Medical Devices: FDA Should Enhance Its Oversight of Recalls
Published: 2011-06-14T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device--class I recalls present the highest risk (including death), followed by class II and class III. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies (1) the numbers and characteristics of medical device recalls and FDA's use of this information to aid its oversight, and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. GAO interviewed FDA officials and examined information on medical device recalls initiated and reported from 2005 through 2009, and reviewed FDA's documentation for a sample of 53 (40 percent) of class I recalls initiated during this period.
section_title: What GAO Found
paragraphs: From 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. FDA classified the vast majority--nearly 83 percent--as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote. Just over 40 percent of the recalls involved cardiovascular, radiological, or orthopedic devices. FDA has used recall data to monitor individual recalls and target firms for inspections. However, it has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls. Thus, FDA is missing an opportunity to use recall data to proactively identify and address the risks presented by unsafe devices. Several gaps in the medical device recall process limited firms' and FDA's abilities to ensure that the highest-risk recalls were implemented in an effective and timely manner. For many high-risk recalls, firms faced challenges, such as locating specific devices or device users, and thus could not correct or remove all devices. FDA's procedures for overseeing recalls are unclear. As a result, FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were effective. FDA had also not established criteria, based on the nature or type of devices, for assessing whether firms corrected or removed a sufficient number of recalled devices. Additionally, FDA's decisions to terminate completed recalls--that is, assess whether firms had taken sufficient actions to prevent a recurrence of the problems that led to the recalls--were frequently not made within its prescribed time frames. Finally, FDA did not document its justification for terminating recalls. If unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market. To aid its oversight of the medical device recall process, FDA should routinely assess information on device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document the agency's basis for terminating individual recalls. HHS agreed with GAO's recommendations.

section_title: Letter
paragraphs: Each day, millions of individual medical devices produced by thousands of  manufacturing establishments in the United States and overseas are used  in hospitals, physicians’ offices, and other health care settings to diagnose,  treat, or prevent illness. For example, in 2007 medical devices were  involved in 45 million inpatient procedures. Also, there were  approximately 117 million visits to hospital emergency departments,   89 million hospital outpatient visits, and 994 million visits to physicians’  offices, which likely all involved the use of one or more medical devices.  Medical devices include those that present little risk—such as tongue  depressors and elastic bandages—and those that are used specifically to  sustain or support life—such as pacemakers and artificial heart valves.  Medical devices are an integral part of patient care. If one proves to be  defective or unsafe once it is in widespread use, the ramifications can be  severe, potentially resulting in permanent injuries or deaths to patients or  providers using the device.
A recall is an important remedial action that can mitigate the risk of  serious health consequences associated with a defective or unsafe medical  device. Generally, the firm that manufactured the device voluntarily  initiates a recall after it has discovered a problem based on its assessment  of complaints or reports of safety issues it has received. The Food and  Drug Administration (FDA), an agency within the Department of Health  and Human Services (HHS), is responsible for ensuring that medical  products sold in the United States are safe and effective. In some cases,  FDA identifies a problem with a device based on its own oversight, such as  an inspection of an establishment where a device is manufactured. In  response, the firm may voluntarily initiate a recall. Additionally, FDA has  the authority to require that the firm initiate a device recall when there is a  serious risk to public health and the firm has not done so.
FDA’s role in the voluntary recall process is generally to oversee a firm’s  management of a recall, which includes monitoring the progress of the  recall. FDA has issued guidance to aid firms in conducting such recalls and  has also established internal procedures to govern its oversight of the  recall process. In addition, FDA assigns each recall a classification level— high, moderate, or low—based on its assessment of the degree of risk that  is posed by the continued use of the device. An effective and timely recall  depends on actions taken by the firm manufacturing the device,  companies distributing the device, users of the device—such as hospitals,  physicians, and patients—and FDA. Recalling firms are responsible for  alerting FDA, their distributors, and users of the device about the recall.  The recalling firm provides instructions on steps to be taken to fix the  device or advises parties to discontinue its use. These parties must follow  the firm’s instructions in order to effectively implement the recall.
Despite efforts by recalling firms, FDA, and others, there have been  reported incidents where individuals were seriously injured or died due to  continued use of defective devices that had been recalled. You expressed  concern with the effectiveness of the medical device recall process and  asked us to follow up on our 1998 report on FDA’s oversight of medical  device recalls. Our preliminary findings were included in an April 2011  hearing on the reform of the medical device approval process before the  Senate Special Committee on Aging. This report identifies (1) the  numbers and characteristics of medical device recalls initiated from  January 1, 2005, through December 31, 2009, and the extent to which FDA  uses this information to aid in its oversight of recalls, and (2) the extent to  which the medical device recall process ensures the effective  implementation and termination of those classified as high-risk recalls.
To identify the numbers and characteristics of voluntary medical device  recalls, we obtained information on all such recalls initiated and reported  to FDA from January 1, 2005, through December 31, 2009. This  information consisted of the most recent 5-year period of available data at  the time we did our work. The source of this information was FDA’s Recall  Enterprise System (RES), the agency’s central repository of recall  information. FDA provided key information on each recall, including  FDA’s unique recall event number; the status of the recall at the time FDA  provided us with this information (e.g., ongoing or terminated); the  reason for the recall; the specific device being recalled; the recall  classification level assigned based on FDA’s assessment of risk; dates the  recalls were initiated, classified, and terminated; and the medical  specialty—area of use—for each device subject to recall (e.g.,  cardiovascular or orthopedic). We also obtained information identifying  which of FDA’s 19 district offices located throughout the United States  were responsible for the day-to-day monitoring of the recalls. We then  used this information to determine, among other things, the number of  recalls initiated per year; the number of recalls by recall classification  levels, the average length of time from initiation to termination for recalls  that were terminated, and the number and percentage of recalls by  medical specialty of the device being recalled.
To assess the reliability of the information FDA provided, we reviewed  FDA’s user guide for RES and interviewed officials responsible for  entering and reviewing the information in RES. Additionally, for a sample  of recalls, we compared information from RES on the status and key dates  to the source documents contained in FDA’s recall files. We determined  the data were sufficiently reliable for the purpose of our review. However,  there are some limitations to our analyses. The data FDA provided may  not include all recalls that firms actually initiated over this period. This is  because FDA is dependent on firms self-reporting most recalls. In addition,  FDA did not consistently enter certain data elements into RES over the   5-year period. For example, in certain cases the dates recalls were  terminated were missing, and in many cases the root cause, or problem  creating the need for the recall, was entered inconsistently. Therefore, we  could not conduct certain analyses for all recalls initiated over the study  period.
In addition to identifying information about the numbers and  characteristics of recalls, we identified the extent to which FDA uses  recall information to aid its oversight of recalls. To accomplish this, we  interviewed officials from FDA’s Office of Regulatory Affairs (ORA), which  develops FDA-wide policy on compliance and enforcement matters and  also has primary responsibility for RES, the day-to-day monitoring of  individual recalls, and conducting inspections of firms. We also  interviewed officials from FDA’s Center for Devices and Radiological  Health (CDRH), which regulates medical devices marketed in the United  States and is responsible for classifying recalls and assessing the adequacy  of a firm’s actions to correct problems leading to the most serious recalls.  In addition, we interviewed representatives from two device manufacturer  associations and several device manufacturers to obtain their views about  the recall process.
