REGULATORY REQUIREMENTS

It is necessary that clinical engineers become familiar with mandated standards, voluntary standards, accreditation body requirements, and licensing agency requirements that apply to their particular health-care institution and to the medical equipment for which they are responsible. Typical examples are shown below (20). An in-depth list of Biomedical Stan­dards is available in The Guide to Biomedical Standards (21).

Voluntary Standards Organizations

American Association of Blood Banks (AABB)

American Dental Association (ADA)

American National Standards Institute (ANSI)

American Society of Histocompatibility and Immunogenet — ics (ASHI)

Association for the Advancement of Medical Instrumenta­tion (AAMI)

College of American Pathologists (CAP)

National Fire Protection Association (NFPA)

Underwriters Laboratories (UL)

Governmental Agency Standards

Federal Communications Commission (FCC)

Food and Drug Administration (FDA)

Standards for the Operation of Hospitals

Local and state requirements, such as the Department of Health

American Hospital Association

Joint Commission on Accreditation of Healthcare Organi­zations (JCAHO)

Joint Commission

The Joint Commission on Accreditation of Healthcare Organi­zations (JCAHO) runs voluntary three-year accreditation pro­grams for health-care facilities aimed at improving the qual­ity of patient care. Information gathered about a hospital can be released to the public. Accredited health-care facilities are eligible to receive federal Medicare reimbursement. Many state governments recognize accreditation as a requirement for licensure and Medicaid reimbursement (22).

The environment of care (EC) in which today’s health care is provided is complex. It includes plant facilities, medical equipment, drugs, information, finance, staff, third-party ser­vices, and diverse technologies (23). JCAHO is concerned that this environment be managed so as to provide a hazard-free environment that reduces the risk of human injury.

JCAHO requires management programs to be set up that deal with safety, security, hazardous waste, emergency pre­paredness, life safety, medical equipment, and utility sys­tems. Clinical engineers tend to be most involved with activi­ties that constitute a medical equipment management program, the purpose of which is to promote the safe and ef­fective use of the institution’s medical equipment. The medi­cal equipment management program encompasses equipment acquisition, technical management, and education for both equipment operators and maintainers. As part of this pro­gram, JCAHO requires clinical engineering to submit periodic reports to the institutions safety committee. Performance standards (quantifying factors relevant to program effective­ness) are developed and selected indicators (activities) such as those dealing with timely PM and repair performance are tracked. Changes observed in the indicators are used to spot and correct deficiencies in the clinical engineering program. The aim of this activity is to improve the quality and cost — effectiveness of the clinical engineering services provided (24).

Safe Medical Devices Act

The Safe Medical Devices Act (SMDA) of 1990 and its 1992 amendment requires health-care institutions to report equip­ment incidents resulting in serious injury or death to a pa­tient or employee. An institution’s risk manager determines whether the incident is reportable, using a documented deci­sion-making process. Medical-device-related deaths must be reported within 10 days to the FDA and to the manufacturer. Medical-device-related serious injuries or illnesses must be reported within 10 days to the manufacturer, or if the manu­facturer is unknown, to the FDA. Periodic summary reports are also required. The SMDA also requires that specific medi­cal devices be tracked, and that medical equipment be prop­erly disposed of when it is taken out of service (25,26). SMDA compliance is also a requirement of the JCAHO.

However, as a result of a reform bill, the FDA Moderniza­tion Act of 1997, in a few years all hospitals may no longer be required to submit reports to the FDA when patient deaths or serious injuries involving medical devices occurs. Instead the FDA will rely on a small sample of representative hospi­tals and nursing homes called ‘‘sentinels’’ to collect the data.

Patient Incident Investigation

When a patient incident occurs, incident reports from nurs­ing, physicians, and others are submitted to the risk manage­ment department. A clinical engineering technical evaluation is also prepared and submitted. Risk management staff uses this material to determine what caused the incident (e. g., was the equipment at fault or was operator error indicated). The intent of the investigation is to prevent a recurrence and to determine if the incident must be reported under the SMDA of 1990.

Clinical engineering should be notified about an incident as quickly as possible to allow a thorough technical evalua­tion to be made. Doing so may allow investigation and on-site testing to be done with the equipment setup still intact (mak­ing note of how the unit was used, dial settings, etc.) and with peripheral equipment still in place. Subsequently the instru­ment, accessories, and disposables are taken out of service and sequestered. Further inspection and testing may be re­quired within the clinical engineering laboratories (Fig. 6), or by a third party. Such determination is made by clinical engi­neering working with the risk manager. The manufacturer should only be contacted with the risk manager’s approval. Sometimes during investigation, minor equipment problems are detected, that could not have caused the incident. Prior to repairing these, the risk manager should be consulted to determine the legal ramifications. Determination must also be made as to whether the equipment needs modification to prevent future recurrences. The clinical engineer’ report will be important should a lawsuit ensue. For this reason impre­cise language must be avoided, so as not to jeopardize the institution’s legal position. For legal reasons, the equipment must be stored in a secure location and not put back into ser­vice until the risk manager concurs.

User Error; Equipment Abuse; No Fault Found

It is important that clinical engineering workers track service requests whose resolution indicates no fault found (NFF), equipment abuse, or user error. This information should be submitted to risk management for analysis even if patient in­jury did not result. User errors are typically more common than true equipment malfunctions. JCAHO requires that user errors that have a potential for harm receive the same type of review that hazardous equipment failures receive. Risk management analysis may indicate the need for additional user in-service education to alleviate future problems.

Informal one-on-one training is provided by clinical engi­neering staff to the user when returning such equipment back to service, by demonstrating the proper equipment operating technique. Through this educational activity clinical engi­neering helps improve patient care and reduces the possibil­ity of lawsuits.

Hazard Alerts and Recalls

The clinical engineering department acts as the hospital’s hazard and recall coordinator. Typically the manufacturer no­tifies clinical engineering and risk management about recalls and alerts. At other times the clinical engineering depart­ment, upon review of commercially available listings, notifies appropriate hospital departments including risk manage­ment. Hazard alerts and recalls are available from the FDA, as well as from private publishers such as the Emergency Care Research Institute (ECRI) and Quest.

The clinical engineering department queries the equip­ment inventory list to locate equipment affected, and when

Figure 6. Incident investigation—fiber optic light. Equipment-related incident investiga­tion is conducted by clinical engineering whenever there is the possibility that a medi­cal device may have caused injury to a patient or clinician. This requires investigation at the scene, as well as additional testing within the clinical engineering laboratories. Picture tak­ing (a digital camera is most useful) docu­ments observations. Clinical engineering staff may also anticipate and resolve equipment problems before they result in an incident. Shown here, an examination lamp bracket was found to not meet the lamp OEM specifi­cation, which could result in the lamp being easily dislodged and falling. The bracket manufacturer in coordination with the lamp OEM worked with clinical engineering to re­solve the issue and supplied newly designed brackets.

required removes it from service and sequesters it until reme­dial action is taken. Should equipment retrofiting be required, the manufacturer may choose to provide an upgrade kit with instructions, opt to send a field-service engineer on-site, or require that the equipment be picked up or sent to the fac­tory. Appropriate paperwork must be provided to the institu­tion for inclusion in the instrument’s history folders, and en­tries made into the computerized equipment records. Updated operators’ manuals and additional user in-service training may also be required.

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