D.C. Mun. Regs. tit. 22, r. 22-B10499

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10499 - DEFINITIONS

10499.1

As used in this chapter, the following terms and phrases shall have the meanings ascribed:

Ambulatory surgical facility (ASF) -a distinct entity that operates for the primary purpose of furnishing same-day outpatient surgical services to patients. An ASF may be either an independent entity (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as under the common ownership, licensure, or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a Federal, state, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF.

Become aware - an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred in the following situations:

(a) Device user facilities are considered to have "become aware" when medical personnel as defined under the term "medical personnel" who are employed by or otherwise formally affiliated with the facility acquire such information about a reportable event;

(b) Manufacturers are considered to have become aware of an event when:

(1) Any employee becomes aware of a reportable event that is required to be reported within thirty (30) days or that is required; or to be reported within five (5) days under a written request; and

(2) Any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable MDR event or events, from any information, including any trend analysis, necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health; and

(c) Importers are considered to have become aware of an event when any employee becomes aware of a reportable event.

Caused or contributed - a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:

(a) Failure;

(b) Malfunction;

(c) Improper or inadequate design;

(d) Manufacture;

(e) Labeling; or

(f) User error.

Device family - a group of one (1) or more devices manufactured by or for the same manufacturer and having the same:

(a) Basic design and performance characteristics related to device safety and effectiveness;

(b) Intended use and function;

(c) Device classification and product code; and

(d) Devices that differ only in minor ways not related to safety or effectiveness can be considered to be in the same device family. Factors such as brand name and common name of the device and whether the devices were introduced into commercial distribution under 21 U.S.C. § 351(k) or premarket approval application (PMA), may be considered in grouping products into device families.

Device user facility - a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility which is not a "physician's office." School nurse offices and employee health units are not device user facilities.

Distributor - any natural or legal person who, on his or her own behalf, sells chiefly to vendors. The term "distributor" does not include a common carrier, a delivery agent, or sales representative, who does not have legal title to a medical device.

Expected life of a device -means the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through maintenance, repair, and upgrades for an estimated period of time.

Five (5)-day report - a medical device report that must be submitted by a manufacturer within five (5) business days.

Hospital - a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (medical, occupational, speech, physical), surgical, and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, rehabilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (that is, not a part of a provider of services or any other facility) or may be operated by another medical entity (such as under the common ownership, licensure, or control of another entity). A hospital is covered by this regulation regardless of whether it is licensed by the District and regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital.

Importer - any person who imports a device into the District of Columbia and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.

Malfunction - the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.

Manufacturer - any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who:

(a) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;

(b) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;

(c) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or

(d) Is the U.S. agent of a foreign manufacturer.

MDR - medical device report.

MDR reportable event (or reportable event) - an event about which user facilities:

(a) Become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(b) An event about which manufacturers or importers have received or become aware of information that reasonably suggests that one (1) of their marketed devices:

(1) May have caused or contributed to a death or serious injury; or

(2) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause a death or serious injury if the malfunction were to recur.

Medical personnel - an individual who:

(a) Is licensed, registered, or certified by a State, territory, or other governing body to administer health care;

(b) Has received a diploma or a degree in a professional or scientific discipline;

(c) Is an employee responsible for receiving medical complaints or adverse event reports; or

(d) Is a supervisor of such persons.

Nursing home - an independent entity (that is, not a part of a provider of services or any other facility) or one operated by another medical entity (such as under the common ownership, licensure, or control of an entity) that operates for the primary purpose of providing:

(a) Skilled nursing care and related services for persons who require medical or nursing care;

(b) Hospice care to the terminally ill; or

(c) Services for the rehabilitation of the injured, disabled, or sick.

A nursing home is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the nursing home must report that event regardless of the nature or location of the medical service provided by the nursing home.

Outpatient diagnostic facility - a distinct entity that:

(a) Operates for the primary purpose of conducting medical diagnostic tests on patients;

(b) Does not assume ongoing responsibility for patient care; and

(c) Provides its services for use by other medical personnel.

(d) Examples include diagnostic radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and in-vitro testing. An outpatient diagnostic facility may be either independent (that is, not a part of a provider of services or any other facility) or operated by another medical entity (such as under the common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility.

Outpatient treatment facility - a distinct entity that operates for the primary purpose of providing nonsurgical therapeutic (medical, occupational, or physical) care on an outpatient basis or home health care setting.

(a) Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. Examples of services provided by outpatient treatment facilities include:

(1) Cardiac defibrillation;

(2) Chemotherapy;

(3) Radiotherapy;

(4) Pain control;

(5) Dialysis;

(6) Speech or physical therapy; and

(7) Treatment for substance abuse;

(b) An outpatient treatment facility may be either independent (that is, not a part of a provider of services or any other facility) or operated by another medical entity (such as under the common ownership, licensure, or control of an entity). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a Federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient treatment facility must report that event regardless of the nature or location of the medical service provided by the outpatient treatment facility.

Patient of the facility - any individual who is being diagnosed or treated, or receiving medical care at or under the control or authority of the facility. For the purposes of this chapter, the definition encompasses employees of the facility or individuals affiliated with the facility, who in the course of their duties suffer a device-related death or serious injury that has or may have been caused or contributed to by a device used at the facility.

Physician's office - a facility that operates as the office of a physician or other health care professional (such as, dentist, chiropractor, optometrist, nurse practitioner, school nurse offices, school clinics, employee health clinics, or free-standing care units) for the primary purpose of examination, evaluation, and treatment or referral of patients. A physician's office may be independent, a group practice, or part of a Health Maintenance Organization.

Permanent - impairment or damage to a body structure or function, excluding trivial impairment or damage.

Remedial action - any action other than routine maintenance or servicing of a device where such action is necessary to prevent recurrence of a reportable event.

Serious injury - an injury or illness that:

(a) Is life-threatening;

(b) Results in permanent impairment of a body function or permanent damage to body structure; or

(c) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Shelf life - as required on the manufacturer's baseline report, means the maximum time a device will remain functional from the date of manufacture until it is used in patient care. Some devices have an expiration date on their labeling indicating the maximum time they can be stored before losing their ability to perform their intended function.

D.C. Mun. Regs. tit. 22, r. 22-B10499

Final Rulemaking published at 60 DCR 10252 (July 12, 2013); amended by Final Rulemaking published at 65 DCR 3648 (4/6/2018)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.