To identify the extent to which the medical device recall process ensures  the effective implementation and termination of the highest-risk device  recalls, we reviewed key documentation related to the recalling firms’  management and FDA’s oversight of a sample of the highest-risk recalls.  We identified 131 recalls initiated over the 5-year period to which FDA  assigned its highest-risk classification—recalls for which FDA determined  that there was a reasonable probability that the use of or exposure to the  devices would cause serious adverse health consequence or death. Of  these 131, we selected a sample of 53 recalls for in-depth review by  identifying the four FDA district offices that had the largest number of  available recall files to review. These 53 recalls represented all such recalls  during the 5-year period that were managed by these four offices and for  which there were files available for our review. For these 53 recalls, we  obtained from FDA and reviewed the recall case files that were maintained  by district offices. These files contained key documents such as  information from the firms on the causes of the recalls, the firms’ actions  to prevent recurrence of similar problems, the recall notifications firms  sent out to customers, FDA’s correspondence with firms, and  documentation from RES. As part of our review, we identified actions  recalling firms took to adhere to FDA’s guidance and regulatory  requirements, and the extent to which the firms were able to recall all of  the affected devices. We also identified whether FDA followed its own  procedures for overseeing and terminating the recalls and whether FDA’s  recall process was in conformance with internal control standards for the  federal government. For example, we reviewed the case files to determine  whether or not FDA conducted recall audit checks in which FDA would  contact a percentage of parties affected by the recall to determine whether  they received the recall notice and followed the firms’ instructions for  removing or correcting the device. This included a review of over 2,000  audits check forms FDA completed for the 53 recalls we reviewed.  Between December 2010 and February 2011 we discussed the recalls with  officials from the responsible FDA district office, and determined the  current status of the recalls.
We conducted this performance audit from January 2010 to June 2011, in  accordance with generally accepted government auditing standards. Those  standards require that we plan and perform the audit to obtain sufficient,  appropriate evidence to provide a reasonable basis for our findings and  conclusions based on our audit objectives. We believe that the evidence  obtained provides a reasonable basis for our findings and conclusions  based on our audit objectives.
subsections: section_title: Background
paragraphs: FDA is responsible for ensuring that medical products—including medical  devices—sold in the United States provide reasonable assurance of safety  and effectiveness and do not pose a threat to public health. FDA’s  oversight responsibilities for medical devices begin before a product is  brought to market and continue after a product is available for sale. Its  premarket responsibilities include reviewing thousand of submissions for  new devices filed each year to decide whether they should be allowed to  be marketed in the United States. Its postmarket responsibilities include  monitoring the safety of thousands of medical devices already on the  market and identifying, analyzing, and acting on potential risks the devices  may pose to the public. This monitoring includes overseeing recalls of  medical devices.
subsections: section_title: FDA’s Classification and Approval or Clearance of Medical Devices
paragraphs: FDA classifies each device type into one of three classes—class I, II, or  III—based on the level of risk it poses and the controls necessary to  provide reasonable assurance of its safety and effectiveness. According to  FDA, the risk the type of device poses to the user is a major factor in the  class it is assigned: class I includes devices with the lowest risk, and   class III includes devices with the highest risk. Examples of types of  devices in each class include the following:    class I: tongue depressors, elastic bandages, reading glasses, and forceps;    class II: electrocardiographs, powered bone drills, and mercury    class III: pacemakers and replacement heart valves.
In general, unless exempt under FDA regulations, medical devices are  subject to one of two types of FDA premarket review before they may be  legally marketed in the United States. These reviews are as follows.
Premarket approval (PMA): The manufacturer must submit evidence,  typically including clinical data, providing reasonable assurance that the  new device is safe and effective. The PMA process is the most stringent  type of premarket review. A successful submission results in FDA’s  approval to market the device.
Premarket notification (510(k)): Premarket notification is commonly  called “510(k)” in reference to section 510(k) of the Federal Food, Drug,  and Cosmetic Act where the notification requirement is listed. Under this  review, the manufacturer must demonstrate to FDA that the new device is  substantially equivalent to a device already legally on the market. For  most 510(k) submissions, clinical data are not required and substantial  equivalence will normally be determined based on comparative  descriptions of a device’s intended use and technological characteristics,  and may include performance data. A successful submission results in  FDA’s clearance to market the device.
Most class I device types and some class II devices are exempt from FDA’s  premarket review. In general, those that are not exempt, but which are  substantially equivalent to a legally marked class I or class II device, are  subject to premarket review through the 510(k) process. Class III device  types are generally required to obtain FDA approval through the more  stringent PMA process.
section_title: The Voluntary Medical Device Recall Process
paragraphs: FDA defines a recall as a firm’s removal or correction of a marketed  product that FDA (1) considers to be in violation of the laws it  administers, and (2) against which the agency would initiate legal action.  Nearly all medical device recalls are voluntarily initiated by a firm, usually  the manufacturer of the device. The recall process generally consists of a  series of steps that we have categorized into broad phases—initiating and  classifying the recall, conducting and overseeing the recall, and  completing and terminating the recall. While the recalling firm has primary  responsibility for ensuring that the recalled devices are corrected or  removed, FDA and other stakeholders each have responsibilities which  they are supposed to undertake in order to effectively implement the  various phases of a recall. FDA’s role is generally to oversee a firm’s  management of recalls. It conducts its responsibilities as part of its  postmarket surveillance. FDA staff from ORA—which is the lead office for  all FDA field activities, including the agency’s district offices—and CDRH  are involved in overseeing recalls. Other stakeholders, including the firm’s  customers—such as distributors—and device users—such as hospitals or  patients—are expected to correct or remove the recalled device according  to the recalling firm’s instructions. A given recall may require the  cooperation of thousands of different stakeholders depending on how  many entities received, purchased, or used the device.
The following sections generally describe the voluntary recall process that  FDA, as well as recalling firms, their customers, and device users, are  expected to follow according to FDA’s regulations, procedures, and  guidance.
subsections: section_title: Initiating and Classifying the Recall
paragraphs: During this phase of a device recall, a firm initiates a recall, while FDA  classifies the recall based on health risks presented by use of the device.  As part of this phase, a firm develops a strategy for implementing the  recall, and FDA reviews and suggests changes to the strategy. In most  cases, a firm arrives at the decision to initiate a recall after discovering a  problem with a device, or a series of similar devices. The firm may then  contact an FDA district office or immediately begin implementing a  recall. A firm may initiate a recall—that is notify stakeholders such as  distributors and device users about the recall—prior to contacting the  FDA district office. However, according to federal regulations, a firm must  provide FDA with a report of correction or removal within 10 working  days of initiating a recall of a product that involves or may involve a risk to  health. As part of its report, the firm is to provide FDA with key  information such as the reason the device is being recalled, the brand  name and model of the device, the lot or serial numbers of the device, the  number of devices subject to correction or removal, and contact  information for its customers and device users who received, used, or  purchased the device. According to FDA’s guidance, the recalling firm is  also asked to develop a recall strategy that takes into account its  assessment of the health hazard associated with the device. The strategy  should contain details on the firm’s plan for ensuring that its customers  and device users correct or remove the device according to the firm’s  instructions, and the need for public warnings about the device. As part of  its oversight, FDA will review the strategy, and may suggest that the firm  make changes to its approach for conducting the recall.
Once the district office is notified about the recall, it should create a  record in RES, notify CDRH, and obtain and evaluate information CDRH  needs to make its classification decision. The district office monitoring the  recall will provide any information it receives from the firm, including the  correction and removal report, to CDRH so it can begin the process of  classifying the recall. For some recalls, the district office may need to  conduct a recall inspection at the establishment where the device is  manufactured in order to obtain additional information needed to classify  the recall. According to FDA’s procedures, when a recall appears to  involve significant health risks, an inspection should be conducted to  determine, among other things, the root causes of the problem and if the  firm is implementing appropriate corrective action. The inspection may be  performed by the FDA district office monitoring the recall or other district  offices, such as those located near the firm’s manufacturing establishment.
To classify the recall, CDRH is to conduct its own health risk assessment  of the device being recalled. Based on this assessment, CDRH classifies  the recall to indicate the relative degree of health hazard presented by use  of the device. According to CDRH’s procedures, the classification decision  should be completed within 31 calendar days from the time it received the  information from the district office. Recalls are classified into one of  three categories:    class I—reasonable probability that the use of, or exposure to, a device  will cause serious adverse health consequences or death. These are the  most serious recalls.   class II—use of or exposure to a device may cause temporary or medically  reversible adverse health consequences, or the probability of serious  adverse health consequences is remote.    class III—use of, or exposure to, a device is not likely to cause adverse  health consequences.
