Anyone who has cracked their smartphone screen or had a rapid oil change knows that sometimes the OEM isn’t the most affordable or convenient service option. Consumer flexibility, paired with lower-cost, high-quality options, is logical, whether it’s in the consumer market or in healthcare.

The right-to-repair movement seen in the electronics, agricultural equipment, and electronics industries is gaining similar traction in healthcare with medical device maintenance. Pivotal to the initiative is flexibility, enabling easier third-party access to repair manuals, components, tools, service keys, and training. The benefits include 1) less equipment downtime, resulting in a reduction in time to therapy for patients; 2) less expense, benefiting healthcare systems and ultimately patients and taxpayers; and 3) the expanded safety, efficacy, and longevity of medical devices.

Legislation could allow hospitals to reduce costs and service delays while simultaneously promoting the need for robust quality management systems (QMS) to ensure consistency and safety. In addition, it’s critical that hospitals ensure patient safety by partnering with third-party providers who also have strong quality standards in place—ensuring consistent oversight and compliance, and ultimately protecting patient care.

The rising need for robust QMS

Based on a 2021 report, the U.S. Food and Drug Administration concluded that it will not impose additional or different regulatory requirements on the third-party servicers of medical devices because “objective evidence indicates that third-party entities provide high quality, safe, and effective servicing of medical devices.”

The report also noted, “The selective adoption and application of quality management principles and processes to medical device servicing contributes to the quality, safety, and effectiveness of these activities.” Because the FDA isn’t requiring oversight, the responsibility falls on the medical device owner to select a high-quality service partner.

A robust and certified QMS isn’t just beneficial but necessary to maintain the quality, safety, and performance of medical devices. As a structured system, a QMS documents the processes, procedures, and responsibilities/qualifications of those involved while also providing a framework that can be used to track, manage, optimize, and promote longevity of the medical equipment. Additionally, risk management principles are applied to identify, evaluate, mitigate, and remediate hazards.

Some key elements of a robust QMS include documented procedures for troubleshooting, repairing, procuring parts, training technicians, demonstrating competence, monitoring complaints, and internal auditing. Equally important is full device life cycle traceability, including scheduled preventive maintenance (PM) and service repair activities.

All these elements should be continuously monitored through metrics and reviewed periodically to assess the health of the QMS. Opportunities for improvement should be formally documented, including root cause analysis, corrective actions, and effective verification of the changes.

These efforts help ensure that medical device life is extended through regular maintenance. In the absence of a robust QMS maintained by a third party, healthcare organizations face the possibility of higher costs, shorter equipment life, and most critically, risk to patient safety.

A perfect pair: QMS and the right-to-repair movement

Right-to-repair legislation is based on freedom of choice. For healthcare providers, this means they no longer need to depend on OEMs for parts, tools, and repair services. Having a robust QMS promotes patient safety, cost savings, and equipment lifespan.

When you marry the healthcare providers’ ability to choose with high-quality, safe devices that last longer, you have a win-win situation for both the provider and the patient.

Key considerations when decentralizing repair

Selecting the right service partner is important. Cost, timeliness, competency, and quality must all be carefully considered. When healthcare providers leverage third-party vendors, several critical elements should be considered including, but not limited to:

Controlled repair guidelines—Ensure that all repair work aligns with current manufacturer specifications and regulatory requirements.

Qualified technicians—Require verified certifications and ongoing training for those involved in repairs, emphasizing the complexity of new medical technology.

Training documentation—Maintain full records for technician training and qualifications.

Detailed service records—Document each repair with full traceability, equipment history, parts used, assigned technician, test equipment, and repair date.

Replacement parts—Ensure that components meet the design requirements of the initial device design.

Device testing—Device function following service must be defined, executed, and documented to demonstrate passing results.

Maintaining care quality as service models evolve

The right-to-repair movement can provide hospitals with more flexibility in how they service medical equipment. However, this flexibility should never affect or compromise patient safety. Healthcare organizations must make educated decisions when selecting third-party providers by ensuring they adhere to strict QMS guidelines so that all service repairs meet the same high standards, regardless of who performs them. With the right QMS, service organizations can remain compliant, protect patient safety, and provide more affordable options to healthcare providers.