MedSun participants get detailed feedback, follow-up questions, and notoriety when their reports contribute to making devices better.

To comply with the Safe Medical Devices Act, clinical engineers, biomedical equipment technicians, and hospital risk managers are all too familiar with the MedWatch 3500 reporting form, the standard method for reporting device failures that result in serious injury or death. But once those reports are filled out, it is difficult to know whether their time and effort just disappeared into the maze of FDA databanks or if the FDA took action on the information.

That lack of response is one reason why biomeds seem to value the extra time spent participating in the FDA’s Medical Product Safety Network, better known as MedSun. MedSun participants not only know their report was received, but they get detailed feedback, follow-up questions, and notoriety when their reports contribute to making devices better.

An Alternative to the MedWatch 3500

Since the passage of the Safe Medical Device Act of 1990, user facilities—hospitals, nursing homes, outpatient diagnostic centers, outpatient treatment centers, home health agencies, and emergency services—have been required to report deaths that involve medical devices and deaths and serious injuries.

The standard way that medical facility biomeds and risk managers comply with the law is by submitting a MedWatch 3500 report to the FDA, which compiles that report into the Manufacturer and User Facility Device Experience—also known as MAUDE—database. However, the FDA found that there was a great deal of underreporting.

Marilyn Flack, MA, director, division safety partnership in the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health, FDA, White Oak, Md, says, “In the mid to late 1990s, we began to investigate why there was underreporting and learned that a lot of the sites didn’t understand the requirements. Many were afraid to tell the FDA something. They thought that we had more regulatory oversight of their sites than we do. The fact is that we have authority to make sure they’re keeping these types of records on deaths and devices, but we don’t regulate the practice of medicine.”

There was also the perception that it was difficult to fill out some of the forms. Perhaps most importantly, the FDA found that the facilities felt that the MedWatch report was an exercise in futility.

“They felt that [MedWatch] was a black hole, and that given everything else that hospital risk managers had to do, they would rather put their energies toward things that gave them something back,” Flack says. “When they sent a MedWatch report to the FDA, they never really knew what happened to it.”

In response, the FDA created MedSun, initially a pilot program with 25 sites on the East Coast. Today, MedSun is fully funded and consists of 350 large and small user sites across the country. Most are hospitals, but some are outpatient services.

By Invitation Only

MedSun is not mandatory, nor is it voluntary. Instead, MedSun invites facilities to join from different areas of the country, ensuring a broad sampling of different types and sizes of medical centers and their various devices. The facilities then choose two lead MedSun reporters, usually a biomed and the hospital’s risk manager, who submit reports and communicate directly with MedSun.

So what’s the difference between MedSun and MedWatch? First, MedSun purposely involves biomeds.

“For MedSun, we wanted to expand the reporting to the biomedical engineers because we thought they were seeing a lot of the problems that never got to the desk of the risk manager,” Flack says. “So we thought as a team, we would get more reports.”

Second, MedSun’s reporting is online and initially easier to fill out than the MedWatch 3500 reporting form. Also, unlike a MedWatch 3500 form, biomeds receive an immediate e-mail response and know right away that their report is going to be quickly reviewed.

“I felt that we’d become the eyes and ears of the biomed/clinical engineering community,” says Arthur R. Bartosch BS, CBET, director, biomedical engineering services at Westchester Medical Center, Valhalla, NY.

Gregory S. Duncan, CBET, CHSP, chief biomedical engineer and safety officer at Children’s Hospital and Research Center at Oakland, Oakland, Calif, agrees. “You’re seeing a positive impact of your efforts. The FDA gets so much data, and you only have so much manpower.” With MedSun, Duncan says he knows his efforts are not lost in the FDA shuffle because of the quick follow-up questions.

“They really are responsive,” says Mary Ann Harrington, patient safety officer, department of patient safety at Westchester Medical Center. “When we report something to them that we considered troublesome, they respond very quickly and want more information. They immediately contact the manufacturer, and we then get a call from the manufacturer with follow-up questions.”

All About Patient Safety, Not Liability

Few turn down the opportunity to join MedSun. Flack notes that facilities that have had reservations about accepting MedSun’s invitation usually were misinformed or had a preconceived notion about privacy and liability concerns.

“Part of our approach to new sites that we invite is to explain to them what the role of the FDA is: patient safety,” Flack says. As a result, MedSun will certainly ask questions about why something happened, but explain that it does not control the practice of medicine. “Everything we do has to do with the functioning of the device and working with the manufacturer to solve any problems,” she says.

Duncan confirms that participating in MedSun does not open the hospital up to any more exposure than with MedWatch reporting. “We had our hospital counsel review the MedSun papers,” he says. “Anything that we would be obligated to report under the Safe Medical Devices Act is still being reported. So, there’s no additional liability for the MedSun reporting.”

More Work, but Worth It

Charles E. McCullough, MSEE, biomedical engineer, MedSun Project, Division of Patient Safety Partnerships, Office of Surveillance and Biometrics, understands the position of biomeds participating in the program because he was formerly one of them. Before joining the FDA, he worked for decades in Washington-area hospitals and had been a MedSun reporter.

