Monthly Archives: October 2012

Most Common Failures of Medical Devices

I am looking for published statistic information of the most common causes of failure on health care technology, could somebody give me some references?

Dear Laura Patricia et al.:

The studies we published on JCE 2010 and 2011 show that the highest amount of equipment failures are typically in the USE category, i.e., caused by abusive use, accidents during use, utilities failures, etc., followed by accessories and batteries. Use error (human factors) are classified as “cannot duplicate” – CND or “no problem found” – NPF during corrective maintenance (please do not confuse them with NPF during scheduled maintenance).

Unpreventable failures (UPF) are the next category. Among the UPFs, the part that is most often replaced is the printed circuit board (PCB) according to a study conducted by J Collins. Very few failures that can be detected or prevented were found in our studies.

I would like to stress that we did not study “real” PMs, i.e., those that involved replacement of parts or chemicals. Our study was mostly focused on safety and performance inspections that are often miscalled “PM” but, in reality, cannot prevent failures but only detect failures that have already occurred or about to occur.

Here is the list of publications:
• Wang B, Fedele J, Pridgen B, Rui T, Barnett L, Granade C, Helfrich R, Stephenson B, Lesueur D, Huffman T, Wakefield JR, Hertzler LW & Poplin B. Evidence-Based Maintenance: Part III, Enhancing patient safety using failure code analysis, J Clin Eng, 2011, 36:72-84.
• Wang B, Fedele J, Pridgen B, Rui T, Barnett L, Granade C, Helfrich R, Stephenson B, Lesueur D, Huffman T, Wakefield JR, Hertzler LW & Poplin B. Evidence-Based Maintenance: Part II – Comparing maintenance strategies using failure codes, J Clin Eng, 2010, 35:223-230.
• Wang B, Fedele J, Pridgen B, Rui T, Barnett L, Granade C, Helfrich R, Stephenson B, Lesueur D, Huffman T, Wakefield JR, Hertzler LW & Poplin B. Evidence-Based Maintenance: Part I – Measuring maintenance effectiveness with failure codes, J Clin Eng, 2010, 35:132-144
• Collins JT. Work Histories in a Medical Equipment Management Program – An Analysis of Parts Replaced, American Society for Hospital Engineering (ASHE), Chicago IL, 2008

Hope this is helpful.

Best regards to all,

Binseng

 

Guess you missed my presentation of Evidence-Based Maintenance in Viña del Mar. We have codified these failures as SIG: service-induced failure, ie, failure induced by corrective or scheduled maintenance that was not properly completed or a part that was replaced and had premature failure (‘‘infant mortality’’). Our statistics from over 150,000 workorders suggest that these failure causes are very rare, typically <<1% in terms of annual probability. Failures caused by scheduled maintenance only would be probably less than one-half of that with very few known exceptions. The vast majority is simply unnecessary work performed to confirm that the equipment is working properly and safely.

The best known exception is one from a sterilizer manufacturer that discovered that one of its valves replaced during scheduled maintenance was failing so often that it was reducing the reliability of the sterilizer they were servicing under agreement. Afterwards, they reduced the replacement frequency from quarterly to semi-annual and improved the design/production of that valve.

Best regards to all,

Binseng

 

 

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Table Comparing ISO 13485:2003 and 21 CFR 820

Thanks to Suresh Singh from LinkedIn for these charts.   Pat

QSR ISO for DB

Kimmelman-Chart

820_comp_table

820 – ISO 13485-2003 Comparison Matrix

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Abbott Getting out of Food Pump Business (Letter Attached)

Good Morning,

The hospital here, got a letter Friday saying that they were no longer doing the food pumps.

By the letter, they will no longer support them after 30 April, 2013  AbbottFoodPumps

Hope this helps

Jim Caudell BS CBET

Account Manager

CREST Services

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