Devices fail for many reasons, the problem is becoming ever more serious and new guidelines are imminent to try to reduce the failure rate and number of recalls we are currently experiencing.
Below re just a few things that may lead to a medical device failures or recalls.
- The innovator may not be familiar with the regulatory process or have the commercial acumen.
- Lack of “Good Manufacturing Practice ” or lack of a quality culture within the company
- Not involving the end user , be it the doctor,nurse or patient. Remember patients often know best as they use the products
- Lack of clear operational instructions or labels. This could also be a cultural or language issue.
- Errors or deviations which may occur at many stages of the process from the planning , design, manufacture, supply chain or at the point of use .
- Devices may be designed for single use but for many reasons could be reused.
The challenge is to improve the quality and safety of the devices without pricing the product out of the market or making the paperwork so onerous that manufactures stop innovating.