What quality standards mean to the medical device industry
When a patient goes to the hospital for any kind of procedure, there is a level trust that individual presumes. He or she trusts that the doctor, surgeon, nurse or other staff has all the necessary credentials and experience to do the job well. He or she also trusts that the facility itself - the equipment, the tools, the lab, the office and so on - is all up to standard and functioning properly. In most cases, those things are up to par - but if anything falls short, the results could be disastrous.
While doctors, nurses and other medical staff are held to a rigorous performance standard, medical devices need to be held to a similar, or even higher standard. These devices are in some instances even more important than the doctors themselves, especially those items that patients rely on for their daily well-being. Medical device manufacturers must work to meet the highest standard of quality for their products so the end users can rests assured knowing their health is in good hands.
ISO standard in the works to improve medical devices
To address the extra care that manufacturers must take to guarantee quality in medical devices, ISO has developed the standard similar to ISO 9001 but tailored for the medical device industry, according to the organization. ISO 9001 lays an excellent framework for organizations to ensure their processes are consistent and efficient, but those manufacturers that produce medical devices should be held to a more specific set of guidelines - that's where "ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes" comes in.
"This International Standard was developed to help to ensure there is global harmonization of the regulatory requirements for quality management systems in the sector and reassure stakeholders that the requirements are being met, at every stage of the product's life cycle," explained Wil Vargas, secretary of the technical committee responsible for the revision.
A revision to the standard is due to be published in in early 2016. Every medical device manufacturer should consider ISO 13485certification to be considered a trusted, quality-centric producer and gain the trust of hospitals and consumers.
FDA highlights medical device quality concerns
ISO isn't the only organization taken by the state of medical device quality control. The Food and Drug Administration began a program called the Case for Quality (CfQ), whereby the organization works with stakeholders to identify shortcomings and steps that would drive better device quality, according to the FDA blog.
The CfQ hopes to move device manufacturers to move past requirements - to go above and beyond what is only basically necessary and take pride in quality. The CfQ outlines three ways to accomplish this:
Focus on quality: Use compliance as a baseline upon which to improve.
Stakeholder engagement: Work with the device industry, solicit feedback and identify pain points.
Data transparency: Make device data openly available to better understand where the industry can improve.
Ultimately, the FDA is motivated to help device manufacturers better serve end users by engaging in impactful processes and activities. As a public health organization, it's in the FDA's best interest to help device manufacturers reach those goals.
The CfQ should also align well with the upcoming medical device standards from ISO in that each focuses specifically on improving medical device manufacturer practices. Those companies should make it a priority to seek out certification - primarily for the sake of end-users, but also as a way to improve their own business. Buyers would prefer to work with organizations that demonstrate a commitment to quality. ISO certification tells potential customers that a manufacturer has taken steps to ensure its practices align with the best industry practices.