The History, Manufacturing Process and Common

Reactions of Examination Gloves

Frances Atkinson National Clinical Advisor Healthline Medical Ltd.

History Medical gloves were first used by

Caroline Hampton in 1890. A scrub nurse of William Halsted, an American surgeon at John Hopkins Hospital.

Carbolic acid was used to sterilise hands prior to surgery.

Halstead approached Goodyear Tyre and Rubber Company to produce a rubber glove that could be dipped in carbolic acid to protect hands due to Hampton suffering from dermatitis.

The first medical glove was born.

History

Gloves were then regularly used by nurses and assistants through surgery but rarely by consultant surgeons.

In 1892, one of Halsted’s protégés: Joseph Goodblood, came to John Hopkins Hospital and regularly started to use gloves stating: “Why shouldn’t the surgeon use them as well as the nurse?”

In 1899, Goodblood published a report regarding 450 hernia operations with a near 100% reduction in infection rates when using gloves.

Gloves were not disposable and were used over and over again and had to be robust enough to withstand repeated washing.

History The use of latex gloves steadily became more popular in surgery and many other areas of healthcare as time went on. Latex was the traditional material used for gloves. Since the mid 1900’s, latex gloves have been predominantly manufactured in Malaysia due to close proximity to the raw materials. The same applies to nitrile and vinyl exam gloves later on. Initially gloves in use were reusable. The first disposable glove was produced in the 1960’s.

Manufacturing Plant Manufacturing Process

• Glove material is “compounded” making it ready to dip.

• Dozens of chemicals are added at this stage Accelerators Antioxidants Preservatives Pigments

A Typical Dipping Line Output ranges from 30,000 per day to over 350,000 per day

Preparation of Dipping Line Attach all the formers

6,000 to 20,000 per line are required Size ratio of formers must match the demand Each former is attached manually

Fill the latex/nitrile tanks, coagulant tanks, leach tanks Fire up the ovens and allow the system the correct temperature for the dipping process to commence.

Porcelain Formers

Dipping Process

Vulcanisation

Leaching Process

Beading and Stripping

Post-Dipping Processes

Chlorination Removes residual powder De-tackifies the surface to make donning (putting on) easier Reduces protein to acceptable levels in the case of latex gloves (it’s

the most effective method) to comply with legislation

Powder was used to aid glove donning, but it was found that the powder helped disperse particles and added to the risk of spreading latex protein. Powder free gloves became the preferred option.

Quality Checks

Sampling AQL Testing Physical Testing Visual Inspection Pass or Re-Screen

Packing and Shipping Packaging

Manual Process Clean Environment

Shipping 30 day ocean voyage

Quality Standards ISO 9001 ISO 13485 ISO 14001 BS EN 455,1,2,3 and 4

Explanation of Standards

Medical Devices Directive 93/42/EEC Designed to harmonise the laws relating

to medical devices within the EU. For a manufacturer to legally put a

medical device on the European market, the requirements of the Directive must be met.

The Medical Devices Directive came into force on 1 January 1995

A transition period applied and ended on 13 June 1998.

All medical devices placed in the market after 13 June 1998 must be CE marked and proven to comply with relevant product standards.

Amended in September 2007 under directive 2007/47/EC, with fundamental revisions of the regulatory framework for medical devices. To ensure a high level of human health and safety, to meet growing expectations of European citizens while preserving its innovation-friendly approach.

Explanation of standards All examination gloves in this country must comply with EN455 parts 1, 2, 3 & 4

Part 1 – Requirements and Testing for

freedom from holes Testing to determine freedom from holes. A batch sample is filled with water to check for pin holes and leaks. A Medical glove should achieve an acceptable quality level of 1.5. Part 2 – Requirements and Testing for

physical properties Testing for dimensions and physical strength. (variable upon material) Surgical gloves must have a force at

break point of a minimum of 9 Newtons. Nitrile examination gloves must have a

force at break point of 6 Newtons. Vinyl gloves must have a force at break

point of 3.6 Newtons.

Part 3 – Requirements and Testing for Biological Evaluation

Testing for potentially hazardous materials that could affect the wearer or be transferred to a patient. E.g. Endotoxins: toxic materials can cause a fever in humans, Latex proteins: can increase the risk of sensitisation, Chemical residues: accelerators used in manufacture, can cause allergic reactions or dermatitis and Powder: less than 2mg powder per glove is considered to be a powder free glove (residual manufacturing particles.) A latex glove should have a leachable

protein level that is as low as reasonably possible (ALARP).

