AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices; AAMI TIR34:2014, Water for the reprocessing of medical devices; ANSI/AAMI RD47:2008, Reprocessing of hemodialyzers; ANSI/AAMI HE75, 2009 Edition Human factors engineering — Design of medical devices.
- ANSI/AAMI HE75, 2009/(R)2013 Human factors engineering—design of medical devices.Google Scholar
- Khassawneh BY, Al-Ali MK, Alzoubi KH, Batarseh MZ, Al-Safi SA, Sharara AM, et al. Handling of inhaler devices in actual pulmonary practice: metered-dose inhaler versus dry powder inhalers. Respir Care. 2008;53(3):324–8.PubMedGoogle Scholar
- Melani AS, Zanchetta D, Barbato N, Sestini P, Cinti C, Aldo CP, et al. Inhalation technique and variables associated with misuse of conventional metered-dose inhalers and newer dry powder inhalers in experienced adults. Ann Allergy Asthma Immunol. 2004;93(4):439–46.PubMedCrossRefGoogle Scholar
- Thomas M, Price D, Chrystyn H, Lloyd A, Williams AE, von Ziegenweidt J. Inhaled corticosteroids for asthma: impact of practice level device switching on asthma control. BMC Pulm Med. 2009;9:1. doi:10.1186/1471-2466-9-1.PubMedCentralPubMedCrossRefGoogle Scholar
- Seebri® Breezhaler®, EMA summary of product characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002430/WC500133769.pdf. Accessed 28 Aug 2014.
- Serevent® Accuhaler®, patient information leaflet. http://www.medicines.org.uk/emc/PIL.3861.latest.pdf. Accessed 28 Aug 2014.
- Spiriva® HandiHaler®, patient information leaflet. http://www.medicines.org.uk/emc/PIL.16286.latest.pdf. Accessed 28 Aug 2014.
- Easyhaler®, patient information leaflet. http://www.medicines.org.uk/emc/PIL.21564.latest.pdf. Accessed 29 Aug 2014.
- Wieshammer S, Dreyhaupt J. Dry powder inhalers: which factors determine the frequency of handling errors? Respiration. 2008;75(1):18–25.PubMedCrossRefGoogle Scholar
- Schulte M, Osseiran K, Betz R, et al. Handling of and preferences for available dry powder inhaler systems by patients with asthma and COPD. J Aerosol Med Pulm Drug Deliv. 2008;21(4):321–8.PubMedCrossRefGoogle Scholar
- Lastow O, Svensson M. Orally inhaled drug performance testing for product development, registration, and quality control. J Aerosol Med Pulm Drug Deliv. 2014;27(6):401–7. doi:10.1089/jamp.2014.1147.PubMedCrossRefGoogle Scholar
- Finlay WH, Golshahi L, Noga M, et al. Choosing 3D mouth-throat dimensions: a rational merging of medical imaging and aerodynamics. In: Dalby RN, Byron PR, Peart J, et al. editors. Respiratory drug delivery 2010. River Grove: Davis Healthcare International; 2010. p. 185–93.Google Scholar
- Burnell PKP, Small T, Doig S, Johal B, Jenkins R, Gibson GJ. Ex-vivo product performance of DiskusTM and TurbuhalerTM inhalers using inhalation profiles from patients with severe chronic obstructive pulmonary disease. Respir Med. 2001;95(5):324–30.PubMedCrossRefGoogle Scholar
- Olsson BL, Borgström L, Lundbäck H, Svensson M. Validation of a general in vitro approach for prediction of total lung deposition in healthy adults for pharmaceutical inhalation products. J Aerosol Med Pulm Drug Deliv. 2013;26(6):355–69.PubMedCrossRefGoogle Scholar
- Gabrio BJ, Stein SW, Velasquez DJ. A new method to evaluate plume characteristics of hydrofluoroalkane and chlorofluorocarbon metered dose inhalers. Int J Pharm. 1999;186(1):3–12.PubMedCrossRefGoogle Scholar
- Higham MA, Sharara AM, Magee RP, Ind PW. Determination of the minimum dose of lactose drug carrier that can be sensed during inhalation. Br J Clin Pharmacol. 1995;40(3):281–2.PubMedCentralPubMedCrossRefGoogle Scholar
- Adams WP et al. Demonstrating bioequivalence of locally acting OIPs. Workshop summary report. J Aerosol Med Pulm Drug Deliv. 2010;23(1):1–29.PubMedCrossRefGoogle Scholar
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use; quality risk management. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. Accessed 27 Aug 2014.
- Brouet G et al. Review of approaches to managing device changes within OINDPs. Poster presented at IPAC-RS conference 2010. http://ipacrs.org/assets/uploads/outputs/33-IPAC-RS.pdf. Accessed 23 Sept 2014.