The MedSun Strategy for Manufacturers

FDA launched the Medical Device Safety Network (MedSun) in 2002 as a supplement to mandatory and voluntary MedWatch reporting. Currently there are 350 healthcare facilities (primarily hospitals) that participate in MedSun. There is evidence that user facilities, physicians, nurses, and other healthcare professionals (HCPs) report at a much lower frequency than manufacturers. In part, this is a result of the specific regulatory requirements for adverse-event reporting, which are somewhat different for manufacturers than for device users, and the extent of FDA’s jurisdiction over those who file adverse-event reports.

Medical device manufacturers are required to file reports (i.e., medical device reports or MDRs) of all deaths, serious injuries, and malfunctions that, if they were to recur, could cause serious injury. In contrast, the mandatory filing requirements of user facilities are limited to deaths (which are reported to FDA and the manufacturer, if known) and serious injuries (reported to the manufacturer only). User facilities include, but are not limited to, hospitals, ambulatory care centers, outpatient clinics, and similar health providers. In contrast, HCPs and consumers are not subject to manufacturers’ and users’ mandatory adverse-event reporting but are encouraged to file voluntary MedWatch reports. Hospitals and other user facilities that are subject to user reporting requirements are required to establish and follow written procedures for investigating and reporting adverse events to ensure conformance with the regulations. Employees must be trained on these procedures.

Like medical device manufacturers, FDA recognizes that the most accurate information regarding adverse events comes from an HCP (or patient) who has first-hand knowledge of the incident. If too much time has elapsed following the incident, companies using traditional complaint and adverse event investigation methods may find that the HCP cannot recall details regarding the event, might be difficult to reach if on a different shift, or is too busy to discuss an event that happened a week or two earlier.

Some companies have improved the quality of their investigations by ensuring that the first incoming call from an HCP who reports an adverse event or serious malfunction is immediately transferred from a general customer service group to a person with a medical background or someone who is trained to ask questions concerning the event. Using the technique of a warm handoff, the customer service representative stays on the line with the customer to ensure that the call is connected to a person trained to record event information and is not lost in the transfer. Scripted questions are best developed by a cross-functional team that includes an HCP. Questions are listed in priority order according to the information that is critically necessary to make an MDR filing decision and as necessary to assess the performance of similar products in the field.

Under the MedSun strategy, FDA trains hospital staff personnel including doctors, nurses, and administrative personnel on how to recognize problems with medical devices, especially those involving human factors. In addition, hospital staff is informed of the benefits of active adverse-event reporting and the methods for filing these reports. MedSun encourages reporting of not only deaths and serious injuries, but also of close calls with the potential for harm.

Another strategic way in which FDA has used MedSun is to target certain device types to obtain additional detailed safety information. This often follows an increase of adverse events above historical levels for a particular device for which FDA is concerned about possible undetected changes in device performance or HCP use of the device. This aspect of MedSun is particularly transferable to manufacturers that can benefit from vigilance on the use of their devices and on possible changes in use patterns.

Applying the MedSun Strategy to Postmarket Surveillance

An excellent link between a product’s performance profile and the manufacturer’s vigilance regarding complaints and adverse events is risk management. The product and process risk assessments established during product development describe the severity and probability of hazards associated with the use of a device. Part of the value of these risk assessment tools is that they are thoughtfully and thoroughly derived by a cross-functional team of engineers, scientists, medical personnel, and others from functions such as quality assurance, research and development, manufacturing, regulatory affairs, clinical research, medical affairs, and marketing. One objective of the MedSun approach is to verify that the performance of the device under actual conditions of use conforms to the initial estimates of risk. As necessary, the manufacturer can revise ratings for factors such as severity and probability of occurrence.

Current Use of Using Risk Information. Manufacturers use product, process, and usability (human factors) risk assessments (commonly failure mode and effects analyses) as an objective basis for decision-making in several important areas including validation, process control, and adverse-event reporting. Examples include but are not limited to the following:

Similar to the manner in which risk assessment tools such as failure modes and effects analysis are very useful throughout the product life cycle as part of the manufacturer’s quality system management process, risk assessment can be the foundation of a company’s own MedSun-like medical surveillance network. Designing a postmarket process for a particular device can start during the design and development phase that precedes design transfer to manufacturing. At this stage, the risk assessment documentation is at or very near its final revision and will likely reflect the final product design based on testing that, for some devices, includes clinical trials.