Table 1 compares FDA’s classification of medical devices and recalls  according to risk. It is important to note that FDA’s device and recall  classification schemes carry opposite designations. The potential degree  of health risk associated with device classes is designated from class III  (high) to class I (low), while the potential risk associated with recall  classes is designated from class I (high) to class III (low).
Once the recall is classified, FDA is to notify the firm, in writing, of the  assigned recall classification. This classification letter should also include  instructions about the extent to which the firm should conduct  effectiveness checks—that is, contacting customers and device users to  determine whether the recall notification was received and acted upon  appropriately. In general, for class I recalls, FDA recommends that firms  conduct effectiveness checks with 100 percent of customers and device  users affected by the recall. For class II recalls, FDA recommends  effectiveness checks with 10 percent of such customers and device users,  and 2 percent for class III recalls.
section_title: Conducting and Overseeing the Recall
paragraphs: During this phase, the firm and recall stakeholders are supposed to  implement the recall as outlined in the approved recall strategy, and FDA  is responsible for monitoring the progress made. Once a recall is under  way, the firm is to conduct effectiveness checks to ensure that those  stakeholders affected by the recall have received notification about the  recall and have taken appropriate action, such as returning defective  devices, or taking actions to correct the known defects. (See app. I for  information on tools to help customers and medical device users identify  recalled devices and an FDA initiative intended to better track devices  through the use of unique identifiers.) Additionally, at the request of the  FDA district office responsible for monitoring the recall, the firm is  expected to provide status reports on the progress of the recall. These  reports should include information on how many customers and device  users have received the recall notification and followed the firm’s  instructions, and how many still need to respond to the recall notice. The  FDA district office reviews the reports, and, using RES, assigns the recall a  status of ongoing if the reports indicate the recall is still under way.
During the recall, FDA district offices independently assess the  effectiveness of the recall by conducting audit checks. According to the  agency’s procedures, for each check, investigative staff from one or more  of FDA’s district offices will contact individual distributors or device  users. These audit checks are generally conducted in person or by  telephone, to confirm that the distributor or device user (1) received  notification from the firm about the recall and (2) properly corrected or  removed the recalled devices in accordance with the firm’s recall strategy.  The FDA district office responsible for monitoring the recall assigns the  audit checks to one or more of the district offices, depending upon the  location of the firm’s customers and the device users. According to FDA  procedures, the district office monitoring the recall should assign audit  checks within 10 days of the recalling firm’s initiation of the recall. The  audit checks should be completed by FDA investigators, if possible, within  10 days of assignment. If an investigator determines that the firm and the  distributor or device user followed the recall strategy, the investigator’s  audit check should conclude that the recall was effective. If not, the  investigator’s audit check should conclude that the recall was ineffective.  The result of the audit check is documented on a standardized FDA form,  and each form is provided to the district office that made the audit check  assignment.
section_title: Completing and Terminating the Recall
paragraphs: Once the firm believes it has completed the recall—i.e., done everything as  outlined in the recall strategy—it needs to submit a final recall status  report/recall termination request to the FDA district office monitoring the  recall. Regardless of the class of the recall, if the district office agrees  that the firm has completed the recall, it is to change the status of the  recall in RES to completed. If it disagrees, it generally requests the firm to  take additional actions, such as re-contacting customers and device users.  The FDA district office bases its assessment of whether the recall has been  effectively completed by reviewing the firm’s status reports and results of  the audit checks. In addition, according to FDA procedures, the final  monitoring step the district office may take is to conduct a limited  postrecall inspection to verify that the recall has been completed. During  this inspection, investigators should witness destruction or reconditioning  of the recalled product, if applicable.
Once the district office considers a recall completed, FDA assesses  whether it can terminate a recall. As part of its assessment, FDA may  review a corrective and preventive action plan submitted by the recalling  firm that describes the firm’s actions to prevent a recurrence of the  problem that led to the recall. Thus, this phase of the recall process is  important because it provides FDA with the opportunity to determine  whether the firm has taken sufficient corrective and preventive actions.  The agency’s procedures state that if a firm’s corrective and preventive  actions are adequate, FDA staff should terminate a recall within 3 months  of completion. When terminating a class I recall, the district office sends a  recall termination recommendation to CDRH. CDRH reviews the recalling  firm’s corrective and preventive action plan, and effectiveness and audit  check results, and makes the decision on whether to terminate the recall.  The district office does not need CDRH approval to terminate class II and  III recalls. If corrective actions are determined sufficient, the recall status  in RES is changed from completed to terminated. When FDA terminates a  recall, the district office will close the recall file and notify the firm, in  writing, that it can cease recall activity. Figure 1 displays the general  process from initiating to terminating a recall.
section_title: Firms Initiated Several Thousand Medical Device Recalls, but FDA Has Not Routinely Analyzed This Information to Aid Its Oversight of Recalls
paragraphs: From 2005 through 2009, firms initiated 3,510 medical device recalls. Most  of these were for medical devices in five areas of use or medical specialty  areas. On average, the recall process took just over 420 days from  initiation to termination, with class I recalls (the highest-risk recalls)  averaging nearly 520 days. FDA has not routinely analyzed information  about recalls to aid its oversight of the recall process, and thus could not  explain trends in recalls over this time period.
subsections: section_title: Several Thousand Device Recalls Were Initiated; Most Were Class II and Involved Cardiovascular and Radiological Devices
paragraphs: Between January 1, 2005, and December 31, 2009, firms initiated 3,510  device recalls, an average of just over 700 per year. The annual volume  fluctuated over this period, and ranged from a low of 658 in 2006 to a high  of 796 in 2008. FDA classified the vast majority of all recalls—nearly   83 percent—as class II, meaning use of these devices may cause temporary  adverse health consequences (moderate risk). FDA classified 14 percent as  class III, meaning use of the device is not likely to cause any adverse  consequences (lowest risk); and 4 percent were classified as class I  (highest risk), because FDA determined that there was a reasonable  probability that the use of or exposure to a violative product would cause  serious adverse health consequences or death (see fig. 2). The number of  class I recalls initiated between 2005 and 2009 ranged from 17 to 41. For  example, in 2007, 25 class I recalls were initiated; in 2008, 17 were  initiated; and in 2009, 41 were initiated. In comparison, the number of  class II recalls generally increased each year and consistently exceeded  500 annually.
Our analysis found that approximately 60 percent of recalls during this  period were for devices from five areas of use or medical specialty areas— cardiovascular, radiological, orthopedic, general hospital and personal  use, and diagnostic chemistry. According to FDA, these medical  specialties are among those with the greatest number of devices on the  market and four of the five specialties—cardiovascular, radiological,  orthopedic, and general hospital—account for the greatest number of  devices cleared or approved for marketing each year. The remaining  recalls were for devices in 19 other areas (such as general and plastic  surgery and neurological devices); no other specialty accounted for more  than 8 percent of recalls (see table 2).
As table 2 shows, for class I recalls, the greatest numbers were for devices  from the cardiovascular medical specialty. In addition, the table shows  that devices from the general hospital and personal use and diagnostic  chemistry medical specialties accounted for a substantial number of class  I recalls. Among class I recalls, we found that the largest number for  cardiovascular devices involved automatic external defibrillators. The  largest number of recalls for general hospital and personal use devices  involved infusion pumps, including implantable programmable pumps.
RES also contains information on the root cause of recalls, that is, the  problem creating a need for the recall. On average, in 2008 and 2009 (the  only years for which FDA tracked these data in RES) the greatest numbers  of recalls were caused by problems with manufacturing processes. FDA  refers to this root cause as process control—developing, conducting,  controlling, and monitoring production processes to ensure that a device  conforms to its specifications. Other leading causes were device design  and software design. The two most common causes of class I recalls were  the same as for all classes—process control and device design—but the  third cause was component design or selection (see table 3). In general,  FDA officials indicated they do not believe that there is a relationship  between root cause and recall class. However, FDA officials indicated that  some root causes of recalls are more likely to affect certain types of  devices. For example, they stated that the root cause “incorrect or missing  expiration date” is typically related to devices that involve sterilization.
