Most people assume that when they use health products, these products will do what they are supposed to. For example, if you are prescribed a medication, you expect that pharmaceutical product will treat your condition and make you feel better. Some local markets in developing contexts, however, are at more risk for poor-quality health care products. Substandard or falsified pharmaceuticals are prominently reported in the literature, but less so for medical devices. For illustration, I did a quick PubMed search using the following keywords: poor, quality, products, and market. In the first 40 results, I found 15 references related to pharmaceuticals and none related to medical devices (the others related to issues for food and sanitation). However, medical devices play just as vital a role in achieving global health goals as medicines.
One such medical device, the condom, is key to preventing HIV transmission (and other sexually transmitted infections) and is an essential commodity for supporting family planning. Product testing laboratories, such as our Product Quality and Compliance (PQC) research team at FHI 360, test a range of pharmaceuticals and medical devices like condoms and provide quality assurance (i.e., dossier reviews, audits, and field complaint investigations) to limit the risk of poor-quality products from reaching local markets. This quality assurance work ensures any product used in global health programs meets the manufacturer’s claim of quality, safety and effectiveness.
After local concerns of potentially poor-quality male condoms in the Dominican Republic market, our PQC research team was commissioned to conduct quality control testing to identify the suspect products, which then facilitated the removal of the poor-quality product through action by the local regulatory authority. Here I describe our findings.