BME analyze a wide variety of failed medical devices to determine the cause, utilizing our engineering skills, data sources, and excellent laboratory resources. We are pinpointing the cause and sometimes the remedy. Here are some examples:
- Arthroscopes used in knee surgeries were failing. Poor quality? Heavy-handed surgeons? No. BME found stress corrosion cracking as the cause - and the remedy was a hot water rinse to remove blood chlorides before the dry sterilization.
- Cataract replacement lenses were breaking from the eyelet. The microscopes at BME revealed hairline cracks in lenses just removed from the packaging, identifying a manufacturing problem.
- A metal fragment was found in a knee joint subsequent to surgery. Our laboratory identified the tiny fragment as having detached from a cracked arthroscope -- and the actual instrument from which it came!
- Intravenous catheter failure - our scanning electron microscope revealed subtle evidence of pinching associated with the fractured tube.
- Treatment chairlift cylinder seizure - we identified corrosion as the cause.
- Hip prosthesis failure - our study led to better understanding of the behaviour of titanium metal in these devices.
BME has proved effective in analyzing medical device failures for hospital administrators, for manufacturers, and for other interested parties. Our assistance is available to you.
