G. Wayne Moore and Jim Nestel
Disclaimer: The opinions expressed in this article are solely those of the authors and do not necessarily reflect the views of 24×7.
As CEOs of third-party service companies that contract with original equipment manufacturers (OEMs), we’ve been struck by the mischaracterizations some independent service organizations (ISOs) have put forward in their attempts to confuse policymakers about the medical device service industry. These ISOs have repeatedly made unjustified accusations, painting OEMs as intent on driving small independent repair shops out of business.
In reality, the issue should be why some ISOs refuse to make investments in implementing quality management systems, safety, and training processes that decrease patient and user risk. Provider and hospital value analysis committees should take heed.
First, let’s address some of the misconceptions. Vocal ISOs range from small independent providers to large conglomerate companies that own and operate unregulated medical device service divisions. These companies incorrectly assert that OEMs are against all third-party service providers and want to capture the market for themselves. Yet at the same time, these vocal ISOs also postulate that the same OEMs rely on ISOs to service equipment. So, which is it? Are medical device OEMs working with or against the ISOs?
We write to set the record straight.
We can say, unequivocally, that medical device OEMs that we have worked with support qualified and responsible third-party service. OEMs are not afraid of competition. What OEMs do oppose is unregulated medical device service that presents significant risks to patients and caregivers. OEMs advocate that any service technician who touches a sophisticated, and expensive piece of medical device technology should be well-trained and properly qualified. And they should be required to demonstrate these qualifications in line with U.S. FDA requirements.
We should know. Our companies perform third-party service as part of our partnerships with OEMs like Sonosite/Fujifilm, Siemens Healthineers, Philips, Samsung, GE, and others. Partnering with an OEM means going through a thorough supplier certification process, which entails OEMs going through every aspect of an applicant’s processes and procedures before certifying the company to work on an OEM machine.
The qualification process, which in some cases can take several months to complete, parallels the process the OEM themselves undertake to meet FDA regulations. Our companies also operate under extensive internationally recognized quality management systems that are regularly audited—both internally and externally—and registered with an accreditation body.
Medical device service engineers—whether at an OEM or ISO—work on a wide variety of equipment that has significant differences across technologies and across manufacturers. Maintaining a CT scanner is quite different from ensuring a ventilator operates according to federal regulations. Repairing any medical device and restoring it to its original condition doesn’t align with a a “one-size-fits-all” approach. The installation, operation, adjustment, and repair of a device can vary notably by model. These variations are often far more significant between OEM brands. Just giving technicians a manual and a few hours of general classroom learning for broad device categories, as it seems the ISO lobby supports, is not just short-sighted. It’s risky.
The approach our companies (and many of our competitors) take is more methodical, anchored by an OEM-certified training process centered on the qualifications of the service providers who maintain complex medical imaging devices and accountability by charting their work. Importantly, at our companies, the training and certification process is an ongoing, ever-evolving program that must be visible to both customers and regulators through detailed historical training records.
Transparency breeds trust. When our customers see the training rigor our service engineers go through before stepping foot in a clinic or hospital, it means they know the job will be done by the book. And if something does go wrong, the issue can be traced and fixed quickly.
ISOs may say that they’re hamstrung by OEM proprietary processes whereby they are denied access to device technical manuals and service codes, but to us, that’s a red herring. If you have a sufficient training regimen, you are taking the right steps to minimize your customer’s risk. Anybody who says, ‘I just need the manual to be able to do it’ is oversimplifying the process and demonstrating their lack of understanding of this equipment.
In the debate between ISOs and OEMs regarding service, ask yourself which side supports fewer federal checks and blanket permission to service multi-million-dollar medical devices without FDA knowledge, and which side supports appropriate FDA oversight and transparency.
OEMs aren’t against third-party service. Rather, OEMs want third-party servicers to take responsibility for the safety and efficacy of their work. And that means being held accountable by the FDA.
We are disappointed by those who don’t feel all service providers should meet the same regulatory requirements. After all, patient safety should always be at the forefront of medical care.
G. Wayne Moore is CEO of Acertara Acoustic Laboratories and James Nestel is CEO, Americas, Asia Pacific, of Simon Hegele Healthcare Solutions.
