Medical device
 Medical device  (medical concept, Big Pharma)   | |
|---|---|
| Any device intended to be used for medical purposes. |
A medical device is any device intended to be used for medical purposes.
Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as medical thermometers, disposable gloves, and bedpans to complex, high-risk devices that are implanted. One example of high-risk devices are those with embedded software such as pacemakers, and which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of biomedical engineering.
The global medical device market reached roughly US$209 billion in 2006[1] and was estimated to be between $220 and US$250 billion in 2013. Manufacturers have paid at least $1.6 billion since 2008 to settle charges of corruption, fraud and other violations with regulators in the U.S. and other countries. They have also paid billions of dollars to patients.[2]
Low safety testing standard
An analysis by ICIJ found that Medical devices that broke, misfired, corroded, ruptured or otherwise malfunctioned after implantation or use — despite assurances by regulators, the industry and doctors that they were safe — were linked to more than 1.7 million injuries and nearly 83,000 deaths in the period 2008-2018.[2]
Health authorities across the globe failed to protect millions of patients from poorly tested implants that can puncture organs, deliver errant shocks to the heart, rot bones and poison blood, spew overdoses of opioids and cause other needless harm. Governments hold even complex implants to a lower safety testing standard than most new drugs. Flawed devices linger on the market as injuries mount. Under a free-for-all global system, device companies pull implants in some countries while continuing to sell them in others.[2]
