Patients exposed

FDA bans powdered gloves but doctors concerned product still being used locally

Observer staff reporter

Tuesday, March 13, 2018

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THE US Food and Drug Administration has banned powdered medical gloves, but locally, there has been no recall of the product.

As a result, a number of doctors are concerned about the risks to which patients are being exposed.

Speaking with the Jamaica Observer, one St Catherine-based medical doctor, who spoke on condition of anonymity, said the gloves are still being used and sold locally, exposing patients and doctors to potentially life-threatening conditions.

“We are exposing our patients to cancer-causing and adhesion-forming agents without their knowledge. It's the responsibility of the Government, through Customs, to ban this. It's the Government's responsibility to regulate and protect the citizenry,” the doctor said.

The ban was proposed by the FDA in March 2016 before being finalised in December of that year. It took effect on January 18, 2017.

The ban applies to the sale, distribution and manufacturing of all powdered surgeon's gloves, powdered patient examination gloves and absorbent powder used to lubricate surgeon's gloves that were already in commercial distribution and for devices that were already sold to the ultimate user, such as small medical practices and hospitals, on January 18, 2017.

Additionally, the ban does not apply to powder used during the manufacturing process for non-powdered gloves, so long as only trace amounts (no more than 2 mg of powder per glove) make it into the finished product.

The ban was effected because substantial evidence exists that powdered medical gloves pose serious risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions.

Further, another doctor employed to the University Hospital of the West Indies (UHWI) said while there has been no local ban or concerted effort to recall the powdered gloves, the gloves are no longer used at UHWI.

“Our operating theatre has been changed out over the last year, so we use non-powdered gloves most of the time. Honestly, it is not great for surgeons because it isn't as comfortable on the hands and it is harder to double gloves. But, as far as I know, islandwide, after the FDA ban, there was a shift to not use powdered [gloves] anymore,” the surgeon said, adding that he is also aware that it is still being used and there has not been a recall.

In relation to the use of the gloves in the public sector, the Observer sought a response from the National Health Fund (NHF) — the entity responsible for procurement of gloves for the public health sector.

Shermaine Robotham, health promotion and public relations manager at NHF, said the institution is aware of the ban on powdered gloves, which was issued by the FDA, and that it has been able to effect changes to contracts with suppliers for non-powdered gloves instead of powdered gloves.

She said, as a result, the NHF ceased the procurement of powdered gloves in September 2017 and is therefore phasing them out.

According to Cynthia Lewis Graham, acting director of the Standards and Regulation Division in the Ministry of Health, the ministry has not yet taken a position regarding the FDA ban on the use of powdered gloves.

In a statement received from Health Minister Dr Chrisopher Tufton, Lewis Graham said: “Please be informed, however, that the use of non-powdered and non-latex gloves in the public health sector in Jamaica was implemented some time ago from a decision taken by the 'Medical Sundries Selection Committee' operating out of the Health Corporation Limited, now National Health Fund (NHF), Warehouse. This decision was taken in response to safety issues regarding the use of powdered and latex gloves, such as topical and respiratory allergic reactions to the powder and or the latex highlighted by the health professionals.”

The acting director said information obtained from the NHF as to the type of gloves available in the public sector revealed that surgeon gloves were 100 per cent powder-free, examination gloves 95 per cent lightly powdered, and examination gloves for individuals with allergy are five per cent powder-free.

She said, too, that the ministry's position regarding the use of powdered gloves can be guided by the findings of the research conducted by the FDA and the European Union.

“The discussions to inform this position will require input from the major health professional bodies — medical doctors, nurses, paramedics — all of which are represented at the head office,” she said.

Lewis Graham said should the proposal be made to implement a ban on the use of powdered gloves, the health ministry must ensure that proper forecasting be done and adequate time be allowed for the phasing out of the powdered gloves currently in stock, so as to prevent a “stock out” situation.

She also suggested that guidelines be issued to ensure that only non-powdered gloves are used during surgery; when attending to open wounds; and to patients who are highly sensitive.

Meanwhile, to better understand the dangers that the use of powdered gloves pose to patients, the Observer contacted surgeon Dr Alfred Dawes.

Using the example of an abdominal surgery, Dr Dawes explained the risk of using powdered medical gloves.

“The powdered gloves have been implicated in causing inflammation and scar tissue formation between the intestines and abdominal wall. These scar tissues or adhesions can cause the bowel to be trapped or kinked causing obstruction of the intestine.

“This is a fairly common condition after abdominal surgery. In some cases, up to 30 per cent of patients will have some form of bowel obstruction post surgery. It may be serious enough to warrant additional surgery to free the bowel from the scar tissue, but that in itself is not a cure as it can recur with new scar tissue forming,” Dr Dawes said.

The surgeon said he supports the FDA's decision and is in full support of a local ban. He said anything that can reduce the risk to patients is welcomed as patients' health and sometimes life are at stake.




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