It basically includes the basic information about different Drug and food safety agencies of countries all over the world and some case studies of banned medical devices by these agencies.
Also a special case study of Electrical stimulation therapy on psychotic patients.
2. A medical device is any instrument, apparatus,implant,
machine, software or other article used in the diagnosis,
prevention,treatment, monitoring or modificationof medical
conditions. Medicaldevices range in complexity from simple
syringes to complex pacemakersand artificiallimbs.
They are essential toolsused in modern medicine and play a
critical role in improving people's healthand well-being.
Here are some of the many different categories of medical
devices:
What is a Medical Device?
3.
4. Regulations on Medical Devices?
United States:
Food and Drug Administration(FDA):
The FDA is responsible for protecting public healthby
ensuring the safety, effectiveness, and security of human
and veterinary drugs, biologicalproducts, medical devices,
medical foods, cosmetics, and radiological products.
5. European Union:
European Commission (EC):
The EC issues regulationson medicaldevices that are
mandatorythroughout the European Union (EU). These
regulationsare designed to ensure the safety, quality, and
performance of medical devices.
6. India:
Central Drugs StandardControl Organization (CDSCO):
The CDSCO is the nationalregulatory body for drugs and
medical devices in India. It is responsible for ensuring the
safety, efficacy, and qualityof drugs and medical devices
imported, manufactured, or marketed in India.
7. Canada: Health Canada
Health Canadais the federal department responsible for helping Canadiansmaintainandimprove
their health. It regulates medical devices in Canadato ensure they are safe, effective, and of high
quality.
Japan: Pharmaceuticalsand MedicalDevices Agency (PMDA)
The PMDA is an independentadministrativeinstitution responsiblefor regulating pharmaceuticals,
medical devices, and cosmetics in Japan.
Australia:TherapeuticGoods Administration(TGA)
The TGA is the AustralianGovernment department responsible for regulating therapeutic goods,
includingprescription and over-the-counter medicines, medical devices, and blood products.
China: NationalMedicalProducts Administration(NMPA)
The NMPA is responsible for the oversight of the safety, efficacy, and quality of drugs, medical
devices, and cosmetics in China.
It's important to note that these are just a few of the many regulatory bodies aroundthe
world that oversee medical device regulations. The specific requirementsfor marketing a medical
device can vary depending on the country or region.
8. Popular Banned Medical Devices by FDA
• Proposalto Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
Proposed March 26, 2024
• PowderedSurgeon's Gloves, Powdered Patient ExaminationGloves, and Absorbable
Powder for Lubricatinga Surgeon'sGlove
Effective January18, 2017
9. Electrical Stimulation Devices for Self-Injurious or Aggressive
Behavior
• FDA give the proposalto ban the electrical stimulationdevices for self-injuriousor
aggressive behaviorand the case is still ongoing.
• These devices have been used on autistic persons in the judge Rotenberg center [J.R.C.]
on the regular basis on the treatment of these kind of patientlocatedin US.
• FDA found the numerous short term and long term risks associated with this therapy.
10. • In 2002, Andre Mccollins, who was in the care of the J.R.C., underwent 31
electric hocks in a seven hour time period while in restraints.
• The given reasons were that he refused to take off his jacket, and then
said 'No'.
• Twenty nine of the shocks he received were for "tensing up" or
"screaming".
• He and his mother, Cheryl, filed a MedicalMalpracticesuit againstthe
J.R.C. which went to trial in April, 2012.
• This was the first time video of the electric shocks being administered
was publiclyreleased,
which lawyersfor the J.R.C. had attempted to suppress. it seems likely
that this was a large part of what spurred the F.D.A. into action
• One of the driving forces in bringing about this change is self advocates
like the amazing
‘Autistic Hoya', otherwise known as Lydia Brown, who does wonderful
work in this area
and writes excellent informative things.
• Now, Thingsare in the hands of the F.D.A. though, and it's up to them to
make the ultimate decision.
They are listening to the public,though, and accepting comments to
consider.
11. Powdered Surgeon's Gloves, Powdered Patient Examination
Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
Banned due to variouscomplicationsrelated to both
patient’sand Doctor’s heath.
Causes Varioustypes of allergies, respiratory disorder’s
and other complications.
12. References:
• FDA Official website: https://www.fda.gov/
• Youtube Sources:
https://youtu.be/ZRcwzWm-AGA?si=Cpceqiqxgul-0PTl
https://youtu.be/t65NsbF1zbU?si=aF5NCBWMIWr3LZBj
