From the August 2018 issue of HealthCare Business News magazine


Bayer has seen firsthand the type of issues that can arise due to inadequate third-party servicing of medical devices that could have posed a risk to patient and provider safety. In one case involving maintenance by a third-party company, an overhead counterpoise support system arm (accessory to a powered contrast injection system) separated and fell, striking a radiology technologist due to a support arm separation. The company providing the servicing didn’t maintain regular records, so it was unclear to Bayer’s service representative when they were called to address the incident if it had been regularly inspected and maintained appropriately.

During a recent service call for an angiographic power injector, it was observed that a third-party service vendor inappropriately substituted an OEM steel pin with a simple wood screw to hold a syringe turret in place. An OEM power injector of this class can inject fluid pressures up to 1200 psi. If the substituted screw were to break during a patient procedure the turret could break free potentially causing the turret and connected syringe to act as projectiles.


Despite these examples submitted to the FDA, the agency acknowledged in their report that extending regulations could be “burdensome.” Bayer doesn’t see extending regulations as burdensome, but as an important step to ensure the safe and effective operation of medical devices.

HCB News: Is there a template, or anything we can learn, based on how other countries have dealt with these kinds of challenges?
DD: There have been other countries struggling with third party service approaches across the globe. The most recent one is within the EU, where there are draft changes to the MDD which to my knowledge have not been implemented.

HCB News: Under the potential legislation, would OEM accountability change at all? For example, would manufacturers be held to a higher standard of sharing sensitive information, such as manuals and passcodes, with compliant third parties?
DD: While there isn’t specific language in the legislation in regard to changes in already rigorous OEM accountability standards, the May 15 FDA report referenced the possible creation of a “collaborative community” framework. We believe it is imperative for third party service providers to have certain basic information regarding the design and testing requirements of devices. Servicing of these technically advanced pieces of equipment is not a right and requires some level of investment regardless of being an OEM or a non-OEM. Whether this is reverse engineering, training, partnership, etc., I believe different products and modalities will have differing solutions in this area. However, adequate quality and regulatory performance of these activities is not dependent only on possession of these materials.

August 2018 Magazine

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