Medical Device Recalls Research Articles

Abstract 343: Cardiovascular Device Recalls in 2012

Background: For the fiscal year 2012, the Food and Drug Administration (FDA) classified 1,190 medical device recalls. Of these, 132 (11%) were for cardiovascular (CV) devices. Class I recalls, representing the greatest health risk, result from finding a reasonable probability that device use will cause serious adverse health consequences or death. FDA approves or clears devices for the US market through either the Pre-Market Approval (PMA) pathway or, more commonly, through a substantial equivalence determination known as 510(k) clearance. Methods: Recalled devices were categorized into nine broad CV device groups. Recall data was included on class, marketing path, and the number of distributed devices. Results: PMA devices represented 14% of the CV device recalls and 510(k) devices represented 82%. There were four Class I recalls -- two PMA and two 510(k). Circulatory support and surgical (CS) was the device group with highest number of recalls (43, 33%). Physiologic monitors (PM) had the second highest (28, 21%) and Vascular catheters (VC) the third highest (17, 13%). The remaining recalls (44, 33%) were included in these device groups: Implanted pacemakers, defibrillators and leads (ID), Non-implantable EP devices (EP), External defibrillators (ED), Vascular access (VA), Stents/grafts/valves (SG), and Others (OT). Over 16 million distributed devices were recalled in the year, with the highest average number per recall seen in the CS group and the lowest in the EP group. Class I recalls varied based both on market pathway and the number of distributed devices. Thoratec’s Heartmate II - PMA - 3,852 St Jude Medical’s Riata - PMA -128,000 Draeger’s Infinity System - 510(k) -1 Cardiac Science Powerheart - 510(k) -12,782 Conclusion: Most of the CV recalls in 2012 were 510(k) devices that were in the CS, PM, or VC device group. Failures in medical devices pose risk to the public and FDA strives to mitigate risk to the public health through the promotion of safe and effective devices, and the removal from the US market of those determined to be unsafe or ineffective.

8.3.1 Towards Integrating Assurance Cases into Risk‐Based Requirements Management

AbstractIn the medical device industry, the FDA has seen an increase in number of recalls of medical devices due to the ever‐increasing complexity in recent years. Several high profile recalls involving infusion pumps have prompted the FDA to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. An assurance case is a resource‐intensive endeavor that requires additional effort and documentation from device manufacturers. Without a well‐organized requirement infrastructure in place, such “additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, we present a Risk‐Based Requirements and Assurance Management (RBRAM) system. The RBRAM is an integrated framework that combines Risk‐Based Requirements Management (RBRM) with the assurance case methodologies. Such an integrated system can help manufacturers leverage an existing risk management framework to present a comprehensive assurance case report with minimal ongoing efforts while providing a supplementary approach to reexamine the integrity of the system design in terms of the mission objective, with which device manufacturers intend to assure.

Managing Medical Device Recalls

Managing Medical Device Recalls

Medical device regulation in Australia: safe and effective?

To describe the frequency, characteristics and outcomes of reports of possible harms related to medical devices submitted to the Australian Therapeutic Goods Administration (TGA) using data made publicly available on the TGA website. A retrospective analysis, conducted in January 2012, of data made publicly available on the TGA website from January 2000 to December 2011. The number and nature of reports of medical device incidents, recalls and alerts. Up to December 2011, 6812 incidents involving medical devices were reported to the TGA, although there were several periods where data were unavailable. Incidents were reported more frequently in later years, most often by device sponsors, and were often attributed to mechanical problems. 295 deaths and 2357 serious injuries have been related to incidents, with serious injury (597) highest in 2009. Most incidents involving medical devices were not investigated (47.5%), or, after investigation, no further action was taken (25.0%). During the same time period, there were 35 medical device recalls and 34 medical device alerts issued by the TGA, with no consistent increase over time. Despite TGA reform proposals, greater transparency is still needed. Issues that have not been addressed include patchy and conflicting data in the public domain and lack of explanations for the large proportion of uninvestigated reports. To maintain public confidence in the national regulatory system these problems need to be resolved.