Among all classes of recalls, we found that a higher proportion of recalls  were for devices which were cleared for market through the 510(k)  process as compared to other FDA review processes. This reflects the fact  that the overwhelming majority of devices—99 percent, according to  FDA—enter the market through this review process. Our analysis of RES  data for 2,773 recalls found that 87 percent of recalls involved a device  cleared through the 510(k) process, nearly 8 percent involved a device  approved through the more stringent PMA or PMA supplement process,  and nearly 6 percent involved devices that were cleared through the 510(k)  process and approved through the PMA process, or that were exempt from  FDA review.
We found similar trends for 101 class I recalls. We found that 74 of the  recalls (73 percent) were for devices cleared through the 510(k) process,  22 percent were for PMA- approved devices, and the remaining 5 percent  involved devices that were cleared through the 510(k) process and  approved through the PMA process, or that were exempt from FDA  review. Compared to all recall classes, a higher percentage of class I  recalls involved devices cleared through the PMA process (22 percent  compared with 8 percent for all classes of recalls combined), which likely  reflects the high risk of these devices.
Additionally, we found that 14 of those 74 class I recalls involving devices  that were cleared through the 510(k) process were for devices that FDA  designated as high-risk devices—class III devices. We further found that  all 14 recalls involved cardiovascular devices, including 12 for automatic  external defibrillators.
section_title: FDA Has Terminated Most Medical Device Recalls, with the Recall Process Taking over 500 Days for the Highest-Risk Recalls
paragraphs: At the time of our review, the 3,510 medical device recalls initiated from  2005 through 2009 were in various stages of the recall process.  Approximately 60 percent—2,050—of all recalls initiated in this period had  been terminated by FDA as of April 16, 2010, the date we received data  from FDA. Firms had completed another 5 percent and were awaiting  FDA’s review and decision on termination. The remaining 36 percent were  ongoing (see fig. 3).
We found that for recalls that had been terminated, the time between the  firm’s initiation and FDA’s termination of a recall varied by class. On  average, over 420 days passed between initiation of a recall and FDA’s  termination. Among all classes of recalls, class I recalls took the longest— on average 516 days, while on average class II recalls took 436 days and  class III took 352 days. The amount of time needed to conduct and  terminate recalls was split roughly evenly between the portions of the  process that are primarily the recalling firms’ responsibilities—conducting  the recall itself—and the portions that are primarily FDA’s responsibility— oversight of the recall (see fig. 4).
FDA frequently did not meet its 3 month time frame for terminating  completed recalls. It did not meet this time frame for more than half of all  recalls and over 70 percent of class I recalls (see fig. 5). On average, FDA  took 192 days to terminate a recall after it determined a recall was  completed, more than twice the time specified in its procedures. For class  I recalls, the average was 250 days. FDA could not specifically identify  reasons that explained why it took this amount of time to make  termination decisions. The agency did indicate that termination time  frames are affected by both FDA’s ability to address recalling firms’  termination requests, as well as firms’ ability to provide adequate  information in support of the termination decision. This information may  include a sufficient corrective and preventive action plan to prevent a  recurrence of the problem which led to the recall. These data indicate that  the timeliness of recall termination decisions appears to have deteriorated  since our 1998 report.
At the time of our review, 36 percent—1,268 recalls—were ongoing. Of  these, most had been initiated in the past few years; however, some have  been ongoing since 2005, the beginning of our review period. Of those  recalls that were ongoing, most were initiated in 2008 and 2009; however,  456 (36 percent) had been ongoing for at least 2 years, including 86 that  had been ongoing for nearly 5 years.
section_title: FDA Has Not Routinely Analyzed Data to Identify Systemic Problems Underlying Device Recalls
paragraphs: Although RES contains numerous data elements that would allow for  analyses of recall data, FDA is not effectively using these data to identify  whether there are systemic problems underlying recalls. Instead of using  RES to conduct systemic analyses of recalls, which would be consistent  with one of the agency’s strategic goals—improving the quality and safety  of manufactured products in the supply chain—FDA has used RES  primarily for processing and tracking the progress of individual recalls.
Agency officials have not been using RES as a management tool to  conduct broad surveillance of recalls and related issues. Neither the  district offices we contacted nor CDRH officials prepared routine reports  that would enable officials to identify areas of potential concern in the  recall process, such as recalls that have been ongoing for an extended  period, or whether specific manufacturing or design problems are causing  increases in recalls or the types of devices being recalled. In fact, FDA  officials appeared to be unaware of RES’s capability to generate summary  data. When we requested data from RES, FDA staff were unable to extract  these data themselves, and initially indicated that it would be impossible  to obtain data from RES. After 2 months, FDA officials concluded that  through a special arrangement with a contractor they could obtain the  RES data and meet our request.
After we completed our analysis of the RES data, we provided key  summaries to FDA officials, and asked them to comment on trends that we  observed. Officials indicated that they have not fully analyzed these data  and could not explain trends without extensive research of individual case  files. They indicated that at most, they could offer speculation about some  of the trends we observed. For example, they could not explain why the  majority of recalls are class II, why class I recalls more than doubled  between 2008 and 2009, or why many recalls had been ongoing for 5 years.  Officials also could not provide definitive answers when we asked them to  comment on other related topics, such as:    common causes of recalls;  trends in the number of recalls over time;   variation in the numbers of recalls by recall classification levels;  types of devices and medical specialties of devices accounting for most  recalls; the length of time needed for firms to complete recalls; and the length of time needed for FDA to terminate recalls.
Although FDA has not been routinely analyzing recall data to identify  whether there are systemic problems affecting recalls, officials indicated  they have used these data to help direct their inspection resources, and to  support compliance and enforcement actions. First, FDA officials  indicated they use recall information as one of many elements to assess  the relative risks that device manufacturers present, and thus which firms  the agency should inspect in a given year. For example, the officials said  that recall data is one of several elements that feed into a predictive model  that determines the likelihood that firms are out of compliance with  applicable laws or regulations, and therefore in need of inspection.  Second, they told us they have plans to use recall information as the basis  for developing a directed inspection plan. As part of this project, officials  would use recall information to identify those firms that generate a large  number of recalls, and target them for inspection. Officials indicated that  these inspections would focus on specific areas—such as a particular  manufacturing process. This effort is still in the planning phase, and  officials have not yet established criteria, such as what constitutes a large  number of recalls, for determining which firms to select. The officials also  indicated that progress may be slow because they do not have sufficient  resources available to devote to this effort.
