Cause of Device-Related Incident
*Not stated

Clinical Specialty or Hospital Department
Anesthesia; Cardiopulmonary Perfusion; CCU / ICU / NICU; Clinical/Biomedical Engineering; Dialysis; Emergency Medicine; Infection Control; Neurological Surgery; Nursing; Obstetrics and Gynecology; Oncology; Ophthalmology; OR / Surgery; Orthopedics; Otolaryngology; Pharmacy / IV therapy; Pulmonary / Respiratory Therapy; Radiology / Ultrasound / Nuclear Med.; Urology

Device Factors
*Not stated

Document Type
Guidance Articles

External Factors
*Not stated

Mechanism of Injury or Death
*Not stated

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

Medical Device Problem Reporting for the Betterment of Healthcare



Guidance [Health Devices Aug 1998;28(8):277-92]

Problem Reporting and Its Benefits

An Incident

A nurse observes that an infusion pump is associated with an underdelivery of medication to a patient and sends the device for repair. The biomedical engineering department examines the device, finds it to be working properly, and returns it to service. The same scenario has been repeated several times before.

End of incident? Probably not. The reason for the occurrence is still a mystery. Was the user not familiar with how to program the pump? Was the pump inherently difficult to program? Was the pump's software faulty? Or might the problem have been caused by misinstallation of, or damage to, the disposable infusion set—a separate device altogether? With none of these questions answered, the problem could recur in a week or a month or a year—and the next time it happens, perhaps a patient will suffer a reaction or even die.

What should be an automatic follow-up to this—or any other—incident is prompt reporting of the problem to the appropriate staff in the hospital and also, perhaps, to the supplier, ECRI, and the appropriate government agency.

What Is Problem Reporting?

Put simply, problem reporting is the communication of a device deficiency or user-related issue to those who are likely to provide or contribute to a constructive response. An effective problem reporting system accurately determines which problems should be reported and provides a mechanism to make, act on, and track reports, and to track any corrective actions. Several different types of problem reporting systems have evolved during the past few decades. They can be grouped broadly into three areas:

  • In-house incident reporting systems
  • Private, nongovenmental systems, such as ECRI's Problem Reporting System and User Experience Network (UEN)
  • Systems maintained by government agencies, such as the U.S. Food and Drug Administration's (FDA) Medical Device Reporting (MDR) system and the U.K.'s Medical Devices Agency (MDA), which is charged with meeting the vigilance requirements of the European Union's (EU) Medical Devices Directive (MDD)

The common goal of these systems is to help reduce the likelihood, seriousness, and recurrence of medical device problems.

The Benefits of Problem Reporting

Within the hospital, an effective reporting system not only helps prevent problems from recurring but also helps meet the requirements of the government, insurers, or certifying bodies (such as the Joint Commission on Accreditation of Healthcare Organizations [JCAHO] in the United States). It also helps lower the institution's liability profile. But reporting device-related problems also has much broader ramifications and can ultimately benefit the entire healthcare community.

For example, disseminating information about device problems outside the hospital prompts the publication of information about those problems. This serves to notify others that the problem exists, possibly helping them avoid the problem altogether, and can prompt an informed person or organization to develop a solution. Medical journals often print letters and case reports describing a problem that arose while using a device and providing recommendations on how the problem can be avoided. A few governments (notably the United States, the United Kingdom, Australia, and Canada) provide user feedback through published articles. In the United States, for example, FDA issues Notices, Public Health Advisories, Safety Alerts, and product recalls (see the discussion under U.S. Problem Reporting Systems, below, for more information). And ECRI consistently, speedily, and comprehensively publishes information about problems—most notably in the Hazard Reports and UEN articles seen in Health Devices and in the weekly abstracts in Health Devices Alerts (HDA).

Moreover, this wealth of published information is also easily retrievable through databases such as FDA's Manufacturer and User Facility Device Experience (MAUDE) and MDR systems, ECRI's HDA database, Index Medicus, Grateful Med, and MEDLINE. Purchasing managers, for instance, can glean from these databases the relative number and types of problems associated with a particular device, making it easier to select a reliable model. Similarly, accident investigators, lawyers, and risk managers need to know about problem trends to help identify the causes of accidents and ways to prevent them.

