Q: Why is regulation important for the servicing industry?
Patient safety should be the priority of all stakeholders in the dialogue concerning service regulation today. Patients, healthcare providers/professionals and institutions, original equipment manufacturers, and third-party service providers all have desire to ensure that patients receive safe and effective medical care. Patients should be able to assume an equivalent level of safety and efficacy regardless of the service provider. This means there should be a service standard that ensures properly trained personnel, using both properly sourced and qualified parts as well as calibrated and appropriate test equipment.
In radiology, the risks to patients of inconsistent servicing standards is either that a patient may be directly harmed due to mechanical, maintenance or device calibration issues, or indirectly harmed due to misdiagnosis as a result of poor image quality. Further, if equipment is not well maintained, in today’s highly challenging healthcare economic environment, services cannot be delivered efficiently.
Q: Why do you believe the QSR should apply to all servicers?
It is important to note that there are many third-party service organizations that have quality systems and operate in a manner that is consistent with what should be expected of organizations working in the healthcare space. At Bayer, as we established and ran our Multi Vendor Service department, we put patient safety first and foremost, and established standards similar to those of manufacturers who are regulated by the FDA. We were not required to submit to, nor did our MVS business have, FDA oversight. We did this because those were best practices that help ensure patient safety and deliver the quality/value that hospitals and practitioners expect.
Unfortunately, there are some service providers in our industry that don’t invest in quality practices or understanding the technology, and ultimately put patients at risk. Not because they are knowingly or willfully doing this, but because they often don’t appreciate the consequences their decisions could have on the lives of loved one.
A simple example could be an O-Ring (a gasket that shields the injector primarily from contrast invasion/spill), which isn’t recommended by the manufacturer). A third-party service provider in an attempt to get a fluid delivery device back up and running may use an O-Ring that appears to be the same size as one that failed. Obviously time is money and they want to support their customer and get patients access to whatever procedure/medical need necessary. Maybe the replacement O-Ring was left over and in the service representative’s bag. Or maybe it was less expensive but appears the same and is purchased online from eBay from a non-qualified supplier. Maybe the O-Ring actually is the exact size as the one that failed but wasn’t made of the same materials. Maybe this particular O-Ring was a key component where tolerances and material properties are critical and without an “equivalent” O-Ring, pressures and flow rates of pharmaceuticals to the patient are compromised.
The FDA requires that each OEM establish a quality system, maintain certain standards in the design, manufacturing, and service of medical devices. This approach and expectations should not be compromised regardless of who manufactures or supports the product after it is on the market. The current action resulting from the FDA’s Reauthorization Act is a positive step in the right direction.
Extending the key QSRs to all medical device service provides will help to ensure that the servicing of equipment upon which patients and healthcare professionals rely is done in a consistent manner across the industry that ensures all patients are afforded equal safety and efficacy regardless of where insurance or government sponsored healthcare is provided.
- It provides accountability to ensure the right parts were used and what actual services were provided. QSRs applied to all service providers ensure that training is provided that ensure the teams servicing the device are effectively trained. As technologies advance, it is critical for service personnel to ensure they are competent to support more advanced products.
- QSRs also require that manufacturers analyze service reports and report adverse events to the FDA. If third-party service providers are not held to these same standards, important information may not be made available to manufacturers that may inform the need for corrective actions.
Just as the FDA does not grant any company the right to manufacture and distribute a medical device, so should the healthcare space not expect that servicing of medical devices does not require some level of minimal investment. A basic quality system, ongoing training of personnel, and engineering expertise of the products being serviced should be minimum expectations.
Q: What would Bayer like to see included in the FDA’s report that will be published in May following the Reauthorization Act request?
Bayer supports extending the same regulations and standards to all entities engaging in medical device servicing activities to consistently ensure the safe and effective operation of medical devices, including medical imaging equipment. This includes training and documentation across all service areas—maintenance, repair, refurbish, recondition, etc.
All entities providing device service should be required to have an appropriately scaled quality system and be registered with the FDA to ensure proper regulatory oversight. Application of consistent regulatory standards promotes not only patient safety, but also the safety of device users and supports medical professionals in providing quality patient care.
Q: What is your perspective on the impact regulations could have on patient care/imaging field?
In the radiology suite, it is essential that imaging equipment performs when needed, often around the clock, in medical emergencies as well as scheduled procedures for patients ranging from routine to critically ill. Ensuring accurate imaging and reducing the need to repeat scans if quality is diminished due to malfunctioning equipment is also a key concern. One hour of downtime for a moderate volume CT suite could easily impact 10 patients. The absence of proper maintenance and software updates may result in reduced system performance and unplanned downtime with implications ranging from workflow inefficiencies and potential loss of patient data/relevant study information pertinent for reimbursement, or more serious risks for patient care and safety.
There is also a risk of direct bodily harm, resulting from mechanical, calibration, maintenance issues, and misdiagnosis. We have seen examples of equipment malfunction due to improper servicing that has created life-threatening conditions, for example a CT injector malfunction that was injecting wrong levels of fluid pressure in a vein due to improper calibration of the system.
Further reinforcing the point on the importance of patient safety/quality is the fact that recently we’ve had two large customers, one a health system and one an OEM, leave to go to third-party services due to perceived “cost savings” and realize that the downtime, patient impacts, and total cost to the hospital was actually negative versus a more comprehensive service offering.
Q: How would you respond to third-party servicers saying the regulations are a way for OEMs to maintain market share?
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 who 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 services.
This is not about market share, but it is about ensuring that – through consistent standards for device servicing – patient and user safety remains at the forefront.
