The New Implant Tracking Regulations: DEFINING, IMPLEMENTING, DOCUMENTING

The New Implant Tracking Regulations DEFINING, IMPLEMENTING, DOCUMENTING Ronni P. Solomon, JD; Frances A. Koch, RN ew federal requirements for tracking permanently implantable devices went into effect on Aug 29, 1993. The tracking requirements were established by Congress a s part of the S a f e Medical Devices Act (SMDA) of 1990. The US Food and Drug Administration (FDA), the agency responsible for enforcing the tracking requirements, issued detailed regulations that outline the responsibilities of implant manufacturers and distributors and of implanting hospitals.' The regulations pose significant challenges for OR managers, who must ensure that their departments meet the legal and regulatory requirements in a cost-effective and efficient manner. For years, many health care facilities have filled out patient identification cards to help medical implant manufacturers locate implant recipients. What is new, however, is the mandatory aspect of implant tracking. Spurred by testimony about the problems associated with notifying recipients of the Bjork-Shiley heart valve and the Vitek j a w implant, Congress believed that a uniform federal tracking requirement was justified to ensure

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public safety and that the federal scheme would help ensure that patients with defective or problematic devices would be notified of recalls or other problems associated with the devices.* Regardless of the new tracking requirements, no tracking program will ever be foolproof. Some implant recipients, for example, will change their addresses or names and fail to notify device manufacturers. Because patient compliance cannot be guaranteed, device tracking will never be 100% effective. Nevertheless, the new requirements are an attempt to achieve more complete records. The new regulations require hospitals that implant or explant certain devices to submit reports to device manufacturers promptly after the devices are received, implanted, and explanted (ie, removed from the patient). Hospitals are not required to track the implant recipients (ie, they do not need to update the address of a patient after submitting an implant report); however, they must notify manufacturers of recipients' identities and addresses at the time the devices are implanted or explanted.

Ronni P. Solomon, JD, is the vice president of legal affairs and the director of risk management services, ECRI, Plymouth Meeting, Pa. She received her J D f r o m Delaware L a w School, Brandywine.

patient care director, Presbyterian Hospital, Dallas. At the time this article was written, she MUZS associate administrator, OR service, Henry Ford Hospital, Detroit. She earned her BSN degree f r o m Texas Christian University, F t W o r t h , and h e r MSN degree f r o m the University of Arizona, Tucson.

Frances A . Koch, R N , MSN, CNOR, i s the 1142

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Who Must Track Implants

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our groups are subject to FDA’s tracking regulations: manufacturers, distributors, final distributors, and multiple distribu-

tors. Manufacturers. Medical device manufacturers are responsible for ensuring that devices can be traced to patients. Thus, manufacturers are responsible for implementing tracking programs that trace the devices from the manufacturing facility through the chain of distribution to the end users. The FDA believes this approach is necessary to ensure that patients and health care professionals can be notified of devices that pose risks of substantial harm. Tracked device importers are considered manufacturers and thus must comply with the requirements. Although FDA regulations do not provide specific methods for tracking, they do establish certain goals. Each manufacturer must be able to provide, within three working days of a request from the FDA, certain specific information on tracked devices that have been provided to hospitals, home care agencies, durable medical equipment companies, and other facilities. This includes device-specific information. After the device is implanted in or distributed to the patient, a 10-day response period applies. The manufacturer’s system must enable it to supply patient-specific information, physicianspecific information, and, if applicable, end-oflife information about the devices. (See “Required Information.”) In addition to obtaining the specified information, manufacturers must develop audit procedures to ensure the effectiveness of their tracking systems. Implanting facilities are to be contacted to ensure that they are collecting, reporting, and maintaining information in accordance with the regulations. Manufacturers are to notify the FDA if a health care facility has not collected or furnished required information, provided that the manufacturer has taken steps to obtain compliance. The FDA then has the option of taking action against the nonreporting facility.

