# NCPS TIPS -- July/August, 2002

### Contents: 1. Could You Say That Again . . . It's a Little LOUD in Here

> 2\. MedWatch Reports
>
> 3\. PSRS Safety Bulletins Coming Soon
>
> 4\. View Point

5.  Safety Spotlight

6.  Sterilizing Medical Devices

7.  Ordering AEDs

### 1. Could You Say That Again . . . It's a Little LOUD in Here

##### From the VA National Center for Patient Safety

Excessive noise levels associated with magnetic resonance imaging (MR)
procedures have been known to be a problem for many years. A study
published in the *Journal of Magnetic Resonance Imaging* (Volume 13, No.
2, 2001) quantifies noise level exposure for patients and staff in the
vicinity of the MR magnet.

The study shows that noise level varies widely among the different MR
systems and with all but one exception, are directly related to the
strength or Tesla (T) rating of the magnet; the stronger the magnet the
louder the noise level. It is worth recognizing that one manufacturer,
Toshiba, has significantly reduced the noise level of their 1.5 Tesla
magnet by reconfiguring and encasing the gradient coil inside a chamber
within the unit.

The accompanying table depicts the noise level of various sounds
compared to the noise levels produced by MR systems covered in the
*Journal of Magnetic Resonance Imaging* article.

When sound levels or noise is discussed in occupational settings it is
discussed in terms of the duration of the exposure (to the sound) as
well as the decibel level of the sound. The Occupational Safety and
Health Administration (OSHA) has established sound exposure limits that
are expressed as time weighted averages. The OSHA exposure table is
included in this article for your reference. If you have any questions
consult with your Industrial Hygienist or Occupational Safety Manager.

NCPS recommends that hearing protection be considered for patients
undergoing MR procedures, taking into account noise level and duration
of exposure. Noise reduction may be accomplished by the use of earplugs
or earmuffs. Earplugs that have a Noise Reduction Rating (NRR) of 30 are
available. Properly using an earplug with a NRR of 30 would reduce the
noise level of a 118 dBA MR scan to 88 dBA. Consult with your Industrial
Hygienist or Occupational Safety Manager for recommendations on the
earplug or earmuff that should be used with your MR system.

It is also important to recognize that with every change implemented new
challenges might arise. Using hearing protection will have an impact on
how the MR technician interacts with the patient undergoing the
procedure. Think about how communication will take place between these
individuals. Also, consult with the MR technicians regarding the impact
of using hearing protection during a MR scan. Will it introduce
artifacts that could negatively affect the results of the test? With
these considerations in mind the correct hearing protection may be
selected without compromising patient safety and comfort.

Additional information on this topic may be found in:

> *Acoustic Noise and Magnetic Resonance Procedures, written by Mark
> McJury, published in the Magnetic Resonance Procedures: Health Effects
> and Safety, edited by Frank G. Shellock*

*Journal of Magnetic Resonance Imaging, Volume 13, No 2. 2001*

![](media/image1.wmf){width="4.4875in" height="5.624305555555556in"}

######### OSHA Exposure Table

+-----------------------------------------------------+-----------------+
| ### How Long Can You Safely Be                      | ### So          |
|  Exposed to Sound Level in Cumulative Hours Per Day | und Level (dBA) |
+-----------------------------------------------------+-----------------+
| ### 8 hours                                         | ### 90 or less  |
+-----------------------------------------------------+-----------------+
| ### 4 hours                                         | ### 95          |
+-----------------------------------------------------+-----------------+
| ### 2 hours                                         | ### 100         |
+-----------------------------------------------------+-----------------+
| ### 1 hour                                          | ### 105         |
+-----------------------------------------------------+-----------------+
| ### 30 minutes                                      | ### 110         |
+-----------------------------------------------------+-----------------+
| ### 15 minutes                                      | ### 115         |
+-----------------------------------------------------+-----------------+
| ### Never                                           | ##              |
|                                                     | # More than 115 |
+-----------------------------------------------------+-----------------+

###  2. MedWatch Reports

##### From the VA National Center for Patient Safety

The Food and Drug Administration (FDA) operates a safety information and
adverse event reporting program called MedWatch. Supplied by both
mandatory and voluntary reports, MedWatch collects safety information
about prescription drugs, biologics, medical devices, and dietary
supplements. The Safe Medical Devices Act of 1990 requires
manufacturers, risk managers, and other hospital personnel including VA
to report suspected medical device-related deaths and serious injuries
using the mandatory reporting form. The RCA SAC scoring system is
harmonized with MedWatch mandatory report requirements.