Managing Multiple Recalls In a Fast-Paced Environment

Successfully managing the recall of a medical device can sometimes mean the difference between life and death. However, executing a recall effectively can be a struggle, particularly when it’s unexpected. What makes it even more challenging is having more recalls hit your desk before you’ve even had a chance to begin addressing the first one. Today, there are 8,000 medical device firms across the country that put a great deal of effort and resources into ensuring a product works correctly, obtaining proper regulatory approvals, before launching it to consumers. Despite a manufacturer’s efforts, there may be unanticipated issues with the product once it’s on the market. When things don’t go as planned, a recall process is set in motion to correct the issue or remove the product from the market. The U.S. Food and Drug Administration (FDA) defines a recall as a “firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.” Recalls occur when a device is defective and/or is a risk to public health. It requires that the product be checked, adjusted, relabeled, fixed, or removed from the market. Although the FDA can legally require a medical device recall, this is rare. In practice, most manufacturers, distributers, or other responsible parties will typically initiate recalls. If there is a reasonable chance that a device will cause serious health problems or death, the FDA will jointly notify the public of the recall. Since 2002, there have been nearly 200 recalls posted by the FDA for devices that are a serious risk to health, and half of these recalls have occurred in the last three years. In the first half of 2010, there were 437 million devices recalled (Figure 1 ). You can imagine the significant impact this has had on the healthcare technology environment. How do we manage all of this activity, and what happens if we don’t manage it? More importantly, what is the patient impact behind these numbers? Bottom line: Recalls are important. We need to focus on developing plans so that we address them appropriately every time.

Device Recalls and the Recalling Company's Website

An ongoing issue with respect to medical device recalls is getting the information to the right people in a timely manner so that appropriate action can be taken. For Class I recalls, this is often addressed by one or more means of professional and public communications, including after-the-fact posting of such recalls by the U.S. Food and Drug Administration (FDA). One resource that could be included in a recall strategy is the recalling company's own website where the information could be readily available in close association with other information on the product, and where it would be readily found by someone making a product specific inquiry. However an investigation of 13 Class I recalls from the 4th quarter of 2010 shows that only four of these included a web presence, and even among these, the recall information was not necessarily easily found, nor closely linked, to other product information.

Should industry share a greater burden for the cost of device recalls?

w a n u Burke et al, in this issue of the Journal, estimated that he cost to Medicare related to the Medtronic Sprint Fidelis ead failures is in the range of $167,000,000 to 806,000,000. Although critics may dispute the methods sed in these calculations, the assumptions are reasonable, nd whatever the true cost may be, it is substantial. In a arger context, the cost to Medicare related to treatment of atients with medical devices that fail or cause less catatrophic problems is a huge number. A recent analysis of edical device recalls identified 113 recalls from 2005 hrough 2009 that could cause serious health problems or eath, and cardiovascular devices comprised the largest ecall category. In 2005, approximately 24,000 patients underwent procedures related to other problems with Medtronic or Guidant devices. Although the companies rovided replacements and compensated patients for up to 2,500 in out-of-pocket expenses, the remaining cost to edicare and private insurers was not shared by industry. y one estimate, the cost to Medicare related to those eplacement procedures was about $120 million. Should industry have a greater responsibility to share in the overall costs related to recalls of their devices? If industry had more liability for these costs, how would it affect their resources for research and development, support of medical education, and other services to patients, hospitals, or physicians? Would they be more cautious about introducing new technologies, and would the risk of device failures decline if industry shared a greater burden for the cost of device failures? Could this burden be counterproductive by stifling innovation at the cost of delaying the introduction of life-saving new technologies? These questions are fraught with the potential for unintended consequences. It is tempting to compare recalls of medical devices to safety recalls by the automotive industry, which can be

Medical Device Recalls: Get It Right the First Time

Medical Device Recalls: Get It Right the First Time

Medical Device Recalls and the FDA Approval Process

Unlike prescription drugs, medical devices are reviewed by the US Food and Drug Administration (FDA) using 2 alternative regulatory standards: (1) premarket approval (PMA), which requires clinical testing and inspections; or (2) the 510(k) process, which requires that the device be similar to a device already marketed (predicate device). The second standard is intended for devices that the FDA deems to involve low or moderate risk. We analyzed the FDA's high-risk List of Device Recalls from 2005 through 2009. Using FDA data, we determined whether the recalled devices were approved by the more rigorous (PMA) process, the 510(k) process, or were exempt from FDA review. There were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death. Only 21 of the 113 devices had been approved through the PMA process (19%). Eighty were cleared through the 510(k) process (71%), and an additional 8 were exempt from any FDA regulation (7%). Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n = 23). Fifty-one percent of the high-risk recalls were in 5 other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology. Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%). These findings suggest that reform of the regulatory process is needed to ensure the safety of medical devices.

