If you suspect a problem with a medical device, either that the device malfunctioned or that the device’s design makes it suspect to cause related problems in a patient, there is quite a bit of public data available to research any reported problems and spot possible trends. This is a suggested sequence whether you are representing a plaintiff who alleges harm from a medical device’s problem, or representing a defendant such as a manufacturer who claims it is not a problem with their device.
The FDA’s website at www.fda.gov is extensive and contains several relevant databases. All of the data queries are free and also generate reports with clickable links to specific guidelines and regulations. Hence, these can be helpful as a first pass to generate raw data.
MAUDE is the medical device reporting database that contains MedWatch and MedSun reports from manufacturers, clinical sites and private citizens. The caveat is that the data is often incomplete, incorrect, duplicated, and the dates of events and the dates reported can be years apart.
Still, it’s very important to look through the reports as some manufacturers have been caught unawares of deaths related to their devices, even though they are in MAUDE. Notice I said the deaths related to their devices, not necessarily caused by the devices. It takes much more research into the circumstances to determine if the device is the cause or merely coincidental. To that end, Total Product Life Cycle reports show recalls and warning letters for devices over the years. Again, not all recalls for a device show a direct link to patient problems. However, it’s useful to track how the manufacturer has handled corrections to the device’s physical properties or the labeling.
FDA regularly inspects manufacturer’s facilities and uses a checklist known as a Form 483 to keep track of any deficiencies. The manufacturer may end up with a warning letter if deficiencies are not corrected in a timely manner. Both 483s and warning letters are also published on the FDA’s site.
Public data should generally complement what the manufacturer’s private files contain, if the manufacturer has been compliant with the FDA’s Quality Systems Regulations, 21 CFR 820. Therefore, some of the most relevant sections of 21 CFR 820 that come up often with medical device problems are:
- Complaints 21CFR820.198;
- CAPA 21CFR820.100;
- Nonconforming Product 21CFR820.90;
- Design Controls 21CFR820.30;
- Production and Process Changes 21CFR820.70(b).
Manufacturers rely on standards to guide their development of the device and help them adhere to FDA’s regulations. Two very common standards are:
- Usability Engineering for Medical Devices ISO 62366.
REVIEW PRIVATE DATA IF PUBLIC DATA REFLECTS A PATTERN
Since many quality systems records encompass thousands of pages, it’s important to know what type of documents to review in addition to public data that we just went through. Manufacturers have to prepare for annual audits with both internal and external organizations so they will have the following records available:
- Design History File – compilation of records which describes the design history of a finished device.
- Device Master Record – compilation of records containing the procedures and specifications for a finished device. This also what is given to a manufacturing location, which can be owned by the manufacturer or an outsourced partner.
- Device History Record – compilation of records containing the production history of a finished device. Again, the factory data is either owned by the manufacturer or provided by the outsourced partner back to the manufacturer.
- Risk File and Risk SOP – the assessment of risk and assigned values of risk for a finished device. Also the standard operating procedure used to define the assessment and assignment of risk, and any risk mitigation strategies.
- Complaint File and Complaint SOP – the complaints related to a finished device and the standard operating procedure used to define how complaints are classified and handled.
- Medical Device Reporting File and SOP – the finished device’s reported problems as communicated to FDA and device users, and the standard operating procedure used to define and also evaluate what device problems trigger medical device reporting requirements.
- Quality Systems training history of all executives, engineering, quality/regulatory, production, shipping and distribution employees and contract personnel involved with the finished device.
- Most new devices sold in the USA go through the FDA 510(k) application process. Ask to review the full 510(k) for the finished device with no redacted data. It will have data from testing that can be compared to any clinical use data after the device was cleared to market by FDA.
About The Author
EXPERT WITNESS E-007962
BS, Mathematics, Oregon State University
MS, Medical Device and Diagnostic Engineering, University of Southern California
Certified, Engineering, California Polytechnic University Pomona
Certified, Quality Auditor, American Society for Quality
Former, Sales and Account Manager, IBM Data Network
Former, Insulin Pump Sales, Medtronic Diabetes
Current, President, a quality consultancy