Voluntary MedWatch reports are stored and are searchable in MAUDE
(Manufacturer User Facility Device Experience Database). The FDA relies
on voluntary MedWatch reports to maintain safety surveillance of all
their regulated products. NCPS has used MAUDE data to expand upon RCA
studies pertaining to medical devices such as pacemakers. Having a
compendium of events strengthened our case when discussing design issues
with manufacturers.

If you are completing your first MedWatch report, then please take note
of the following details:

• The user facility number for your first mandatory report is
0000000000-2002-0001 (Please note that this number is for use during
calendar year 2002). After receiving your first mandatory report, the
FDA will assign you a specific number, which you should use in future
reports.

• The patient ID number **should not** contain patient initials, social
security number, or personal information like birth date. Make sure,
however, that you can cross reference the patient ID number with your
records of the adverse event.

For more information about MedWatch reporting, please visit
http://www.fda.gov/medwatch/index.html. If you are completing a MedWatch
report and need further assistance, contact the FDA at (301) 594-2735.
They also have a toll-free number, at (800) FDA-1088.

### 3. PSRS Safety Bulletins Coming Soon

##### From the VA National Center for Patient Safety

The Patient Safety Reporting System (PSRS), a NASA/VA collaboration
independently operated by NASA to improve patient safety, has begun to
receive patient safety reports from VA medical facilities at a rate that
will allow the NASA PSRS office to issue de-identified findings. The
NASA PSRS office will soon begin issuing PSRS Patient Safety Bulletins.
PSRS Patient Safety Bulletins will be different from VHA Patient Safety
Alerts. These Bulletins will identify significant vulnerability,
however, they will not identify a specific solution that must be
implemented. Bulletins will also be different in that each one will be
based on reports of adverse events and close calls sent to NASA from
your colleagues. VHA Patient Safety Alerts come from various sources
including manufacturers' recalls in addition to VHA RCAs and other
reports. We recommend that facilities carefully consider, act on as
appropriate, and retain the Bulletins \-- they will contain information
about real hazards and safety issues that are known to affect patients
at VA facilities.

### 4. View Point

##### From the VA National Center for Patient Safety

Once upon a time . . . I used to be able to walk across the hospital
grounds and not think about patient safety. Trees used to offer shade,
now I see branches that are too close to the ground (*there's a
potential hanging point or a place where a patient could climb up and
fall*), and tree roots heaving the pavement (*tripping hazards*).

I didn't think much about the building's doors and windows, now I see
windows that should be locked that are open (*fall hazard*) and doors
that should be unlocked that are locked (*evacuation route blocked*). I
see doors that open to grassy areas behind shrubs and not directly to
sidewalks (*how is a wheelchair going to navigate that and what if it
snows -- who shovels the grass?).*

I used to see patients out at the smoking shelter, now I see the oxygen
cylinders that they brought with them (*fire* !). I'd see the new
construction and marvel at how fast they were progressing, now I see the
construction fence is partially down or I see an open excavation.

The new one I just added to my mental safety list was that exterior
stairway from the basement. It was only six or seven steps up from the
basement level to ground level; it looked a lot like the picture below.
Who would of thought that a patient in a wheelchair would fall down
these steps and die from the fall? After all, it isn't that far and it
even has a handrail! I must have walked by that stairway a few hundred
times without really seeing it. No, I'll never look at things the same
way again. Oh, we'll be putting up a swinging gate at these exterior
stairs, and yes, it will swing in the direction of egress from the
building.

I see now that you don't look at things the same way anymore either.