A protein labelling claim of below 50µg/g is not allowed.

Manufacturers cannot label latex gloves as low protein or low allergenicity.

Part 4 – Determination of shelf life This includes a set of tests to determine how long an exam glove will be fit for use after storage in warehouses or store rooms of end users. The maximum shelf life time for an exam glove is 5 years.

Explanation of Standards EN374 European Standard EN 374 consists of the

3 parts under the general title: “Protective gloves against chemicals and micro-organisms”

• Part 1: Terminology and performance requirements

• Part 2: Determination of resistance to penetration by chemicals

• Part 3: Determination of resistance to permeation by chemicals

Part 1 Terminology and Performance Requirements.

Performance criteria and Mechanical and physical integrity of the products.

Part 2: Determination of resistance to penetration of chemicals

Two tests in this part. The air leak test: involves inflating a glove with air pressure, submerging it in a tank of water. Any leaks are identified by visible bubbles. The water fill test: involves suspending a glove filled with water and examining its outer surface for water droplets. Part 3: Determination of resistance to

permeation by chemicals A glove material placed in contact with a challenge chemical. The rate at which this chemical permeates through the material is determined. The breakthrough time is the time at which this permeation rate exceeds 1µg/cm2/min. Breakthrough time will determine performance level. Gloves must achieve a minimum of level 2 (breakthrough time of greater than 30 minutes) against at least 3 listed chemicals to achieve chemical protection status.

Irritations & Allergic Reactions to exam gloves

Some people may experience an irritant reaction when using products made from NRL, which is known as Irritant Contact Dermatitis. Health and Safety Executive

Irritation A non allergic reaction, usually reversible. Allergic reaction Type IV Caused by chemicals that are used in the manufacturing process of exam gloves, usually accelerators. Allergic reaction Type I Caused from 1gE (immune) mediated reactions to the natural proteins found in natural rubber latex.

Irritation Type IV Allergy A rash can occur on the back of the hands which is characteristically dry and itchy It is important to note that skin irritation could be caused by a wide range of substances. Occupational Health involvement is vital to gain diagnosis

A delayed hypersensitivity reaction usually occurs 6-48 hours post exposure

A red itchy scaly rash, often localised to the area of use, but with repeated exposure may spread to other areas

Accurate diagnosis is essential and avoidance of the specific chemicals in future use

Type I Reaction An immediate allergic reaction to NRL

proteins and potentially life threatening. Deaths have occasionally been reported due

to latex allergy. In many cases symptoms become

progressively more severe on repeated exposure to NRL allergens, so it is important for sensitized individuals to avoid further contact with NRL proteins.

An itchy nettle rash (urticaria, hives),

where the latex touches you Swelling (angioedema) from touch Asthma symptoms Swelling in the throat, causing difficulty

in swallowing or breathing Vomiting Cramping abdominal pains Diarrhoea Faintness and unconsciousness Death due to obstruction to breathing or

extreme low blood pressure (anaphylactic shock). However, it does seem that death from anaphylaxis due to latex allergy is a great rarity.

Asthma and Allergy Information and Research (AAIR)

Diagnosis of problems Visit Occupational Health Department or

GP

There is currently no completely reliable investigation for Type 1 NRL allergy. Diagnostic practice varies across the country. In general, the diagnosis is made on the basis of a Clinical History plus a positive allergen-specific IgE blood test or skin prick / glove challenge test.

Type IV allergy is generally diagnosed by standard patch testing, although the recommendation to use accelerator free gloves is often made without going through this.

Avoid contact with NRL gloves or use appropriate alternative gloves (Nitrile), or products where possible.

Inform employers and healthcare providers of issues.

Avoid areas where inhalation of powder from NRL gloves worn by others or from balloon displays may occur.

Recommend use of Medic-Alert bracelet, stating natural rubber latex allergy.

Precautionary Guidance

Who is at risk? ‘inappropriate glove use (over or under use of gloves) can place staff or patients at risk of contact dermatitis, infection and missed opportunities for hand hygiene. Glove use is widespread throughout health care, and an estimated 1.5 billion pairs of gloves are issued across the NHS in England every year. Creating a culture of appropriate glove use creates opportunities to avoid unnecessary financial costs through unwarranted use and preventable risks to patients.’ Tools of the Trade - RCN guidance for health care staff on the prevention of contact dermatitis 2012

All NHS organisations should develop a comprehensive working policy, or where necessary review their existing policy on the use and purchasing of latex products.