Distributors. Medical device distributors also are subject to the FDA’s tracking requirements. Distributors must provide device-specific information to the manufacturers promptly upon purchasing or otherwise acquiring any tracked devices. No specific methodology is required. Final, multiple distributors. Health care facilities may fall under the requirements for final distributors or multiple distributors. A facility is a final distributor when it “distributes a tracked device intended for use by a single patient over the useful life of the d e ~ i c e . ” ~ Thus, a hospital that implants a pacemaker, replacement heart valve, or other permanently 1143

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implantable device is a final distributor. A facility is a multiple distributor when it “distributes a life-sustaining o r life-supporting device intended f o r use by more than one patient over the useful life of the device.”j This applies when the life-sustaining or life-supporting device is used outside a hospital, nursing home. ambulatory surgical center, or outpatient treatment or diagnostic facility. Thus, a hospital-based home health care program that provides apnea monitors or ventilators for use in patients’ homes is a multiple distributor.

Devices That Must Be Tracked

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he FDA has developed a list of implants that must be tracked. The list, which is illustrative and may be modified by the FDA, includes permanently implantable devices, FDA-designated devices, and life-sustaining or life-supporting devices used outside device-user facilities.’ Permanently implantable devices include 0 vascular graft prostheses, 0 ventricular bypass (ie, assist) devices, implantable pacemaker pulse generators, cardiovascular permanent pacemaker electrodes, 0 annuloplasty rings, 0 replacement heart valves, 0 automatic implantable c a r d i o v e r t e d defibrillators, tracheal prostheses, implanted cerebellar stimulators, implanted diaphragmatic/phrenic nerve stimulators, implantable infusion pumps, 0 total temporomandibular joint prostheses, glenoid fossa prostheses, mandibular condyle prostheses, and interarticular disk prostheses (ie, interpositional implants). Devices designated by the FDA include silicone inflatable breast prostheses, silicone gel-filled breast prostheses, silicone gel-filled testicular prostheses, silicone gel-filled chin prostheses, silicone gel-filled antireflux prostheses,

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inflatable penile implants, and infusion pumps. Life-sustaining or life-supporting devices used outside device-user facilities include breathing frequency monitors (eg, apnea monitors), including ventilatory efforts monitors, continuous ventilators, and 0 direct-current defibrillators and paddles.

What Hospitals Must Report

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ccording to the regulations, implanting hospitals are required to report to the manufacturers at three times: upon receipt of implants, upon implantation, and upon explantation or other permanent disposal of devices. Specific information requirements must be met at each of these times. Receipt of implant. Upon purchasing o r receiving a tracked implant, the hospital must promptly provide manufacturers with devicespecific information and the name and address of the facility. The specific method for providing information is not included in the regulations; thus, the hospital could fulfill this requirement in a variety of ways (eg, providing copies of the packing slip, completing the manufacturer’s form, completing the hospital’s form). In some cases, hospitals d o not receive implants directly from manufacturers. For example, a surgeon may bring a device directly to the OR, or a device may be obtained from a distributor or another hospital. In these cases, the report should document the person or institution from whom the device was obtained. Operating room managers should assess how implants are entering their facilities and ensure that there are mechanisms for collecting and reporting the required information. Implantation. The implanting facility must provide its name and address, device-specific information, patient-specific information, and physician-specific information to manufacturers promptly after implantation. Some hospitals obtain patient authorization for the release of social security numbers. One way to do this is to insert appropriate language in the admission 1145

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If the manufacturer’s identity is not apparent upon explantation of a device, the hospital must attempt to discover it. consent form or the operative consent form. Ideally, the physician would discuss the tracking requirement and the need for a social security number with the patient during the informed consent discussion. In some cases, it may be efficient to combine the notice of receipt with the notice of implantation. This would make sense, for example, if the hospital used “just in time” inventory. It would be inappropriate, however, to combine the two reports if the implant is received and implanted more than a few days apart because the regulation requires prompt reporting. Explantation. Explanting facilities a r e required to provide manufacturers with devicespecific information, patient-specific information, a n d physician-specific information. Explantation reports are required even if the implant was inserted at a different facility. If the manufacturer’s identity is not readily apparent upon explantation of the device, the hospital must make a good-faith effort to discover it (eg, by questioning the patient or the patient’s family members). After the manufacturer receives notice of explantation from the facility, there is no further obligation for tracking the patient.

