Potential risk to patient safety by discontinuation of production of classical T-drains?

Abstract

The revision of the medical device regulation (MDR) legislation by the European Union and supplementations by the member states has been implemented for good reasons but causes dramatic side effects. It is no longer allowed to produce some rarely used medical devices by various manufacturers that have been successfully used for decades. Before production, anew application to the MDR would be necessary, which is not arealistic business case for companies producing rarely used devices. This problem currently relates to the Kehr T‑drain made from soft rubber or latex that has been in use since the late nineteenth century. Asurgically placed T‑drain, although rarely necessary nowadays, is still in use worldwide for special indications in an attempt to avoid severe complications. These special indications include complex hepato-pancreato-biliary (HPB) procedures and perforations of the upper gastrointestinal (GI) tract where T‑drains may be used to secure the hepatojejunostomy or to create astable fistula. The HPB working group (CALGP) of the German Society of General and Visceral Surgery (DGAV) provides astatement from asurgical perspective on this matter after asurvey of all its members. Politics should be very careful not to generalize when implementing useful new regulations at a European and national level. Established and comprehensible treatment concepts should not be restricted and exemption permits should be quickly granted in these cases because the discontinuation of these niche products may lead to potential patient safety issues and even fatalities.