What’s inside:
Healthcare providers must act promptly upon receiving recall notifications for medical devices and implants. This article will look at:
- The importance of medical device recall management
- Best practice in managing medical device and implant recalls
- Why automated pre-consumption recall alerts are a game-changer
- The role of technology in improving patient safety and preventing litigation.
Healthcare organizations must act quickly when they receive an FDA product recall. It’s a race against time to identify all affected patients and provide them with prompt medical advice that could save their lives!
What is Medical Device Recall Management?
Unfortunately, product defects are a fact of life, and when they occur, urgent action is required. There are various reasons for product recalls, which dictate the size and scope of the recall.
- It is possible that an emerging issue with product design may lead to the full withdrawal of the product.
- Software issues may be affecting the performance of implants.
- The issue may not be product-related at all, but may concern mislabeling.
- Products could have adverse effects on patients.
- Another scenario is that it’s just a faulty batch, affecting specific lot numbers.
FDA Medical Device Recall Statistics
- Medical device recall events rose from 837 in 2021 to 932 in 2022 – a rise of 11.4%
- In 2022, the FDA issued 70 Class I recalls, compared to an average of 47 over the previous five years. This indicates a significant increase in the most serious type of recall, where there is a reasonable probability that a product will cause serious adverse health consequences or death.
- In Q1 2023, the number of medical device recalls increased by 4.6 percent to 252 events.
(Data sources at the end)
The management of medical device and implant recalls is a patient safety issue that every healthcare organization needs to be prepared for.
Medical Negligence and Litigation Around Implant Recalls
While manufacturers are most likely to be sued for medical device defects, healthcare organizations and physicians are also at risk. It is therefore essential to have systems and procedures in place that not only safeguard patients but also protect healthcare providers from litigation. So, what constitutes negligent practice?
The following scenarios all put the hospital or physician at risk of very expensive litigation:
- Failing to take appropriate action after the issuing of a recall notice, if that failure results in the injury or death of a patient.
- Not keeping accurate records causes delays in a patient receiving care.
- Surgical use of a recalled implant or medical device constitutes a negligent practice.
For these reasons, it is crucial to have an effective implant tracking system in place, as well as the tools to achieve complete and accurate point-of-care documentation. It should be easy to interrogate the data stored.
Medical Malpractice: An Administrative Issue
Medical device recall management is an administrative responsibility, and failure to have robust processes in place can expose the healthcare organization to litigation. There have been legal cases against hospitals that have used items that should have been recalled.
In one particular recall litigation case, the hospital attempted to have the case dismissed on a technicality related to pre-trial notifications of medical malpractice. However, the court confirmed that the claim centered on the lack of administrative policies and the failure of staff to respond to a recall notification, and thus, the case proceeded. In this particular case, the use of a blood thinner called heparin, which had been recalled months prior to the surgery, yet remained in the hospital’s active inventory, sadly resulted in amputations for the affected patient.
This clarification by the courts underscores the importance of administrative processes in supporting high-quality patient care, organizational compliance, and risk reduction.
The Importance of Accurate Medical Device Recall Management
Effective recall management requires two main tasks:
- PROACTIVE – Preventing consumption: Locating and removing any recalled items stored in your supply storage spaces.
- REACTIVE – Tracing and tracking patients: Identifying and contacting all patients who have already consumed the affected item.
Although these tasks appear to be simple, many healthcare providers struggle to gather the full information required for smooth recall management.
It comes down to two types of data – inventory information and patient records.
Let’s look a little closer at these two requirements:
- Item Identification. At the time of a product recall, health systems, hospitals, and ambulatory centers may have the affected item in stock. Their task is to locate all items and prevent them from being used accidentally during surgery.
- Patient Identification. Providers need to identify the group of patients affected by the recall. This group could be all patients who received the implant, or a subset of the group, such as those who received a specific batch. Once the affected group has been identified, clinical staff are tasked with making prompt contact with each patient in order to minimize the harm caused by the faulty implant.
In addition to protecting patients, there are also PR and legal reasons for healthcare organizations to get recalls right.
- Avoiding Litigation: If not handled correctly, medical implant and drug recalls can lead to legal action against healthcare providers. Effective medical device recall management can help mitigate legal risks and protect healthcare providers from liability. Product recalls are a fact of life, but slow and ineffective handling of a recall could be considered negligence.
