NO FAULT OF THE SURGEON

EDITORIAL

NO FAULT OF THE SURGEON

BY

Raouf Sallam

     When a surgical instrument is labeled and stamped " Made in Germany ", one would expect that this particular instrument was made in Germany. For over fifty years of practice in surgery I thought so , but apparently I was wrong.. This is according to a B.B.C. documentary and an investigative journalist,Samantha Poling, who spent one year exploring the world of surgical instruments production from the factory to the hands of the surgeon.

      She tells us that the European Union law allows stamping the instrument as made in any of its countries as long as this country " helps substantially transform the product ".So according to this vaguely phrased law instruments made in Pakistan from German steel is stamped "Made in Germany " quite legally. By the way, 2/3 of the world's surgical instruments are made in Pakistan.

     She found , on a field survey, that respectable manufacturers,by outsourcing, use smaller manufacturers  , those in turn outsource to small factories and workshops, some of which exist in unsuitable environments and produce substandard products.

     Hospitals at the receiving end rarely employ an expert technologist to examine the delivered instruments. When this was done one of every five instruments was rejected for flaws that cannot be detected by the naked eye and only show up during use in surgery; flaws that can pose a danger to the patient. When examined under magnification the following defects were detected:

- Fractured and rewelded instruments.

- Corrosion. 

- Faulty screw heads.

- Jagged and sharp edges.

- Fragments.

     What does this mean for the patient?  An imperfect instrument can:

- Lacerate the tissues. 

- Cause bleeding or leakage. 

- Cause micropunctures of the surgeon's gloves which in turn lead to infections. It is estimated by the FDA that about 1000 infections are caused every year through micropunctures of the gloves. Experts consider faulty instruments as the main cause of these micropunctures ,which cannot be recognized by the surgeon during work.

    What does an imperfect instrument do for the surgeon:

- Frustration.

- Loss of operative time in repeating steps or repairing damage done.

     In an era of a trend to judge - and even reimburse - surgeons by outcome, the surgeon will be penalized for an inferior outcome when it is not his fault.

     If most of the instruments produced are of a satisfactory standard why should'nt the rest be so? Obviously quality control should be implemented at the production site and inspection is also needed at the receiving hospitals. These improvements will add to the cost of instruments but will not add to the overall cost of health care if we consider the savings from avoiding the complications of faulty instruments.

     On mentioning the cost, may I remind my colleagues that in Egypt even if we spend 15 percent of our g.n.p. on health care it will not be enough to deliver western style health care to the 90 million Egyptians. We, the professionals, should develop alternative protocols of management to suit our pocket.

Prof. Raouf Sallam F.R.C.S.

Editor-in-Chief