Consider the incident described at the beginning of this article. If the problem were appropriately reported, then risk management, nursing, and pharmacy staff might review procedures for using the pump and identify a lack of training that led to the incident. The supplier might realize that the instructions for using the pump are too complex or confusing. ECRI might alert others to the potential for such an incident and provide specific recommendations to prevent it, while strongly encouraging the supplier to address the problem. The government might require corrective measures to prevent similar problems in the future. This government action could be logged into a number of problem reporting databases throughout the world and help identify trends in incidents involving the device in question.

Problem Reporting within the Hospital

Who Should Report

Problem reporting is not the exclusive province of any department or specialty. Anyone who is involved with or who discovers a problem should report it internally—not just physicians and nurses, but also engineers and any other staff members who use or maintain medical devices.

Every healthcare institution should carefully instruct its personnel about the importance of immediately reporting any device-related adverse incident or product defect, as well as facilitating any subsequent investigation. ECRI has published a poster, "Accidents Happen—An Immediate Action Plan" that instructs healthcare workers on the steps to take following an incident. These instructions include securing the equipment involved and preserving the scene so that an investigation can be conducted. All staff members should be made aware of these instructions.

What Should Be Reported?

Reportable Problems and Outcomes

A problem can be defined as an event that is unexpected within the normal use of a medical device and that causes or could potentially cause harm or difficulty. Healthcare workers need to be aware of what sorts of device-related events and outcomes should be reported.

Health-Threatening Problems. Obviously, any incident or device problem that directly harms a patient or caregiver must be reported. Examples are administering the wrong dosage of a potent medication and the occurrence of an airway fire during a tonsillectomy. Some problems hold a less obvious potential for harm but still require reporting. These include mislabeled packaging and a device failure detected during setup; either could cause injury or death.

During ECRI's 27 years of investigating medical device problems and accidents, we have identified the causes and adverse outcomes of most types of device problems. From these, we have identified nine basic types of problems that should be reported. We have also identified the serious outcomes that can result from these incidents. These problems and outcomes are listed below.

Difficulties and Nuisances. Difficulties are problems involving ease-of-use issues, increased maintenance, repeated repair requests, higher costs, or other nuisances. They include incomplete distribution of service bulletins and poor seals leading to device corrosion. Difficulties generally do not pose a significant risk of harm but should be reported internally and often externally to improve the quality, timeliness, and cost-effectiveness of care.

Sometimes the difference between a serious problem and a minor difficulty is not readily apparent. Consider the infusion pump problem described at the beginning of this article. While the problem did not cause a patient injury, it certainly had the potential to do so. And in any event, the time and effort wasted in checking the pump created a difficulty. Should it be reported internally? Yes. Externally? Probably—so that others can be made aware of it and perhaps even diagnose the cause. Discussing such an event with a knowledgeable third party (e.g., risk manager, ECRI) can help determine its reportability.

What to Include in a Report

A problem report should allow readers to identify the device, the problem, and the actual or potential outcome or difficulty.

Identifying Information. To begin with, the patient's name and physician and the device user's name should be recorded. (Note, however, that if the report will be sent to an outside agency, patient and staff confidentiality and liability issues may arise. Facilities need to have policies in place addressing these issues—as well as the other confidentiality issues described below.)

The device or its packaging will typically be labeled with the device's name, supplier, serial number, model number, catalog number, lot number, or other specific identifiers; all these should be reported. The report should also include the age of the device and the date it was last inspected and/or serviced, the expiration date of a disposable device, how long the device was in use, the facility's history of use of the product line, and the date of the incident. These items are not only important for initial record keeping but also help define the type of problem (e.g., manufacturing defect, user error, adverse clinical effect) and provide perspective on the incidence of the problem. Any accessories used with the device should also be listed and described. Finally, the reporter should also provide his or her complete address, telephone number, fax number, and e-mail address so he or she can be contacted for further detail if needed. (Note, however, that e-mail transmissions may not be secure, and the advisability of sending sensitive information by this method should be carefully considered.)

Description of the Incident. A clear and complete description of the incident is critical to the report's usefulness. Such a description explains what happened, how it happened, why it happened, when it happened, where it happened, what the outcome was, and any other information that could be pertinent. Without all this information, the report becomes next to useless in helping to prevent future problems.

What constitutes a comprehensive description depends on the complexity of the problem. Most reports can be defined in one or two short paragraphs. In a few cases, a simple descriptive sentence is all that is needed: "The cannula was found to be broken in its package." In contrast, some problems require a full-page description supplemented with photographs or drawings.

