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medical device
any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by human beings for a medical purpose
regulations
an official rule or the act of controlling something
silkworm gut
what was arguably the first IUD?
1909
When was the first non-hormonal contraceptive introduced?
Dr Richard Richter
Who invented the first non-hormonal contraceptive?
1960s
when did the first plastic IUDs emerge?
1968
When was the Dalkon Shield invented?
early 1970s
When were the initial results for the Dalkon Shield published?
there weren’t any regulations
why were no regulations broken in the Dalkon Shield case?
the pill
what did Dr Davis claim the Dalkon Shield was comparable to?
12,000,000
how many women did Dr Hugh Davis claim were fitted with an IUD worldwide in 1972?
vigorous
How was the Dalkon sales campaign described?
3.6 million
How many dalkons were prescribed by 1974?
2% to 1%
how did population growth change in the US in the 60s and 70s?
Depression, blood clots, strokes
what were side effects of the old pill?
6
how many plan B’s was the old pill equivalent to?
10
how many modern pills was the old pill equivalent to?
1969
In what year did Barbara Seaman’s book ‘The doctor’s case against the pill’ come out?
Irwin Lerner (EEE) and Dr Hugh Davis
Who invented the dalkon shield?
pelvic sepsis, neoplasia
what were feared side effects of the dalkon shield?
A H Robins
Who bought the rights to the dalkon in 1970?
80
how many countries was the dalkon sold in?
after use in women
when did AH Robins test plastic in animals?
diliked it
what attitude did the head of AH Robins have towards regulation in 1966?
no
was the dalkon shield seen as a medical device?
no
was pregnancy classed as a medical condition when the dalkon shield was in use?
yes
is pregnancy considered a medical condition today?
10x
how much higher than other IUDs was the force to insert the dalkon shield?
3x
how much higher than other IUDs was the force to remove the dalkon shield?
strong cord
what did the high removal force of a dalkon shield indicate for design?
polyfilament vs monofilament
what was the difference in cords for the dalkon compared to other IUDs?
braided
what was the design of the polyfilament dalkon cord?
wicking bacteria
what was the major issue with the dalkon shield cord?
242
How many ‘spontaneous midtrimester septic abortions’ occured with the Dalkon?
10
How many maternal deaths were associated with the Dalkon?
18
How many overall deaths were associated with the Dalkon?
4.7-10.4%
what were the pregnancy rates at 2 years of use for the dalkon?
1.1%
what pregnancy rate did Dr Davis report with the Dalkon?
5x
How much higher were reported pelvic inflammatory disease cases than other IUDs?
The Nelson Pill Hearings
In what hearing did Dr Davis testify before the senate on the pill in 1970?
$712,500
How much money did Davis make from the Dalkon shield?
30
What percentage of the dalkon corporation royalties did Lerner give Davis?
5.5 months
what was the average wear time for the dalkon?
1 year
what was the reported wear time for the dalkon?
spermicide
what did davis recommend be used alongside the dalkon?
barium and copper powder
what ‘non-drug’ did AH Robins add to the dalkon for radiopacity?
2.3
what pregnancy rate were AH robins aware of when advertising at 1.1%?
June 1974
when did the FDA stop the sale of the dalkon?
December 1974
when did the FDA reauthorise dalkon sales, against advice?
it wasn’t
when was the dalkon shield recalled?
1975
when did the dalkon shield come off the market?
threat of losing money
why did the dalkon shield come off the market?
pelvic inflammatory disease, miscarriage, loss of fertility
what were the claimed medical consequences against the dalkon shield?
<200,000
how many women made claims against the dalkon shield?
1984
when was dalkon compensation introduced?
$615 million
what was the settlement fund created when dalkon filed for bankruptcy?
$245 million
how much were 7600 claims against dalkon settled for in 1984?
4500
how many medical bills did dalkon pay after advising women got the shield?
$2.23 billion
how much money has the dalkon shields claimants trust paid out to date (from 1989)?
women ignored, no regulations, no monitoring, doctors “persuaded” into using it
contributing factors to dalkon shield disaster
1976
when was US Medical Device Amendments introduced?
9000
how many years were dental drills invented?
4000
how many years ago were peruvian surgical instruments dated?
332-395 BC
When was well documented GrecoRoman surgery taking place?
man or other animal
who do US medical regulations apply to?
human
who doe TGA, EU and UK regulations apply to?
TGA, EU, FDA
who regulates sterilising devices as medical devices?
claimed primary medical purpose
when is a borderline product a medical device?
IVDs
In Vitro Diagnostics
2022
When was the EU IVD regulations meant to be introduced?
2027-2029
When will the EU regulations be introduced?
notified body
an organisation designated by an EU country to assess conformity of certain products before they’re placed on the market
low patient and public health risk
Class A IVD
Moderate patient risk and/or low public health risk
Class B IVD
High patient risk and/or moderate public health risk
Class C IVDhi
High patient risk and public health risk
Class D IVD
AIMD
Active Implantable Medical Devices
AIMDs and IVD
What two types of medical device have extra regulations?
pharmacological, immunological, metabolic
what are the three mechanisms of medicines?
integral medicinal product
combined medical device and medicine
yes
does an integral medical product need a CE mark?
co-packaged medicinal product
separate medical device and medicine to be used together
yes
does a co-packaged medicinal product need to be CE marked?
combination product
what does the FDA call a combined medicine and medical device?
FDA
who decides if a combination product is a medicine or a device?
much cheaper
why could companies rather have something as a medical device not a drug?
RCT
Randomised Controlled Trial
medicines
what product has to undergo an RCT?
need training, very subjective, impossible to blind, lots of design variation
why is it hard to do RCTs for a medical device?
inform the MHRA
what do medical device manufacturers have to do in case of adverse incidents involving medical devices?
Class III and implantable
Which devices need clinical investigations under EU MDR?
Clinical investigation
‘Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device’ - MDR
3-7 years
How long does it take to get a medical device to market
12 years
how long does it take to get a drug to market?
no, healthy babies wear them
Are babies’ nappies a medical device?
yes, needed for medical condition
are adults’ bladder leakage products medical devices?
clean, perfume, change the appearance, protect, keep in good condition, correct BO
what are the six functions of cosmetics?
if it protects the patient
generally, when is PPE a medical device?
if it protects the healthcare worker
generally, when is PPE not a medical device?
Class I
which class of medical device is lowest risk and includes things like glasses, gloves and wheelchairs?