HIMA Position on Health Care Worker and Patient Safety and Accidental Sharps Injuries

Our Priority: Health Care Worker and Patient Safety

The Health Industry Manufacturers Association (HIMA) is a Washington, D.C.-based trade association and the largest medical technology association in the world. HIMA represents more than 800 manufacturers of medical devices, diagnostic products, and medical information systems. HIMA's members manufacture nearly 90 percent of the $58 billion of health care technology products purchased annually in the United States, and more than 50 percent of the $137 billion purchased annually around the world.

We are in the business of improving health care and patient well being. Health care workers use our products every day to treat patients in the struggle against disease and pain, as well as in a constant effort to advance the public health. Patient care and health care worker safety continue to be one of our industry's top priorities, especially because of the dangers posed today by bloodborne diseases like HIV, hepatitis B and hepatitis C, that can be spread by accidental sharps injury. Our industry continues to develop and produce a broad array of medical devices designed to enhance patient and health care worker safety, including devices with safety-engineered features and conventional products with proven effectiveness.

A Matter of Choice for Quality Care & Safety

Health care worker and patient safety have always been important issues for our industry. As a result, HIMA member companies continue to develop a wide range of products designed to enhance safety. With the growing awareness of the dangers of bloodborne pathogens, this issue has become increasingly important.

As part of their clinical practice, we believe that health care workers should have products with safety-engineered features available for their use to the maximum extent practicable. This is a logical, common sense approach to safeguarding the health of people who give so much of themselves in the care of others. In the past, health care workers have not always had a choice, because of limitations in the availability of safety-engineered devices. Health care workers who want to use products with safety-engineered features have not always found these products widely or readily available; not in all health care institutions or not for all procedures.

HIMA believes that government regulation can play a constructive role in encouraging the wider development and use of an array of products and procedures that are designed to produce improved health care worker and patient safety. In fact, HIMA believes that expanding the array of competing alternatives is the best way to ensure health care workers will have ready access to the products that they find most effective, whenever they need them.

There is a firm awareness of the need for an array of products, both among health care workers themselves and in the minds of the general public. The state efforts such as those by California's Cal/OSHA to institute regulations regarding health hazards for health care workers indicates that industry, government, health care workers and institutions, as well as the public, are moving toward a consensus on the need for some government intervention on this issue.

However, any regulations must be carefully formulated to be effective.

The Foundation for Appropriate Regulations

Here are some of the broad areas of substance that we think any regulations must address:

• A fundamental principle of any regulation in this area must be that it promotes both quality patient care and health care worker safety.
  
  
• We must ensure that regulations are appropriate to the demands of the workplace and feasible in terms of the products that are available.
  
  
• A routine review of the regulations should take place at appropriate intervals (we suggest once every two years) to determine which parts of the new regulations are effective and which should be modified to meet real world factors.
  
  
• Regulations must encourage the industry in its research and development of more advanced technology, facilitate the adoption of new and improved devices, and allow the expedited introduction of new products to the market. In other words, regulations must be open to new options and technological innovations, not tied down by language that would hinder the advancement of improved patient care and health care worker safety.
  
  
• Regulations must be written in a way that specifies appropriate standards of care and safety, neither requiring the use of specific manufacturers' products nor setting specific technological details that products must meet. Health care providers are in the best position to evaluate which products are of highest quality in terms of patient care and worker safety, and those are the ones they will buy.
  
  
• Regulations should not require that health care workers use specific products with safety-engineered features. The option of using a proven conventional product should be available in limited circumstances: if safety-engineered products for a particular purpose are not available; if safety-engineered products are medically contraindicated in a particular case; or if a safety engineered product has not been proven to be effective in reducing or preventing exposure incidents. Any regulations that attempt to limit health care workers' choices of products or procedures strictly would be counterproductive and a possible detriment to quality patient care and health care worker safety.

Some Specific Suggestions

Here are some specific points we believe should be included in any new regulations regarding health care worker safety and bloodborne pathogens:

• Health care workers should always be trained to use “ universal precautions” as products cannot be designed to take the place of good safety practices.
  
  
• With the increasing virulence of bloodborne pathogens and the spread of hepatitis B and hepatitis C, there must be a renewed emphasis on good safety and hygiene practice and on cleaning and decontamination of the work site.
  
  
• Facilities should provide health care workers with educational programs to build awareness of the risks associated with bloodborne pathogens and with information on the best available alternative products and practices to reduce these risks. The more aware health care workers are of the problems and solutions, the more focused they can be on avoiding accidental injury to themselves and to patients.
  
  
• Regulations should introduce a better, more streamlined method for reporting sharps injuries to encourage health care worker and employer compliance. Federal regulations should institute a universal reporting program that gathers statistics and information from all over the nation.
  
  
• When regulations are formulated, they must take into account the technical nature of our industry and of contemporary medical practice. The emphasis on government documents written in “plain language” for easier access by the layman is commendable, but that language is not always adequate to the need for technical accuracy in the health care industry and medical science.
  
  
• Adequate time should be allowed for a phase-in of any new regulations to avoid disruption of patient care, accommodate the alterations in training and procedure that health care institutions may have to make, and minimize any resulting increase in health care costs. Guidance on what will be expected of facilities in terms of compliance and the time frame for compliance should be clear and concise.

HIMA's Vision for the Future

We believe all regulatory agencies with responsibility for the health care workplace and products need to work together to ensure health care worker and patient safety. HIMA stands ready to cooperate with all the stakeholders in this issue to help formulate practical solutions to the problems of health care worker safety and accidental sharps injuries. We envision regulations that emphasize effectiveness in maintaining quality patient care, not rules that impose undue restrictions on the informed choices of health professionals and the innovations of our industry. Regulations must enhance patient care and the health care worker's ability to do his or her job well, while at the same time helping to reduce health hazards in the workplace.

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