More than 1000 medical devices were recalled for potential safety problems in the first half of 20091. Of those, more than 100 Class I recall notices were distributed for defects serious enough to cause a reasonable probability of adverse health consequences and death. Yet many medical device and life science manufacturers still rely on monolithic enterprise resource planning (ERP) systems that actually slow their ability to track and manage recalls. Some don’t even have a warehouse management system (WMS) in place to help them understand where product is in the supply chain.
The problem with the ERP approach is that very often those systems require manual processes to track the data manufacturers need to implement a recall effectively—and the more manual the process, the more errors, omissions, and delays can occur. Additionally, legacy systems commonly do not have the ability to track shipment and inventory information at a level granular enough to perform a focused product recall.
That’s why many medical device and diagnostic manufacturers are examining their existing processes for managing recalls and adapting some of the best practices already proven to work in managing recalls in the automotive, electronics, and retail industries. Many of these processes rely on business intelligence tools that incorporate analytics, alerting, and reporting with supply chain execution systems that provide visibility across the supply chain. Medical device manufacturers are also going another step further, moving away from managing their own supply chains and using third-party logistics (3PL) providers to manage their supply chains.
Whatever system an OEM chooses, the responsibility of medical device manufacturers for managing product recalls does not diminish as far as FDA, healthcare providers, patients, and lawyers are concerned. Outdated systems or a lack of infrastructure offer no defense for a poorly timed or poorly executed product recall. Whether your company continues to manage its recalls through an in-house system or partners with a 3PL, there are some things you need to know.
The Regulatory Landscape
The FDA’s system for medical device recalls relies on current good manufacturing practice (CGMP) regulations under quality system regulation (QSR) 21 CFR 820. They are designed to ensure proper design, monitoring, and control of manufacturing processes and facilities to prevent contamination and ensure medical devices meet quality standards.
Medical device manufacturers and their 3PL partner should establish a recall team whose members have clearly defined roles and responsibilities and represent the organizations from, at minimum, the following areas:
• Senior management.
This team needs to be identified and prepared ahead of time so that when a field corrective action or recall situation arises, the team is ready to swiftly make the decision on whether a device needs to be recalled.
Once the decision is made to recall a medical device, the recalling firm needs to have an execution team that follows preestablished standard operating procedures based on the guidelines in FDA’s 21 CFR, Part 7, to ensure full compliance with FDA guidelines for recalling medical devices. The recalling firm should also adhere to FDA’s established guidelines for electronic records in FDA’s 21, CFR Part 11. This regulation implements controls, including audits, system validation, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data used in a recall.
The burden of proof that all reasonable efforts have been made to remove the violative product from the market rests with the recalling firm. FDA will classify the recall as Class I, Class II, or Class III, depending on the relative degree of health hazard associated with the product being recalled and the classification of the medical device for its intended use. The recall classifications are:
Class I Recall. A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II Recall. A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III Recall. A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
According to FDA, there are three classes of medical devices, which should not be confused with the recall classification but certainly play a part in the recall classification.
Class I devices are subject to the least regulatory control. They present minimal potential for harm to the patient and are often simpler in design than Class II or Class III devices. Class I devices (e.g., bandages, gloves, etc.) are subject to General Controls, as are Class II and Class III devices2. Class II devices are more complex and carry a higher level of control due to a higher level of risk. Controls may include special labeling, mandatory performance standards, and post-market surveillance (e.g., powered wheelchairs, infusion pumps, surgical drapes, etc.). Class III devices require stringent controls, including premarket approval and clinical trials, and include products used to support or sustain life (e.g., heart valves, breast implants, implantable defibrillators, pacemakers, etc.).
Keep in mind that Class II and Class III devices are required to be tracked down to the serial level for the patient for whom the device is implanted and explanted if the devices fit the following criteria:
• Those devices whose failure would reasonably have serious adverse health consequences.
• Those devices intended to be implanted for more than one year.
• Life-sustaining or life-supporting devices intended for use outside the device user facility.
Depending on the product's degree of hazard and extent of distribution, the recall strategy specifies the level in the distribution chain to which the recall is to extend. For example, Class I recalls require wholesaler notification; Class II recalls require notification at the retail level notification; and Class III recalls require notification of the end user, consumer, or patient.
Whom to Notify
Medical device manufacturers have to handle complex domestic and international distribution requirements, as well as compliance with FDA regulations. They ship product to a wildly diverse group of customers—hospitals, integrated health systems, distributors, alternate care locations, sales representatives, and even the federal government—all with varying levels of IT systems and savvy.
Tracking all of those customers and how they want to be contacted can be overwhelming if the system isn’t set up properly. In a normal business-to-business environment in other industries, a manufacturer can often send out recall notices automatically through their electronic data interchange (EDI) application. However, in the healthcare industry, recall notifications are sent manually because recall notifications via EDI have not yet been adopted across the industry.
For instance, sales representatives carrying trunk stock, who spend a lot of time on the road, may not have integrated inventory management systems and would prefer to be notified by a text message. Some physician offices may prefer an email notification when a recall occurs, while others may prefer to be notified by a digitized voice mail. Therefore, it is important to know not only who needs to know, but also how they need to be contacted to get the recall information in a timely manner.
The numerous contact points that need to be reached during a recall can add a lot of complexity. Therefore, these notifications should not be managed manually. Contact details, including escalation contacts, are ideally saved in a database so automation used by the recall software system can trigger communications based on business rules, escalation, and by a concept called one-button recall (discussed later).
