Medical device recalls can be a catastrophic event for any one of a number of reasons. The largest concern when a recall is issued is for the health and safety of the patient. Over a ten-year span, roughly 83,000 deaths and 1.7 million injuries have been linked to defective medical devices. Moreover, there is a …
The outbreak of COVID-19 has caused much-documented shortages of medical supplies around the globe. Countries, states and hospitals have had to scramble as their provisions dwindle in the face of being inundated with patients. Faced with a supply crunch, people have had to resort to various methods to procure supplies and have even been ordered …
Cardinal Health recently announced that it would recall over nine million surgical gowns due to issues with possible contamination. The recall is expected to be a costly one for the company. Cardinal Health recently informed its shareholders that it would be taking a $96 million charge against its earnings in the second quarter of 2020. …
When a patient is injured by a medical device, there is an FDA system through which they can report the problem. The Vaccine Adverse Event Reporting System (VAERS) exists so data regarding medical devices that harm can be studied for any patterns. Both the FDA and the public have access to this data so regulators …
After increasing to a historic level in 2018, the amount of medical device recalls remained elevated in 2019. This is borne out by the statistics that quantify exactly how widespread the problem has become. The number of medical device recalls has increased for several reasons, and one of the primary causes is the increasing sophistication …
The FDA has been regulating medical devices since it was given the authority to do so by the Medical Device Amendments of 1976. However, the level of regulation that the FDA performs is not the same for all medical devices. Oftentimes, people have a different impression of the level of FDA involvement with a medical …
As of this writing in September 2019, there have been a total of 26 medical device recalls this year. These have impacted approximately 50 million people in this country. These recalls have ranged from minor issues to major ones that could potentially be life threatening. Here is some information on the nine most consequential medical …
While one of the main focuses of the FDA is making sure that healthcare providers and patients have the most complete information about medical devices, the agency is not always effective in rapidly disseminating this information. In some cases, affected individuals have to closely monitor the internet and other information sources to learn crucial information …
When patients undergo a medical procedure or receive a medical device, they need to know that it is worthwhile and justifies its expense, risk, and discomfort. While most medical procedures and devices have measurable benefits, the same cannot be said for every medical treatment. In fact, a recent study has found that nearly 400 medical …
Pacemakers are medical devices that require an electrical current to operate. This battery needs to be changed periodically in order to keep the pacemaker working properly. Pacemaker batteries generally last from seven to eight years (some can last as long as ten years), and there are definite risks if the battery ceases to work prematurely. …