ONLINE PURCHASE OF MEDICAL DEVICES FOR PERSONAL USE

Management of health conditions such as hypertension, diabetes, asthma and others does not rely on strict adherence to medications and lifestyle modifications alone but also the use of medical devices at home outside hospital settings. This is done to help monitor fitness level, to help one know how controlled the health condition is and to increase quality of life and reduce morbidity and mortality.

The Public Health Act of 2012, Act 851 defines medical device  as  a medical equipment, machine, contrivance, implant, in vitro reagent or any other similar or related article, including a component, part or an accessory which is intended for use in the diagnosis of a disease or any other condition, or in the cure, mitigation, treatment or prevention of disease in humans and animals, or intended to affect the structure or a function of the body of the human being or other animal and which does not achieve any of its principal intended purposes through chemical action within the body of the human being or any other animal and which is not dependent on being metabolized for the achievement of any of its principal intended purposes.

Medical devices are used in a wide range of health conditions, from simple medical procedures like dressing of cuts and wounds to complex procedures such as implanting a pacemaker.  Medical devices are not used by health personnel in clinic settings alone but also patients/caregivers trained in their usage at home.

 Medical devices that are used at home to monitor, manage or diagnose medical conditions include blood pressure monitors, blood glucose monitors, rapid diagnostic test (RDT) kits (e.g. pregnancy test kits, ovulation test kits, malaria test kits) among others.

Some vendors have taken advantage of the need and demand for medical devices mostly used at home and are selling these items online, without due regard to their safety, quality, and performance.

The safety, quality, and performance of medical devices are assured by the Food and Drugs Authority (FDA) through a registration process. As part of the mandatory registration of medical devices, the FDA evaluates relevant documentation associated with the development, production, and use of the medical devices. The FDA also undertakes Good Manufacturing Practice inspection of the manufacturing facility to ensure that the facility consistently produces medical devices to the required quality, safety, and performance standard. In addition, samples of medical devices are also evaluated in the FDA’s Medical Devices Laboratory to ensure they meet the requisite standards.

Prior to buying a medical device online for home use, always check for the following basic information:

• Information on the label and package insert of the medical device must be in English Language

• Generic and brand names

• Name and address of the manufacturer

• Direction for use (mostly indicated on the package insert or as pictorial diagram on the product label)

• Shelf life of the medical device

• Check for storage condition (Eg. improper storage may render an antigen/antibody RDTs inactive which may intend give inaccurate results leading to wrong diagnosis)

• Finally, verify a medical device’s registration status with the FDA on the Authority’s website www.fdafgana.gov.gh and the following contacts:

Hotlines - 0551112224/0551112225

WhatsApp - 0551112224

The purchase and use of unsafe, poorly performing medical devices at home may lead to inappropriate management of health condition and associated negative effects such as complications, hospitalization, and even death.

It is worth emphasizing that the public should always check the registration status of any medical device online with the FDA prior to purchase and use to ensure their safety and performance.

Additionally, medical devices such as blood pressure and blood glucose monitors that require calibration must be regularly calibrated according to the manufacturer’s instructions to ensure accurate results.

Remember to always use new batteries for medical devices that require batteries, because malfunctioning batteries may give wrong results, which can negatively affect the management of health conditions.

Medical devices play a crucial/important role in the prevention, diagnosis, treatment and management of diseases. Their effectiveness depends on them being safe, high quality and performing satisfactorily. The source from which you obtain your medical device is important to derive the intended benefits. To ensure you gain the intended benefits, it’s important to obtain your medical device (s) from reliable sources. Avoid purchasing unregistered medical devices from social media platforms since the safety, quality and performance of medical devices from these sites cannot be guaranteed.