Keep Track of Components
Lot and serial number traceability at the component-part level is extremely critical to managing recalls for medical devices. A single device can contain hundreds or even thousands of components. When a defect is identified for a component, manufacturing batch records are used to determine specifically where the part was used based on the lot and serial number of the medical device. Procedure kits containing multiple medical device SKUs may end up getting mixed and matched based on a patient’s unique physical characteristics. For instance, for a knee replacement there might be 25 SKUs sent to the procedure and only 10 SKUs used for that procedure based on a particular patient’s physical size and knee restoration requirements. Typically, the SKUs that are not used are sent back through the supply chain for possible later use.
The reverse logistics of such a situation create even more complexity in tracing all of the SKUs used in a procedure at both the lot and serial number level. The hospital has to be able to document only the SKUs that were used and on whom they were used. It also has to send that information back to the manufacturer so they have full traceability in case of a recall. The manufacturer has to document not only the SKUs that were used and on whom they were used but also the reverse logistics of the SKUs from the procedure kit that were put back into finished goods within the warehouse.
Hospitals, which aren’t typically known for having the best inventory-control systems, have to track who used components and in whom they were actually implanted. This information is vital in a case such as a heart patient who has a pacemaker implanted. If that pacemaker is recalled, the explants can be a very painful process, so it is critical that the tracking goes all the way down to the serial number level in those situations.
Such drilldown is also critical when it comes to expiry date notification. Because kits may have been separated for different uses in different areas with different patients, any system being used has to be able to track the expiry dates at the SKU, lot, and serial number level.
The key is having an effective data structure for manufacturing batch records that incorporates a multilevel bill of material (BOM) that tracks the serialization, country of origin, and lot down to the component level. That data structure enables the kind of inventory genealogy that is needed to understand what parts were used to make a finished product, and if the product goes bad, where that product ended up. Having the data structured correctly from the start, so that it efficiently identifies the location of tainted product or components, is important in any recall for which accuracy, focus, and speed are paramount to its success.
Automation is Best
Factoring in the complexity of procedure kits and the numerous component parts of a medical device, the range of locations of recalled product, the people who need to be notified, and the audit trails required to verify steps have been taken, it becomes clear that automation is the only way to execute a recall quickly and efficiently. Based on the number of such recalls each year, the alternative to automation is strain on personnel, slow execution, and potentially increased liability.
In recognition of this need for automation, many forward-thinking companies have prepared for recalls by setting up integrated business and process controls that extend beyond their internal manufacturing and ERP systems into a supply chain management software system or systems. The most advanced approach is a one-button recall within these software systems. In this approach, as the name suggests, the decision maker for the product clicks on one button in a software application to do a system-wide recall.
Once the button is pushed and confirmed, a cascade of sequenced and automated steps are initiated, sending messages to business partners and customers, freezing the SKU in sales and shipping systems, and many other related tasks. Integration with business partners can even freeze sales at retail and wholesale POS systems, so more product cannot be moved into hands of hospitals, doctors, or patients. In many cases, one-button recall also freezes inbound receiving from the manufacturer until an all clear is received and the scope of the recall is clearly understood.
If a product is manufactured in a foreign country, it is important to have the systems in place in the warehouse and throughout the supply chain to know if it is on a quarantine hold. Not only should the system be able to stop shipment of products on hold in the warehouse, it also should be able to give logistics personnel through the supply chain an inside view of the truck to ensure the product doesn’t leave the dock.
One-button recall also includes automated confirmations so staff can view exceptions reports and determine the level of compliance for the recall, what actions still need to be taken, and what bottlenecks may need personal attention.
Of course, this automation is only as effective as the planning that has gone into the system, and the ability of the system to track and trace the genealogy of complex or kitted products. Although this preparation is time-consuming, the investment pays dividends in patient safety, partner relationships, reduced liability, and reduced time to completion. Speed is essential not only for safety, but also for efficient operation down the road. The last thing you want is to have a recall linger for months and tie up personnel who are tracking unaccounted product inventory. Once the recall has been performed—hopefully like clockwork —there is one more phase.
Quarantine and Destroy
The last phase of a well-executed recall is the quarantine and destruction of recalled product, and there are requirements for documentation that this has occurred, including detailed reporting.
Again, having the inventory controls inherent in a supply chain execution system can help meet federal requirements for tracking and tracing SKUs, lots, or serial numbers of products that have been destroyed as a result of a recall. The recalling firm will report on a regular basis its progress in successfully removing the violative product from market to the regional FDA field coordinator and will indicate the volumes of product in quarantine. At this point, any serial or lot number information is helpful in proving the effectiveness of a company’s efforts in removing the affected product from market separate from nonaffected product and can also help close out the recall sooner.
Product recalls will always be challenging for any medical device manufacturer, especially in today’s global economy. But with the right set of analytics, alerting, and reporting capabilities combined with proven supply chain execution systems that provide visibility across the supply chain, medical device OEMs can enhance their recall management capabilities and improve the speed of their response. That preparation can mean the difference between life and death.
1 Associated Press, “Tracking of medical implants is lacking,” in Arizona Daily Star, October 6, 2009, http://azstarnet.com/news/science/health-med-fit/article_6c60abcc-2fdf-562f-a059-684f76156b7d.html.
2 General and Special Controls, [online] (FDA, 23 April 2009 [cited 13 May 2011]); available from Internet: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm.
Denise Odenkirk is vice president of OM Healthcare Logistics (Louisville, KY). Tom Kozenski is vice president of product marketing for RedPrairie (Alpharetta, GA).