Geïmporteerd goedkoop chirurgische instrumentarium uit Pakistan gevaarlijk!

Surgical tools used in NHS operations 'substandard'

Ook in België is dit helaas het geval.

Door de aanhoudende besparingen en de zoektocht naar goedkope alternatieven circuleert heel wat “slecht” chirurgisch materiaal ook in België. Wij wensen dan ook te benadrukken dat in het Therapeutisch Vasculair Centrum olv Dr. Harry Spoelstra, reeds meer dan 20jaar gewerkt wordt met chirurgisch materiaal afkomstig uit Duitsland en Zwitserland. Kwaliteit had en heeft nog altijd de hoogste prioriteit bij Dr. Harry Spoelstra in zijn privé centrum.

Bron: http://www.bbc.co.uk/news/uk-13894880

Artikel:

Microscopic shards of steel can puncture surgical gloves or become dislodged inside patients

Substandard surgical tools from Pakistan are putting UK patients at risk of potentially deadly injury and infection, BBC Panorama has found.

Faults include rough edges, steel burrs that can splinter during operations and corroded metals.

All surgical instruments have to meet regulatory standards but only one of the more than 180 NHS trusts and boards conducts rigorous tests on every tool.

Barts and the London NHS Trust reject almost 20% of tools as unsafe for use.

Tom Brophy, the dedicated technologist at Barts, said the prevalence of faulty equipment that could endanger patients' lives or cause serious injuries is so worrying that he has started documenting the faults.

While he is able to return unsuitable or faulty tools to suppliers, he said there is nothing to stop those same instruments from being sold on to another UK hospital, either within the NHS or private.

"On more than one occasion a supplier has rung me up and said that the instrument you rejected, I passed it onto another hospital and they accepted it," he said. "Of course they're going to accept it, because they haven't checked it."

While most hospitals carry out some degree of visual checks on instruments, only Barts employs a dedicated technologist.

Blood traces.

Poor quality surgical implements have been identified as a likely cause of MRSA infections because shards of steel have caused microscopic holes in surgical gloves.

Badly made instruments that have unwanted grooves or trenches can trap body tissue and fluids - another possible source of infection.

Pakistan's industry.

100 million instruments made annually in Sialkot

One in 10 sold to the UK

Only Germany and America buy more

70% of manufacturers registered in the UK are based in the country

12 of 19 samples collected in Sialkot by Panorama and tested in London were rejected

All of the 916 companies making or supplying surgical instruments in the UK must be registered with the Medicines and Health Care Products Regulatory Agency (MHRA), but responsibility for quality rests with suppliers and manufacturers.

Neither the NHS or the MHRA requires suppliers to inspect manufacturers.

In a statement, the MHRA said "it has no evidence that non-compliant instruments are being supplied to the NHS", but added that if there were such evidence, it had "a range of powers and sanctions available to deal with the problem".

In addition to rejecting poor quality equipment that is sold to Barts, Mr Brophy said he has been sent used equipment - with traces of blood still on the instruments - being passed off as new.

No hygiene.

Two-thirds of the world's surgical instruments are made in the city of Sialkot in northern Pakistan and 70% of the UK's registered manufacturers are based in the city.

While some of the larger companies operate state-of-the art facilities and have rigorous quality-control procedures in place, Panorama found evidence of smaller firms that do not use magnifying glasses to inspect finished instruments before putting the required quality stamp on them.

Others outsourced manufacturing to some of the 3,000 back-street workshops in the city where undercover filming revealed a complete lack of hygiene or quality control.

Professor Brian Toft, a government adviser on patient safety, said if procurement officers in both the NHS and private hospitals in the UK knew of the conditions in which the surgical instruments were being made, they would "faint at the thought of it".

"I cannot believe that anybody in the NHS knows this is going on," he said.

Bron: http://www.bbc.co.uk/news/uk-13894880

New Guidelines

New guidelines released for the evaluation and treatment of varicose veins

Wednesday, 11 May 2011

New guidelines for the management of varicose veins and associated chronic venous disease (CVD) were recently published in a supplement to Journal of Vascular Surgery (J Vasc Surg 2011;53(5 Suppl):2S-48S), journal of the Society for Vascular Surgery. The guidelines, which focus on evaluation and treatment of varicose veins of the lower limbs and pelvis, were developed by a joint Venous Guideline Committee of the Society for Vascular Surgery and the American Venous Forum. An estimated 23% of the adult population in the USA has varicose veins, and 6% has more advanced chronic venous disease, including skin changes and healed or active venous ulcers. Long considered a cosmetic problem, varicose veins are now known to cause more serious disability, ranging from discomfort and pain that cause lost work days and decreased quality of life to, in the most serious cases of chronic venous disease and venous ulcers, loss of limb or loss of life. “Improved technology and new surgical techniques, many of which can be done in an office setting, have led to dramatic changes in the treatment of varicose veins,” said Peter Gloviczki, professor of surgery, Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, USA, who chaired the Venous Guideline Committee and is the vice- president of the Society for Vascular Surgery and past president of the American Venous Forum. “The new treatment options can significantly improve patient outcomes. They can experience less discomfort, improved quality of life and earlier return to work than was previously possible.”   Key recommendations The guidelines feature nine key recommendations. The strength of each guideline varies based on the benefits as compared to the risks, burdens and costs. We recommend that in patients with varicose veins or more severe chronic venous disease, a complete history and detailed physical examination are complemented by duplex scanning of the deep and superficial veins. We recommend that the CEAP (clinical, etiologic, anatomic, pathophysiologic) classification is used for patients with chronic venous disease and that the revised venous clinical severity score is used to assess treatment outcome. We suggest compression therapy for patients with symptomatic varicose veins but recommend against compression therapy as the primary treatment if the patient is a candidate for saphenous vein ablation. We recommend compression therapy as the primary treatment to aid healing of venous ulceration. To decrease recurrence of venous ulcers, we recommend ablation of the incompetent superficial veins in addition to compression therapy. For treatment of the incompetent great saphenous vein we recommend endovenous thermal ablation (laser) over high ligation and inversion stripping of the saphenous vein to the level of the knee. We recommend phlebectomy or sclerotherapy to treat varicose tributaries and suggest foam sclerotherapy as an option for treatment of the incompetent saphenous vein. We recommend against selective treatment of perforating vein incompetence in patients with simple varicose veins (CEAP class C2), but we suggest treatment of pathologic perforating veins (outward flow 500 ms duration, vein diameter 3.5 mm) located underneath healed or active ulcers (CEAP class C5-C6). We suggest treatment of pelvic congestion syndrome and pelvic varices with coil embolization, plugs, or transcatheter sclerotherapy, used alone or in combination. The abstract can be found on http://www.jvascsurg.org/article/S0741-5214(11)00327-2/abstract

 

 

 

 

 

Statistieken 2010

Resultaten voor 2010:

 

Bij de verwerking van onze Endolaser 1470nm EVLT ingrepen voor patiënten met varices(spataders) voor het jaar 2010 blijkt dat de resultaten volledig overeenstemmen, zelfs beter zijn,  dan die van de reeds gepubliceerde resultaten in de wereldliteratuur. In het bijzonder kennen wij een direct slaagpercentage van 99,3%. Dit wil zeggen dat wij verleden jaar slechts één patiënt hebben gekend waarbij de procedure mislukte. Dit door anatomische problemen, waarbij de laser fiber niet tot in de lies(cross) kon worden gebracht. Een mooi resultaat kon daarna wel bereikt worden door een combinatie met Foam-sclerotherapie. Alle ingrepen vonden plaats onder plaatselijke verdoving.

Als wij dan de Duplex echografie controles analyseren 3, 6,9 en 12 maanden na de ingrepen, dan zien wij dat een initieel succes zo blijft. Er werden geen recanalisaties of heropeningen gezien in de dicht gelaserde VSM of VSP segmenten. Wellicht is dit te wijten aan onze techniek, waarbij qua tumescentie en laser energie een welbepaald schema wordt gevolgd. Voor 2010 betekent dit dan dat wij een succesratio hebben van 100%. Dr H. Spoelstra en zijn team realiseren zich goed dat dit unieke cijfers zijn, maar ze zijn er ook trots op. Dit betekent even wel dat Dr H. Spoelstra dit jaar dezelfde resultaten wil en zal nastreven. Een uitdaging die hij graag aanneemt!