Implementing a Tracking Program

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perating room managers, including those in ambulatory centers and physicians’ offices, must ensure that their facilities develop and implement effective implant tracking programs that address the devices on the FDA’s current list. These programs should assign responsibility, identify tasks t o be performed, s e t documentation requirements, and detail the flow of information. The OR managers must decide if information will flow into centralized or decentralized data collection systems. 1146

Multihospital systems may prefer to centralize tracking on a mainframe computer or a local area network (LAN) computer system with individual institutions providing information to one location or entering data directly into the LAN. Hospitals with satellite ambulatory care facilities may implant devices in the main OR and explant them in an ambulatory care facility, and thus, the need for coordinating data exists. Centralized tracking systems provide complete patient information in one file. They may, however, require the development of new computer programs, which can be expensive, and OR managers may feel insecure if they are required to send information to another site f o r data entry. Decentralized tracking programs offer department-specific information that is available within individual departments, but not all of the information for an individual patient is in one location. The implant tracking program should function like the program developed for the userreporting provision of the SMDA.6 Hospital and departmental policies and procedures should indicate who will obtain and record data, how data will be routed, and who will submit data to manufacturers. Many OR c o m p u t e r p r o g r a m s provide implant tracking modules; however, they may not provide data fields for capturing all the information required by the new regulations or requested by manufacturers. Hospitals may need to create standardized data collection forms. A sample form (Fig 1) includes space for all data required by the FDA regulations. The reverse side of the form could include a list of devices that must be tracked along with instructions for completing and routing the form. Forms could be kept in each department that receives, implants, or explants tracked devices (eg, ORs, cardiac catheterization laboratories. ambulatory care facilities). There also should be

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Device Tracking Report Facility name: Facility contact name: City: Country:

Telephone: ( )

StateProvince:

Zippostal code:

Section I: Report type 0 Receipt 0 Implantation/Distribution Department: Name of employee:

0 Returned to inventory 0 Retired from service 0 Explantation 0 Returned to manufacturer Date action performed: Date of report:

Section 2: Device information Manufacturer’s name: ECRI manufacturer’s code: Address: Address: Telephone: ( ) City: Stateprovince: ZipPostal code: Country: Device supplier: Address: Address: Telephone: ( ) City: StateProvince: Zippostal code: Country: Device type: ECRI device code: Model namemumber: Serial number: Lot number: Hospital identifier: 0 Single patient use 0 Multiple patient use Intended use:

Section 3: Patient information Name: Address: Address: City: Country: Telephone:( ) Date of patient death:

Patientwedical record number: Stateprovince:

ZipPostal code:

Patient’s social security number: Patient refused release of social security number:

0 Yes

Section 4: Physician information Name: Address: Address: City: Country: Physician type: Name: Address: Address: City: Physician type:

Telephone: ( ) Stateprovince: 0 Implanting

0 Implanting

0 Explanting

0 Explanting

Zippostal code: 0 Prescribing

0 Prescribing

0 Primary care/Following

0 Primary care/Following

Fig 1. Device tracking report. (Reprinted with permission f r o m ECRI, Plymouth Meeting, Pa) 1147

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procedures and protocols for completing forms so that patient confidentiality is maintained. All OR staff members must be educated about the requirements for implant tracking, and all sources of implants must be identified. Staff members on all shifts must be aware of the importance of documenting information regarding the receipt of implants, implantation and explantation of devices, and the location of the tracking log or other documentation manuals. Some manufacturers have developed device tracking systems and provide information and posters for staff inservice programs. Additionally, implant packaging may include distinctive identification marks (eg, labels) to alert users that tracking information is required for the product. Those ORs that establish decentralized tracking processes will need to establish systems for maintaining all necessary information (Fig 2 ) . Manufacturers and the FDA are entitled to audit device-tracking documentation and may d o so semiannually for the first several years of the program.

