Medical Devices Regulatory Requirments

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208 Terms

1
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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

2
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regulations

an official rule or the act of controlling something

3
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silkworm gut

what was arguably the first IUD?

4
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1909

When was the first non-hormonal contraceptive introduced?

5
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Dr Richard Richter

Who invented the first non-hormonal contraceptive?

6
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1960s

when did the first plastic IUDs emerge?

7
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1968

When was the Dalkon Shield invented?

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early 1970s

When were the initial results for the Dalkon Shield published?

9
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there weren’t any regulations

why were no regulations broken in the Dalkon Shield case?

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the pill

what did Dr Davis claim the Dalkon Shield was comparable to?

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12,000,000

how many women did Dr Hugh Davis claim were fitted with an IUD worldwide in 1972?

12
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vigorous

How was the Dalkon sales campaign described?

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3.6 million

How many dalkons were prescribed by 1974?

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2% to 1%

how did population growth change in the US in the 60s and 70s?

15
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Depression, blood clots, strokes

what were side effects of the old pill?

16
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6

how many plan B’s was the old pill equivalent to?

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10

how many modern pills was the old pill equivalent to?

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1969

In what year did Barbara Seaman’s book ‘The doctor’s case against the pill’ come out?

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Irwin Lerner (EEE) and Dr Hugh Davis

Who invented the dalkon shield?

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pelvic sepsis, neoplasia

what were feared side effects of the dalkon shield?

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A H Robins

Who bought the rights to the dalkon in 1970?

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80

how many countries was the dalkon sold in?

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after use in women

when did AH Robins test plastic in animals?

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diliked it

what attitude did the head of AH Robins have towards regulation in 1966?

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no

was the dalkon shield seen as a medical device?

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no

was pregnancy classed as a medical condition when the dalkon shield was in use?

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yes

is pregnancy considered a medical condition today?

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10x

how much higher than other IUDs was the force to insert the dalkon shield?

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3x

how much higher than other IUDs was the force to remove the dalkon shield?

30
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strong cord

what did the high removal force of a dalkon shield indicate for design?

31
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polyfilament vs monofilament

what was the difference in cords for the dalkon compared to other IUDs?

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braided

what was the design of the polyfilament dalkon cord?

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wicking bacteria

what was the major issue with the dalkon shield cord?

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242

How many ‘spontaneous midtrimester septic abortions’ occured with the Dalkon?

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10

How many maternal deaths were associated with the Dalkon?

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18

How many overall deaths were associated with the Dalkon?

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4.7-10.4%

what were the pregnancy rates at 2 years of use for the dalkon?

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1.1%

what pregnancy rate did Dr Davis report with the Dalkon?

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5x

How much higher were reported pelvic inflammatory disease cases than other IUDs?

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The Nelson Pill Hearings

In what hearing did Dr Davis testify before the senate on the pill in 1970?

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$712,500

How much money did Davis make from the Dalkon shield?

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30

What percentage of the dalkon corporation royalties did Lerner give Davis?

43
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5.5 months

what was the average wear time for the dalkon?

44
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1 year

what was the reported wear time for the dalkon?

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spermicide

what did davis recommend be used alongside the dalkon?

46
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barium and copper powder

what ‘non-drug’ did AH Robins add to the dalkon for radiopacity?

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2.3

what pregnancy rate were AH robins aware of when advertising at 1.1%?

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June 1974

when did the FDA stop the sale of the dalkon?

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December 1974

when did the FDA reauthorise dalkon sales, against advice?

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it wasn’t

when was the dalkon shield recalled?

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1975

when did the dalkon shield come off the market?

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threat of losing money

why did the dalkon shield come off the market?

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pelvic inflammatory disease, miscarriage, loss of fertility

what were the claimed medical consequences against the dalkon shield?

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<200,000

how many women made claims against the dalkon shield?

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1984

when was dalkon compensation introduced?

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$615 million

what was the settlement fund created when dalkon filed for bankruptcy?

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$245 million

how much were 7600 claims against dalkon settled for in 1984?

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4500

how many medical bills did dalkon pay after advising women got the shield?

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$2.23 billion

how much money has the dalkon shields claimants trust paid out to date (from 1989)?

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women ignored, no regulations, no monitoring, doctors “persuaded” into using it

contributing factors to dalkon shield disaster

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1976

when was US Medical Device Amendments introduced?

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9000

how many years were dental drills invented?

63
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4000

how many years ago were peruvian surgical instruments dated?

64
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332-395 BC

When was well documented GrecoRoman surgery taking place?

65
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man or other animal

who do US medical regulations apply to?

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human

who doe TGA, EU and UK regulations apply to?

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TGA, EU, FDA

who regulates sterilising devices as medical devices?

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claimed primary medical purpose

when is a borderline product a medical device?

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IVDs

In Vitro Diagnostics

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2022

When was the EU IVD regulations meant to be introduced?

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2027-2029

When will the EU regulations be introduced?

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notified body

an organisation designated by an EU country to assess conformity of certain products before they’re placed on the market

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low patient and public health risk

Class A IVD

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Moderate patient risk and/or low public health risk

Class B IVD

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High patient risk and/or moderate public health risk

Class C IVDhi

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High patient risk and public health risk

Class D IVD

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AIMD

Active Implantable Medical Devices

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AIMDs and IVD

What two types of medical device have extra regulations?

79
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pharmacological, immunological, metabolic

what are the three mechanisms of medicines?

80
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integral medicinal product

combined medical device and medicine

81
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yes

does an integral medical product need a CE mark?

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co-packaged medicinal product

separate medical device and medicine to be used together

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yes

does a co-packaged medicinal product need to be CE marked?

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combination product

what does the FDA call a combined medicine and medical device?

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FDA

who decides if a combination product is a medicine or a device?

86
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much cheaper

why could companies rather have something as a medical device not a drug?

87
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RCT

Randomised Controlled Trial

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medicines

what product has to undergo an RCT?

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need training, very subjective, impossible to blind, lots of design variation

why is it hard to do RCTs for a medical device?

90
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inform the MHRA

what do medical device manufacturers have to do in case of adverse incidents involving medical devices?

91
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Class III and implantable

Which devices need clinical investigations under EU MDR?

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Clinical investigation

‘Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device’ - MDR

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3-7 years

How long does it take to get a medical device to market

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12 years

how long does it take to get a drug to market?

95
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no, healthy babies wear them

Are babies’ nappies a medical device?

96
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yes, needed for medical condition

are adults’ bladder leakage products medical devices?

97
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clean, perfume, change the appearance, protect, keep in good condition, correct BO

what are the six functions of cosmetics?

98
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if it protects the patient

generally, when is PPE a medical device?

99
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if it protects the healthcare worker

generally, when is PPE not a medical device?

100
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Class I

which class of medical device is lowest risk and includes things like glasses, gloves and wheelchairs?