by
Gus Iversen, Editor in Chief | August 10, 2018
From the August 2018 issue of HealthCare Business News magazine
It is pretty simple, registering with the FDA would take minutes and, if there is nothing to report, then this should not be “burdensome. The FDA’s report also raised an important distinction between servicing and remanufacturing. Overall, we feel there is more guidance that needs to be provided in this area, as there appears to be confusion from various stakeholders concerning the difference between the two. As such, clarifying the difference between the two is an important focus area as remanufacturers are regulated by the FDA as manufacturers and are subject to the Quality System Regulation. Further establishing a better understanding of the activities that are defined as remanufacturing will help to extend more oversight of these activities to protect patient safety.
HCB News: You have an extensive background with Bayer MVS (formerly Medrad) which gives you a unique insight to this conversation. What do you tell third-party stakeholders who see this type of legislation as an effort to hurt their business?
DD: While many third-party servicers perform high-quality work, the current gap in regulation isn’t in the best interest of patients. The number of unregulated and unregistered service organizations and persons servicing medical devices has dramatically increased over the last 20 years without any comparable adjustment in the regulatory framework governing these activities. As a company that actively participated and competed in the third-party service business, there are ways to create OEM alternative business models that offer quality solutions at a competitive price. However, under no circumstances should quality and/or patient safety be compromised, and some level of minimal consistent regulation would better ensure that hospitals are not unknowingly tempted by unsafe/substandard service offerings.
This is absolutely not about business, but it is about ensuring that – through consistent standards for device servicing – patient and user safety remains at the forefront. The bipartisan Medical Device Servicing and Accountability Act, if passed, would be a major first step toward solving this problem.
HCB News: What is your response to third party stakeholders who tout ECRI's analysis of the FDA's MAUDE database, which found no evidence that a safety problem exists in relation to medical device service and maintenance?
DD: In the simplest of terms, I don’t appreciate how referencing the ECRI database can be used to validate safety of third party servicing when there is no requirement for third party servicers to report any findings. Of course we would expect to see no evidence there.