Monitoring, Documenting the Progrunz

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egardless of who has hospital-wide responsibility for complying with the device-tracking requirements, the OR manager will play an important role in monitor-

ing the program. The appropriate device-specific, patient-specific, and physician-specific information must be coordinated, stored, and reported. A flowchart of the process may be helpful in planning the program. Additionally, someone in the institution should be designated as a device-tracking liaison between the institution and manufacturers and the FDA. I n a decentralized system, the liaison should be someone on the OR staff. When the OR tracking program is up and running, the OR manager should monitor the program’s success, including whether tracking forms are completed accurately and in a timely manner, 0 patient authorization for the release OF social security numbers is obtained, vendors have requested any additional information, and the hospital has the most current list of devices from the FDA. One critical question is whether the hospital is able to easily access information about a particular device because information must be accessed when requested by the FDA. Some manufacturers have been requesting implant information from hospitals for years: these requests may involve specific protluct, procedure, or patient information not required by the new law. In conjunction with the new l a w , t h e Health Industry M a n u f a c t u r e r s

Prescribingl explanting Phone Following Phone physician Addrw number phJsician Addre\\ nun1hc.r

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Manufacturer Type Model number Serial number Lot number Batch number Date received Date implanted Date explanted Fig 2 . One example of a patient implant registry. 114

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Fig 3

Device Explant Process

f send to

wipe device per infection controllOR

*

send device to

contact clinical engineering

reprocessing

f central reprocessing calls manufacturer for return

Yes

a=* device be

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clinical engineering conducts evaluation complete explant form

central reprocessing cleans device per manyfacturer 's instructions

injury1 illness?

f complete explantform

f send copy of explantform to quality assurance (QA) department

complete Safe Medical Devices Act (SMDA)form

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t send explantform and SMDA form to QA, US Food and Drug Administration, ECRI, and manufacturer

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and form to

complete MedWatch (MW) reportform 1

send explant form and SMDA form to QA, ECRI, and manufacturer

-

send explant form, MW form, and device to manufacturer I

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I * sequester device pending investigation

forms to QA

Fig 3. One hospital's explant process. (Reprinted with permission from Henry Ford Hospital, Detroit) 1150

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Association and the American Hospital Association have developed standardized implant and explant tracking forms that are being used by some manufacturers. These forms are completed by implanting facilities and returned to the manufacturers. Copies of these forms can be retained as the OR implant log if a manual system is used; however, not all manufacturers belong to these organizations, and therefore, the forms are not used universally. The implant tracking regulations require that specific information be provided to manufacturers. The new regulations also may trigger mandatory SMDA user reports. If an explanted device has failed and caused a serious injury, for example, it must be reported as part of the user reporting provisions of SMDA.7 Certain

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explanted devices may need to be examined by pathology department personnel. An explant flowchart (Fig 3) may be useful for processing explanted devices. 0 Notes 1. “Medical devices; device tracking; final rules and request for comments,” Federal Register 58 (Aug 16, 1993) 43442-43455. 2. “Medical devices: Device tracking,” Federal Register 57 (March 27, 1992) 10702. 3. “Medical devices; device tracking; final rules and request for comments,” 43448. 4. Ihid, 43449. 5.h i d , 43449,43455. 6. F A Koch, R P Solomon, S E Nash, “The Safe Medical Devices Act: What nurses should know about user reporting, implant tracking,” AORN Journal55 (February 1992) 537-548. 7. /hid.

Five Members Win Free Congress Registration To determine the most effective and efficient method of informing AORN members about Congress, the AORN Center for Member Services this year sent a “Mardi Gras” card to 2,000 randomly selected members. AORN asked members in this survey sample who wanted a Congress brochure to return the card to Headquarters. All 388 cards that were returned were entered in a drawing for free Congress registration. The five members whose names were drawn follow. Carole Sue Heisserer, RN, CNOR, clinical specialist, St Francis Medical Center, Benton, Mo Shirley A. Wagner, RN, CNOR, staff nurse, St Alexius Medical Center, Bismarck, ND Margaret P. Nolan, RN, CNOR, RN first assistant, Wayne Memorial Hospital, Waymart, Pa Victorina A. Socorro, RN, CNOR, staff nurse, Department of Veterans Affairs

Medical Center, San Mateo, Calif Regina M. Neff, RN, CNOR, staff nurse, Conemaugh Valley Memorial Hospital, Johnstown, Pa Congratulations to all the winners!

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