Unfortunately, problem reports are too often sketchy and vague, which can create difficulties in identifying trends or otherwise applying the information the reports provide. The medical device databases are replete with reports stating only that the device "broke." Some reports, on the other hand, provide exhaustive detail about the patient's prior condition, the procedure, or follow-up treatment, but fail to explain the basic problem that caused the incident. Although irrelevant details should be avoided, the more essential details the report contains, the more useful it will be.

Complicating the picture, however, is the fact that too much detail can raise liability concerns. While most internal problem reporting systems provide a degree of confidentiality, the occurrences described in a report may be so specific that the actual incident will be identifiable by parties outside the institution (e.g., a lawyer or expert witness reviewing a problem reporting database). The information in the report can be potentially damaging in any subsequent legal action, especially if the information is preliminary or inaccurate. Therefore, reports should be reviewed by risk management or legal counsel (if deemed necessary) before being sent out of the facility.

Who Receives the Report and the Actions They Take

Problems are typically reported first to the facility's risk manager or other problem reporting coordinator. This person ensures that there is a system in place to evaluate the problem, act on it to prevent its recurrence within the facility, and report it as required or requested by outside agencies. Some facilities have a dedicated risk manager. Others use the operating room supervisor, biomedical engineering director, chief engineer, purchasing manager, or head nurse as the problem reporting coordinator. Still others give such staff members the authority to report problems directly to outside agencies.

Depending on the specifics of the problem (e.g., severity, potential for litigation), the risk manager or problem reporting coordinator must ensure that certain actions are taken and that the efforts of various groups are coordinated, as listed here.

  • Review and follow up on the internal report form.
    • Contact the problem's reporter for more detail on the problem.
    • Have the biomedical engineering staff impound the device, including disposables, until its performance can be reviewed. If appropriate, consider quarantining other similar devices pending preliminary investigation results.
    • If the model name is unfamiliar, ask the purchasing manager or the clinical engineering department to identify the supplier of the problem device(s).
    • Contact the supplier's quality assurance manager or regulatory affairs officer to report the problem and, if appropriate, coordinate repair or replacement of the problem device.
    • Review ECRI's HDA database for similar problems.
    • If appropriate, have an independent third party investigate the problem.
    • Based on the preceding steps, evaluate the problem and identify the cause.
  • Document any investigation findings.
  • Make recommendations for corrective actions to prevent future occurrences.
    • Develop preventive policies or procedures.
    • Have the chief physician or head nurse review these new policies or procedures.
    • Have the nurse educator or clinical educator set up user education programs.

Ensure that corrective action is taken.

  • Have the risk manager or safety committee order the implementation of preventive procedures.
  • Follow up to ensure that preventive recommendations are implemented, and verify that they are effective.
  • Complete any required regulatory reports (e.g., FDA MedWatch Mandatory Form 3500A).
      Determine what to report and how to report it; be judicious in making this determination (e.g., consult legal counsel).
    • If a report was not submitted to a regulatory agency, internally document the reasons.
  • Provide a report summarizing the problem and its resolution to
    • the safety committee, quality assurance office, and others who may be concerned about the problem;
    • regulatory agencies as required (e.g., annual reports to FDA); and
    • ECRI.>
  • Retain appropriate documents and materials.

The Importance of Timely Reporting

Regardless of the type of event, the speed of its reporting can have significant consequences. For example, stocks of disposable devices are used up quickly, and any problem involving a specific device lot needs to be promptly addressed to help prevent other occurrences. Problems that are very likely to recur or cause serious injury or death also require fast reporting.

Some governments have time specifications for reporting. For example, in the United States, FDA requires healthcare facilities, under penalty of fines, to report some types of device incidents within 10 working days of their becoming aware that a specific device caused the incident. Similarly, the EU and Canada require manufacturers to report incidents within 10 days. Timely methods for alerting other governments to serious, widespread problems are being developed by the Global Harmonization Task Force, which is working to make various countries' problem reporting systems as compatible as possible.

