Why are medical device recalls soaring?
During the second quarter of 2017, medical device recalls at the Class 1 level spiked by an alarming 88 percent. Recalls at that level typically involve potentially life-threatening situations. Worse, the number of devices affected by those recalls is nearly triple the per-quarter average from 2016. Under normal circumstances, the medical device industry faces demanding quality control and regulatory challenges, so this occurrence is bad news indeed.
Deadly medical device recalls
According to Medical Design and Outsourcing, some of the most notable FDA Class 1 recalls from Q2 2017 included:
- Thoratec HeartMate II controllers (recalled after the death of a patient)
- Getinge/Datascope IABP (recalled after the death of a patient)
- HVAD system controller
- Medtronic’s StrataMR (recalled after a reported patient death)
- Philips Respironics V60 ventilator
- Prelude sheath introducer
- Select Abbott heart catheters (recalled after the death of a patient)
- Vascular Solutions Venture catheters
- Zimmer Biomet SpF spinal fusion stimulator (recalled after a routine monitoring procedure uncovered possible toxicity to tissues and organs)
Four elements played active roles in these serious Class 1 recalls: a lack of quality control, failure to establish durability, approval of products prior to readiness and an overall poor quality of equipment manufacturing components. These recalls could have been mitigated or altogether prevented by more vigilant attention to ISO 13485 compliance and by utilizing the “plan-do-check-act” cycle prompted by an automated quality management system.
ISO 13485 compliance elements
ISO 13485 helps organizations in any stage of a medical device’s life cycle in:
- proving compliance with industry regulatory and legal requirements
- ensuring that QMS practices are in place and consistently result in quality medical devices
- managing risk
- improving processes to become more efficient
- gaining a competitive advantage
The latest revision of ISO 13485 decreases the chances of a recall by placing a greater emphasis on appropriate production infrastructure, on increased alignment with regulatory requirements, on those organizations which interact with a medical device manufacturer and on post-market activities such as complaint handling and regulatory reporting.
The next step is EQMS
To manage the ISO 13485 standard, medical manufacturers must do more than rely on a paper-based or spreadsheet approach. Instead, they need an integrated and inclusive quality and compliance approach with automation, which includes:
- an efficient way to identify, monitor and ensure industry and customer compliance
- a transparent means of analyzing and reporting how systems and processes are working
- closed-loop collaboration, accountability, and traceability; in other words, people talk to one another, accept responsibility, and know who is responsible for what
- modern tools to get the software up and running and ready to do the job
- an intuitive, user-centric design for quick adoption-software that does not require a degree in IT to operate
- buy-in by everyone involved to transform the organization’s culture to one that focuses on quality
EQMS, a quantum leap beyond a to-do list or a spreadsheet accounting system, comprehensively provides for each of these. Good quality management software possess the following capabilities:
- mobile auditing
- document tracking and control
- personnel training
- supply stream management
- modules focusing on risk management and customer feedback for closed-loop quality management
Why you need EQMS
Companies that make quality a priority and automate their quality control processes have made great strides in cutting costs, attracting new customers, driving innovation in their organization and reducing manufacturing defects. Also, Enterprise Quality Management Software helps solve the problems of dealing with the variety of ISO 13485 exclusions and coping with constantly evolving local and foreign regulations. EQMS provides a hub for coordinating compliance, product quality and best practices in manufacturing operation solutions.
IQS can help
Please visit our Medical Device Industry page to learn more about how the IQS platform approach can help you achieve ISO 13485 compliance. After watching our demo video, fill out your contact information. We will be in touch to set up a product demo.