Decontamination legislation, standards,
and guidelines– what are they and what do they cover?
By Dr. Andrew Smith
Most laws encompassing the decontamination of dental devices are enshrined within legal documents applicable to the whole of the European Union. Failure to comply with these laws may result in members of the dental team or manufacturers of dental devices facing criminal or civil proceedings.
Consumer Protection Act: The Consumer Protection Act was incorporated into European legislation as a result of the European Community Directive No. 85/37/374/EEC. Part 1 of the Consumer Protection Act 1987 covers product liability. It enables a claim to be made where harm has arisen as a result of a defect in a product. A legitimate defense is that, in light of the state of scientific and technical knowledge at the time, the product supplied was "state of the art." It is an essential piece of legislation for the consumer since negligence by the supplier or manufacturer does not have to be established, only a defect in the product need be demonstrated.
The Medical Devices Directive: The Medical Devices Directive (MDD) was implanted into U.K. legislation under the Medical Devices Regulations 2002, updating the previous version to include the In Vitro Diagnostics Directive. The Medical Devices Regulations 2002 came into effect on 13 June 2002 and implements the provisions of the Medical Devices Directive 93/42/EEC. The European directives for medical devices were devised to create a single European market by removing trade barriers and allowing the free movement of goods. This can only be accomplished if devices meet minimum safety requirements accepted by each member state. However, the health and safety of citizens is the responsibility of each European Union member state.
The three European directives for medical devices are:
1. Active Implantable Medical Devices Directive: Powered medical devices implanted and left in the body.
2. Medical Devices Directive (relevant to the dental team and dental manufacturers): Devices from bandages to dental chairs.
3. In Vitro Diagnostic Medical Devices Directive: Deals with the safety and effectiveness of diagnostic test kits.
Most dental equipment and devices are classed as medical devices. The MDD also applies to decontamination equipment such as steam sterilizers and washer disinfectors. Toothbrushes, dental sticks, and dental floss are examples of dental products not considered medical devices. The manufacturer assigns and determines the specific medical purpose of the device through the label, the instructions for use, and promotional material related to it.
The level of control applied to these devices is designed to reflect the perceived risk associated with them (see "MDD classes" sidebar, left). Factors influencing this risk depend on whether the product is supplied sterile or is to be used to make measurements (e.g., pocketing depth). The CE mark accompanying each device means that the manufacturer is satisfied that the product complies with the essential requirements of the Medical Device Directive. (Note: When several CE marked devices are assembled together in a procedure pack, the pack itself does not bear the CE mark.) The responsibility for ensuring that a device complies falls directly on the manufacturer.
Dental appliances such as dentures made for a specific patient are defined as custom-made devices and are covered by Annex VIII of the MDD. From an infection control viewpoint, dental laboratories (manufacturers) must be able to demonstrate appropriate cleanliness and cross-infection controls for the dental appliance.
The essential requirements of the MDD summarize the factors to be considered for a device to meet minimum safety requirements. These include, for example, requirements to use a validated process for sterilization of medical devices and to supply information to the user "on the appropriate processes to allow re-use, including cleaning, disinfection, packaging, and where appropriate, the method of sterilization of the device and any restriction on the number of re-uses."
Although the decontamination of dental instruments remains the responsibility of the dental team, advice on compatible methods of decontamination should be sought from the supplier. Manufacturers are required by the Medical Devices Regulations to supply information for use, but it is incumbent on the purchaser to ask for the information prior to purchase.
Liability for injuries
An individual who is injured by a defective medical device essentially has three potential courses of action against the manufacturer. Each member state of the EU will have its own national legislation and established case law regarding the first two courses of action outlined below.
1. An action in contract
3. Product Liability Directive (85/37/374/EEC): The Product Liability Directive was implemented into the U.K. as the Consumer Protection Act 1987. The directive imposes a strict liability upon a manufacturer for a defective product. Four types of defects could affect a medical device:
a. Design defect: The product complies with the specifications, but is still unreasonably dangerous.
b. Manufacturing defect: A mistake in manufacture or in a particular batch of the product results in a failure to meet the manufacturer's own specifications.
c. Failure to warn or give adequate information: Insufficient information supplied by the manufacturer fails to enable the product to be used as intended and to adequately warn the user of potential risks associated with use of the product. (If the information supplied is inadequate, the manufacturer is potentially liable under the Product Liability Directive as well as being in breach of the Medical Devices Directive).
d. Product misuse: This has a very important implication for practitioners because, as producers of sterilized instruments, practitioners may be liable if a defect occurred leading to an adverse event.