McCullough says, “Biomeds often feel like they’re a misunderstood group within the hospital. They’re looked at as these ‘repair guys.’ But when they start to interact with the FDA, they find out that they’re our best friends.”

Participating biomeds are highly valued at MedSun because they have access to a variety of departments and medical equipment. “We’re very interested in their voluntary reports,” McCullough says. “We want them to tell us about the near misses and the concerns they have. Those are things that don’t often get to the risk managers, but by reporting those types of things, maybe those reports can lead to avoiding any serious injuries.”

MedSun biomed reporters do more than just fill out reports and track down any additional information. They also help the FDA to investigate other MedSun facility’s reports through device surveys.

The electronic MedSun reporting is just a fraction of the biomed’s MedSun responsibilities. Harrington agrees that being a participant does require more effort. “Back in the day when you did MedWatch, nobody really followed up that carefully,” she says. “This is different. The challenges are that you really have to do your homework. They will continue to call you up and make sure that every stone has been turned.”

Of course, that extra work also helps MedSun analysts to more accurately compare devices and accident reports from various facilities and issue any necessary alerts.

“We understand it’s a time commitment and that everybody is so busy,” Flack says. “But many people understand that by participating, they’re going to increase recognition of problems in their own facility and be able to fix them and become a safer site.”

McCullough adds, “We try to make it easy. They have access to a Web-based interface, which makes it kind of simpler to fill out an on-screen form. They can also call us and ask whether something is worth reporting and what we think about it before they go through the trouble of reporting.”

In the end, all that work does make a difference. Flack says that of the 3,000 reports MedSun receives every year, 80% are evaluated as true close calls that have a potential for harm. “That’s really what we wanted: to be much more proactive in addressing problems as quickly as possible, rather than waiting for someone to be injured,” she says.

Access to Safety Resources

As much as biomeds give MedSun data, they also receive recognition and many useful resources in return that benefit their facilities.

For example, when a facility’s report results in a recall of a product or an improvement by the manufacturer to prevent potential injury, MedSun sends a signed certificate back to the biomedical engineer or the facility’s lead representative that has the name of the hospital on it. Those certificates bring positive safety recognition to the biomeds as well as to their hospital.

Facilities also make use of MedSun’s Web site (www.fda.gov/cdrh/medsun) and monthly e-mail updates that give biomeds timely medical device alerts that may impact patient safety.

While anyone can access this public MedSun information, participants also benefit from the quick turnaround response and analysis of their reports and a MedSun Web site that allows them to search and run their own internal reports.

MedSun also provides free educational resources, such as free safety videos and safety posters that help remind clinicians about the proper handling of devices and the removal of defective devices.

“There’s a wonderful DVD called Recognize, Remove, and Report,” Bartosch says. “It goes through the scenario of a device that’s not removed from the system, creating all kinds of problems because the clinical conditions have been misread from a failed product. It’s an excellent video that we’ve shown to staff and nursing staff here, and we’ve used it many times.”

MedSun has also developed subnetworks for participants, which help filter and focus collected data relevant to their own medical niches. These subnetworks include:

  • LabNet, which focuses on promoting awareness of medical devices in hospital laboratories;
  • HeartNet, which focuses on issues with medical devices used in electrophysiology laboratories;
  • KidNet, which focuses on issues relating to devices in the neonatal and pediatric intensive care units;
  • EyeNet, which reports on adverse events observed with ophthalmic medical devices; and
  • HomeNet, which focuses on problems with medical devices used in the home environment.

Participating biomeds also help one another by submitting more reports with digital photographs of the devices with circled areas of concern or graphic arrows pointing to the defect.

Finally, biomeds greatly appreciate the various conferences. Since its inception, MedSun has had national annual conferences where attendees discuss the latest findings and listen to renowned guest speakers. Recently, MedSun has gone a step further with smaller, regional conferences that allow for more intimate interaction with biomeds in the same region.

Duncan notes that while these conferences may be smaller, MedSun still manages to invite a sufficient cross section of biomeds from other regions to compare their device safety concerns with other areas in the United States.

Here to Stay

Although MedSun was initially a pilot program, Flack says it is now a fully funded part of the FDA’s budget and will be a regular part of the agency’s device safety programs. As medical devices include more software-based algorithms, MedSun is currently seeking more reports on software issues. It also wants to encourage biomeds to offer their honest points of view and share their opinions.

Are you a MedSun reporting facility? Blog about it.

McCullough says, “We have a staff of five MedSun engineers here right now, and we like it when they [participating hospitals] file reports and tell us what they think. Don’t wait for any injury. When they see devices where they think it could be designed better, or this looks really dangerous, or notice that nurses frequently make the same common mistake because this thing is so confusing, we want them to tell us those stories by way of a report and to put some opinion in there. We love that.”

Tor Valenza is a staff writer for 24×7. For more information, contact .