Human factors engineering deserves special mention here. Having a close relationship with hospital, medical, engineering, and risk management staff provides the ability to learn about the suitability of the device design under various installation conditions as well as when used by individuals with different training and skill levels. If not valid, root cause conclusions of user error are not tolerated by hospital personnel, but clear feedback on patient and user interfaces is invaluable.

In general, complaint and failure investigations should not stop with a simple high-level failure such as “the tubing was kinked” or “the battery failed early.” There should be a follow-up action that includes process or component changes and the selection of a new supplier.

Incorporating Risk Assessment Tools. A manufacturer’s field-based sales and service personnel are typically trained at national or regional sales meetings and with computer-based training on procedures for complaint and adverse-event reporting. Adopting a MedSun approach would further heighten vigilance among employees who have daily contact with users of a company’s medical devices.

As part of the product launch at a sales meeting with field personnel, product development personnel who participate in device design and development can identify aspects of a device and its use that are particularly relevant to safe and effective performance. Field personnel can also be trained on the failure modes experienced among other manufacturer’s similar devices and the company’s previous generation products. It is important to stress what’s in it for them and for their customers, consistent with the five points discussed later.

One approach would be to create a training tool for field personnel that alerts them to particular adverse events, malfunctions, and user complaints when the company wants complete and timely reporting. Field personnel include sales, marketing, service, and clinical specialists. These field personnel should understand that this information can help the company in several important ways.

Patient Safety. In the event that there is an unanticipated design issue or product malfunction that could adversely affect the health or safety of a patient or user, it is important to respond quickly with a remediation and, if necessary, a notification. There are advantages to maintaining a separate database for use-related issues that include categories such as design, labeling, and training.

Product Improvement. Reporting malfunctions and use problems to the complaint department, regardless of whether there is an injury or illness, facilitates continuous improvement of products and processes. Such reports lead to greater safety assurance, increased customer satisfaction, increased sales, fewer service calls, and reduced cost of poor quality. For example, problems with electromagnetic interference in an unusual use environment might not have been detected in the manufacturer’s design validation. Good vigilance after launch can lead to a rapid design or labeling improvement, if required.

Regulatory Compliance. A proactive method for gathering complaint and adverse-event data on targeted hazards and malfunctions can increase compliance for global surveillance reporting processes. The method also helps to ensure that regulatory requirements for investigation, documentation, and reporting are met.

Employee Satisfaction. It is important for field personnel to know that product performance issues they report as complaints are acted upon quickly and effectively. Companies observe that field reports increase when it is clear that input from field personnel results in meaningful quality improvements. Although there can be an increase in complaints, the quality of reports will improve and the resulting gains in product quality will ultimately reduce complaint volume as part of this program.

Business Interruption. Failure to detect product problems at the first available opportunity prevents a manufacturer from making changes quickly, which can prevent a widespread field correction and cause a loss of revenue and customer confidence. As a result, sales personnel are left without the affected product to sell during the recovery period.

Overcoming Barriers

There are several hurdles that must be overcome when dealing with complaint and adverse-event reporting.
Failure to Understand the Rationale and Importance of Reporting. As discussed earlier, field personnel might not realize that their input could be what enables their company to take immediate action to either prevent patient or user injury or to correct a product performance issue. Let sales personnel know that their input will be taken seriously, acted upon quickly using established and reliable investigation and root cause analysis tools, and result in effective corrective actions. Stress the importance of retrieving and returning complaint devices to improvements in product design and customer satisfaction.

Acting in Haste and Without a Valid Reason to Recall a Product. Some people that acting in haste causes the volume of MedWatch reports from HCPs to be low compared with manufacturers’ reports. There appears to be a concern among some HCPs that a device that is imperfect (but which in their eyes provides patient benefit) could be recalled and as a consequence be unavailable for an extended period of time. The remedy for this problem is to demonstrate that actions taken on the product will be based on facts-for example, an objective health hazard evaluation that is prepared with strong cross-functional input and review. Engaging customers and field-based employees in a creative postmarket surveillance program modeled after MedSun can establish the basis for a partnership that has field staff recognizing the extremely important role that they serve in protecting patients and users as well as accelerating product improvement efforts.