Although FDA has not regularly been using data to identify systemic  problems, we found one example of FDA using recall data to detect and  address safety issues with a particular type of device. In December 2010,  FDA held a conference on a variety of issues related to automatic external  defibrillators, including the safety of these devices. During this conference  it presented historical recall data to help demonstrate the need for a  specific focus on safety improvements for this type of device.
section_title: Gaps in the Medical Device Recall Process Limit the Effective Implementation and Termination of the Highest-Risk Recalls
paragraphs: Gaps in the medical device recall process limit firms’ and FDA’s ability to  ensure that the highest-risk recalls are implemented effectively and  terminated in a timely manner. We found that both FDA and recalling  firms generally upheld their respective responsibilities in the course of  initiating and classifying recalls. However, FDA did not always follow its  own procedures and some procedures are unclear. FDA did not  consistently inspect the manufacturing establishments of recalling firms as  outlined in the agency’s procedures. FDA has also not established criteria,  such as thresholds, based on the nature of devices, for assessing whether  firms effectively completed recalls by correcting or removing a sufficient  number of recalled devices. Further, we found that firms face challenges,  such as locating specific devices or users of devices, and often could not  correct or remove all devices. We also found that audit checks, a key  mechanism for FDA’s oversight of firms’ conduct of recalls, are limited in  scope. In addition, because of a lack of clarity in FDA’s audit check  procedures, they have been implemented inconsistently by FDA’s district  offices. Finally, FDA frequently failed to make recall termination decisions  in a timely manner, and kept no documentation to justify its termination  decisions.
subsections: section_title: Firms and FDA Have Generally Implemented Recalls Appropriately in the Initiation and Classification Phases, but FDA Has Failed to Consistently Conduct Recall-Related Inspections
paragraphs: In our review of a sample of the highest-risk device recalls initiated from  January 1, 2005, through December 31, 2009, we found that once firms  initiated recalls, they generally provided FDA with a correction or removal  report in a timely manner—within FDA’s 10-day time frame. In 51 of the   53 recalls (96 percent), firms submitted a correction or removal report to  FDA. For 43 of these 51 recalls, firms submitted the report within 10  working days of initiating the recall. For 6 of the remaining 8 recalls, the  correction and removal report was submitted within 21 business days; the  reports for the other 2 recalls were submitted 62 business days and 227  business days after the recall was initiated, respectively. Table 4 shows the  proportion of recalls, by district, where firms submitted these reports and  whether they were submitted within 10 working days.
Although our analysis indicates that firms generally provided these reports  after initiating the recalls, FDA officials cautioned that this does not mean  firms fully complied with the regulatory reporting requirements. They  indicated that in some cases, firms’ initial correction or removal reports  lack some of the information needed and extra time was required for firms  to provide additional information. To help address this, officials indicated  that in November 2010 they began a recall process improvement project.  As part of this initiative, CDRH plans to develop Web-based training  modules for industry clarifying the information that needs to be provided  when reporting corrections and removals to FDA.
FDA infrequently—in less than one-half of the recalls—conducted an  establishment inspection upon learning of a recall. According to FDA’s  procedures, upon learning of a potential class I recall, district offices  should conduct establishment inspections to obtain further information  about the recall. We found that FDA conducted such recall-related  inspections for 20 of the 53 class I recalls we reviewed. The frequency of  inspections varied across the four district offices monitoring the recalls.  Three of these offices (Detroit, Los Angeles, and New England) conducted  recall-related establishment inspections upon the initiation of a recall  between 25 percent and 38 percent of the time, while the Minneapolis  district office conducted them in 62 percent of recalls (see fig. 6). Based  on interviews with FDA officials in four district offices, we found that  decisions to conduct such inspections, given their overall inspection  workload, are a matter of resources and timing. Some district officials also  said that the decision to conduct a recall-related inspection is based on the  firm’s recall history and indicated that FDA may be less likely to inspect a  firm with a history of completing recalls successfully. Finally, some of  these officials FDA said that this is because firms that have successfully  completed recalls generally provide the necessary information, such as  determinations of the root cause of the recall, as part of their correction or  removal reports.
FDA generally followed its procedures by classifying each of the 53 recalls  in our sample and providing written notification to the recalling firms.  However, for 28 of the 53 recalls, FDA did not make its classification  determination within 31days as outlined in its procedures. The amount of  time from recall initiation to classification varied, ranging from a few days  to several months, with an average of 47 days.
Representatives from two device manufacturer associations and several  device manufacturers expressed concern about the length of time it can  take FDA to classify recalls. For a class I recall, firms must make greater  efforts to identify and contact customers than for class II recalls. Thus,  delays in FDA’s classification can affect firms’ decisions. For example,  officials indicated that if they send out a recall notice that they believe will  be a class II, and after a significant amount of time FDA informs them it is  a class I recall, the firm will have to revise the notice to indicate that the  risks posed by the recall were more severe than they initially anticipated.  The firm will also have to identify additional customers and device users  to contact, in order to meet FDA’s recommendation that they conduct   100 percent effectiveness checks for class I recalls. Firm officials said that  they will then send out the revised notice, which can create confusion  about whether this is a new recall or whether it is an update with new  instructions for the already ongoing recall.
section_title: Firms Faced Challenges in Correcting or Removing All Recalled Devices
paragraphs: Our review of firms’ action in conducting recalls found that the status of  recalls varied and that firms face challenges in correcting or removing all  recalled products. Of the 53 recalls we reviewed, we found 13 were  ongoing, 10 were completed—meaning that an FDA district office  concluded that the firm had essentially fulfilled their responsibilities for  correcting or removing the devices—and 30 were terminated—meaning  FDA headquarters determined that firms’ corrective actions taken were  sufficient to prevent a recurrence of the problems that let to the recall (see  fig. 7).
Of the 40 recalls in our sample that were either completed or terminated— meaning that FDA concluded that the firm had taken sufficient effort to  correct or remove recalled devices—we found that for 19 (48 percent) of  these recalls, firms were able to correct or remove all products. In the  other 21 recalls (53 percent) firms were unable to correct or remove all  products. These recalls ranged widely, in both volume of devices subject  to recall and the types of devices being recalled. Some recalls involved  hundreds of thousands of disposable products, while others involved a  small number of life-sustaining implantable devices. Although recalling  firms took steps to notify customers and device users, they were often  unable to correct or remove all devices. This was because firms could not  locate some of the customers or device users, or these customers or  device users could not locate the device subject to recall. In other cases  this was because the devices had been disposed of (such as defective  syringes), or were sold at retail outlets (such as glucose test strips) to  individuals who may not have known about the recall. For example, in a  recall of tracheal tubes included in certain pediatric medical kits, 1,400  tubes had been distributed, but only 200 were returned to the recalling  firm. The firm said that the rest had likely been used. Finally, users  occasionally were unwilling to return a device. For example, one recall  involved a magnetic device designed to treat a variety of medical problems  such as lower back pain, fibromyalgia, and arthritis. This device was never  cleared or approved by FDA, and despite FDA warnings about the device,  users who had purchased units refused to return them. Details concerning  the 21 recalls for which firms were not able to correct or remove all  devices are presented in appendix II.
section_title: FDA’s Oversight of Recalls Is Inconsistent and Narrow in Scope and Its Procedures Are Unclear
paragraphs: Our review of FDA’s actions for conducting and overseeing recalls  revealed that FDA generally conducted audit checks for the class I recalls  we reviewed, but we found unclear procedures led to numerous  inconsistencies in how different investigators conducted these checks and  made their determinations about the effectiveness of recalls. FDA  conducted audit checks for 45 of the 53 recalls (85 percent) we reviewed.  Our analysis of 2,196 audit check forms associated with these recalls  found that audit checks completed for nearly 90 percent of the recalls  contained a variety of inconsistencies in how the audit checks were  implemented and documented. For each of these recalls we found  inconsistencies in how different investigators determined whether a recall  was effective or ineffective when conducting their audit checks of recalls.  We also identified inconsistencies in the level of detail provided in the  audit check report, and the level of effort undertaken by different  investigators. Specifically, we found the following.
Some investigators’ audit checks concluded that recalls were effective,  despite noting problems (such as device users not following the firm’s  instructions), while other investigators concluded that similar instances  were ineffective. For example, in 2008 a firm initiated a recall of an  implantable pump because of problems in the connection between a  catheter and the pump, which could result in improper amounts of  medication being delivered to a patient. The firm’s recall notification  alerted physicians to this problem, and provided instructions for  monitoring patients who already had the implanted pump and for revising  future implant procedures. As part of the audit check program for this  recall, FDA’s investigators contacted a sample of physicians to determine  whether they received the notification and followed the instructions. Our  review found that out of 68 audit checks, there were 14 instances where  the investigators noted that physicians either did not receive the recall  notification, or did not remember receiving it, and thus could not have  followed the recall notice instructions. In 8 of these 14 instances,  investigators concluded that the recall was ineffective, noting that the  physicians did not implement the recall instructions. In contrast, in the  other 6 instances they concluded the recall was effective, even though  physicians could not have followed the recall instructions. In some cases  this was because the firm provided evidence that they had notified the  physician, and in others the investigator noted that the physician did not  have any pumps on hand.
