Respect for regulations: How can we ensure this?

Medical Plastics News editor Laura Hughes discusses how to ensure regulations are respected.

Recently, The National Institute for Health and Care Excellence (NICE) has published updated guidelines that include the use of the controversial, surgical vaginal mesh implant. The publication of these guidelines has attracted mass media attention and disappointment amongst campaigners and people who have previously experienced negative consequences as a result of having the implant.

The announcement of these guidelines comes at a time where the regulations surrounding some medical devices are being tightened. I believe this is partly due to the wide portrayal of this field in the media via online articles and through documentaries on platforms such as Netflix. Following this coverage, I think lay people are beginning to question certain regulations and approvals practiced by medical professionals.

I find it really interesting to compare the various regulations surrounding the two very different fields of medical drugs and devices.

Medical drug and device regulations are thought to be highly regarded and respected by medical professionals, as well as the general public. The difference it can mean for a device to be certified by a regulatory body has recently been highlighted by Rightpoint, an independent customer experience agency, who has announced the formalisation of its healthcare practice, as well as a new medical software certification which will enable the company to deliver the Food and Drug Administration (FDA)-approved medical grade software. Rightpoint believes this will be hugely advantageous to the company commercially.

However, programs such as the FDA’s Breakthrough Devices Program raise a lot of questions. The FDA aims to rapidly approve some devices through this program, which was launched in 2016.

For standard practice, the process can take as little as three years to bring a device to market, which is significantly less than the process of bringing a drug to market, which on average can take 12 years. However, time does not always define the success and safety of a new process or product. Most people will be aware of drugs such as thalidomide, which caused life-changing side effects and even resulted in death in some cases.

I think the FDA’s overhaul of its regulations, which was announced late last year, will help to instil respect and trust in our regulations and regulatory procedures, within the general public and healthcare professionals, who may have previously had their doubts.

The ever-growing presence of social media enables the patient’s voice to be heard and allows constant questions to be raised by experts and non-experts alike. The option for the patient to make the choice and be in control is clear within the updated mesh implant guidelines, and may be something that is to be incorporated in to many other future guidelines.