May 19, 2022
Publication by NotiSphere
Are you frustrated with the number and quality of recall alerts you receive today?
Do you find yourself trying to determine if you are affected by a recall by looking at all or most of the alerts you receive, then running reports, checking inventory locations, and then realizing at least half of the alerts don’t apply to you?
Maybe what really irks you is receiving an alert with hundreds of serial, batch, or lot numbers in a format that’s not easy to disseminate to your teams?
You are not alone. This happens to thousands of recall coordinators across the country.
This problem is exacerbated by the increase in the number of events reported and recalls issued in the past few years.
Medical device reports and recalls issued by year. Source: Device Events.
Let’s look at why the medical device recall process is so frustrating.
There are several different ways for recall alerts to arrive to a healthcare provider organization:
- The official channel is the paper notices that medical device manufacturers and distributors send via certified mail, FedEx, or UPS.
- There are third-party solutions that aggregate recall alert feeds that we call broadcasters.
- There are also, in some cases, supplier reps who show up with good intentions, explaining that there is an impending recall that will be issued in the very near future.
While each of these examples illustrate good intentions, each of these methods have undesirable side effects:
Although it’s the official notice, the paper notices sent by mail (even express mail) can be slow, taking more than two weeks on average to show up in front of the right person at the hospital. Multitudes of letters for the same recall are being delivered to different parts of your organization because they are being sent to ship to addresses rather than the person who manages recalls. Compounding the confusion, if you don’t respond in a timely way, the supplier will send repeat notifications.
Third-party solutions generate many recall alerts that are not actually applicable to or do not affect the provider organization. In some cases, up to 95% of all received alerts do not apply to the organization. These extra notifications take a significant amount of time to manage, requiring providers to investigate a very large number of recall alerts that ultimately don’t apply to them.
The well-intentioned supplier rep providing some information related to the impending recall creates another undesirable situation because the recall coordinator at the hospital now knows that something is happening with a specific product, but doesn’t have enough information to act.
Why hasn’t the medical device communication process changed in decades?
Simple, any process that involves many stakeholders and involves regulations and risk will tend to change slowly if at all. Achieving consensus and change from providers, manufacturers, distributors, solution providers and other stakeholders takes time and commitment. The medical recall process needs to be improved; stakeholders should not be relying on paper or “fire-hose” size feeds for such an important safety process.
So how do we move the industry to change the way recall management occurs?
Applying technology that has been in use in other industries for many years is an effective way to tackle the challenge. To do that, we must gain collaboration from stakeholders and make sure there are incentives enticing everyone to take a step forward. Change requires the participation of organizations that are strategic, innovative, and known to lead the way in adopting new processes and technologies. The medical device recall process can be improved through a platform for recall communications that connects suppliers and providers directly, eliminating the challenges both stakeholders currently face.
Elimination of the paper process and directly connecting suppliers and providers has significant benefits for the entire industry:
- Direct, efficient communication
- 99% improvement in the time it takes to be notified
- Elimination of false-positive alerts to providers by 95%
- Repeat notification reduction of 100%
- 80% improvement in process efficiency
- Reduced patient exposure to recalled products
- Savings in cost for the suppliers and providers
Paper is slow, inefficient, and these delays are a risk to patient safety. Suppliers need to listen to their clients carefully and understand the challenges and inefficiencies that the current communication process creates for providers. For the healthcare supply chain to modernize the recall process, manufacturers, distributors, and providers need to partner to streamline communications, improve the integrity of the data being communicated and ensure they embrace technology to improve patient safety and traceability.
At NotiSphere, we are partnering with other leaders in the industry to make change happen. We are demonstrating that the medical recall communication process can be improved, frequently with immediate benefits that exponentially compensate the small effort required to make the change. Ultimately, improved communication results in reduced patient risk.
More importantly, we are innovating while reducing the overall cost to the industry. If you want to learn how our medical device recall software can make a difference in your organization and in the industry at large, contact us here.
On demand recording: Usability of Product Recalls