Problem Reporting to Outside Organizations

Procedures Involved in Outside Reporting

Once it has gone through the necessary in-house processing, a problem may need to be reported to a governmental or regulatory agency or other organization—such as FDA in the United States or MDA in the United Kingdom—and in some cases to the manufacturer of the device(s) involved in the problem. The problem reporting coordinator must be familiar with the prevailing national requirements and thus be able to identify how and under what circumstances outside reporting is appropriate. Problems should also be reported to ECRI, which, while not a governmental agency, encourages facilities to use its Problem Reporting System.

When a report is received by most suppliers or agencies, it is subject to the same general process. The report is first reviewed to determine its severity and likelihood of recurrence. These factors will determine how the report is acted on. For example, a report identifying a known complication may not require action, while an incident determined to be caused by a defective device may initiate a recall or the publication of a notice about the problem. The agency will often notify the reporter about the outcome of his or her report.

The Problem Reporting Systems of Different Countries

Even though problem reporting is important throughout healthcare, supplier, and regulatory circles, only a few governments (e.g., the United States, EU member states, Australia, Japan) require that problems involving death or serious injury be reported to the supplier and/or a governmental agency. The requirements of these countries generally apply to users, facilities, and/or device suppliers, and fines can be imposed on those who do not report. Below, we detail the reporting protocols of some of the better-known problem reporting systems.

U.S. Problem Reporting Systems

FDA's MDR and MedWatch Systems. FDA set up its problem reporting system, the MDR system, in 1984, based in part on ECRI's Problem Reporting System. In its initial stages, the MDR system required device manufacturers and importers to report device-related deaths, serious injury, and certain malfunctions identified through user reporting. Subsequently, as a result of the Safe Medical Devices Act (SMDA) of 1990, the MDR system expanded to include the requirement that healthcare facilities report to the manufacturer events in which a device caused or contributed to death or serious injury. As noted earlier, healthcare facilities must report these incidents no later than 10 working days after becoming aware of them. SMDA also requires facilities to provide FDA with an annual summary of reported incidents (using FDA Form 3419). In addition, SMDA requires facilities to develop, implement, and maintain written procedures for medical device problem reporting.

Problem reports were initially collected in FDA's Device Experience Network (DEN) database. Under SMDA, a new database was created, the MAUDE system. In late 1997, the MAUDE database was made publicly available. It will eventually incorporate the DEN and will be linked to other FDA databases such as the device registration and premarket review databases. This linkage should enable better identification and tracking of problems and trends.

FDA provides two MedWatch forms for problem reporting: Form 3500A, which is used for mandatory reporting "by user-facilities, distributors, and manufacturers," and Form 3500, which is used "for voluntary reporting by health professionals of adverse events and product problems." (The identity of facilities filing many of the MedWatch reports would have become public knowledge had not ECRI and FDA urged legislators to change the law—the Modernization Act of 1997—to provide anonymity for database reporters. This change was enacted just before the MAUDE database was made public.) ECRI has set up a Computerized Problem Reporting System through which healthcare facilities and users can electronically file MedWatch forms with FDA or manufacturers. ECRI forwards the forms and automatically files the required annual reports.

Once FDA receives a report from the healthcare facility or the manufacturer, it enters the report in its database. Health hazards and trends are identified, an assessment is conducted, and additional information may be requested from the user or the manufacturer. Manufacturers are required to investigate, evaluate, and identify the underlying cause of each problem reported to them. Often the manufacturer initiates solutions to the problem, and FDA typically relies on the manufacturer's conclusions to close the problem's file or start any needed regulatory action (e.g., recall, retrofit).

Depending on an incident's nature and severity, FDA occasionally publishes Notices, Public Health Advisories, or Safety Alerts to make healthcare providers, facilities, and organizations aware of the problem. Notices are letters sent to healthcare professionals and organizations involved in a particular problem. Public Health Advisories are widely distributed statements about a problem, its risks, and general recommendations for its prevention. Safety Alerts are also widely distributed but specifically address high-risk problems involving death or serious injury. Problems reported to FDA are also communicated through the FDA Medical Bulletin, the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, the American Journal of Nursing, the Journal of the American Medical Association, and ECRI's Health Devices Alerts. And some problems also result in medical device recalls, either voluntarily by the manufacturer or imposed by FDA.

JCAHO's Sentinel Event Program. In early 1996, JCAHO released its Sentinel Event Policy, which encouraged healthcare organizations to voluntarily report certain events to the organization. This policy defines a sentinel event as "an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof." It also describes the steps by which a hospital should uncover the root causes of problems to improve its quality of care, which goes a step beyond FDA reporting requirements. JCAHO's attempts to enforce this policy have created some controversy, and the future of the policy is not clear.