### 5. SAFETY SPOTLIGHT

######## From the VA National Center for Patient Safety

# (On a regular basis we feature teaching examples pulled from medical literature and similar RCAs that we feel are applicable and of interest to the entire VHA health care system. The following represents information taken from an aggregate of RCAs; it is presented to spark discussion and [does not]{.underline} represent NCPS policy. Depending on the specific circumstances at any given facility, there are various systems-level solutions that will be most appropriate.)

# Wrong ID Band

# Description

Two patients with the same last name and same first initial were
admitted to the hospital emergency room within ten minutes of each
other. The ER was very busy at the time and the patients were mistakenly
given each other's patient identification band by the admissions staff.
Both patients were experiencing chest pains and consulted with a
cardiologist. It was then discovered that they were wearing each other's
ID band, before any type of procedures were performed on them. No harm
was caused to either patient.

Identified Vulnerabilities

The following vulnerabilities and systems weaknesses were identified:

A lack of a formal process verifying patient identification increased
the likelihood that a patient may receive the wrong ID band, which could
lead to receiving the wrong medical treatment.

Same name admissions may lead to patients with the same name being
misidentified and potentially receiving the wrong medical treatment.

# Actions Taken

In response to this case, the following actions were taken:

A program will be developed to include a detailed validation process,
correct ID band placement, who will place the ID bands, and same name
alerts.

A specific color band will be placed on all same last name patients.
These will be placed on the same arm or leg of the ID band. "SAME NAME
PATIENT" will be printed across this colored band. Staff who print ID
bands will be trained on proper usage of the machines and the need for
all patient identification information and barcodes to be clear and
legible.

# *NCPS Comments*

*Patients need to be actively included in the identification process
whenever possible. Consider this as a key element of patient-provider
dialogue (e.g., "This is who I am. Who are you?"). Of note, people with
frequently occurring, easily misunderstood, incorrectly pronounced,
misspelled or sound-alike names are familiar with how easy it is to be
incorrectly identified in daily life.*

*Engage patients overtly in the identification process dialogue. Asking
the patient to state rather than confirm their name helps prevent
miscommunication and wrong patient procedures. Patients who are hard of
hearing or who are distracted by illness or other temporary or permanent
disability may say "yes" to a name that is not theirs, but it is very
unlikely that they will misstate their own name when asked. For example,
"Hi, I'm John Smith, the nurse who will be taking care of you this
afternoon. Even though we met yesterday, I want to be 100% sure I know
who you are, so please tell me your full name while I check your ID band
..."*

*Of course, conversational verification is dependent upon a patient's
cognitive and speaking abilities. Where there are cognitive or speech
issues, staff should take separate process steps to confirm
identification. Also, be aware that some patients are very compliant and
will answer to other names if prompted.*

### 6. STERILIZING MEDICAL DEVICES

##### From the VA National Center for Patient Safety

On June 19, 2002, Advanced Sterilization Products (ASP) issued a letter
reminding its customers that all manufacturer instructions need to be
followed when sterilizing and rinsing medical devices and products. The
letter specifically addresses three ASP brands: CIDEXR OPA Solution,
CIDEX Activated Dialdehyde Solution, and CIDEXPLUSR Solution. A copy of
this letter is available on the NCPS intranet site at
*[vaww.ncps.med.gov/aspltr]{.underline}*.

### 7. ORDERING AEDs

##### From the VA National Center for Patient Safety

VA facilities who order automated external defibrillators for their
public facilities should be aware of the different types of AED models
in the market. Since the majority of the AEDs will be used by a
layperson with little or no CPR training, the devices must be user
friendly, intuitive, and provide clear concise audio and visual
instructions.

Electric shock is only one of the therapies applied in a CPR. A complete
CPR kit should include at a minimum latex free gloves, a resuscitation
bag and mask, electrodes and instructions for use of all the items in
the kit. A qualified Biomedical Engineer should conduct a pre-purchase
evaluation to confirm compatibility with accessories and supplies, and
verification of the AED arrhythmia detection software's accuracy
(specificity and sensitivity).

To view the complete NCPS recommendations for acquisition and
implementation of AEDs in the VA system, visit
*[vaww.ncps.med.gov/aed]{.underline}*.

#######