Some investigators determined that device users were not notified of the  recall by the recalling firm, but instead learned of the recall through other  means. In some of these instances, investigators’ audit checks concluded  that recalls were effective, while in other similar cases investigators  concluded the checks were ineffective.
Some investigators wrote detailed comments on the audit check form as to  why the investigator determined the recall was effective or ineffective,  while others did not. Without comments, it may be difficult for FDA  supervisors and district recall coordinators to verify whether an  investigator correctly determined whether the recall was effective or  ineffective.
Some investigators noted actions they took when they discovered  problems with recalls, such as providing the device users with a copy of  the recall notice or instructing them on actions to take in order to  implement a recall. In contrast, other investigators did not indicate  whether they made any attempt to help facilitate the recall. For example,  in 2009 a firm initiated a recall of an automated external defibrillator  because of reports that some of these devices failed to discharge sufficient  energy due to problems with batteries. The firm issued a notice that  instructed users to replace batteries and update software for the devices.  As part of the audit checks for this recall, FDA investigators contacted a  sample of users of the device, to check whether they received the recall  notification and followed the firm’s recall instructions. Our review found  that out of 67 audit checks, there were 35 instances where investigators  noted problems with the recall—generally that the user did not receive the  notice or failed to follow recall instructions. In 29 of these cases, the FDA  investigator noted taking actions, including providing the recall notice or  instructing the user to contact the recalling firm so they could obtain  software needed to perform the needed actions. However, in 6 cases we  found no indication that the FDA investigator took actions to ensure the  recall was carried out effectively.
FDA officials at both ORA and the district offices we contacted  acknowledged that there are no detailed instructions or requirements for  conducting audit checks, and that there can be inconsistencies in the  process. Officials told us that when determining whether or not a check is  effective, investigators should be assessing whether the recalling firm  provided the notice and instructions to the customers or device users, and  whether the customers or users followed instructions. They  acknowledged, however, that some investigators may approach these  checks differently, and that this may be an area where clarification of the  agency’s procedures is needed. During our interviews with officials from  the Detroit, Los Angeles, Minneapolis, and New England district offices,  some officials said that audit checks are typically conducted by new  investigators, and that investigators receive classroom and on-the-job  training on how to conduct such checks. Some district officials also noted  that audit checks are reviewed by a supervisor as well as the recall  coordinator in the district office that is monitoring the recall, and this  serves as a quality control function to ensure consistency. Also, officials  from FDA headquarters and some district offices stated that they have  attempted to institute measures to improve the audit check process.  Specifically, they noted that they recently updated the audit check form to  more precisely reflect what makes a recall ineffective. Also, ORA officials  indicated that they plan to automate the audit check forms, which will  make the forms accessible to officials in FDA’s headquarters. FDA officials  said that they are considering applications for analyzing the automated  data, but have not completed any specific plans.
In addition to the inconsistencies, we found other gaps in FDA’s oversight  related to the audit checks. First, FDA’s audit checks were often narrow in  scope, in that FDA instructs investigators to contact only a small number  of customers or device users—between 2 percent and 10 percent of those  affected by the recall. Therefore, if there are thousands of customers or  device users, the audit checks provide FDA with a means to contact a  relatively small number of them. For the 45 recalls for which FDA  completed checks, we found the number of audit checks conducted varied  widely, from 2 to 271, with an average of 51 audit checks per recall.  Second, FDA investigators did not always conduct the assigned number of  audit checks. We compared the number of audit checks that should have  been conducted based on the audit check assignments to the numbers of  checks actually completed. We found that for 17 of the 45 recalls   (38 percent) fewer than the assigned number were conducted. Third, even  though most checks were done in person, consistent with FDA’s  procedures, over 22 percent of the checks were done by telephone. In  these cases, the audit check relied extensively on anecdotal information  provided by the customer or device user. According to FDA, the number of  checks it can perform is limited by available resources. Based on our  review of files, we found that if patients or consumers are involved (e.g., if  FDA needed to contact someone with an implantable device), these were  often done by telephone. We also found checks that were done by  telephone for other device users including hospitals, retailers, and doctors’  offices.
section_title: Gaps in FDA’s Completion and Termination Process Increase the Risk That Unsafe Medical Devices May Continue to Be Used
paragraphs: We found FDA lacks specific criteria for making decisions about whether  recalling firms have adequately completed their recalls—a key oversight  activity of the recall process. FDA officials indicated they consider a recall  complete when a firm has completed actions outlined in its recall strategy.  In particular, they evaluate whether firms completed their assigned level  of effectiveness checks, and have corrected or removed recalled devices in  “an acceptable manner.” However, our review of FDA’s recall procedures  found—and FDA officials confirmed—that the procedures do not contain  any specific criteria or general guidelines governing the extent to which  firms should be correcting or removing various types of devices before a  recall should be considered completed. For example, FDA does not have a  benchmark recovery rate or threshold to assess whether firms effectively  completed recalls, although the recovery rates of devices could be  expected to vary, depending on whether a recalled device was a large  piece of hospital equipment or a disposable device, such as a syringe.
Representatives from medical device firms stated that there are no criteria  or guidance from FDA on the percentage of recalled products that must be  corrected or removed. Further, these firm representatives said that FDA is  generally satisfied with three attempts at communicating with customers  and device users affected by the recall.
In addition, for a majority of the class I recalls we reviewed, FDA’s actions  to ensure that recalls were complete were inconsistent with its procedures  for overseeing recalls. According to FDA’s procedures, districts should  conduct a limited postrecall inspection to verify that the recall is complete,  and to witness destruction of defective products, if applicable. In 21 of the  40 completed and terminated recalls (53 percent) we found no  documented evidence that FDA took actions besides audit checks to verify  that the recall was complete. In the other 48 percent of recalls, FDA made  an assessment via inspection, witnessing destruction of devices, or  verifying that software corrections were completed.
Another gap we found in the recall process is that FDA does not maintain  sufficient documentation to justify its termination decisions. Although  FDA may request that firms submit corrective and preventative action  plans for review and approval before a recall can be terminated, we found  little documentation on how FDA assessed whether such plans were  sufficient when it terminated recalls. When we asked to review  documentation justifying the decisions for the terminated recalls in our  sample, FDA officials indicated that they do not maintain extensive  documentation justifying the basis for their termination decisions. They  told us that creating documentation to support concurrence with the  termination recommendation is not part of past or current termination  procedures. This approach is inconsistent with internal control standards  for the federal government, which indicate “that all transactions and other  significant events need to be clearly documented” and stress the  importance of “the creation and maintenance of related records which  provide evidence of execution of these activities as well as appropriate  documentation.” Without such documentation, we were unable to assess  the extent to which FDA’s termination process appropriately evaluated  recalling firms’ corrective actions.
Also, we found that FDA termination decisions were frequently not made  in a timely manner—within 3 months of the completion of the recall— increasing the risk that unsafe or defective devices remained available for  use. Of the 53 files in our sample, 30 were terminated—meaning FDA  headquarters determined that firms developed sufficient corrective actions  to prevent a recurrence of problems which led to the recalls. For   73 percent of the terminated recalls, FDA did not make its termination  decision within 3 months of the recall’s completion, as indicated by FDA  procedures. Overall, termination decisions took between 10 and 800  business days from completion to termination, with an average of   187 business days. Failure to make termination decisions in a timely  manner increases the risk that patients and healthcare providers may  continue to use unsafe or defective devices. For example, one firm  requested termination from FDA for its recall of a portable external  defibrillator in February 2006. However, FDA did not begin its termination  assessment until May 2010. In this case, officials indicated that, due to  staff turnover in the district office, they were unaware that this recall was  still ongoing until a new recall coordinator searched for ongoing recalls. In  2010, following an FDA inquiry, the firm stated that it had not received  confirmation of a required upgrade from 91 end users and an additional   13 devices could not be located. Because FDA did not follow up on this  recall until 2010, 4 years had elapsed before the agency became aware that  the recalling firm had not corrected or removed a substantial number of  devices subject to the recall. According to FDA officials, their ability to  terminate recalls in a timely manner is affected by resources, and  termination decisions are a lower priority than other issues because the  recalling firm has completed its actions.
