title: The Emperor's New Clothes II--time for regulators to wake up and take responsibility for unnecessary asthma morbidity: time for the second aerosol 'transition'.
abstract: The rate of technological improvement continues to accelerate. Regulators in every field dealing with consumer products continue to set ever higher standards to protect consumers from adverse events and use 'recalls' to remove products that prove to be harmful from the market. In the field of medical products in general the issues of 'human factors' and 'usability' are now, quite rightly, a major issue at least among regulators in the USA. The elephant in the inhaled therapy room is of course the continued use of obsolete, portable inhalers which few patients can use effectively for the treatment of asthma. Countless studies have demonstrated that the inability of patients to use these devices effectively is a major factor in perpetuating unnecessarily high levels of morbidity. They fail to meet basic usability standards and do not incorporate the facility to provide feedback to patient and clinician. More than 20 years ago regulators deemed that pressurised metered dose inhalers containing chlorofluorocarbons should be removed from the market on environmental grounds even though their use accounted for less than 0.5% of chlorofluorocarbon use. Surely asthmatic patients require the same level of protection. Unfortunately regulators appear determined to fossilise the field in a 1950's time warp by ensuring that the failings of obsolete technology are perpetuated in any 'generic' device. The time has come for regulators to meet their obligations to 'protect the public health by assuring the safety, effectiveness, and security of drugs, vaccines and other biological products, medical devices….' and mandate the phasing out of these antiquated devices within the next decade in order to reduce the unacceptably high burden of preventable morbidity and death associated with their use.
authors: Department of Respiratory Medicine, Sheffield Children’s Hospital, Western Bank, Sheffield S10 2TH, UK. m.l.everard@sheffield.ac.uk
authors: Mark L
authors: ML
authors: Everard
mesh_terms: D001249:Asthma / Q000188:drug therapy*; D016503:Drug Delivery Systems; D004867:Equipment Design; D006801:Humans; D062307:Medical Device Legislation; D036501:Metered Dose Inhalers / Q000592:standards*
keywords: Inhaler devices