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Home infusion medical device safety monitoring & reporting under ISO 13485

As a home infusion medical services provider, keeping patients safe is always your highest priority.

Patients at home can have varying degrees of support, which is why their safety requires ongoing, comprehensive efforts — especially when patients or family members operate the device as opposed to skilled clinicians or technicians.

One way you can help keep patients safe is to follow home infusion medical device safety monitoring and reporting standards. That's why you'll want to use an ISO-certified biomedical equipment provider for your equipment maintenance needs.

In today's healthcare climate, that means using a medical equipment company that has earned a third-party ISO 13485 certification.

Before ISO 13485's 2016 revision, ISO 9001 compliance may have been adequate for home infusion providers. But any type of organization can use ISO 9001's quality-management requirements regardless of industry, product, service or company size. Its broad focus limits ISO 9001's relevance to healthcare, with its high stakes and limited tolerances.

In contrast, ISO 13485 is healthcare-specific. Here's what you need to know about how ISO 13845 helps you protect your patients and limit your risk as a provider.

What is ISO 13485?

This International Organization for Standardization (ISO) standard focuses solely on medical devices. Its quality-management system (QMS) covers the full life cycle of a medical device, including:

  • Design
  • Production
  • Distribution and storage
  • Installation
  • Servicing and maintenance
  • Disposal

ISO 13485 can also apply to suppliers or vendors that provide QMS-related services.

Who needs to follow ISO 13485?

Organizations involved in the design, production, installation and servicing of medical devices and related services. ISO 13485 applies to all medical device-related organizations regardless of their size and type.

Biomedical equipment providers can choose to invest the considerable resources needed to earn and maintain an ISO 13485 certification. Certification requires them to demonstrate their ability to service medical devices while consistently meeting applicable regulatory requirements. In these instances, medical device safety and medical device repair training are paramount.

How does ISO 13485 support patient safety?

This ISO standard makes sure that manufacturers apply risk management principles systematically to every stage of a medical device's life cycle. In other words, it bakes safety into each device throughout its expected lifespan.

Starting with design and development, companies must identify potential patient safety risks and develop ways to eliminate or mitigate these risks. During device production, the company must test extensively to demonstrate the effectiveness of its risk-control measures. The company must also show that potential clinical benefits outweigh any remaining risks. During the device's use phase, the manufacturer must continue to monitor its performance for any unidentified risks so that it can act promptly and efficiently if any unexpected hazards emerge.

With ISO 9001, the ultimate goal is to use quality and continuous improvement to support customer satisfaction. With ISO 13485, the main focus is on patient safety and device performance. Customer satisfaction may increase as a result of this focus, but it's not the standard's overarching goal or purpose.

Keep your patients protected with an ISO-certified biomedical equipment provider. Learn more about McKesson Biomedical Solutions™.

What are some of ISO 13485's requirements?

Service providers that earn a third-party ISO 13485 certification must establish and maintain the effectiveness of their QMS. This includes:

  • Documenting procedures to maintain an effective QMS
  • Maintaining records throughout the medical device life cycle
  • Taking a risk-based approach to servicing activities
  • Documenting a thorough and continuous training program for technicians and support staff
  • Achieving continuous improvement through customer feedback

Resource management is also an important part of ISO 13485. The standard calls for adequate facilities for medical device manufacturing and servicing. This includes tools, equipment, computer systems and physical space. These vital business components must also undergo proper maintenance. Upkeep is not an afterthought with ISO 13485, either: Each company's QMS must include processes to ensure successful completion of required maintenance.

How can ISO 13485 help improve medical device safety monitoring and reporting?

ISO 13485's resource management requirements extend to device recalls, too. If you choose an ISO 13485-certified vendor for servicing, they will contact you in the event of device recalls. They will identify affected devices in your fleet and develop a plan to perform recall-related work promptly. This attention to detail supports patient safety even as it helps you minimize downtime and service disruptions.

Perhaps ISO 13485's biggest benefit to patient safety is intangible: Many believe that certification gets people in the mindset that quality happens at every stage of a medical device's life cycle and that they can only reach high standards through a sustained effort at every level of the organization.

Sean Keener, senior quality assurance engineer at McKesson Medical-Surgical, has found this to prove true.

"The most important thing for home infusion providers to know is that McKesson has invested in becoming and remaining fully ISO-compliant," he says, noting that his role is to oversee compliance with ISO and FDA standards. "The work in a McKesson facility is done the same way and according to the original equipment manufacturer's manual. Our biomedical technicians receive the same high-quality medical device repair training and are held to the same exacting standards, and that's good news for our customers."

© 2022 McKesson Medical-Surgical Inc.