Solutions For Manufacturers

In an increasingly global device market, Manufacturers are more likely than ever to face global responsibility when a device fails.

Recalls which are spread across multiple regions or more than one country are more logistically challenging than concentrated recalls, especially if the manufacturer lacks effective tracking systems.

A costly recall can become unmanageable if the manufacturer can't track unique product identifiers or customer complaints. Proactive and reactive management can be challenging and costly to resolve and/or investigate without visibility into the supply chain.

Manufacturers host mechanisms for the registration of their medical devices based on end-users completing registration warranty cards. These are unreliable processes, inevitably culminating in outdated and inaccurate records of device registers.

During our research into providing the best outcomes for our end users. We reviewed the recommendations with the Cumberlege Review – First Do No Harm and the processes for medical device recalls. The impact on our healthcare services is to ensure that medical devices and drug products are being monitored and tracked and that there is clear communication with our end users.

Evidence has highlighted that there is missing and inaccurate data with the absence of tracking systems for monitoring expiration dates and batch numbers of medical devices and drug products.

The current process:

• Digital notifications to all medical resources
• Hospitals, GP practices, Pharmacies etc
• Time to track patients with the device
• Product Alerts sent out by trusts etc to relevant NHS parties (time costs -£100k) nationally
• Overall Cost of an untargeted notification ~£110k
• Huge waste of time/ Still doesn’t get to the relevant party/end user