Complexity of Reporting Systems. It is essential that the manufacturer’s reporting forms contain all essential information that is required for the initial assessment by FDA or by a company to determine the level of risk reflected by the report. On the other hand, it may not be deemed necessary to request information that can be obtained upon subsequent follow-up and whose nature is not critical to a health hazard evaluation when contact time with the HCP is extremely limited. 

Manufacturers can adopt a MedSun approach by developing reporting processes that are neither complex nor time-consuming. Some companies have incorporated a means whereby a service technician sends a complaint to the complaint department with the push of one button on a handheld computer. Service personnel are taught the regulatory definition of a complaint to assure that reporting is complete. For adverse events, field personnel report immediately by a direct means such as a phone call to customer service or the medical department.

Failure to Develop Standardized Questionnaires for Interviewing HCPs. One reason why field surveillance activities fail to gain support is a lack of effectiveness of the reporting tools. This problem can stifle product improvement when the information collected does not support a meaningful failure investigation. The lack of improvement based on field reports causes field personnel to assume that their actions have been wasted and the level of reporting can diminish.

It is important to establish structured questionnaires for anticipated adverse events and significant malfunctions prior to commercial distribution of a new device. Medical input is useful when designating these tools and can include internal clinical staff or outside experts. As discussed earlier, these questionnaires can be based on the design risk assessment (severity levels) and experience with this particular class of devices through the company’s own experience with a current generation of the device or reports on other companies’ similar devices. Reports of experience with other manufacturers’ devices can be found in the literature and in FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which can be accessed on FDA’s Web site.

Using Available Risk Information from One’s Own Device and Similar Devices. The final version of the questionnaire should be reviewed with HCPs who routinely use the specific device and those marketed by the device's competitors. The use of prioritized questionnaires anticipates that one’s contact time with the HCP who has the greatest knowledge of the event will be limited. Accordingly, the questions are prioritized to ensure that essential information is collected (such as the patient’s or user’s condition, the device failure mode, information about the device including model and serial numbers, interventions, and human factors concerns).

Lack of a Simple Means for Returning Product Complaint Units. Companies have developed creative means for enabling rapid failure investigations. For large devices, onboard diagnostics with transmission to a central service depot is helpful. For smaller disposable devices, some companies have provided high-volume users and field staff with overnight mailers that fully comply with applicable regulations for air shipment of used devices that have been exposed to blood or other body fluids. For sites that refuse to return a device that has been associated with an adverse event or malfunction, creative measures might be needed. Some companies send engineers to the hospital to test the device in the presence of hospital biomedical engineers. Consideration could be given to arranging for a hospital biomedical engineer to travel to the company with the device and participate in the complaint investigation to gain a better understanding of the device design.

Using FDA’s Strategy to Enhance Postmarket Surveillance

MedSun is an important part of FDA’s postmarket surveillance effort. FDA relies on the program to collect data from hospitals, nursing homes, and other healthcare facilities about product problems that may warrant action by FDA or device manufacturers. The primary goals for MedSun are to identify, understand, and share information about problems with the use of medical devices. A company can create the same sense of importance among field personnel regarding the benefits of focused and proactive postmarket surveillance to patients, users, and the company.

MedSun is designed to foster a partnership between clinical sites and FDA. The MedSun program helps FDA work with manufacturers to produce a safer product when problems have been identified in the field. The program also serves as a powerful two-way channel of communication between CDRH and the clinical community. Once a problem is identified, MedSun researchers work with each facility’s representatives to clarify the situation and understand the problem. Reports are then shared without facility identification so that clinicians can take necessary preventive actions.

A company can target high-volume users who will be the first to use a new product and whose use of the company’s products over time is high. It is important for a company to impress upon the institution’s staff that it seeks to establish a partnership in surveillance and reporting to help increase safety assurance and product quality. The relationship between the institution’s staff and the sales and service personnel who support them will not only foster the business relationship, but also can result in improved medical devices.

