BME’s Professional Engineering staff comprise experts capable of analyzing Class 1, Class II, Class III and Class IV medical device failures.
Medical Device manufacturers of Class II, Class III or Class IV medical devices are required to comply with ISO: 13485 “Medical Devices — Quality management systems — Requirements for regulatory purposes”. Traceability of all components and sub-components, work routings, external suppliers and all other information pertaining to the design, development, manufacture, sale and end-use of each individual device is of paramount importance when a device fails resulting in injury, or possible fatality, to an individual.
Analysis of a failed medical device at BME may comprise one or more of the following depending on our clients requirement :
- Materials analysis of the physical device;
- Analysis of the injured individuals medical records;
- Analysis of the manufacturer’s design history file documentation (as per requirements set out in ISO:13485, “Medical devices — Quality management systems — Requirements for regulatory purposes”);
- Analysis of the manufacturers risk assessment protocols, procedures and findings (as per requirements set out in ISO:14971, “Application of Risk Management to Medical Devices”);
- Analysis of all manufacturing documentation;
- Analysis of device usability and end-user interaction;
BME has analyzed a wide variety of failed medical devices to determine the cause, utilizing our engineering skills, data sources, and excellent laboratory resources. We have been retained to pinpoint the cause and, in certain circumstances, to develop the remedy. Here are some examples:
- An arthroscopic instrument 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 dry sterilization.
- Cataract replacement lenses were breaking from the eyelet. The failure analysis experts 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 arthroscopic instrument — 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.
BME has proved effective in analyzing medical device failures for hospital administrators, for manufacturers, and for other interested parties.