The European Union's Medical Devices Directive

The EU recently enacted the MDD, which requires EU member states to establish vigilance systems for monitoring medical device problems. These systems will eventually be harmonized, and the information from them will be shared throughout the EU. Incidents, as the EU calls medical device problems, are defined as device-related events that cause, or have the potential to cause, death, injury, deterioration of health, or unreliable test results. They are reported to the local Competent Authority—usually a national regulatory body—which has the governmental authority to act on the problems as it sees fit. Reports are required from manufacturers and are voluntary from users.

The U.K.'s Competent Authority, for example, is MDA. One of MDA's agencies is the Adverse Incident Centre (AIC), established in 1987 as the National Reporting and Investigation Centre. AIC actively solicits and collects user reports on incidents (called adverse incidents in the United Kingdom) and on minor faults and discrepancies that may indicate poor quality assurance with a device. AIC received 5,383 reports in 1997 and anticipates that this number will increase by about 500 reports each year. AIC typically deals with routine reports by working with the supplier to understand the problem and how to correct it. More serious reports are actively investigated by both AIC and experts within MDA. This type of investigation may result in Hazard Notices, Safety Notices, or Safety Action Bulletins that communicate the problem and its corrective measures to U.K. healthcare facilities, manufacturers, and—possibly in the future—appropriate journals.

In addition to member states of the EU, other countries are cooperating with the MDD, even though they are not bound by its provisions. These countries include signatories of the European Free Trade Agreement, Australia, and Canada.

ECRI's Problem Reporting System

ECRI founded the concept of medical device problem reporting in 1971 and continues it today by encouraging voluntary problem reports from its network of member institutions and other contacts around the world. Hospitals in this network—or anyone else wishing to report a device problem—can complete our Problem Reporting Form. (As an alternative, we also accept copies of FDA MedWatch forms.) Upon receipt, the report is quickly reviewed for seriousness and likelihood of recurrence. Dangerous problems receive immediate action. Other, less critical problems are cross-checked in our problem reporting, HDA, and FDA databases for similar reports. (One tool for classifying these reports is ECRI's Universal Medical Device Nomenclature System , or UMDNS.

In our weekly triage meeting, experienced engineers and scientists sort the recently received reports into four categories:

  1. Problems that call for further investigation. These reports are assigned to an engineer or scientist knowledgeable about the involved device or technology. This person further reviews our databases for other information on the problem and contacts the reporter and supplier in an effort to resolve the problem and prevent its recurrence. (We do not divulge any information about the reporter or the facility to anyone except the supplier, and then only if it is appropriate and the reporter agrees.) The involved device may be examined, similar devices may be tested, and the device's design may be reviewed. However, many problems are concluded through telephone discussions, and the report files are closed but retained in our database.
  2. Isolated incidents. These are events that appear unlikely to recur (e.g., the device was operated under unusual circumstances, the problem involved a random component failure). Information on these incidents is maintained in ECRI's problem reporting database so that trends can be identified if similar reports are received.
  3. Known complications. These are problems that have a known history of occurrence. They will often have been described in the literature. Users should read the literature to become aware of the potential problems associated with the use of any given device.
  4. New problems—that is, those of a type never before reported. These are evaluated and then re-sorted into either of the first two categories.

Some investigated reports result in conclusions that need to be communicated to the healthcare community. A problem that presents an immediate and serious danger of a widespread nature is quickly acted on and results in an ECRI Hazard Bulletin, which is sent to all Health Devices System members, all hospitals in North America, and most ministries of health around the world. Problems that are likely to cause harm are described in a Hazard Report published in Health Devices. Problems that are unlikely to cause harm but that will cause some difficulty or nuisance are defined in a UEN article, also published in Health Devices. Some problem report investigations prompt the supplier to distribute a voluntary statement about the problem and its corrective action; these statements are abstracted in HDA (as are all Hazard Reports and most UEN articles).

To date in our 27 years of doing this work, ECRI has published more than 25 Hazard Bulletins, about 800 Hazard Reports, and more than 300 UEN articles. These have resulted in hundreds of improvements to medical devices and the avoidance of countless deaths and injuries.

