“Who do you usually speak with regarding the recall process?”Hospitals Everywhere
This is the most common question I’ve been asked when I call into a health system and as who owns their medical device recall process. Medical device recalls touch multiple different departments. Materials management, supply chain, biomed, patient safety, compliance, quality outcomes, and the list can go on. Everyone cares about patients, but they don’t at the same time. Everyone wants to look for someone else to tell the patient their device is recalled. When a manufacturer issues a recall, it is generally the supply chain team’s duty to remove the device from the shelf so it can no longer be used, but who notifies the patient?
What happens when the device has been used and is either implanted or with a patient? How does the patient get notified their device (which could result in death) is recalled? In Allergan’s case, many women found out through the media or on social media sites. For the current recall on Philips’ Respironics devices, at least one individual found out after a tiki boat ride with our CEO Ryan Bass.
Is it the manufacturers duty to notify the patient?
As a patient, you have the right to opt out from providing your personal information to the manufacturer of your medical device when there is a “required to track” order on that specific device. If you choose this option, the best the manufacturer can do is to notify the health system or group purchasing organization (GPO) that purchased the device, thus putting pressure on health systems to notify patients.
How does a patient get notified of a recall?
If contact information is known, the manufacturer will make attempts to send a physical letter to the last known address, they will post a notice on their website, and will provide 1-800 numbers for patients to call and see if they are impacted. These “attempts” put the responsibility of the patient constantly watching company websites or following social media groups to hopefully alert them if/when an issue is identified.
How does the health system know the letter was received?
If I was one of the patients to be notified by letter from a manufacturer, I’ve moved three times in the last two years. USPS will only forward my mail for a year. Odds are, I would never receive that letter and I also didn’t think to update the manufacturer with my new address.
Who owns the recall notification process?
Everyone! This includes the patients themselves and is why it is imperative they are included in the flow of information. The burden shouldn’t fall on one department in one hospital to be responsible or to look at another department and say “We don’t notify the patients. That’s risk management’s job.” It is all our responsibility to ensure patients are safe and healthy!
Like I said, recalls touch many different entities and at the end of the day, recalls are a pain in the ass. The recall process should be streamlined to reduce the burden on everyone!!!
CAREier is the healthcare customer relationship management (CRM) tool for medical devices facilitating better communication and outcomes. Led by healthcare regulatory expert, Ryan Bass, CAREier addresses the gap in current processes related to medical devices. Health systems are now required to be 2015 certified electronic health record technology (CEHRT) compliant for their submission to Promoting Interoperability (formerly Meaningful Use Stage 3) and the new requirements allow for a first of its kind process and solution.
CAREier’s mission–and passion–is to facilitate the delivery of messages between hospitals, providers, device manufacturers, payors, regulators, and patients – thus impacting lives and making the world a healthier place for all. For more information, visit us at www.CAREier.com or contact us at (202) 571-6164 or Info@CAREier.com.