By Boyd Campbell
As someone who attends numerous biomedical conferences, I often hear discussions about how new technologies have improved patient safety. I agree that innovations in medical technology have dramatically enhanced diagnostic capabilities and introduced devices that make health care safer. Over my 37 years in the biomedical field, I’ve witnessed significant shifts – AC defibrillators replaced by lower energy Biphasic units, bouncing ball patient monitors now have arrythmia detection and data storage, and film processors have been replaced by more advanced digital solutions giving the physician instant retrieval and comparison capabilities.
Beyond the marvels of technology, we cannot overlook the crucial role that government regulations have played in enhancing patient safety. Many biomedical technicians in this field recall the landmark Safe Medical Device Act (SMDA) of 1990, which mandated that medical device users report serious injuries and deaths to the FDA and manufacturers. The Patient Safety and Quality Improvement Act of 2005 took things a step further, encouraging broader reporting of patient safety incidents. Alongside these regulations, organizations like AAMI, ANSI, ECRI, JCAHO, and DNV have set standards that reflect the ever-changing landscape of health care.
Yet, while we often hear about the role of new technologies and regulation in making patient care safer, we rarely give enough credit to the professionals working behind the scenes – biomedical technicians. In my experience, our primary role has always been to ensure the safety of both patients and staff when it comes to medical devices. Though we may not have been present when laws like the SMDA were drafted, it is often biomedical professionals who identify trends, report issues, and enforce compliance, sometimes having to be the enforcer.
Without us standing our ground would all these improvements be made. I recall a technician that worked for us informed a customer that a new O2/NO2 mixer failed. It was replaced and the second failed in the same manner. Once again it was replaced and the third one failed as well. At this point the physician was sure that the technician was obviously the problem. How could three brand new devices all be defective? After an uncomfortable discussion with the physician and the manufacturer, reviewing his testing methods many times, the manufacturer determined that their testing methods were flawed, and a recall was issued for all the units already in the field. Why did this safety issue get resolved? It was due to one technician who stood his ground under the scrutiny of both the health care provider and manufacturer.
Let’s think for a moment about what happens when we do not have the proper enforcement of regulations. Under 21 CFR certain manufacturers are required to provide complete service manuals with calibration and adjustment procedures. This is a battle that many of us have faced when requesting these and being told they are proprietary and will not be provided. While this is clearly written in the Code of Federal Regulation, without enforcement what is motivation for compliance?
In addition, as biomedical technicians we have demanded improvements in test devices to keep up with the changes in technology. When Biphasic defibrillators first hit the market all we had were defib analyzers that were designed for monophasic units. These analyzers gave readings that were close, but we required that changes be made in order to make sure what we were measuring was absolutely correct. Another improvement that we demanded are test devices that are more efficient with the use of automation which still is being improved upon today.
While we view ourselves in the present day as making health care safer, let’s not forget the contribution of those that have gone before us and accept the challenge to be the change that takes medical device safety into the future. How do we do this?
The first step is to cultivate a mindset focused on continuous improvement. This mindset is essential for health care as a whole. Many companies, especially those striving for ISO certification, must document and demonstrate continuous improvement. However, simply continuing to do what has always been done is insufficient in an ever-evolving industry like health care.
We, as biomedical professionals, must actively look for areas where processes can be improved. A key part of this is clear communication. As technicians, we cannot be afraid to speak up when we notice risks or identify potential areas for improvement. Speaking up may not only involve identifying problems but also asking questions to gain a deeper understanding of processes and devices. Fear of asking questions should never be a barrier when the purpose is greater understanding because this curiosity is what ultimately leads to improvements.
Another vital aspect of improvement is offering input. While one person may not have all the answers, sharing ideas and suggestions can lead to significant breakthroughs. Often, the best solutions arise from collaborative efforts. When a few people contribute different perspectives or ideas, those contributions can evolve into a practical solution that benefits the entire organization or field as a whole.