Most organisations now have mostly gone latex free, apart generally from the operating theatres.

How to reduce risk

Risk Assess!!

• Gloves are not required for:

Basic care procedures with no contact with bodily fluids or blood borne pathogens or sharps

Transferring food from food trolleys to patients bedside Making uncontaminated beds or removing uncontaminated clothing Taking patients observations Answering telephones

Benefits of using Synthetic Gloves Most Trusts have now gone latex free in the majority of areas this has therefore:- Reduced the risk of patient/practitioner harm as a result of Latex exposure

Reduced the number of patient/practitioner safety incidents associated with Allergic Reaction to Latex

Helped NHS organisations to comply with COSHH regulations (A duty to eliminate, substitute and limit exposure to Latex where possible)

COSHH Regulations 2002

What does the law say? The Health and Safety at Work Act 1974

places a general duty on your employer to safeguard your Health & Safety at work. It also places a duty on them to ensure that others, such as patients, visitors etc. are not put at risk.

As NRL is a substance hazardous to health (once sensitised) your employer will undertake a risk assessment of its use, eliminating it where appropriate, substituting to other less hazardous substances or limiting exposure where it is deemed absolutely necessary.

You should have a skin care policy

available or a glove policy which should give you the steps to follow in your organisation to allow you to get the help should you need it.

Health & Safety Commission

RCN Tools of the Trade recommendations Appendix 7: Putting in place a skin surveillance programme for contact dermatitis

1. Use the COSHH assessment process to identify whether staff are exposed to substances or work processes that could cause contact dermatitis.

2. Where the risk of contact dermatitis has been identified, and that risk cannot be eliminated, put in place a health surveillance programme.

3. Visual skin inspections are an important part of health surveillance for workers exposed to substances that cause contact dermatitis, and should be included in health surveillance programmes.

4. The type and frequency of the surveillance programme should be determined by a medical practitioner with sufficient expertise in occupational health or an occupational health nurse.

5. The Health & Safety Executive recommend a brief weekly or monthly routine of skin inspections. An annual surveillance questionnaire can also be used to support visual inspections.

6. A responsible person should carry out visual skin checks. A responsible person can be a nominated employee with suitable training e.g. a registered nurse or health care assistant or occupational health support worker.

RCN Tools of the Trade recommendations

7. The role of the responsible person is to: check the skin on the hands and forearms for early signs of dermatitis; keep secure records of these checks locally; advise an employee with symptoms how to seek help; and alert the employer to any problems.

8. The responsible person should have suitable training and competence assessment by an occupational health adviser (nurse or doctor). Training should include: the causes of dermatitis; early signs and symptoms and their recognition; what to do in the event of identifying problems; and the need for discretion in recording personal information about employees.

9. Train employees at risk to recognise symptoms of contact dermatitis and report these. Photographs of damaged skin may be helpful in training staff. This could be undertaken by the occupational health adviser or responsible person in line with local protocols.

10. Results of skin inspections should be reported to occupational health service to collate and identify trends or problem areas.

11. Results of health surveillance need to be retained for a period of 40 years from the last entry.

Hand washing Both proteins and chemicals remain on the hands following glove use so hands must be washed following “Infection Control Nurse Guidelines.” Glove use must be minimised to reduce exposure and only used following a risk assessment of the task. Gloves are not a substitute for hand washing. If using hand gels, wash hands as per manufacturers guidelines. i.e.. After 5 applications Infection Prevention Society 2002

References Cameron J L ‘William Stewart Halsted. Our Surgical Heritage.@ Annuls of surgery 2006:243 (3) :418-425 Bloodgood J C ‘Operations on 459 cases of hernia in the John Hopkins Hospital from June 1889 to January 1899’ John Hopkins Hospital Bulletin 1987; 7:223-563 Infection Prevention Society www.ips.uk.net Glove Usage Guidelines 2002 Royal College of Nurses Tools of the Trade Document 2012 National Institute for Clinical Effectiveness www.nice.nhs.uk The Health & Safety Executive www.hse.gov.uk/latex COSHH Regulations Asthma & Allergy Information & Research (AAIR) www.aaircharity.org Latex Allergy support Group www.lasg.co.uk The Trade Union Congress www.tuc.org.uk NHS Plus. www.nhsplus.nhs.uk The Nursing Times www.nursingtimes.net