated software and complementary hardware.

Put simply, technological advances started to become transformational.

This fostered a growing dependency among medical professionals on device companies for technical support, because clinical teams could not be expected to be expert in every aspect of every piece of technological wizardry being introduced to hospitals.

Knee arthroplasty demonstration in simulation by consultant surgeon

As a result, surgery today invariably involves personnel above and beyond the surgeon, nurses and anaesthetists. Frequently, representatives of pharmaceutical companies, surgical instrument companies and medical device firms are in attendance to observe the use of the company’s products or calibrate the item for use by the surgeon.

For some products, the company representative is a necessary part of the surgery without which the procedure could not proceed.

This advancing process is relentless and in some fields is accelerating, which means the reliance on outside technical support and expertise remains vital.

Consultants and surgeons continue to learn new techniques from the medical device sector, and industry support for clinicians to become proficient in these procedures is essential to successful patient outcomes.

Poor clinical results with new technology can, at best, result in a device being branded unreliable, which can have huge commercial implications or, worse, lead to litigation.

At worst, they can massively impact on patients’ lives.

A successful partnership between technology and frontline clinicians is, therefore, imperative.

However, problems surround the interpretation of technical assistance. There is evidence it has become flexible and blurred between the margins of “hands-off” and “hands-on”, which presents legal and ethical dangers to surgeons, hospital managements and healthcare companies.

Surgically gloved hands in operating room

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.

Training reduces or eliminates legal risks to hospital managements and to the pharmaceutical or medical device company – plus it legitimises the product specialist’s extended 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, sometimes under difficult circumstances and at critical times.

The term “medical device” covers a wide spectrum of healthcare products, ranging from sticking plasters to heart valves. Devices used in operating theatres include surgical instruments, gowns and drapes, operating tables, arterial grafts, orthopaedic implants, ophthalmic implants, anaesthetic machines, patient monitors and X-ray machines.

All of them – and those using them – have to come under the scope of credible training that places the emphasis on successful surgical outcomes and the highest professional standards that will be able to withstand scrutiny, whether clinical, ethical or legal.