The MAUDE (Manufacturer and User Facility Device Experience Database) reporting system is administered by the FDA to record adverse effects resulting from the use of a medical device.
As a Mechanical Engineer I find it can be a very useful development tool for identifying challenges encountered in the real world with a specific device design.
Experts in the regulatory world can provide insights into the mechanics of this system and how to respond to issues that have been flagged through this Database. This blog illustrates three ways MAUDE can help development efforts and includes a real life example.
The MAUDE database can provide:
- Risk Analysis Session Input – Probability, severity and detectability are metrics prescribed by ISO 14971 and should be in your risk analysis. Review of the database can provide insight into failure modes encountered by competitive products. Additionally, events that may be identified as ‘remote’ (1/1,000,000) prior to this analysis, may not be remote after all, and 14971 indicates that field data from similar devices may be used for estimating probability. Of course, specific consideration to your design is required when generating and reviewing your risk analysis. It is worth noting that not all adverse events are properly recorded in the database and complaints not related to safety or usability are not likely to make their way into the database.
- Design / Usability – Decisions can be made to minimize or eliminate inherent clinical problems with competitive products. This is not only useful from a safety, usability, and efficacy perspective, but may also provide marketing and strategic advantages in the marketplace. For example, significant clinical challenges associated with a competitor’s User Interface was identified as an area of improvement by one of our clients. Through collaboration, clinical investigation, and some creative thinking on how to interact with the device, a historically problematic user interface became a selling feature, not only because people enjoyed interacting with it, but also because it was an inherently safer device.
- Reduced submission timelines – When a new product is being considered for clearance, the FDA (or other body) will consider competitive device adverse events. By ensuring that you have properly addressed risks associated with predicate devices, your probability of a swift and successful submission increases. The MAUDE database may provide additional items to consider for your Design History File (DHF) and are particularly useful in Risk Analysis, Verification and Validation Test Plans and Reports.
A case study:
I reviewed the Maude Database for Bausch & Lomb’s Crystalens accommodative intraocular lens. The intent of this blog is not to highlight a problem with the Bausch and Lomb design – in fact they have put together a great attempt to solve a very challenging clinical problem. The intent is to highlight how MAUDE can be a useful tool to identify real world issues with a specific design.
Of the 17 reports posted to the FDA website for the month of September 2014 for the Crystalens Accommodative Intraocular Lens (a more chronologically extensive search could have been conducted), the general challenges documented include:
- Dislodged or Dislocated, Vaulted asymmetrically (Z-syndrome) (9)
- Dislodged or Dislocated, Capsular Contraction Syndrome, lens vaulting (4)
- Injury – Posterior sub-capsular cataract and symptoms of glare. Two small lumps of vitreous face were noted around superior IOL Optic on both sides. (1)
- Injury – Starburst and night and glare during day (1)
- Lens Explanted – Reasons not yet resolved (2)
Additional details on each of these incidences, as well as a response from the manufacturer are also to be included in the database. This may provide increased knowledge of the specific physiology, clinical challenges, or other items associated with the device. This analysis also provides a convenient Voice of Customer forum for determining relative weightings for frequency, severity and possibly detectability.
A review of this database should not substitute for good design practices. Understanding the clinical challenges, with feedback from practitioners, patients, payers, and other stakeholders is more important than searching these databases. However, engineers, regulatory advisors, and patent filing teams can complement their work and ensure that relevant challenges have been addressed by reviewing the MAUDE database as part of their development and due diligence process.
Mark Drlik is a StarFish Medical Mechanical Engineer and Project Manager. A two-time recipient of the company’s Chris Denny Memorial Award for Innovation, he brings engineering curiosity and passion to product definition, technology development and product development.