Sunday, September 9, 2012

Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices

 
Lawrence F Muscarella, Guest Contributor to UK Health Radio, writes:
 
Several well-publicised cases of improper cleaning, disinfection or sterilisation of contaminated reusable medical equipment that posed an increased risk of patient-to-patient disease transmission were reported within the past few years, resulting in the notification of approximately 20 000 patients.
 
These medical errors, the specific infection-control standards they breached, and assessments of the risk of infection associated with each are discussed. Other topics discussed include the Food and Drug Administration’s (FDA) regulation of medical devices and infection-control products; the use of adulterated, misbranded, and investigational devices; consent decrees and associated Certificates of Medical Necessity; and informed patient consent.
 
Focus is placed on liquid chemical sterilization, its history, and the FDA’s recent censure and discontinuation of a medical device labelled with this claim, namely, the STERIS System 1 processor.
 
Recommendations are provided for healthcare facilities, regulatory agencies, manufacturers of reusable medical devices, and professional healthcare organisations and administrations to improve public health and prevent healthcare associated infections.
 
For the full article, please visit: http://www.myendosite.com/articles/WJCID2012.pdf
 
© 2012 Baishideng. All rights reserved.
 
 
 
Please note that all information and content on UK Health Radio and this blog is provided by the authors, producers and companies themselves and is only intended as additional information to your general knowledge. This information is not in any way a substitute for professional medical advice or treatment, so please do not delay or disregard any medical advice received due to information gathered on the UK Health Radio.
UK Health Radio – the health radio station for the United Kingdom, Europe and beyond at www.ukhealthradio.com– is kindly sponsored by www.1-stop-health-shop.com