Product Recalls in the Medical Device Industry: An Empirical Exploration of the Sources and Financial Consequences

Medical devices play an increasingly significant role in the delivery of health care today. However, persistent quality problems with medical devices and the associated recalls present potential health risks to patients and personnel using these devices. This study addresses three key issues in this regard. First, it empirically assesses the financial implications of medical device recalls to understand if these consequences are severe enough to deter firms from introducing potentially hazardous medical devices into the market, as can be inferred from the literature. Second, the study considers a cross section of medical device manufacturers to examine the effect of firm characteristics on the costs of poor quality. Third, in an attempt to explore the sources of recalls, this study investigates firm characteristics that are likely to be associated with device recalls. The econometric analyses in the study are based on data from manufacturers in the medical device industry over a four-year period (2002–2005). Contrary to our expectations, the findings of the study indicate that at an aggregate level, the market penalties for medical device recalls are not significant, i.e., at the aggregate level, the costs of poor quality are not severe. Furthermore, we find that the magnitude of financial consequences of device recalls is affected by the product scope, sales, growth prospects, and the capital structure of a firm. In our analyses exploring the sources of device recalls, we find that firms with a research and development focus, developing broader product portfolios, have a higher likelihood of device recalls. Also, we find that the likelihood of recalls decreases with prior recall experience, indicating the presence of learning. Implications of the study findings, limitations, and directions for future research are identified. This paper was accepted by Sampath Rajagopalan, operations and supply chain management.

Management Insights

Management Insights

Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts

BackgroundMedical devices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact...

An Analysis of Software-Related Recalls of Medical Devices

In Brief Medical device recalls for software-related issues for 2009 were collected from the Food and Drug Administration database and analyzed. The recalls were analyzed by classifications, device categories, and failure symptoms. The results indicate the growing importance of software in the domain of medical devices and in medical device problems. The study also presents some suggestions for both device companies and biomedical and clinical engineers. Medical device recalls for software-related issues for 2009 were collected from the Food and Drug Administration database and analyzed. The recalls were analyzed by classifications, device categories, and failure symptoms. The results indicate the growing importance of software in the domain of medical devices and in medical device problems. The study also presents some suggestions for both device companies and biomedical and clinical engineers.

Active Surveillance Systems for Early Detection and Improved Recall Decision Making

Abstract Medical device recalls have received significant publicity regarding the timeliness and breadth of the response by the manufacturer. It has been suggested that third party oversight and enhanced public disclosure would improve the recall process. This paper discusses the limitations of passive surveillance systems and proposes new active surveillance systems to support early detection and improved recall decision making. This paper also describes additional benefits of obtaining surveillance information to support iterative design changes and product enhancements.

Keeping Biomedical Engineers Informed on Medical Device Recalls

Keeping Biomedical Engineers Informed on Medical Device Recalls

Abstract No. 376 EE: The Anatomy of a Medical Device Recall

Managing a medical product recall requires cooperation from a number of physician and nonphysician hospital personnel to quickly identify all affected patients and to implement an action plan with fail safe mechanisms. We present our response to a mediport recall which affected 68 patients (reportedly nationally the largest number in a single institution).

Medical Device Recalls and Warnings Soar in 2005

Medical Device Recalls and Warnings Soar in 2005

2005 Medical Device Recalls and Field Corrections-Year in Review

2005 Medical Device Recalls and Field Corrections-Year in Review

Medical Device Recalls Continue to Soar

Medical Device Recalls Continue to Soar

2004 Medical Device Recalls and Field Corrections-Year in Review

2004 Medical Device Recalls and Field Corrections-Year in Review