The Project on Government Oversight

The Project on Government Oversight

The FDA has an incident reporting database called MAUDE. While this database is interesting, it has no search parameters for electrical injury and death resulting from causes related to product safety. Additionally, this database is a voluntary reporting database for incidents, relying on a variety of different sources. Many of these sources are people who have no training in electrical safety, and are not even minimally qualified to judge the root cause of the incident, much less to determine if an incident was the result of leakage current. In the end, this database is not a reliable source for any scientific analysis of electrical injury or death from equipment.

The FDA also ignores the issue of electrical safety certification to U. S. standards. Many do not understand that because a device functions correctly that does not mean it is electrically safe. Additionally, The Project on Government Oversight reports that decisions by senior FDA officials in 2006 eliminated critical measures that keep manufacturers of medical devices compliant with high quality standards.8 Many other problems with the FDA make it a highly questionable source for research on the subject.

In a recent regulatory bulletin provided by Bureau Veritas, it was revealed that under the provisions of legislation introduced earlier this year in the U.S. House of Representatives, manufacturers may soon face liability for medical devices that harm consumers, even if those devices received pre-market approval from the U.S. Food and Drug Administration (FDA). The proposed H.R. 1346: Medical Device Safety Act of 2009 would amend the Federal Food, Drug and Cosmetic Act to provide legal recourse to patients who are injured by a medical device that malfunctions. 9

Why would the U.S. Congress be considering a bill that would allow lawsuits against FDA-approved products? Most likely because FDA-approved products have injured and killed, and the Supreme Court decision of 2008 was a grave mistake. As many of us in product safety are well aware, the FDA 510(k) Premarket approval process is a flawed and highly questionable regulatory requirement. As more product recalls are being reported by the media, a new administration in Washington, D.C., and a newly appointed FDA commissioner has said “there obviously have been some problems” at the Center for Devices and Radiological Health and has designated device reform as “a high priority” for the immediate future. Former FDA Commissioner David Kessler described the device center as “dysfunctional” and “in meltdown.” According to the new FDA chief, Margaret Hamburg, “Agency scientists have said some devices that received 510(k) approval should have been required to show more data on safety and efficacy”. 10

In addition to these problems, the FDA has historically ignored the requirements for electrical safety and federal workplace law. Obviously the FDA in its current state is an unreliable source for any research or meaningful data.

Our biomedical/clinical engineering departments are a major force protecting our patients and healthcare staff. These specially trained and hardworking technicians and engineering professionals are working every day to insure the safety and proper operation of equipment for our procedures and operations. Their diligence and commitment to patient safety is generally unseen and under-appreciated, much like product safety certification experts.

Biomedical engineers and technicians perform preventive maintenance of portable equipment. These duties include repair and maintenance (cords, leads, equipment subject to abuse…), leakage current, grounding and other tests, depending on the equipment being used. They also ensure equipment is operating properly so that patients will not be put at risk from faulty equipment. Grounding is the weak link and doorway to leakage current injury. Regular tests are critical to ensuring these conditions do not put our healthcare workers and patients at risk. Frequency of tests required or recommended by product varies from three months to two years, depending on the type and use of the equipment. This is a well-known fact in the biomedical engineering field. These biomedical departments are on the front lines of electrical safety in healthcare facilities. Recently, these departments have been reporting the use of regular consumer computer equipment in patient areas as being non-certified, but their objections have been ignored by hospital administrators.

Scott Trombley is a certified biomedical equipment technician (CBET) who has been working in this field for over twenty-five years, previously with COHR MasterPlan, then with hospitals in Atlanta and now Central Florida. He is currently on the Agency for Healthcare Administration’s (AHCA) expert list and was a speaker at the 23rd AHCA seminar. Scott and his employer InterMed work closely with the biomedical advisory board of Santa Fe College. He is also a founding member of Tyler’s Hope, a non-profit organization in search of a cure for Dystonia Scott is currently vice president of InterMed Biomedical Services where he oversees operations, employee safety and writes policy procedures to comply with authorities having jurisdiction. These AHJs include The Joint Commission, Agency for Healthcare Administration, and city and county electrical inspectors. Scott has the answers for questions about leakage current and other testing in healthcare facilities.