From pacemakers to stents: sex and gender also make a difference for medical devices

From pacemakers to stents: sex and gender also make a difference for medical devices

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There is no shortage of examples. Think about pacemakers: women have smaller chests than men, so a device designed on the model of a male body could cause more pain in women, or even interfere with breathing. Let’s also think about stents, those metal retractors that are inserted into the vessels to facilitate the flow of blood: since women’s coronary arteries are smaller, if designed for men they may not be effective or even cause damage. Smaller or differently shaped ones would be needed.

Devices designed for men

Sex-gender medicine has long supported the fact that males and females are physiologically different, and therefore respond to therapies differently. We already know, for example, that the metabolism of drugs varies in the two sexes, so much so that women generally need different doses of a certain medicine, or alternative molecules to obtain the same therapeutic effect. To date, however, the knowledge accumulated in this sector has rarely been applied to the medical device sector. Now one instead review conducted by Ilaria Campesi, Flavia Franconi And Pier Andrea Serra of the University of Sassari, and just published on Life, shows how the sex and gender of patients often also influence their effectiveness and safety. Starting from a fact, as the authors of the research explain: that not only have women been excluded from drug testing for too long, but also that most medical devices are designed with men in mind, and that women are rarely taken into consideration when it comes to developing not only stents or pacemakers, but also defibrillators, mechanical ventilation devices, hip replacements and even surgical masks or contact lenses.

Intramuscular more difficult for women

Here then are the consequences of a “gender-blind” approach, that is, one that does not pay attention to the differences between male and female sex: cardiac defibrillators, for one thing, risk being less effective in women. Or again: since men and women have different lung capacities, they can respond differently to assisted ventilation. If we then think about personal protective equipment, the so-called PPE such as suits and gas masks, the panorama is identical: these tools are often designed based on the average male build, which can make them uncomfortable or ineffective on a female body. Are we talking about syringes or needles? We must remember, the scholars add, that to give an intramuscular to a woman, especially if she is overweight or obese, it would be better to have a syringe with a longer needle, to prevent the drug from being mistakenly injected into the subcutaneous tissue. It is no coincidence that the rate of failed intramuscular injections is significantly higher in females (54% compared to 5%), which puts the effectiveness of many therapies administered in this way at risk.

Biomaterials and allergy risk

Even biosensors, such as those used to monitor heart rate, are not free from sex and gender bias: in fact, most of these devices do not consider the differences between men and women when it comes to the number of beats per minute , which are on average 70 – 72 for a male and 78 – 82 for a female, with differences that may increase during physical activity or a state of stress. Another aspect to consider, continue the authors of the review, concerns the biomaterials used to repair damaged tissues or organs. Firstly for a question of biocompatibility, given that the body’s response to a material can vary depending on sex and gender. For example, some materials may trigger allergic reactions more frequently in women than in men. The issue of degradation should also be considered, given that the way in which a material is reabsorbed by the body can be influenced by hormonal factors, which vary depending on sex. And the long-term effects of exposure to certain materials, the researchers say, may also be different between men and women.

Improve equity and safety

The problem not only affects patients, but also healthcare workers who have to implant the devices. Some of these, say the researchers, could be more difficult to use depending on gender: a defibrillator with handles that are too large or a lung ventilator that is too heavy could create some difficulties for a nurse, with the risk of suboptimal use. “A collective effort is needed to improve the equity and safety of medical devices for all. Sex and gender should be taken into consideration from the early stages of the development and testing of these devices”, conclude the authors of the research. By developing biocompatible materials taking into account the differences between men and women, it will be possible to create even safer and more effective medical devices for all patients, and tools that healthcare personnel are able to use correctly.

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