Patient Safety, FDA Requirements and an Effective Recall Process

April 1, 2001

Patient Safety, FDA Requirements and an Effective Recall Process

By Edwin Ross, BS, MS

half of the last decade (1995-2000), awareness has been heightened concerning
patient safety. Organizations such as Health Care Financing Administration (HCFA)
and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
have added regulatory requirements and accreditation standards to protect

Recently another regulatory body, the FDA (Federal Drug Administration),
announced that it would be conducting research concerning hospital practices
related to the reprocessing of single-use devices (SUDs). The main objective is
to gather data about Class III Medical Devices that pose the highest potential
risk for patients.1

On their Reuse Web Site (,
the FDA states:

  1. One of the goals of the FDA is to protect the health of the public by
    assuring that the practice of reprocessing and reusing single-use devices (SUDs)
    is safe and effective and based on good science.
  2. The FDA has designed an approach that applies existing regulations for
    original equipment manufacturers (OEMs) to third parties and hospitals to
    minimize risks associated with reprocessed SUDs.
  3. The public expects and the law requires all medical devices to be safe,
    effective, and manufactured in accordance with Good Manufacturing Practices
    (GMPs) now referred to as Quality System Regulations (QSRs).
  4. Based upon an assessment of potential risk, the FDA plans to phase-in
    additional oversight to ensure those organizations that manufacturer or
    re-manufacture medical devices, to include SUDs, are in compliance with the
    FDA guidance.

JCAHO announced that the FDA selected them as the organization that will, for
the next six months, collect, aggregate and report the aggregated data about the
current practices of healthcare organizations concerning the reuse of SUDs.2
With that being the current state of affairs, it does not take much effort to
determine what the future may hold for healthcare organizations that not only
reprocess and reuse SUDs, but also process any items that may put a patient at

Healthcare organizations may be required to have a manufacturing process that
will mirror or replicate the requirements of QSRs used by medical device
manufacturers for not only SUDs but also all processed items. This process will
require standardized/validated cleaning and decontamination procedures,
packaging criteria, labeling of items, loading of sterilizers, sterilization
processes (i.e., equipment, sterilant quality, and quantity), controlled
quarantine, transportation, storage sites, documentation of the above, and a
method of recall if the manufacturing system fails.

Results learned from a study conducted in 1997, and subsequently published in
Surgical Services Management in 1998, indicated that the best way to
prevent a recall situation is effective quarantine and biological monitoring.
The study showed that as the frequency of biological monitoring increased, the
following occurred:

  • Patient safety increased through the potential reduction of
    healthcare-acquired infections.
  • Costs were reduced by controlling the risk of liability and minimizing the
    number of items that were to be recalled. Limiting the subsequent
    reprocessing associated with multiple load recalls further reduced cost.
  • Most difficult to objectively determine is the loss of confidence in the
    sterile processing system that is proportionate to the size of the recall
    conducted within the organization.

The conclusion of that study demonstrated that it was clinically and
operationally more effective to monitor every load with a biological indicator,
which requires as little as a one to three-hour quarantine period, than to
monitor daily or weekly.3 This is because the cost of every load
monitoring with a rapid readout biological indicator and short term quarantining
is less expensive than the costs associated with recall, healthcare-acquired
infections and litigation.

However, monitoring is only one component of the complex scientific
sterilization process. Each component of that process should be able to pass
several challenges to its validity both as a stand-alone sub process and as a
component of a larger system. In the future, the FDA may require the use of
legally binding protocols or that the organization has a process that has
demonstrated it is scientifically and operationally sound. While it is
preferable for a healthcare organization to have its sterilization processing
system working according to design, this does not always happen. Of all the
sterile processing subsystems, the final safeguard and last chance to prevent
patient harm is to have an effective recall system.

The FDA has specific guidelines for recalls:

  1. Recall is required if a product may cause serious adverse health
    consequences or death [FDA, Title 21, Part 7, Section 3 (m)(1)].
  2. Recall is required if a product may cause temporary or medically
    reversible adverse health consequences or where the probability of serious
    adverse health consequences is remote [FDA, Title 21, Part 7, Section 3
  3. Recall is required if a product associated with a situation in which use
    of or exposure to a product is not likely to cause adverse health
    consequences [FDA, Title 21, Part 7, Section 3 (m)(3)].

For medical device manufacturers, the reasons for recall are very broad.
Product maybe recalled because of questionable sterility but also because the
product performance may affect the safe and efficacious use of the product.
Because a medical device manufacturer uses a validated process and items are not
released until all the testing indicates that the sterilization process was
effective, a recall due to ineffective sterilization is rare in the medical
device industry. In healthcare organizations, a recall is usually the result of
concern over the sterility of the medical device.

When and how to recall medical devices processed in a healthcare facility is
defined by the recommended practices published by the Association for the
Advancement of Medical Instrumentation (AAMI).4-7

These recommended practices clearly state that a healthcare facility must
have written policies and procedures for the recall of supplies sterilized by
the healthcare facility that are issued or stored. These policies should be in
compliance with the Safe Medical Devices Act of 1900.9 This act
requires that a healthcare facility establish a recall procedure to quickly
retrieve processed medical devices that are suspected to be non-sterile and to
ensure adequate follow-up with physicians and patients. These policies and
procedures must be developed in cooperation with the infection control committee
and risk management.

The recommended practices state that a healthcare organization should recall
all medical devices processed in a sterilizer when there is a positive
biological indicator or any monitoring controls such as the mechanical monitors,
internal or external chemical indicators suggest that the load was not properly
run or was questionable. In the case of a positive biological indicator (BI),
all loads processed in the sterilizer in question should be recalled since the
last negative biological indicator was obtained.4-8 Recall steps are
listed in Table 1.10

In conclusion

Most healthcare organizations do not have the time, money, space or human
resources required to document such high standards as required by QSRs. In fact,
most organizations do not have processes that would minimally meet QSRs.
Therefore an effective recall system is needed. Additionally, it is only because
the FDA, to this point in time, has not regulated hospital sterile processing
systems that healthcare organizations have been allowed to claim that they are
able to manufacture to the same level of patient safety assurance as medical
device manufacturers without proving it. This should be coming to a stop.

Edwin Ross is Chief Executive Officer of Applied Healthcare Research,
Inc., Santa Clarita, Calif. He has extensive operational and consulting
experience, is a lecturer and author and has special interest in patient safety,
infection control, sterile processing, and regulatory requirements.

For references, visit

Solutions to Sterilization Problems

By Phillip Davis

long and continuing problem encountered with steam and/or ethylene oxide
sterilization is the presence of moisture associated with instrument and basin
sets, which is commonly known as "wet packs." There are numerous
factors that can contribute to this problem, such as:

  • Excessive weight in instrument trays or basins
  • Boiler or plumbing changes
  • New or different sterilizers
  • Staff changes and/or new personnel
  • New medical devices
  • Changes in seasons
  • New rigid containers or wrap material

As indicated in the ANSI/AAMI ST46-1993: Good Hospital Practice: Steam
Sterilization and Sterility Assurance, page 13 (1994), a towel or other
absorbent material may be placed in the tray or between nested basins to
facilitate drying. A new highly absorbent, lint-free foam Instrument Tray Liner
and Basin Divider manufactured by General Hospital Supply Corporation in Wilton,
Conn., is now available. This product can be used in a Closed Container System
as well as an open Sterilizing Tray.

In conclusion, there is no easy solution to the continuing "wet
pack" problem that exists during the sterilization process at present;
however, identifying the causes and improving techniques is a step in the right

Gas Plasma Sterilization

There are generally three sterilization processes for use on surgical
equipment: High-temperature steam, ethylene oxide, and low temperature
hydrogen-peroxide gas plasma. For a number of reasons, hydrogen-peroxide gas
plasma sterilization is becoming a preferred sterilization method by many
technicians. For example, hydrogen-peroxide gas plasma sterilization has
significantly less corrosive effect on metal surgical instruments and leaves no
residue that may cause the sterilized surgical instruments to be irritating or
toxic to patients.

In addition, hydrogen-peroxide gas plasma sterilization produces no toxic
by-products and requires no special ventilation or aeration.

A STERRAD® hydrogen-peroxide gas plasma sterilization system
available from Advanced Sterilization Products of Irvine, Calif., for example,
is designed to provide non-toxic, dry, low temperature sterilization in about
one hour without toxic residues. However, the STERRAD system (at left) is not
usable with cellulose-based products like linen or paper normally used in other
sterilization processes.

A tray liner is then needed to cushion articles such as fiber optic
endoscopes, laser handpieces, power drills, and ophthalmic devices as they are
placed in a hydrogen-peroxide gas plasma sterilization system. Preferably, the
trayliner should have low absorbency, yet will allow the passage of plasma
therethrough such that an article can be effectively sterilized in the system.

General Hospital Supply Corporation manufactures a lint free foam Instrument
Tray Liner, available to hospitals and surgicenters. This product is the only
disposable tray liner that is "Sterrad" compatible and will sterilize
lumen devices as well.

Phillip Davis is the president of General Hospital Supply Corporation and
has been in the medical industry since 1972. Mr. Davis has worked for Aesculap,
J. Sklar and V. Mueller in the past. For more information, call 1-800-548-1004.

Table 1:

Positive biological indicator--recall steps to take

Recall all medical devices processed in that sterilizer since the last
negative biological indicator was obtained. To speed up the process, call
the departments first to ensure notification of the recall.

Issue a written recall order that outlines:

  • Why are the medical devices being recalled?
  • Who authorized the recall?
  • Who is responsible for reporting the results of the recall?
  • Amount of product produced, time frame and where was distributed.
  • Which medical devices are to be recalled (include load label
    information-sterilizer number, load number, and processing date)?
  • Which products were not recalled because of usage?
  • To which persons or departments the order is addressed?
  • A method for recording the number and type of products recalled by
  • Who and when to return the recalled medical devices to sterile

Quarantine all recalled medical devices until completion of the
investigation, then reprocess. If not practical, reprocess immediately.
When opening packs, check all internal chemical indicators and record any
that do not reach their end point response.

  • Notify infection control so that follow-up surveillance of patients
    can be conducted, if need be, as determined by the healthcare
    facilities policy.
  • Try to determine the cause of the sterilization process failure.
  • Check other monitoring controls from the cycles before and after the
    load was run such as Bowie-Dick test results, mechanical monitors,
    chemical, and biological indicators.
  • Determine that the correct biological indicator and test pack was
    used for the load.
  • Check all areas of the process for possible errors; sterilizer
    performance, sterilant quality and quantity, packaging and loading
    technique, appropriate cycle parameters for the load, and relative
    humidity in the processing area.
  • If using spore strips that require sterile transfer to a media,
    subculture the biological indicator according to the manufacturer's
    instructions. If using self-contained biological indicators,
    subculture if you suspect that the biological indicator was not
    correctly activated and incubated.

Correct the identified problem. Retest the sterilizer before returning
to routine use:

  • For vacuum-assisted steam sterilizers run a Bowie-Dick type test
    pack in three consecutive empty cycles.
  • For all steam and low temperature sterilizers, run a biological
    indicator test pack in three consecutive empty cycles.
  • Place the sterilizer into routine use if all results indicate the
    sterilizer is functioning properly.

Verbally report results to your supervisor and file a written report.
The information should include:

  • Time and date of questionable sterilization process.
  • Description of sterilizer and load (include load label
    information--sterilizer number, load number, and processing date).
  • The monitoring results of the questionable load (e.g.,
    equipment control--mechanical monitors and pack control--internal
    chemical indicators).

Recall report must include:

  • Why the medical devices were recalled.
  • What the corrective action was to prevent recurrence.
  • Percentage of products actually located in the recall.
  • Verification that recalled items were destroyed or reprocessed.

For a complete list of references click here