Hazard and Recall Management for Medical Devices and Systems
A key responsibility for many biomedical engineering programs is the management of hazards and recalls for medical devices and systems. Typically, the biomedical engineering program, whether it is an in-house department or an independent service organization (ISO), manages this information for only the devices it is responsible for servicing. Hazards and recalls for other devices or systems are often managed by other departments like materials management, radiology, or the clinical laboratory. A less typical approach is for one department or individual to have centralized responsibility for hazards and recalls for all medical devices and systems in the institution.
Regardless of the approach used for managing hazards and recalls, the challenge for any institution is to make sure that the process is handled consistently throughout the institution. Key safety or device-failure information must get to the right personnel in the institution, without creating a drain on the institutions resources. To meet this goal, each institution needs to establish clear responsibilities, use consistent naming conventions for devices and systems, establish approved and comprehensive sources for information, disseminate information in a reliable manner, and set up a process for accountability and follow-through. This article provides some examples of how this can be done and is in part based on ECRIs 30-plus years of experience with disseminating medical devicerelated hazards, recall notices, and other safety information. This information can be used by institutions starting a hazard-and-recall management program or as benchmark for improving an existing program.
Johns Hopkins University is known for having one of the best medical centers in the world. It is not uncommon for Johns Hopkins to make national news about developing a new medical breakthrough or about its highly ranked medical specialties. However, Johns Hopkins also had the misfortune to be the subject of a national news story about a problem with a medical-device recall. Bronchoscopes were recalled by the manufacturer because of their potential for causing infections. Instead of being sent to the Johns Hopkins department that used the bronchoscopes, the manufacturers recall was sent to a loading dock at another department across the street. The recall was never forwarded to the department that uses the bronchoscopes. In fact, the hospital did not learn about the recall until it began investigating unexpected infection rates in some of its pulmonary patients. In the end, several hundred patients were exposed to the potentially contaminated bronchoscopes. As a result, infections related to contaminated bronchoscopes may have contributed to the deaths of two patients. Also, Johns Hopkins had to contact more than 400 patients for evaluation and offer everyone testing for possible infections.1, 2 The lesson from the Johns Hopkins experience is that even the best institutions can have gaps in a critical responsibility like hazard-and-recall management and should be able to find strategies for improvement from the following information.
Roles and Responsibilities
Every hospital should have a centralized list of who is to receive, disseminate, and resolve hazards, recalls, and other safety information about medical devices. The list should be specific, so that all classes of medical devices are clearly covered by the list. The list should cover all medical devices used or supported by the institution, for example, home-care services or satellite facilities. Clear responsibilities should be delineated for hybrid devices that might be supported or managed by two departments, like drug/device combinations or computer-based medical devices. Responsibilities also need to be defined for rental equipment, equipment on loan, and physician- or patient-owned equipment.
Some staff may be assigned the responsibility of combing through approved sources for hazards and recalls. Relevant reports can be forwarded to staff responsible for resolving information in the hazard or recall notices. Resolution may be as simple as verifying that the hospital does not have the affected products, or it may involve informing appropriate staff about the reported problem and recommended solutions.
In order to put together a comprehensive list of who is responsible for management of hazards and recalls for every class of medical device, an institution needs to have a comprehensive inventory of the devices used in its system. Ideally the inventory should be accessible from a central location and cover the full range of devices used in the institution. This includes capital equipment, disposable products, reagents for devices like clinical laboratory analyzers, hybrid devices like drug-eluting stents, and computer-based or network-connected medical devices.
We have reviewed hundreds of hospital medical device inventories as part of a compliance service during the Y2K days and for various other services. Many of the inventories that we have seen over the years have serious problems with nomenclature. It is not uncommon for one hospitals inventory to have six different names for one type of medical device in its database and even more names for the same medical device vendor. This problem is even worse for hospital systems, especially when each hospital in the system manages its own inventory.
Check your inventory to see if your hospital has used consistent and up-to-date terminology. Try a test by checking all of your entries for electrosurgical units and blood-pressure monitors. For electrosurgical units, we have seen a broad range of device-type names, including Bovie, ESU, cautery units, electrocautery units, and diathermy units. Do you see a mix of these names and maybe others in your inventory? For blood-pressure monitors, we have also seen a range of device-type names, including Dynamap, BP monitor, monitor, and pressure monitor. ECRI has also seen many creative abbreviations used for the names listed above. Try the same test for a few manufacturers names. If you find inconsistencies in your database, they need to be corrected. If not corrected, a search in your database for a match to a hazard or recall notice about an electrosurgical unit, for example, will not find the devices recorded incorrectly as electrocautery units or Bovies. Ideally your database should be corrected with commonly used or standard names and spellings for device types and manufacturers.
The Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) Environment of Care Standard EC.6.10 requires that health care organizations manage medical-equipment risks by identifying and implementing processes for monitoring and acting on equipment hazard notices and recalls. Note that hazard notices" is underscored to emphasize that we are not just talking about recalls. Some of the most serious device problems that we have reported on were abstracted from the clinical literature or identified by our independent hazard investigation research. In most cases the problems were never classified as recalls by FDA or medical-device manufacturers. Unfortunately this distinction between hazards and recalls is not appreciated by many health care organizations. They attempt to comply with JCAHOs standard by monitoring only for recalls. This puts their accreditation and, more important, their patients at risk by overlooking critical safety information.
Every hospital should have an approved list of sources for medical devicerelated hazards, recall notices, and other safety information. Sources should include manufacturers, regulatory agencies like FDA, hazard-and-recall notification services, and clinical literature. Facilities should have a system in place for checking the device identifier information in their source data against the device identifier information in their inventories. They will save a tremendous amount of time and avoid the risk of having critical safety information slip through the cracks if the naming convention in their source data is consistent with the naming conventions in the inventory.
Also, keep in mind that some source information can be wrong or incomplete. Heres another test for your system. Ask your source providers how they verify the information you receive. Is their nomenclature consistent with the one used in your inventory databases? If additional recommendations are included in the data provided, what are the qualifications of the individuals creating those recommendations? Also, does your source data include more than recalls?
In January 2002, a problem was widely reported regarding misconnection of a nitrous oxide regulator in a cardiac catheterization laboratory in Connecticut. Two patients died because they were accidentally given nitrous oxide instead of oxygen.3 The information about how this problem could occur and, more important, how to prevent it from happening again is critical for several specialty areas in your institution. These include at least anesthesia, cardiac catheterization, clinical or biomedical engineering, nursing, respiratory therapy, plant operations, and risk management.
Look back at your hazard-and-recall distribution records for early 2002. Do you have a report on the nitrous oxide misconnection problem? If so, does it have recommendations for how to prevent the problem? Can you verify that this information was disseminated to responsible individuals in the departments listed above? Can you think of other departments in your institution that should have been informed of this problem? If so, do you have a record that this was done? If you cannot answer yes to each of these questions, you may need to look at the how hazard-and-recall information is distributed within your institution. If you are not aware of the misconnection incident and the recommendations on how to prevent the problem, then you need to consider using additional or better sources for medical-device hazards and recalls. If the specialty areas listed above did not receive the report or if you dont have records that they did, then you may need to reconsider how you disseminate medical-device hazard-and-recall information within your institution.
Accountability and Follow-Through
A hospital may have a very reliable method for disseminating hazards and recalls. If it does not have a good feedback mechanism for what is being done with the information, however, then it has no assurance that the problems are being addressed. Regarding the nitrous oxide misconnection problem, does your hospital have a record showing that the recommended user training was done? Your hospital may have made a conscious decision that training the staff related to this problem was unnecessary. If so, do your records related to this problem include justification for why the training was not needed at your facility?
As you review your program for medical-device hazard-and-recall management, make sure that it includes an effective feedback loop. Everyone who receives hazard-and-recall notifications should have an easy method for communicating back to hazard-and-recall coordinators what is being done about the problems. As noted above, each class of medical devices should have an individual responsible for receiving and resolving hazards and recalls in that category. Those responsibilities should be clearly communicated to the appropriate staff. And, hazard-and-recall coordinators should have mechanism for routinely checking the status of their reports. If nothing is being done, coordinators should have the clout either to push the responsible staff to action or to find other staff to help resolve the problem.
Management of medical-device hazards and recalls is a critical task for every health care institution. With the rapid growth of medical technology, very serious problems can slip through the cracks and result in unnecessary patient deaths or injury. A well-organized program for managing hazards and recalls with a reliable feedback loop will not prevent problems from happening at your institution. However, it will significantly increase your odds addressing problems quickly.
James P. Keller, Jr is director, health devices group, ECRI.
1. Defective Bronchoscopes Identified as Probable Cause of Infections Are Part of Manufacturers National RecallHopkins Launches Effort to Contact, Evaluate All Potentially Exposed Patients [press release]. Baltimore: Johns Hopkins Medical Institutions, Office of Communications and Public Affairs; March 4, 2002.
2. Altman, LK, Grady, D. Hospital says faulty recall may have exposed 400 to infection, New York Times. March 5, 2002: A1.
3. Misconnected flowmeter leads to two deaths. Health Devices Alerts Action Items. Special Report. January 25, 2002: 26 (A4): 1.