Health & medicine

How are devices approved for paediatric patients?

Medical technology has done nothing but accelerate over the last decade, but many devices are never approved for use in infants and children. Why do paediatric device approvals lag behind so significantly, and how can the industry improve? Abi Millar reports.

Over the last decade or so, medical device innovation has gathered pace. In 2018, the US Food and Drug Administration (FDA) approved 35 high risk and 44 low-risk novel medical devices, compared to 22 and three respectively in 2010. New technologies, such as artificial intelligence and 3D printing, have opened new possibilities, and the industry has been highly responsive.

Unfortunately, not all patients have benefited equally from this wave of innovation. Paediatric device approvals continue to lag behind adult ones, with many devices never approved for use in infants and children.

Between 2009 and 2019, only 24% of all FDA-approved devices had labelling inclusive of paediatric populations. Even within that bracket, there is a skew towards older age groups. Over 90% of that paediatric labelling is for 18-21-year-olds, who are considered part of paediatrics when it comes to medical devices.

Often, paediatricians will use a device ‘off-label’, which has never been formally tested in children. Although they may have evaluated the devices themselves, using small studies, they lack the assurance of large clinical trials. The parents are placed in the awkward position of choosing between a device only approved for adults, or no treatment at all.

Read the rest of this article in the April 2021 edition of Medical Technology

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: