Issued: January 15, 2008
Dear Healthcare Practitioner:
This is to advise you of serious adverse events associated with unretrieved device fragments (UDFs) and provide recommendations to mitigate these events. A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties.
To read the complete report please go to this link :
http://www.fda.gov/cdrh/safety/011508-udf.html
e mërkurë, 16 janar 2008
e martë, 8 janar 2008
Avoiding Hazards from Using Cleaners and Disinfectants on Electronic Medical Equipment
FDA, CDC, EPA and OSHA have issued a Public Health Notification on how to avoid hazards when using liquid cleaners and disinfectants on electronic medical equipment. The Notification covers a wide range of equipment, including infusion pumps, ventilators, analgesia pumps, computer workstations and monitoring equipment.
This action was prompted by reports of fires and other equipment damage, as well as burns to healthcare workers, when these types of liquids were used inappropriately on equipment that has unsealed electrical circuits. In many cases, healthcare workers routinely sprayed the equipment with disinfectants or wrapped the housings with disinfectant-soaked towels, causing damage to the circuitry.
The Notification provides a number of recommendations to reduce the risk. Here are some of the highlights:
• Protect equipment from contamination during use, which can help avoid the need for disinfection.
• If equipment becomes contaminated, remove it from use and be sure it's serviced before returning it to use.
• Clean equipment surfaces according to the instructions from both the equipment manufacturer and the chemical manufacturer.
Additional Information:
FDA MedWatch Safety Alert. Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment. November 1, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cleaners
This action was prompted by reports of fires and other equipment damage, as well as burns to healthcare workers, when these types of liquids were used inappropriately on equipment that has unsealed electrical circuits. In many cases, healthcare workers routinely sprayed the equipment with disinfectants or wrapped the housings with disinfectant-soaked towels, causing damage to the circuitry.
The Notification provides a number of recommendations to reduce the risk. Here are some of the highlights:
• Protect equipment from contamination during use, which can help avoid the need for disinfection.
• If equipment becomes contaminated, remove it from use and be sure it's serviced before returning it to use.
• Clean equipment surfaces according to the instructions from both the equipment manufacturer and the chemical manufacturer.
Additional Information:
FDA MedWatch Safety Alert. Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment. November 1, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Cleaners
e hënë, 7 janar 2008
Ireland Issues Guideline on Device Reprocessing
Ireland Issues Guideline on Device Reprocessing
Ireland’s Health Service Executive has released a practice guideline on decontamination of reusable invasive medical devices (RIMDs).
The new code of practice sets standards and best practices for facilities operating within Ireland’s public health system.
“Decontamination facilities should be designed, constructed, maintained and controlled to provide effective segregation of clean and dirty activities and to provide an environment that minimizes contamination of clean and disinfected RIMD,” the guideline says.
The seven-part guideline includes sections on recommended practices for central decontamination units, endoscopy units and dental services, as well as an audit prototype for evaluating decontamination procedures.
The guideline, “Code of Practice for Decontamination of Reusable Invasive Medical Devices,” can be viewed at:
www.hse.ie/en/Publications/HSEPublicationsNew/AcuteHospitalReportsGuidelines/#d.en.8696.
Ireland’s Health Service Executive has released a practice guideline on decontamination of reusable invasive medical devices (RIMDs).
The new code of practice sets standards and best practices for facilities operating within Ireland’s public health system.
“Decontamination facilities should be designed, constructed, maintained and controlled to provide effective segregation of clean and dirty activities and to provide an environment that minimizes contamination of clean and disinfected RIMD,” the guideline says.
The seven-part guideline includes sections on recommended practices for central decontamination units, endoscopy units and dental services, as well as an audit prototype for evaluating decontamination procedures.
The guideline, “Code of Practice for Decontamination of Reusable Invasive Medical Devices,” can be viewed at:
www.hse.ie/en/Publications/HSEPublicationsNew/AcuteHospitalReportsGuidelines/#d.en.8696.
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