Adverse incident reporting
In 1998 the U.K. Medical Devices Agency—now called the Medicines and Healthcare products Regulatory Agency (MHRA)—issued a Safety Action Notice (SAN) requiring users of medical devices to promptly report adverse incidents to the MHRA. An adverse incident may be caused by shortcomings in "…the device itself, instructions for use, servicing and maintenance, locally initiated modifications or adjustments, user practices, including training, management procedures, the environment in which it is used or stored, or incorrect prescription. (SAN 1998)" Similar guidance has been issued in other member states.
Health and safety laws
Health and safety laws are a complex mixture of statutory provisions (many as a result of directives from the European Community) and member countries case law. Many practitioners are familiar with some aspects of Health and Safety law but may not have considered how it affects the decontamination of dental instruments.
In the U.K. the Health and Safety at Work Regulations 1992 spell out in detail many of the requirements that had been in place in the Health and Safety at Work Act of 1974 as well as introduce new requirements. The Health and Safety legislation places a general duty on employers to ensure the work health, safety, and welfare of all their employees and others who might enter the work place such as patients "so far as is reasonably practical." Specifically, employers must ensure that the work place and materials used in the work place are safe and do not pose a health risk.
The laws also require practitioners to provide all the necessary information, instruction, training, and supervision for staff members. The 1992 regulations emphasize sound safety management, require a risk assessment to be carried out, and appropriate measures taken to reduce risk.
Risk assessment: Health and safety risk assessment and management is a statutory duty in the dental workplace. A hazard is defined as something with the potential to cause harm. Risk is defined as the likelihood of potential harm from that hazard being realized. The extent of the risk will depend on the likelihood of the risk occurring, the potential severity of harm from the risk, and the populations that might be affected by the hazard (Management of Health and Safety at Work Regulations 1999).
Some simple approaches to common problems within the dental surgery can go a long way to reducing or avoiding hazards. A good example is to avoid the use of chemicals for disinfecting dental instruments. Chemical disinfection is a poor choice for decontamination and may present a number of hazards (depending on the nature of the chemical) to staff. A review of purchasing procedures to ensure that all reusable dental instruments can be steam sterilized at 1348C for three minutes would be a simple means of risk assessment to manage health and safety within the surgery.
Central to risk management is good recordkeeping, which includes noting the action taken and the outcome of the action. Risk management also is embraced within the concept of clinical governance.
Control of Substances Hazardous to Health regulations 1988 (COSHH): COSHH regulations have been updated since first introduced in 1988 (HSE 1999). The COSHH regulations apply to all substances hazardous to health, including chemicals, drugs, and micro-organisms. Exposure to such substances can occur by inhalation, ingestion, injection, or absorption directly through the skin. It is incumbent on employers to identify substances that may represent a hazard, to assess the degree and nature of the risk, and to take action to minimize the danger to those who handle them.
The COSHH Regulations govern the labeling and storage of antiseptics and disinfectants and provide handling instructions, including the use of gloves, protective clothing, and protective eyewear (supplied free to staff by the employer).
All staff members must be familiar with the hazards of these substances, must know the correct strength of solution for each particular purpose, and understand the actions to be taken in event of accidental spillage or contamination.
It is a legal requirement that individual COSHH assessments be made for each disinfectant or chemical that is used to implement infection control in the practice, and that practice records show what the results of the assessment are, the action taken, and regular reviews. It also is essential that practice employees be given information, instruction, and appropriate training.
In summary, the COSHH Regulations require an employer to control cross-infection risks by demonstrating good working practices, sterilizing instruments, and using personal protective equipment.
Reporting Injuries, Diseases and Dangerous Occurrences Regulations 1985 (RIDDOR)
These U.K. regulations, updated in 1996 (HSE 1996), may affect practitioners in two ways:
1. If an accident occurs such as a needlestick, or if a staff member develops a health problem as a result of work.
2. If an employee suffers from a disease that could be aggravated by certain work procedures such as a staff member who suffers from dermatitis.
Therefore, all accidents must be recorded in an accident book and records kept for a minimum of three years. The information required to accompany an incident includes the date, time, and place of the accident; personal details of the injured party; written description of the accident; and date/method of reporting the incident to competent authorities. As with all accidents, prevention is a key management strategy, and it is essential that all practices have a written protocol for dealing with injuries with the name and address of the local occupational health physician. All notifiable diseases and dangerous occurrences must be reported.
Decontamination legislation, standards, and guidelines can be difficult material to grasp. The documents are well intentioned but are not user-friendly. We hope that we have highlighted the important features of these essential documents here. A key to avoid falling foul of the law lies in the understanding that the rationale behind these documents is to promote good working practice.