- Maintaining Patient Trust: Patients expect healthcare providers to prioritize their safety and well-being above all else. Product recalls cause alarm among the public and need to be handled very carefully. By demonstrating an effective medical implant recall management system, healthcare providers can strengthen patient trust and loyalty.
So, how can healthcare providers improve their handling of product recalls?
Key Elements of Effective Medical Device Recall Management
Organizations looking at best practice in medical implant recall management need to focus on several key elements, including:
- Monitoring recall announcements: Healthcare providers need to stay up to date with new recalls and safety alerts.
- Quick identification of items: Systems must be in place to check if there are any recalled items in stock, and if so, to locate and identify every item.
- Quick identification of patients: Healthcare providers need to be able to “track and trace” every patient who consumed the recalled item.
- Patient follow-up: Once the group of patients who consumed the medical device has been identified, the lead physician will need to communicate with each patient, discuss the associated risks and any necessary follow-up care, which may involve the correction or removal of the implant, or could result in no action at all.
How technology is aiding recall management
Technology is transforming the way healthcare providers respond to medical implant recalls.
Hospitals and ambulatory care centers are leveraging health technology solutions to enhance their medical device recall management.
New innovative technology is now available to improve both implant tracking and pre-consumption product checking – two crucial foundations for effective product recall management.
There is a stark difference between the manual and automated handling of recalls, as summarized in the chart below.
The information on automated systems varies depending on their level of sophistication. The details we use are based on our own products: Total Sense, a smart cabinet suitable for medical devices, implants, and other consumables, and Snap & Go, a point-of-use implant documentation system.
| Element | Description |
| Recall Monitoring | Manual: A process is needed to ensure ongoing awareness of new recalls and safety alerts, as well as a method to check whether any of these items are in stock.
Automated: The Total Sense smart cabinet has a management system that hosts a centrally updated recall list. The system compares this list to the stock at hand to see if there is a match. In the event of a recall, email alerts are generated if any items are in stock, providing the healthcare provider with complete peace of mind. |
| Product Removal | Manual: Manually tracking down every recalled item is a time-consuming and error-prone process. If a specific batch is being recalled, each affected product will need to be carefully checked. There’s no room for error; if any items are left in stock, they could be accidentally used – a huge patient risk.
Automated: The Total Sense provides real-time inventory vision and can identify exactly where the affected products are located. Staff can be directed to the exact location of every recalled stock item, allowing these to be swiftly removed from the shelves. |
| Patient Identification | Manual: It’s a challenge to identify all affected patients using manual medical records, implant books or outdated systems. Ultimately, manually handling recalls is a long, inaccurate process that risks patients remaining unidentified.
Automated: Full, accurate digital documentation at the point of care enables quick and straightforward identification of patients who have consumed the recalled medical device. |
| Outcome: | Manual: Manual systems are slow and inefficient, making it hard to identify recalled stock items and patients who consumed specific products. Manual recall handling poses a high risk to patient safety and litigation.
Automated: Precise identification of both recalled stock items and affected patients – for robust and speedy recall management. |
Best Practices for Recall Device Management
Effective medical device recall management is essential for patient safety and well-being. Healthcare providers should have systems in place that accurately track their medical devices and implants, both before use and after disposal.
Automated implant tracking systems and point-of-use documentation systems ensure that best practices for medical device recall management are in place.
RFID smart cabinets are commonly used to track implants, and the best cabinets can support easy recall management.
The point of care is probably the most challenging data-capture point in any healthcare organization, but it’s also the most crucial.
The surgical setting is the last opportunity the organization has to check items before consumption.
Tools that provide recall alerts at the point of care provide a critical layer of protection.
If product utilization is not accurately recorded, then the patient is not being adequately protected.
Healthcare providers seeking to enhance medical device recall management can utilize technology as a safety net. Automated management solutions are a quick and precise tool that lightens the weight of responsibility felt by nurses, physicians, and management.
Automating recall management with high-quality inventory management solutions enables healthcare providers to minimize patient harm, avoid litigation, and maintain patient trust.
Contact us to discover how AI-powered solutions can enhance your medical device recall management.
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FDA Data:
