MEDTECH trainers, HC Skills International, have upped the standard of the Theatre Access qualification courses they offer to medical device industry representatives.
The new award, which is recognised by the UK and European governments, has been raised from Level 4 on the national qualifications framework to Level 5, which is equivalent to second-year undergraduate standard.
HC Skills, who are based at the Golden Jubilee National Hospital in Clydebank, near Glasgow, have led training and qualification access programmes for more than 7,000 industry professionals, to date.
The revised Theatre Access course is aimed at representatives of firms 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 CEO, Diane Irvine, said: “A regulated qualification that complies with every hospital’s performance standards promotes a level of quality for all medical device and pharma companies and gives all hospitals a uniform assurance for all company representatives that are present in their patient care areas.
“We have worked hard to upgrade what was already the definitive qualification in the sector to one that raises the bar and shows our commitment to improving standards of support to hospital clinical teams. Patient safety and best practice are paramount, and this qualification will allow companies to demonstrate a commitment to that.
“There is no law broken when medical device company representatives are present in hospital clinical areas providing verbal and technical assistance supporting the safe and effective use of their products.”
Adds a spokesperson: “There is a hospital requirement for all company representatives to know and understand the protocols necessary to be present in a clinical areas – including inoculations, background checks, drug tests , infection control and others.
“However, there is no standardisation among hospitals or health boards of what they require from company representatives. While one hospital may require background checks (eg paediaric/psychiatric), another may not, creating confusion and disorganisation between hospitals and companies.”
Diane Irvine added: “The standards that apply to the development of medical device products are high – and we provide the critical support that company representatives need to safely take those devices to the patient.
“It is clearly in no one’s interest to demean the role or competence of company representatives providing verbal technical assistance for the safe use of products in operating theatres.
”What we provide is academic education allied to practical training and assessment in hospital clinical settings, reflecting reality.”
HC Skills have also just developed a new suite of post-graduate qualifications in medical device regulatory affairs, which will help companies gain a better understanding of compliance and other issues.
All HC Skills courses result in a recognised, externally validated, competence-based qualification, which ensures that the role of the medical technology companies and their representatives are not compromised.
The spokesperson added: “Their qualifications reduce or eliminate legal risks to hospital managements and to the medical device company – plus they legitimise 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 crucial times.
“The term, ‘medical device’, covers a wide spectrum of healthcare products, ranging from sticking plasters to heart valves. Devices used in clinical areas 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.
“The professional awards offered by HCS and accredited by internationally recognised education services provider ABP (Association of Business Practitioners) form a credible occupational perioperative standard.”
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