Abstract
International Organization for Standardization (ISO) standards in healthcare aim to improve the quality, safety, and efficiency of medical devices, clinical processes, and health management systems of various countries across the world. This study reviews the perception of healthcare professionals about ISO standards at Saudi Arabia concerning patient safety, medical device management, and their overall influence on clinical and nonclinical practices. The previous study was based on the global healthcare systems of the US and Europe-like developed countries. The online cross-sectional survey of 300 respondents was selected from all regions and professions. Most of the respondents were from urban regions: Riyadh represented 30.4%, Jeddah 25.2%, and the Eastern Province represented 18.6%. The biomedical engineers constituted 43.3%, physicians comprised 29.2%, and most of the participants were males, 87%. Response to the question about ISO standards was that 79.8% agreed that ISO standards play a critical role in improving patient safety; biomedical engineers demonstrated 85.2%, while physicians were at 82.6%. Medical device calibration garnered 81.0% agree that ISO standards on calibration of medical devices are important. Differences across the 4 major regions demonstrated a strong level of agreement among respondents in Riyadh and Makkah but weaker levels among those in Asir and the Northern Borders, as follows: Riyadh 81.5%, Makkah 78.9%, Asir 58.9%, and Northern Borders 53.2%. ISO adoption barriers were reported for mostly nonclinical areas; training shortage, 56.8%, and resource unavailability were the main factors that acted as the main barriers. Besides, full agreement with relevance among ISO standards came to 85.9% among professionals with more than 15 years of experience. The inference to be drawn from such findings is that the same throw a critical light on the reception and application of ISO standards in Saudi healthcare and pinpoints those areas that require further amelioration and awareness across regions and professional groups.