We found at least one instance where FDA’s failure to make a timely  termination assessment allowed for a potentially unsafe product to be  reintroduced into the market and used for surgical procedures. In this  case, based on adverse event reports that screws in its spinal fixation  system were becoming loose postoperatively, the firm decided to recall  the device in December 2005. The firm implemented its recall and removed  all devices. The firm indicated that it developed a corrective action for the  screw problem, and relaunched the device in April 2006. It then requested  termination from FDA in May 2006. FDA followed up on this request by  leaving three voice mail messages with the firm, and received no response.  The agency sent out a request for information a year later, in May 2007. In  June 2007, the company again indicated that the recall was complete, and  requested termination. In September 2007, FDA conducted an inspection  of the company’s manufacturing facility, and found that while the recall  was complete, the corrective action was not adequate. Over the course of  the next 2 years, the firm worked with FDA to get revisions to the device  approved, but eventually agreed to a second recall for the revised device.  This recall was initiated in May 2009. We identified five reports of adverse  events related to continuing problems with the implanted device that were  filed with FDA subsequent to the firm’s relaunch of the device in April  2006. These reports were filed from December 2006 through March 2007,  and revealed that in all cases, patients required surgical intervention to  correct or remove the device.
section_title: Conclusions
paragraphs: The medical device recall process is complex, requiring the coordination  and timely action of potentially thousands of parties. It is an important  tool used by firms and FDA to protect the public and mitigate health risks  from unsafe or ineffective devices. While the recall process may not  eliminate 100 percent of health risks associated with recalled devices,  careful implementation and evaluation are critical to minimizing health  risks.
FDA has a key role in identifying and minimizing the public health risks  presented by defective or unsafe devices. In this regard, FDA has  opportunities to close some of the gaps that currently exist in the medical  device recall process, and enhance its oversight of device recalls. As  currently structured, FDA’s approach to oversight of medical device  recalls is reactive—responding to individual recalls as they occur. Rather  than pursuing a strictly case-by-case approach to overseeing recalls, FDA  could take a more proactive approach to its oversight. The agency has a  plethora of data available on thousands of recalls, but at present, is not  effectively reviewing and analyzing these data in a systematic manner.  More routine analyses of these data could help FDA identify trends in the  numbers and types of devices being recalled, as well as the underlying  causes of device recalls. Such information would provide FDA with a  better understanding of the risks presented by defective or unsafe devices,  which could lead the agency to proactively identify strategies and  measures needed to address systemic problems with the design or  manufacture of individual devices or entire categories of devices. Armed  with the results of these types of analyses, FDA could then be in a position  to help mitigate safety risks before they occur, and thus minimize the need  for recalls. This is particularly important for the devices involved in the  highest-risk recalls, which place the public at risk of serious health  consequences, including death.
Furthermore, while the agency has devoted substantial resources to  monitoring individual recalls, opportunities for enhancing its oversight of  specific recalls also exist. A key FDA mechanism for overseeing individual  recalls—audit checks of a small portion of customers and device users  involved in the recall—are often implemented inconsistently. This is due  to unclear procedures that investigators are using for implementing and  documenting audit checks and making their final assessments. As a result,  investigators can make inconsistent determinations about whether firms,  customers, and device users have effectively conducted a recall.  Additionally, FDA lacks clear criteria for determining whether firms have  successfully completed recalls, and has failed to maintain important  documentation justifying its decisions to terminate the highest-risk recalls.  This impedes independent assessments of FDA’s decision making and  leaves the agency vulnerable to questions about the basis it used to  determine that recalling firms fulfilled all their responsibilities when  conducting recalls. By addressing these weaknesses, FDA could reduce  the risk that defective or unsafe medical devices remain on the market,  potentially endangering public health.
section_title: Recommendations for Executive Action
paragraphs: To enhance FDA’s oversight of medical device recalls, and in particular,  those medical device recalls that pose the highest risk, we recommend  that the Commissioner of FDA take the following four actions:    Create a program to routinely and systematically assess medical device  recall information, and use this information to proactively identify  strategies for mitigating health risks presented by defective or unsafe  devices. This assessment should be designed, at a minimum, to identify  trends in the numbers and types of recalls, devices most frequently being  recalled, and underlying causes of recalls.
Clarify procedures for conducting medical device recall audit checks to  improve the ability of investigators to perform these checks in a consistent  manner.
Develop explicit criteria for assessing whether recalling firms have  performed an effective correction or removal action.
Document the agency’s basis for terminating individual recalls.
section_title: Agency Comments
paragraphs: We provided a draft of this report to HHS for review. HHS’s written  comments are reprinted in appendix III. HHS agreed with our conclusions  and recommendations and stated that the agency is committed to  exploring each of our recommendations fully. HHS reported that FDA  plans to convene a working group to both evaluate improvements to the  recall process and to develop strategies to implement our  recommendations. According to HHS, FDA recognizes that standardized  guidance will strengthen the management of the recall process. In  addition, HHS elaborated on some of FDA’s efforts to enhance its  oversight by, for example, developing more routine analysis and reporting  of recall data. HHS also provided technical comments, which we  incorporated as appropriate. We are greatly encouraged by the agency’s  response, and believe its expeditious implementation of the  recommendations will serve to enhance the safety of medical devices used  by millions of Americans each day.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the Commissioner of FDA  and appropriate congressional committees. The report also will be  available at no charge on GAO’s Web site at http://www.gao.gov.
If you or your staffs have any questions about this report, please contact  me at (202) 512-7114 or crossem@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made major contributions to this report  are listed in appendix IV.
section_title: Appendix I: Tools to Help Identify Recalled Devices and Planned Initiatives for Assisting with Device Recalls
paragraphs: Several key stakeholders involved in the medical device recall process,  including recalling firms, device distributors, and device users—such as  hospitals—share responsibilities for effectively implementing recalls. To  implement an effective recall, stakeholders need mechanisms to ensure  timely and open communication about the recalls, and a means of locating  devices subject to recall. This appendix describes the recall notification  and tracking systems available to help manage device recalls. It also  provides information on the status of the Food and Drug Administration’s  (FDA) unique device identification (UDI) initiative—which is intended to  enable the identification of a device throughout distribution and use.
To obtain this information, we interviewed officials from FDA and key  stakeholders, including representatives of firms providing subscription- based recall alert information, manufacturers, distributors, group  purchasing organizations, hospital systems, and patient safety groups.  Through these interviews we obtained information on what these  stakeholders considered to be the key challenges they face in  implementing device recalls. We also obtained information about  mechanisms which, in particular, hospital systems use to help identify  devices subject to recall. Further, we reviewed FDA’s progress in  implementing its UDI initiative. To accomplish this, we examined  published studies on this initiative, reviewed stakeholder comments  submitted for FDA’s public meetings on the UDI, and interviewed FDA  officials responsible for managing the UDI program.
subsections: section_title: Many Stakeholders Use Electronic Recall Notification and Tracking Systems to Help Manage Device Recalls
paragraphs: We learned through stakeholder interviews that instead of relying solely  on notifications from medical device manufacturers, health care providers  and other stakeholders have come to rely on other sources of information  to stay abreast of potential recalls. Furthermore, these electronic  communication technologies are evolving and, over time, stakeholders  have begun recognizing that they can play a role in helping to effectively  implement recalls.
