CD22 Labelling of medical devices used in dermatology

Abstract A medical device is defined as any instrument, equipment, material or product intended to be used in humans for medical purposes, the main action of which is not of a pharmacological or immunological nature. Allergic reactions to medical devices have been well reported. However, allergen labelling or full composition and ingredient lists in medical devices are often lacking. Currently, only latex has its own unique packaging symbol. This study aims to quantify the proportion of medical devices with a full composition and ingredients list and latex allergen labelling. The data for this study were collected by individually reviewing the outer and inner packaging, as well as the available information sheet of each medical device used in the dermatology department at Ninewells Hospital, Dundee. Data were then stored and analysed using Microsoft Excel. There was a total of 152 products in the department that fulfilled the criteria as medical devices – 69 (45.4%) were dressings, 58 (38.2%) were instruments or equipment used in dermatological surgery, and 25 (16.4%) were miscellaneous items. There were only 45 (29.6%) products with labelling indicating their latex status. Two (1.3%) products contained latex, which was labelled on the packaging, while 43 (28.3%) had labels indicating that they did not contain latex. However, only 39 out of the 43 had the more well-known, standard latex-free symbol on either the outer or inner packaging or the information sheet, while three had ‘latex-free’ wording printed on the packaging instead of the standard symbol. Only three (2.0%) products contained the full composition or ingredient list; these were all dressings. The remaining 66 (43.4%) dressings did not contain any composition or ingredient list at all. This study confirmed that there is poor allergen labelling in medical devices. The majority also did not have any composition or ingredients list available. In addition, there is a lack of adequate latex labelling and variation in how the latex status is highlighted on the packaging, which could cause problems when managing patients with latex allergy and confusion among staff. A larger study looking at medical devices used in other specialties would be useful to further highlight the scale of the problem and hopefully help in changing legislation to make allergen labelling mandatory in medical devices.