Requirements and Benefits for Participation

FDA selects MedSun participants based on a number of factors, including size and location of the facility, to ensure a representative sample of healthcare facilities.

Requirements. Participants in the MedSun program must do the following:

A company can target high-profile surveillance customers in a manner similar to FDA's method with respect to staff functions, orientation, training, and surveys. As with MedSun, in-house and customer partners must demonstrate a commitment to openly and completely share injury and malfunction experience.

Benefits. How does FDA encourage facilities to participate in MedSun?  In addition to the important role that the facility will play in ensuring the safety of medical devices, FDA points out that the institution will benefit from the feedback it receives. This includes personal follow-up from MedSun project staff members after filing a report, as well as information sharing among healthcare organizations in the MedSun system. Additionally, MedSun staff members are available to present materials to facility staff to aid in increasing awareness of the safe use of medical devices and the importance of reporting problems.

In a similar manner, a manufacturer can communicate the benefits of engagement in its active surveillance program to selected customers and to sales and service personnel. Establishing trust and a strong relationship between the healthcare institution and company personnel in this area encourages HCPs to provide feedback to the company regarding not only adverse events, but also suggestions for improved product designs. The overall results are greater satisfaction for the customer and focused feedback for the manufacturer.

MedSun Newsletter

CDRH posts information about MedSun reports and other feedback on its public Web site at www.fda.gov/cdrh/medsun. Such information includes

In addition, MedSun participants receive a monthly electronic newsletter that contains project updates, information about MedSun educational programs, and a summary of recent FDA actions.

Companies that have the best results with respect to receiving prompt, complete input from the field personnel typically excel in communicating outward on what is being done in response to their input. Some companies fail to recognize the importance of communicating important quality and safety information to field sales, service, and clinical personnel. This communication is particularly important when a problem arises with a company’s product or a similar product produced by another manufacturer.

Special Database Analyses

MedSun participants can request special analyses of the MedSun database, as well as the MAUDE database. FDA tells prospective participants that the MedSun staff will assist facilities in their research, helping to retrieve quality information quickly.

As much as some hospitals have staff that are motivated to monitor product safety and are willing MedSun partners, some sales, service, and clinical personnel are particularly interested in the performance of the products they support. These individuals are great target candidates for a company’s proactive postmarket surveillance program.

In a company program, field support personnel should be kept apprised of product improvement activities so that they can provide information to customers who have experienced issues with a particular product. This feedback can strengthen the relationship and trust between the company and the customer.

FDA has contracted with Social and Scientific Systems Inc. to manage the patient safety reporting project. A large corporation could possibly benefit from a similar approach of using outside expert consulting experience to help establish a proactive postmarket surveillance program.

Other Advantages

MedSun representatives at participating facilities can reap the benefits of receiving  CDRH alerts, advisories, and recall notices soon after release. They can also participate in educational programs, conference calls, and meetings where they hear news from FDA and discuss recent problems and solutions regarding medical device safety issues.
Similarly, companies can proactively involve field sales, service and clinical management in activities that increase awareness of product safety, problem reporting, and continuous improvement initiatives. Regional and national sales meetings are an appropriate venue for these types of communications. Overall, these interactions can materially improve a company’s safety assurance programs.

Conclusion

Proactive postmarket surveillance has several important benefits—not the least of which is early detection of safety hazards, which can prevent or minimize harm to patients and users. A company’s risks can be reduced in other areas including regulatory compliance, product liability, loss of customer goodwill, and loss of sales. Medical device manufacturers can adopt several elements of the MedSun program to strengthen their postmarket surveillance programs and foster increased communication between the company and the healthcare providers who use its medical devices.

More information about MedSun can be found at www.medsun.net. It is also important to review FDA guidance and other agency publications on human factors considerations in medical device design labeling.

The following links are examples of such documents: 

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094460.htm
http://virtual2.pcisys.net/h/humancenteredstrategies.com/UPCARE_paper.pdf
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095300.pdf
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/ucm119185.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/ucm128192.htm