Our interviews with stakeholders revealed that a number of different  privately developed, subscription-based electronic notification and  tracking systems are available to help identify and process recalls.  Stakeholders indicated that these systems are primarily used by hospitals,  but that the systems are available to others involved in recalls as well.  Available services identify recalls from a number of sources, including  device manufacturers and FDA’s Web site. The services compile lists of  recalls and send electronic messages about recalls to paid subscribers.  These services vary in sophistication and price. One service we learned  about was limited to periodic electronic notification of all recalls at a cost  of about $500 per year. Others include software to help individual  hospitals specifically delegate responsibility within their hospital system  to specific officials who will manage certain aspects of the recalls—such  as removing recalled products from inventory—and for tracking the  progress of the recalls. These systems can cost several thousand dollars  per year. Owners of these systems that we spoke to indicated that  hundreds of hospitals subscribe to their systems (see table 5).
Stakeholders we interviewed identified several operational benefits of  using recall notification systems. First, they indicated these systems allow  for an increased ability to identify the universe of recalls rather than  simply relying on receiving notices from recalling firms. Second,  stakeholders indicated that quality assurance measures used by the  systems help ensure that the recall notifications contain sufficiently  detailed and accurate information. They indicated that personnel working  for such systems will review the recall notifications they compile prior to  sending them to the subscribers. If needed, those providing the recall alert  services will contact the recalling firm and update the notice for the  subscribers if information is unclear or missing. Third, stakeholders  indicated that such systems can help ensure that recall notifications are  routed to specific personnel within an institution responsible for managing  the recall, reducing the likelihood that implementing the recall is delayed  or overlooked. Officials from some hospitals we spoke with indicated that  manufacturers will frequently notify the department in a hospital that  received the product, which may not be the best point of contact for  ensuring recalled devices are corrected or removed. However, one  hospital system indicated that by using the more sophisticated alert  systems, they are able to automatically forward recall alerts to key  personnel specifically identified by the hospital. This ensures that only the  appropriate departments at the hospital are alerted. Finally, stakeholders  stated that these systems allow hospitals to identify and process recalls  sooner.
section_title: Status of UDI Initiative
paragraphs: The Food and Drug Administration Amendments Act of 2007 (FDAAA)  required FDA to develop a UDI system—a major initiative to better track  and identify devices. Through the UDI, FDA plans to require that the label  of a device bear a unique identifier that is able to identify the device  throughout its distribution and use. Figure 8 displays an example of the  key attributes that might be included in a UDI. In this example, the label  includes key information, such as a device’s lot number and expiration  date which could be scanned into databases.
FDA has been working on the UDI since 2005, prior to the enactment of  FDAAA, and has made some preliminary decisions about the system.  According to FDA, it currently has a proposed schedule that calls for  implementation of the UDI in phases over several years.
Key activities completed for the UDI include the following.
April 14-15, 2005: FDA held a workshop to obtain comments from various  stakeholders on the UDI. A draft report about the UDI prepared by a  contractor for FDA, known as “The White Paper,” was provided to  attendees prior to the workshop to use as background for workshop  discussions.
August 17, 2005: The White Paper was issued and provided information on  technologies and standards available for the UDI initiative and the  possible benefits of automatic identification of devices. The paper also  identified key issues FDA should consider moving forward, including costs  of the UDI. Also, the paper incorporated stakeholder comments from the  workshop held in April 2005.
March 22, 2006: Another contractor issued a report outlining the possible  benefits of the UDI and decisions FDA must make to implement the  system, including the technology needed to use the UDI.
August 11, 2006: FDA formally solicited comments in the Federal Register  for the UDI initiative.
September 27, 2007: FDAAA enacted, requiring FDA to develop and  implement the UDI.
February 12, 2009: FDA held a public workshop on the UDI to identify  remaining issues related to the establishment of a UDI system and to  request comments on this topic.
November 20, 2009: FDA published the results of a pilot test of the UDI.  The results included several recommendations for the future of the UDI  including specific enhancements that could enhance the UDI’s  functionality.
November 30, 2010: Another report on pilot activities was published  containing feedback from organizations that will label the devices and  internal FDA stakeholders. The report stated that fewer concerns remain  as FDA is close to releasing the UDI regulation.
According to FDA, the UDI implementation schedule calls for a phased  approach that will take several years to reach full-scale implementation.  FDA is currently working on a proposed rule and intends to publish it and  seek public comments in spring 2011, and issue a final rule 12 to 18  months later. According to FDA’s senior advisor for the UDI, the proposed  rule will include several key decisions that FDA, based on its prior studies,  has reached regarding the UDI. These key decisions include the following.
Provisions for a UDI database that FDA will maintain. Manufacturers will  send key information about their devices to FDA, which will maintain a  database containing a device identifier for all devices distributed in the  United States.
Flexibility to allow manufacturers to decide how to label their devices  using automatic identification and data capture. This could mean using a  linear or two-dimensional bar code, or radio frequency identification.
In addition, FDA indicated that there are other issues for which they have  not yet made final decisions, and they are still assessing these before they  issue a proposed rule. These include the following.
The labeling requirements for different devices, for example, riskier  devices may be labeled with a unique identifier individually, while  disposable, low-risk devices may be labeled based on how they are  packaged (e.g., bandages will have their UDI identifier on their box).
If the UDI should have a phased implementation schedule for  administering the identifiers, for example, class III devices—the most  risky devices, including some that are implantable—may use the UDI  within 1 year of publishing the final rule, while class II and class I devices  might follow meeting the UDI requirement within 3 and 5 years,  respectively.
Figure 9 presents a timeline of key activities since FDA began  assessing the UDI and its planned implementation schedule.
An FDA official said that the agency expects that the UDI will provide  benefits beyond increased precision in identifying recalled devices, and  that some benefits of the UDI will be realized immediately after its  implementation. According to the UDI senior advisor, these benefits  include improved tracking of adverse events associated with medical  devices and prevention of device counterfeiting. He also stated that many  manufacturers already use identifiers on their devices and should have  little problem adapting to the new UDI system.
Despite the potential benefits of the UDI, some stakeholders expressed  concern that the success of UDIs depends on hospitals’ ability to utilize  these identifiers, and that it may be years before the benefits to the recall  process are realized. Manufacturers we contacted stated that many  hospitals do not use the lot and serial numbers currently provided by  manufacturers to track devices, and FDA does not have authority to  require providers to use the UDI. This concern was also reflected in  comments from officials at several hospitals that we contacted. Some  indicated that they do not have inventory systems in place that enable  them to track devices throughout their hospitals. Therefore, they must  manually search their inventory, sometimes at multiple locations. Locating  a recalled device can be particularly difficult because a device may contain  multiple identification numbers assigned by manufacturers and  distributors for their own tracking purposes. Without upgrades to these  hospitals’ systems, officials acknowledged that the UDI will be less  effective in enhancing patient safety. FDA’s UDI senior advisor stated that  larger hospitals might be more eager to adopt the technology necessary to  track devices using the UDI once it is implemented, but acknowledged that  benefits for the recall process are greatly dependent on hospitals’  implementation of the UDI, which could take up to 10 years for many  hospitals, especially smaller ones.
section_title: Appendix II: Class I Medical Device Recalls from Our Sample for Which Firms Were Unable to Correct or Remove All Devices
paragraphs: In some instances recalling firms are not able to correct or remove all of  the devices subject to a recall. Of the 53 class I recalls in our sample of  recalls that were initiated during the period of January 1, 2005, through  December 31, 2009, there were recalled medical devices that firms were  unable to correct or remove. Table 6 includes information on the number  of devices subject to these 21 recalls, the number corrected or removed,  and if available, reasons firms provided to FDA explaining why they could  not correct or remove 100 percent of the devices.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Geri Redican-Bigott, Assistant  Director; Kaycee Glavich; Cathleen Hamann; Eagan Kemp; Julian Klazkin;  Zachary Levinson; David Lichtenfeld; Daniel Ries; Christina C. Serna; and  Katherine Wunderink made key contributions to this report.