Hospital patients to benefit from new EU safety standards...

Hospital patients to benefit from new EU safety standards for surgical drapes and gowns

A major step forward in reducing the risk of post-operative infection for hospital patients was taken on 26 March when EU medical experts finally approved testing standards for the performance of surgical drapes, gowns and clean air suits.

"EN 13795 has the potential to raise infection prevention standards in surgery across Europe and I am delighted that it has been ratified and look forward to its implementation", says Kate Woodhead, President of International Federation for Perioperative Nurses and also an Independent Perioperative Consultant.

The new controls will safeguard patients, who are exposed to the risk of wound infection during every surgical operation, as well as save treatment costs and medical resources.

Effective surgical drapes, gowns and clean air suits are extremely important in helping to prevent the spread of bacteria during operations. The scale of the problem is highlighted by research that shows approximately 1 in 20 of all surgical operations leads to post-operative infection¹ prolonging hospitalisation on average by 7-9 days and resulting in additional patient treatment costs of more than 3,000 Euros.

The new harmonised test methods and acceptable performance levels devised by the European Committee for Standardisation (CEN) have taken many years to finalise. The approved standards now set out how manufacturers, suppliers and hospital authorities should comply with the essential requirements of the Medical Devices Directive, adopted by EU and EFTA members in 1998.

Apart from helping to prevent infection, the new performance standards are likely to prompt a wide-scale move away from traditional cotton and poly-cotton drapes and gowns, which currently account for more than one third of the products used in European hospitals. These traditional products will not meet the standards for effective barrier protection against the spread of bacteria. In contrast, the majority of single-use drapes and gowns will comply.

"The standards are good news for both patients and hospitals," says Dr. Jan Hoborn, Director of Medical Sciences at Mölnlycke Health Care and one of the driving forces behind the development of the standards. "We now have an accepted means of measuring the performance of all surgical drapes and gowns. For example, it has been recognised for some time that the effectiveness multiple-patient products declines as a result of constant reprocessing, even though they may have provided acceptable protection when new."

¹ Emmerson A M et al, J.Hosp.Inf. 1996; 32:175-90