How to Improve Your Hospital's Recall Management Process

According to the Office of Inspector General, more than 900 hospitals failed to reimburse $33M to the Centres of Medicare and Medicaid Services for credits associated with recalled implants. Ensuring your facility's implant recall management process is compliant with CMS regulations is critical to minimising the risk of OIG exposure and ensuring patient safety.

What Needs to Happen When a Recall Is Issued

• Identify if recalled products are being held in existing inventory and sequester any affected products
• Submit the recall response form to the recall-initiating manufacturer or vendor
• Identify patients affected, including when, where, and who were potentially exposed to the recalled medical devices
• In certain cases, notify surgeons and patients potentially exposed to recalled medical devices or implants
• Issue required credits for cases involving Medicare and Medicaid patients
• Issue credits to other payers based on the requirements of federal regulations

What Are the Obstacles to Timely Compliance?

• Not enough resources or staff familiar with enterprise IT systems to compile required data
• Identifying when a recall is issued and which hospital departments are to be alerted
• Coordinating a recall plan among a diverse group of stakeholders including Contracting, Supply Chain, Health Information Management, Compliance, Risk Management, Finance, Revenue Cycle, and IT

The Challenging Realities Holding Hospitals Back

Limited technologies exist to alert hospitals of recalled items, and all fall short of identifying the patient by name where recalled medical devices were used or implanted. At best, hospitals can only pull recalled inventory from their shelves. They are unable to identify patients impacted and notify all involved.

Bandwidth is limited. Hospitals simply do not have the available staff to proactively monitor recalls and do the detailed research to identify past cases. Recall information is also frequently delayed and incomplete, missing key data such as date ranges, item numbers, or lot numbers.

Tips for a Successful Implant Recall Management Process

1. Designate a central contact who can act swiftly and delegate

The success of the process hinges on assigning a central point of contact for receipt of recall notifications. This person should have both the responsibility and the authority to initiate required actions and delegate tasks. Immediately communicate this contact information to all device manufacturers.

2. Assemble your Implant Recall Team and set response goals

A team comprised of stakeholders from each impacted department should be formed, including supply chain, risk management, revenue cycle, health information management, patient safety, and clinical areas. The team authors, manages, and executes the process when a recall is issued, with clear KPIs for timeliness of response.

3. Discover usage and existing inventory (Notify and Sequester)

When the recall is received and interpreted, the most important step is discovering product usage and existing inventory. The recommended Notify and Sequester approach includes notifying impacted patients as necessary and sequestering existing unused product currently in inventory. If you do not have ready access to the patients impacted by a recall, this is a good indication that you may not be capturing the data in theatre as required by applicable regulations.

4. Collaborate with finance and accounts payable to address credits

To keep your facility off regulatory scrutiny radar, it is important to enlist finance, revenue cycle, compliance, and managed care teams into the recall process. The goal is to determine whether the facility received a manufacturer or vendor credit for the product already purchased, and whether the patient exposure warrants a credit to the patient payor.

What a Best-in-Class Recall Management Process Looks Like

A complete recall management capability combines real-time feeds from the MHRA recall database with digitised implant case history and the ability to parse complex combinations of manufacturer part numbers with ranges of lot and serial numbers to pinpoint recalled items. Patient-level traceability means that when a recall is published, affected patients can be identified within minutes, not days. Genesis Inventory provides this capability as part of the platform's clinical traceability layer.