SurgiDat Serenity Audit and Recall: A simple solution designed to provide compliance.

AAMI Recommended Practice ANSI/AAMI ST79:2006 & ANSI/AAMI ST79/A1:2008

Section 1

Introduction: Need for the recommended practice


  1. appropriate documentation and reporting practices that enable traceability of each facility-sterilized medical device to the patient on whom it was used.

It might not be possible for a health care facility to implement all the provisions of this recommended practice because of environmental restrictions and/or limitations in capital funding. However, it is recommended that the health care facility's administration be made aware of any current deficiencies so that the allocation of needed resources can be planned.

Steam sterilization in office-based, ambulatory-care medical, surgical and dental facilities:

...The general concepts in this recommended practice apply to these settings. In some sections, processes or equipment used most frequently within the office-based and ambulatory setting are specifically addressed.

Flash sterilization:

...documentation of the flash sterilization process is necessary and should be consistent with the requirements applicable to and the practices used in documenting the routine processing of wrapped loads.

Sections 10-11

10.11 Product Recalls

To ensure patient safety and compliance with the user facility reporting requirements of the Safe Medical Devices Act of 1990, the health care facility should establish recall procedures to expedite the retrieval of processed items that are suspected to be nonsterile and to ensure adequate follow-up actions such as quarantine of the sterilizer, notification of physicians and affected clinical departments, and surveillance of patients.

10.11.3 Recall order

A recall order should

  1. include all items processed back to the last negative Bl;
  2. be immediately communicated to affected departments and followed by a written order;
  3. identify by sterilization lot number the products to be recalled;
  4. identify the persons or departments to whom the order is addressed;
  5. require the recording, in terms of kind and quantity, of the products obtained in the recall; and
  6. specify the action to be taken by the persons receiving the order (e.g., destruction or return of product).

10.11.4 Recall report

A report of a recall order should

  1. identify the circumstances that prompted the recall order;
  2. specify the corrective action(s) taken to prevent a recurrence;
  3. state, in terms of the total number of products intended to be recalled, the percentage of products actually located in the recall; and
  4. provide verification that the recalled items were reprocessed or destroyed, as appropriate.

10.3 Product Identification and traceability

10.3.1 Lot control numbers

Each item or package intended for use as a sterile product should be labeled with a lot control identifier. The lot control identifier should designate the sterilizer identification number or code, the date of sterilization, and the cycle number (cycle run of the sterilizer).

Ideally, every reprocessed medical device, especially an implant, should be fully traceable to the patient on whom it is used or in whom it is implanted

A lot number should be assigned to each flash sterilization load and a load record should be generated for each sterilization cycle. The load record should document

  1. the assigned lot number, including sterilizer identification and cycle number;
  2. the general contents of the load;
  3. the duration and temperature of the exposure phase of the cycle;
  4. the signature or other identification of the operator; and
  5. the date and time of the cycle.

Flash sterilization of implantable devices is not recommended; however, if it is unavoidable, full traceability to the patient should be maintained. Rationale: Lot identification enables personnel to retrieve items in the event of a recall and to trace problems (e.g., wet packs) to their source.

Accountability to the patient and surgeon for the sterility of a reprocessed device requires documentation that can be directly traced to the patient. Traceability of implants is especially important because the consequences of implant-related infections are particularly severe and result in increased morbidity and mortality.

10.3.2 Sterilizer records

For each sterilization cycle, the following information should be recorded and maintained:

  1. the lot number;
  2. the specific contents of the lot or load, including quantity, department, and a specific description of the items (e.g., towel packs, type/name of instrument sets);
  3. the exposure time and temperature, if not provided on the sterilizer recording chart;
  4. the name or initials of the operator;
  5. the results of biological testing, if applicable; the results of Bowie-Dick testing, if applicable;
  6. the response of the Cl placed in the PCD (Bl challenge test pack, Bl challenge test tray, or Cl challenge test pack), if applicable; and
  7. any reports of inconclusive or nonresponsive CIs found later in the load (see also

The time and temperature recording chart, printer, or tape should also be dated and maintained, and each cycle on the chart should be reviewed and signed by the operator.

Electronic records of sterilization process monitoring results, including specific load item identification, are recommended. The length of time that records must be retained varies throughout the country. Each health care facility is responsible for determining its record-retention policy based on state and local regulations, legal considerations (e.g., statutes of limitation for lawsuits), and its individual situation. Sterilization records should be retained according to the policy and procedure established by the individual health care facility.

Documentation ensures that the sterilization process is monitored as it is occurring, ensures that cycle parameters have been met, and establishes accountability. In addition, documentation helps personnel determine whether a recall is necessary, should evidence subsequent to lot release, such as a positive Bl or nonresponsive Cl, suggest sterility problems. Knowing the contents of the lot or load enables personnel to identify the medical devices to be recalled. Digitization of this process will allow quick access to load information, facilitating a quick response. In addition, this documentation provides evidence of the department's quality control program. How long to retain sterilization records depends on many factors.

  1. Monitor Frequency of use Application (release of sterilizer, package, load)
  2. Physical monitors
  3. Time, temperature, and pressure recorders, displays, digital printouts, and gauges
  4. Should be used for every load of every sterilizer. Part of load release criteria.

10.5 Sterilization process monitoring devices

10.5.1 Physical monitors

Physical monitors include time, temperature, and pressure recorders; displays; digital printouts; and gauges. For sterilizers with recording charts, the operator should ensure that at the beginning of the cycle the chart Is marked with the correct date and sterilizer number. For sterilizers with printouts, the printout should be checked to verify that the cycle identification number has been recorded and that the pen or printer is functioning properly. At the end of the cycle and before items are removed from the sterilizer, the operator should examine and interpret the chart or printout to verify that all cycle parameters were met and initial it to permit later identification of the operator (see 10.3.1 and 10.3.2). Sterilizers that do not have recording devices should not be used.


Written procedures should be reviewed, and current practices audited for compliance in the areas included in the CQI program, for example

  1. product identification and traceability, i.e., lot control numbers (see Section 10.3.1) and load records (see Section 10.3.2);
  2. sterilizer physical monitoring records (Section 10.4);
  3. sterilization process indicator records (Section 10.5);

For further information, please refer to the complete document at the AAMI website.