Mining the Databases for Information

The Utility of Database Information

Problem reporting databases around the world contain valuable information that healthcare institutions can use to identify trends in medical device incidents and solve specific device-related problems. For example, as described earlier, ECRI's Problem Reporting System relies on database searches to help define the seriousness of problems, as well as the likelihood of their recurrence.

Challenges in Identifying Data Trends

Certain difficulties inherent in problem reporting can present challenges to effective trending of database information.

Lack of a Unified Database

In an ideal world, every problem report from across the globe would be held in a single consolidated database. Unfortunately, such a database does not yet exist. The largest centralized repository of problem reporting data is ECRI, whose databases contain almost 850,000 citations. We are working to merge our databases with those of countries such as Australia, Canada, and the United Kingdom. And, as noted, the Global Harmonization Task Force is working along similar lines. Perhaps someday these efforts will result in a single unified repository for problem reports accessible from anywhere in the world.

Overreporting

Overreporting is the filing of more than one problem report describing the same problem or incident. This can happen if a problem is separately reported to ECRI, the supplier, and FDA, ending up as three separate database citations. Or a device's market share can skew the statistics: a particular model may have no greater rate of problems than any other but still be the subject of a greater number of reports because it is more widely used.

Overreporting suggests a greater incidence of a problem than actually exists. Although this might occasionally prove beneficial—by allowing a serious problem to be identified and remedied all the more quickly—it is more likely to overload problem reporting systems with extraneous data. Most systems can do little to cross-check for overreporting. Therefore, it is important that data be interpreted by persons—such as investigators—who are knowledgeable about the devices and about the specific types of incidents and how they occur.

Underreporting

On the other hand, a particular problem may not be reported by everyone who experiences it, leading to the conclusion that the problem is not as great as it really is. For example, suture needles are known to fail from several understood causes, yet these failures are infrequently reported because "everyone knows" that needles break occasionally. As a result, the actual reasons for some of the failures may never be identified and therefore may never be corrected.

In late 1997, FDA stated that it receives about 100,000 medical device reports a year, but the agency considers this number just the tip of the medical device problem iceberg. Based on information from our contacts throughout the world healthcare community, ECRI agrees that medical device problems are grossly underreported. Accurate reporting of every problem—which requires adequate staffing of the problem reporting function and, in some cases, enforcement within or from outside the hospital—would help eliminate underreporting and improve the quality of healthcare.

Failing to Attribute the Problem to the Correct Device(s)

Often, several devices are involved in an incident. Careless investigating or reporting could result in all these devices being reported as "causing" the incident, when in fact only a single device, or perhaps the interaction between two devices, was the source of the problem. Such carelessness results in both overreporting and misreporting—overreporting because the same incident is cited several times, and misreporting because the actual cause of the incident is not identified.

This difficulty can be minimized by meticulous investigation of the incident (by an independent third party if warranted), clear understanding of the roles of every device involved in the incident, and accurate reporting that cites only the root-cause device or devices.

Identifying Subtle Trends

Trends in problem reporting data are sometimes obvious but more often are not. Obvious trends can be seen, for example, in multiple reports of broken (and unsterile) packaging in specific lots of a product or early failure of a brand of defibrillator batteries. On the other hand, reports of "underdose" and "overdose" involving a particular infusion pump could have any number of causes: they could be separate problems, or they could be caused by poor infusion data entry, complex software, battery failure, use of the wrong infusion set, or several other difficulties. Without clear, detailed reports or significant, knowledgeable investigation, specific trends cannot be easily identified from these sorts of problems.

The Future of Problem Reporting

With experience comes wisdom. In the United States, problem reporting has evolved over three decades into a tool that has been wisely used by the healthcare community to reduce deaths, injuries, and costs. And this evolution will continue. New computer systems and programs are enabling faster reporting and better data analysis. Other countries are developing their own problem reporting systems, often adapting to their own needs the methods established by ECRI and FDA. Efforts—such as those of the Global Harmonization Task Force—to link various agencies' problem reporting systems may soon allow a problem reported in Australia to alert device users in Russia to the problem and inform them of how to avoid it. Eventually, problem trends will be quickly identified and prevented from growing.

But this will not happen without the continued reporting efforts of the nurses, physicians, and engineers who work with the devices and see the problems firsthand. All these individuals must be encouraged to clearly report problems and see to it that those problems are corrected.


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